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companies DermaFungal Generic Name: miconazole topical (my CON a zole) Brand Name: Azolen, Baza Antifungal, Critic-Aid Clear AF, Cruex Prescription Strength, DermaFungal, Dermagran AF, Desenex Foot, Desenex Jock Itch, Fungoid, Lotrimin AF, Micaderm, Micatin, Micro-Guard, Mitrazol, NuZole, Ony-Clear, Remedy, Secura Antifungal, Soothe & Cool Inzo, Tetterine, Triple Paste AF, Zeasorb-AF Drying Gel Overview Side Effects Dosage Interactions Pregnancy More Breastfeeding Warnings User Reviews Support Group Q & A Pricing & Coupons What is DermaFungal (miconazole topical)? Miconazole topical is an antifungal medication. Miconazole topical prevents fungus from growing on your skin. Miconazole topical (for the skin) is used to treat skin infections such as athlete's foot, jock itch, ringworm, tinea versicolor (a fungus that discolors the skin), and yeast infections of the skin. Miconazole topical may also be used for purposes not listed in this medication guide. Slideshow Cancer Prevention: Live Longer With These Simple Steps What is the most important information I should know about DermaFungal (miconazole topical)? Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use. What should I discuss with my healthcare provider before using DermaFungal (miconazole topical)? You should not use this medicine if you are allergic to miconazole. Ask a doctor or pharmacist if it is safe for you to use this medicine if you have other medical conditions, especially: if you are using a blood thinner such as warfarin, Coumadin, Jantoven. It is not known whether miconazole topical will harm an unborn baby. Do not use this medicine without a doctor's advice if you are pregnant. It is not known whether miconazole topical passes into breast milk or if it could harm a nursing baby. Do not use this medicine without a doctor's advice if you are breast-feeding a baby. How should I use DermaFungal (miconazole topical)? Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Do not take by mouth. Miconazole topical is for use only on the skin. Do not use this medicine on open wounds. Miconazole topical is not for use in the vagina or rectum. Wash your hands before and after using this medication, unless you are treating a skin condition on your hands. Clean and dry the affected area. Apply the cream, lotion, spray, or powder once or twice daily as directed for 2 to 4 weeks. Do not cover the treated skin area unless your doctor tells you to. A light cotton-gauze dressing may be used to protect clothing. Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antifungal medicine. Call your doctor if the infection does not clear up in 2 weeks (or 4 weeks for athlete's foot), or if it appears to get worse. Store at room temperature away from moisture and heat. Keep the tube tightly closed when not in use. What happens if I miss a dose? Apply the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. What should I avoid while using DermaFungal (miconazole topical)? Avoid getting this medication in your eyes, nose, or mouth. Avoid wearing tight-fitting, synthetic clothing that doesn't allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed. DermaFungal (miconazole topical) side effects Get emergency medical help if you have signs of an allergic reaction : hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using miconazole topical and call your doctor at once if you have: severe blistering, redness, or irritation of treated skin. Common side effects may include: itching, peeling, or dry skin. Although the risk of serious side effects is low when miconazole topical is applied to the skin, side effects can occur if the medicine is absorbed into your bloodstream, including: dry mouth, sore tongue, tooth pain, red or swollen gums; altered sense of taste; nausea, diarrhea; or headache. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Side Effects (complete list) What other drugs will affect DermaFungal (miconazole topical)? It is not likely that other drugs you take orally or inject will have an effect on topically applied miconazole. But many drugs can interact with each other. Tell each of your health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products. Next Side Effects Print this page Add to My Med List More about DermaFungal (miconazole topical) Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Interactions Support Group Pricing & Coupons En Español 0 Reviews Add your own review/rating Drug class: topical antifungals Consumer resources DermaFungal Other brands: Monistat 7 , Aloe Vesta , Zeasorb-AF , Mitrazol , ... +31 more Professional resources Miconazole Nitrate (AHFS Monograph) Miconazole (FDA) Related treatment guides Cutaneous Candidiasis Tinea Corporis Tinea Cruris Tinea Pedis Tinea Versicolor Where can I get more information? Your pharmacist can provide more information about miconazole topical. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed. Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist. Copyright 1996-2012 Cerner Multum, Inc. Version: 4.02. Date modified: December 03, 2017 Last reviewed: September 13, 2016 Drug Status Rx OTC Availability Rx and/or OTC N Pregnancy Category Not classified N/A CSA Schedule Not a controlled drug Drug Class Topical antifungals Related Drugs Cutaneous Candidiasis nystatin topical , clotrimazole topical , ketoconazole topical , terbinafine , Lamisil , ciclopirox topical , More... Tinea Cruris clotrimazole topical , ketoconazole topical , Lotrisone , terbinafine topical , Lamisil , More... Tinea Versicolor clotrimazole topical , ketoconazole topical , terbinafine topical , ciclopirox topical , miconazole topical , econazole topical , More... Tinea Pedis clotrimazole topical , ketoconazole topical , Lotrisone , terbinafine topical , Lamisil , More... 1 more conditions... DermaFungal Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! Help and Support Looking for answers? 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well-deserved Demser Generic Name: metyrosine Dosage Form: capsule Overview Side Effects Dosage Professional Interactions More User Reviews Drug Images Support Group Q & A Pricing & Coupons Rx only Demser Description Demser 1 (Metyrosine) is ( )-α-methyl-L-tyrosine or (α-MPT). It has the following structural formula: Metyrosine is a white, crystalline compound of molecular weight 195. It is very slightly soluble in water, acetone, and methanol, and insoluble in chloroform and benzene. It is soluble in acidic aqueous solutions. It is also soluble in alkaline aqueous solutions, but is subject to oxidative degradation under these conditions. Demser is supplied as capsules, for oral administration. Each capsule contains 250 mg metyrosine. Inactive ingredients are colloidal silicon dioxide, gelatin, hydroxypropyl cellulose, magnesium stearate, titanium dioxide, and FD&C Blue 2. 1 Registered trademark of Valeant Pharmaceuticals International Inc. or its affiliates Valeant Pharmaceuticals North America LLC All rights reserved Slideshow FDA-Approved Weight Loss Drugs: Can They Help You? Demser - Clinical Pharmacology Demser inhibits tyrosine hydroxylase, which catalyzes the first transformation in catecholamine biosynthesis, i.e., the conversion of tyrosine to dihydroxyphenylalanine (DOPA). Because the first step is also the rate-limiting step, blockade of tyrosine hydroxylase activity results in decreased endogenous levels of catecholamines, usually measured as decreased urinary excretion of catecholamines and their metabolites. In patients with pheochromocytoma, who produce excessive amounts of norepinephrine and epinephrine, administration of one to four grams of Demser per day has reduced catecholamine biosynthesis from about 35 to 80 percent as measured by the total excretion of catecholamines and their metabolites (metanephrine and vanillylmandelic acid). The maximum biochemical effect usually occurs within two to three days, and the urinary concentration of catecholamines and their metabolites usually returns to pretreatment levels within three to four days after Demser is discontinued. In some patients the total excretion of catecholamines and catecholamine metabolites may be lowered to normal or near normal levels (less than 10 mg/24 hours). In most patients the duration of treatment has been two to eight weeks, but several patients have received Demser for periods of one to 10 years. Most patients with pheochromocytoma treated with Demser experience decreased frequency and severity of hypertensive attacks with their associated headache, nausea, sweating, and tachycardia. In patients who respond, blood pressure decreases progressively during the first two days of therapy with Demser; after withdrawal, blood pressure usually increases gradually to pretreatment values within two to three days. Metyrosine is well absorbed from the gastrointestinal tract. From 53 to 88 percent (mean 69 percent) was recovered in the urine as unchanged drug following maintenance oral doses of 600 to 4000 mg/24 hours in patients with pheochromocytoma or essential hypertension. Less than 1% of the dose was recovered as catechol metabolites. These metabolites are probably not present in sufficient amounts to contribute to the biochemical effects of metyrosine. The quantities excreted, however, are sufficient to interfere with accurate determination of urinary catecholamines determined by routine techniques. Plasma half-life of metyrosine determined over an 8-hour period after single oral doses was 3-3.7 hours in three patients. For further information, refer to: Sjoerdsma, A.; Engelman, K.; Waldman, T.A.; Cooperman, L.H.; Hammond, W.G.: Pheochromocytoma: Current concepts of diagnosis and treatment, Ann. Intern. Med. 65: 1302-1326, Dec. 1966. Indications and Usage for Demser Demser is indicated in the treatment of patients with pheochromocytoma for: 1. Preoperative preparation of patients for surgery 2. Management of patients when surgery is contraindicated 3. Chronic treatment of patients with malignant pheochromocytoma. Demser is not recommended for the control of essential hypertension. Contraindications Demser is contraindicated in persons known to be hypersensitive to this compound. Warnings Maintain Fluid Volume During and After Surgery When Demser is used preoperatively, alone or especially in combination with alpha-adrenergic blocking drugs, adequate intravascular volume must be maintained intraoperatively (especially after tumor removal) and postoperatively to avoid hypotension and decreased perfusion of vital organs resulting from vasodilatation and expanded volume capacity. Following tumor removal, large volumes of plasma may be needed to maintain blood pressure and central venous pressure within the normal range. In addition, life-threatening arrhythmias may occur during anesthesia and surgery, and may require treatment with a beta-blocker or lidocaine. During surgery, patients should have continuous monitoring of blood pressure and electrocardiogram. Intraoperative Effects While the preoperative use of Demser in patients with pheochromocytoma is thought to decrease intraoperative problems with blood pressure control, Demser does not eliminate the danger of hypertensive crises or arrhythmias during manipulation of the tumor, and the alpha-adrenergic blocking drug, phentolamine, may be needed. Interaction with Alcohol Demser may add to the sedative effects of alcohol and other CNS depressants, e.g., hypnotics, sedatives, and tranquilizers. (See PRECAUTIONS, Information for Patients and Drug Interactions ) Precautions General Metyrosine Crystalluria Crystalluria and urolithiasis have been found in dogs treated with Demser (Metyrosine) at doses similar to those used in humans, and crystalluria has also been observed in a few patients. To minimize the risk of crystalluria, patients should be urged to maintain water intake sufficient to achieve a daily urine volume of 2000 mL or more, particularly when doses greater than 2 g per day are given. Routine examination of the urine should be carried out. Metyrosine will crystallize as needles or rods. If metyrosine crystalluria occurs, fluid intake should be increased further. If crystalluria persists, the dosage should be reduced or the drug discontinued. Relatively Little Data Regarding Long-term Use The total human experience with the drug is quite limited and few patients have been studied long-term. Chronic animal studies have not been carried out. Therefore, suitable laboratory tests should be carried out periodically in patients requiring prolonged use of Demser and caution should be observed in patients with impaired hepatic or renal function. Information for Patients When receiving Demser, patients should be warned about engaging in activities requiring mental alertness and motor coordination, such as driving a motor vehicle or operating machinery. Demser may have additive sedative effects with alcohol and other CNS depressants, e.g., hypnotics, sedatives, and tranquilizers. Patients should be advised to maintain a liberal fluid intake. (See PRECAUTIONS, General ) Drug Interactions Caution should be observed in administering Demser to patients receiving phenothiazines or haloperidol because the extrapyramidal effects of these drugs can be expected to be potentiated by inhibition of catecholamine synthesis. Concurrent use of Demser with alcohol or other CNS depressants can increase their sedative effects. (See WARNINGS and PRECAUTIONS, Information for Patients .) Laboratory Test Interference Spurious increases in urinary catecholamines may be observed in patients receiving Demser due to the presence of metabolites of the drug. Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term carcinogenic studies in animals and studies on mutagenesis and impairment of fertility have not been performed with metyrosine. Pregnancy Pregnancy Category C Animal reproduction studies have not been conducted with Demser. It is also not known whether Demser can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Demser should be given to a pregnant woman only if clearly needed. Nursing Mothers It is not known whether Demser is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Demser is administered to a nursing woman. Pediatric Use Safety and effectiveness in pediatric patients below the age of 12 years have not been established. Geriatric Use Clinical studies of Demser did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Adverse Reactions Central Nervous System Sedation: The most common adverse reaction to Demser is moderate to severe sedation, which has been observed in almost all patients. It occurs at both low and high dosages. Sedative effects begin within the first 24 hours of therapy, are maximal after two to three days, and tend to wane during the next few days. Sedation usually is not obvious after one week unless the dosage is increased, but at dosages greater than 2000 mg/day some degree of sedation or fatigue may persist. In most patients who experience sedation, temporary changes in sleep pattern occur following withdrawal of the drug. Changes consist of insomnia that may last for two or three days and feelings of increased alertness and ambition. Even patients who do not experience sedation while on Demser may report symptoms of psychic stimulation when the drug is discontinued. Extrapyramidal Signs: Extrapyramidal signs such as drooling, speech difficulty, and tremor have been reported in approximately 10 percent of patients. These occasionally have been accompanied by trismus and frank parkinsonism. Anxiety and Psychic Disturbances: Anxiety and psychic disturbances such as depression, hallucinations, disorientation, and confusion may occur. These effects seem to be dose-dependent and may disappear with reduction of dosage. Diarrhea Diarrhea occurs in about 10 percent of patients and may be severe. Anti-diarrheal agents may be required if continuation of Demser is necessary. Miscellaneous Infrequently, slight swelling of the breast, galactorrhea, nasal stuffiness, decreased salivation, dry mouth, headache, nausea, vomiting, abdominal pain, and impotence or failure of ejaculation may occur. Crystalluria (see PRECAUTIONS ) and transient dysuria and hematuria have been observed in a few patients. Hematologic disorders (including eosinophilia, anemia, thrombocytopenia, and thrombocytosis), increased SGOT levels, peripheral edema, and hypersensitivity reactions such as urticaria and pharyngeal edema have been reported rarely. To report SUSPECTED ADVERSE REACTIONS, contact Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Overdosage Signs of metyrosine overdosage include those central nervous system effects observed in some patients even at low dosages. At doses exceeding 2000 mg/day, some degree of sedation or feeling of fatigue may persist. Doses of 2000-4000 mg/day can result in anxiety or agitated depression, neuromuscular effects (including fine tremor of the hands, gross tremor of the trunk, tightening of the jaw with trismus), diarrhea, and decreased salivation with dry mouth. Reduction of drug dose or cessation of treatment results in the disappearance of these symptoms. The acute toxicity of metyrosine was 442 mg/kg and 752 mg/kg in the female mouse and rat respectively. Demser Dosage and Administration The recommended initial dosage of Demser for adults and children 12 years of age and older is 250 mg orally four times daily. This may be increased by 250 mg to 500 mg every day to a maximum of 4.0 g/day in divided doses. When used for preoperative preparation, the optimally effective dosage of Demser should be given for at least five to seven days. Optimally effective dosages of Demser usually are between 2.0 and 3.0 g/day, and the dose should be titrated by monitoring clinical symptoms and catecholamine excretion. In patients who are hypertensive, dosage should be titrated to achieve normalization of blood pressure and control of clinical symptoms. In patients who are usually normotensive, dosage should be titrated to the amount that will reduce urinary metanephrines and/or vanillylmandelic acid by 50 percent or more. If patients are not adequately controlled by the use of Demser, an alpha-adrenergic blocking agent (phenoxybenzamine) should be added. Use of Demser in children under 12 years of age has been limited and a dosage schedule for this age group cannot be given. How is Demser Supplied Capsules Demser, 250 mg, are opaque, two-toned blue capsules coded Aton 305 on one side and Demser on the other. They are supplied as follows: NDC 25010-305-15 bottles of 100 Manufactured for: Aton Pharma, Inc., a division of Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA Manufactured by: Pharmaceutics International, Inc. 10819 Gilroy Road Hunt Valley, MD 21031 USA 9643-C68 Rev. 11/2015 9493900 PRINCIPAL DISPLAY PANEL - 250 mg Capsule Label Demser 250 mg (Metyrosine) NDC 25010-305-15 Distributed by: ATON PHARMA, INC. LAWRENCEVILLE, NJ 08648, USA Rx only USUAL ADULT DOSAGE: See accompanying circular. This is a bulk package and not intended for dispensing. Package not child resistant. Dispense in a well-closed container. 100 Capsules Demser metyrosine capsule Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:25010-305 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength metyrosine (metyrosine) metyrosine 250 mg Inactive Ingredients Ingredient Name Strength silicon dioxide FD&C Blue No. 2 gelatin HYDROXYPROPYL CELLULOSE (TYPE H) magnesium stearate titanium dioxide Product Characteristics Color BLUE (two-toned blue) Score no score Shape CAPSULE Size 22mm Flavor Imprint Code Aton;305;Demser Contains Packaging # Item Code Package Description 1 NDC:25010-305-15 100 CAPSULE in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA017871 10/03/1979 Labeler - Aton Pharma, Inc. (795419675) Registrant - Valeant Pharmaceuticals North America LLC (042230623) Establishment Name Address ID/FEI Operations Pharmaceutics International, Inc. 878265586 MANUFACTURE(25010-305) Establishment Name Address ID/FEI Operations Draxis Pharma, Inc. (Produits Pharmaceutiques Specialises Draxis Inc.) 243604761 PACK(25010-305) Revised: 11/2015 Aton Pharma, Inc. Next Interactions Print this page Add to My Med List More about Demser (metyrosine) Side Effects Dosage Information Drug Images Drug Interactions Support Group Pricing & Coupons En Español 0 Reviews Add your own review/rating Drug class: miscellaneous cardiovascular agents Consumer resources Demser Demser (Advanced Reading) Related treatment guides Pheochromocytoma} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug 10 + years Approval History FDA approved 1979 Manufacturer Valeant Pharmaceuticals International, Inc. Drug Class Miscellaneous cardiovascular agents Related Drugs miscellaneous cardiovascular agents cilostazol , midodrine , Pletal , Corlanor , ivabradine , ProAmatine Pheochromocytoma propranolol , labetalol , Inderal , Normodyne , Trandate , phentolamine , phenoxybenzamine , metyrosine , Regitine , Dibenzyline , More... Demser Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! Demser Images Demser 250 MG (DEMSER MSD 690) View larger images} } most excellent


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captivating According to the Centers for Disease Control, infertility is fairly common . Around 12 percent of women under the age of 45 find they can t get pregnant after a year of trying. The majority of these women will go on to have children, either naturally or with the help of a variety of technologies available to treat infertility. Finding you re unable to get pregnant can take a toll on your body, mind, and spirit. If you can t get pregnant, it s important to take an educated, systematic approach to figuring out the problem and working to correct it. What Causes Infertility? In about one-third of infertility cases, the issue is with the woman, and in another one-third of cases, the issue is with the man. The remaining one-third of cases are caused by issues with both the man and the woman, or no cause can be found. Causes of male infertility include: Abnormal sperm production or function. Sexual problems like premature ejaculation, some genetic diseases, or a blockage in the testicle Exposure to environmental toxins like pesticides or other chemicals Cigarette smoking, drug and alcohol abuse, and some medications Cancer-related damage, including from radiation or chemotherapy Causes of female infertility include: Ovulation disorders like polycystic ovary syndrome Excessive exercise or an eating disorder Abnormalities with the cervix or uterus, including uterine fibroids or problems with the opening of the cervix Blockages or damage in the fallopian tubes due to problems such as pelvic inflammatory disease Endometriosis, a disorder that causes the tissue that lines the uterus to grow outside the uterus, causing problems with the ovaries, fallopian tubes, and the tissue around the uterus and ovaries Cancer, particularly those related to female reproduction, and the radiation or chemotherapy used to treat it Poorly controlled medical problems like celiac disease, diabetes, or autoimmune diseases like lupus Risk factors for male and female infertility include: Age: Female fertility begins to decline with age , starting around the mid-thirties and rapidly decreasing after age 37 due to fewer eggs or lower quality eggs. Men over the age of 40 are typically less fertile than younger men. Smoking: Cigarette and marijuana smoking by men and women reduces fertility, and smoking also reduces the effectiveness of fertility treatments. Alcohol use: Alcohol use may contribute to infertility in both men and women. Heavy alcohol use among men can reduce sperm count and affect the mobility of sperm. Overweight or underweight: Both obesity and being underweight increase the risk of infertility. Eating disorders, restrictive diets, excessive exercise, and a lack of exercise may also cause problems when you re trying to conceive. What You Can Do If You Can t Get Pregnant If you can t get pregnant, your first instinct may be to make a doctor s appointment to try to pinpoint the problem. But while your doctor will probably be happy to offer tips to help increase your chances of conceiving, she probably won t order any tests this early in the game unless you or your partner have a known problem with sexual function. At what point should you see your doctor for a serious look at infertility? The U.S. Office of Women s Health recommends making an appointment with your doctor to discuss infertility if: You re under 35 and haven t conceived after a year of frequent sex without birth control. You re over 35 and haven t conceived after six months of frequent sex without birth control. You or your partner has an issue with sexual function, such as premature ejaculation or abnormal periods. Additionally, you should talk to your doctor if you have: Irregular periods or no periods. Painful periods. Pelvic inflammatory disease, or PID. A history of miscarriage. Meanwhile, there are a number of things you can do to improve your odds of getting pregnant. Understand Conception The better you understand your anatomy and the mechanics of conception, the better you can make choices that will increase your chances of getting pregnant. Every month, a group of eggs in your ovaries begins to grow inside a small sacs called a follicle. Around two weeks before your next period, one of the eggs emerges from the follicle. This is known as ovulation. The egg develops into what s called the corpus luteum, which releases a hormone that causes the lining of your uterus to thicken. The egg moves into the fallopian tube, where it stays for 24 hours waiting to be fertilized by a sperm. If the egg isn t fertilized, it moves through the uterus and disintegrates. Shortly after, your hormones go back to normal, and the thick lining of the uterus is shed, resulting in your period. If the egg is fertilized, it will stay in the fallopian tube for three or four days. Within 24 hours of fertilization, it begins dividing into numerous cells. As it moves through the fallopian tube to the uterus, it continues dividing, and once it reaches the uterus, it attaches to the thickened lining. This is known as implantation. As soon as the dividing egg is implanted in the uterus, a hormone called hCG is released. This is the hormone that s detected by a pregnancy test. Levels of hCG are high enough to be detected between three and four weeks after the first day of your last period. Understand Your Menstrual Cycle Knowing the length of your menstrual cycle helps you determine your fertile zone. Since sperm can live for five days waiting around for an egg, which has a lifespan of just 24 hours, the fertile zone is comprised of the six days that lead up to and include ovulation. The most fertile days are the three days leading up to and including ovulation. Ovulation occurs around 14 days before the day your period starts. If your average menstrual cycle is 28 days, you ll ovulate around day 14, and your fertile zone will be days nine through 14. Your most fertile days are days 12, 13, and 14. If your cycle is irregular, figure out the length of your average cycle, with the first day of your period counting as day one and the day before your period counting as the last day. Subtract 14 to determine when you ovulate, and subtract six from that number to identify the day your fertile zone begins. Once you know your fertile zone, you ll know when to clear your calendar and plan some romantic candlelight dinners. Get Medical Conditions Under Control If you have a medical condition, visit your doctor to get it under control with treatment. Untreated sexually transmitted diseases, high blood pressure , eating disorders, and chronic diseases like diabetes can impede your ability to get pregnant as well as put your pregnancy and the health of your baby at risk. Make Essential Lifestyle Changes The lifestyle choices you make have a major impact on your ability to get pregnant. The Centers for Disease Control stresses the importance of preconception health for not only improving your chances of conception but also for helping to ensure a safe pregnancy and healthy baby. Make these important lifestyle changes to boost your odds of conception: Quit smoking . A British Medical Association report found that smokers may have up to a 40 percent lower monthly fertility rate than non-smokers. Your partner s smoking may also affect your ability to conceive. Stop drinking and using drugs. Drugs and alcohol reduce your chances of getting pregnant, and they can lead to problems during pregnancy as well as cause birth defects. Lose or gain weight. Hormonal shifts that come with extra weight can influence ovulation and semen production. Conversely, being underweight can lead to irregular periods or cause your period to stop. Studies show that losing just five percent of your body weight can improve your chances of getting pregnant. Eat healthy food. Limit or avoid processed foods, added sugar, and saturated fat. Indulge every now and then, but for the most part, eat healthy, whole foods every day, including plenty of fruits and vegetables, beans, whole grains, lean proteins, and low-fat dairy. Limit caffeine. Studies show that even small amounts of caffeine may reduce your chances of getting pregnant. One study found that women who consumed more than 100 milligrams of caffeine per day were half as likely to conceive as those who consumed less. Get plenty of quality sleep. Inadequate sleep affects the functioning of your body s systems, including your immune and reproductive systems. The hormone leptin, which has a crucial role in conception, is reduced when you re deprived of sleep, and a lack of sleep increases your stress level, which can also reduce your ability to get pregnant. Strive for at least seven hours of sleep each night for optimum health and systemic functioning. Reduce Your Stress A study published in the journal Fertility and Sterility found that stress significantly reduces the probability of conception each day during the fertile window. Keeping your overall stress levels down and reducing acute stress on the spot with breathing exercises or visualization may increase your chances of conception. Excellent ways to reduce stress include: Meditation, which also helps your body better respond to stress. Exercise, which also improves your mood and increases feelings of wellbeing. Deep breathing, which reduces levels of the stress hormone cortisol on the spot. A healthy diet, which helps produce more serotonin, a brain chemical associated with relaxation. Adequate sleep, which helps you cope effectively with stress. A hobby you enjoy, which puts you in a relaxed, meditative state. Track Your Attempts at Conceiving In the event you re unable to conceive within a reasonable time frame, your doctor will want to know all about your diet and lifestyle, when you started trying to conceive, how often you have intercourse during your fertile window, and what medications, vitamins, herbs, and other supplements you ve been taking, including the doses and how often you take them. Keeping track of all this information as you go will help you answer questions with a high level of accuracy, which can help rule out possible causes more quickly and with fewer expensive tests. Get support Difficulty getting pregnant can lead to chronic stress, anxiety, and depression. It can leave you with feelings of isolation, frustration, anger, and even guilt. It can take a toll on your relationship with your significant other, and it can affect your self-esteem. Strong emotional support is essential for helping to ward off these negative feelings. If you can t get pregnant, finding support is extremely important for your mental health and wellbeing. Support groups for infertility bring you into contact with others who are going through similar circumstances, and they offer the opportunity to share experiences, advice, tips, and resources. Find a support group online or in your community to help you: Reduce feelings of isolation. Reduce the stress associated with the challenges of infertility. Gain a sense of empowerment and control. Improve your coping skills. Express your feelings openly and honestly. Reduce depression and anxiety. Maintain high self-esteem. Options for Infertility If you can t get pregnant despite lifestyle changes and you ve spent six months to a year trying depending on your age it s time to pay a visit to your doctor. After an extensive interview about lifestyle and medical history, your doctor may order some tests for one or both of you. These may include a semen analysis, ovulation testing, hormone or genetic testing, and imaging tests. Depending on the specific diagnosis, infertility treatment may help you conceive. The most common infertility treatments include: Fertility-enhancing drugs to boost ovulation. Artificial insemination, during which sperm is inserted directly into the cervix, fallopian tubes, or uterus. In vitro fertilization, or IVF, wherein an egg is fertilized in a laboratory dish and transferred to the uterus. Zygote intrafallopian transfer, or ZIFT, which is similar to IVF, except the fertilized egg is transferred to the fallopian tube instead of the uterus. Gamete intrafallopian transfer, or GIFT, involves placing eggs and sperm into the fallopian tube so that fertilization occurs in the body. Intracytoplasmic sperm injection, or ICSI , which is used for serious problems with the sperm or when IVF fails for older couples. ICSI involves injecting a single sperm into a mature egg in the lab and transferring the embryo to the uterus or fallopian tube. Other options for infertility include: Using donor eggs or donor sperm, which come from another woman or man in the event a woman can t produce eggs or the man has poor quality sperm. A surrogate is a woman who agrees to become pregnant using her own eggs and the sperm of the man. After birth, the infertile couple will adopt the baby. Gestational carrier. Similar to a surrogate, a gestational carrier is another woman who carries a baby to term for a woman who shouldn t become pregnant due to health problems. The egg and sperm come from the couple. The fertilized egg is implanted in the gestational carrier, who gives the baby to the couple after birth. Don t Give Up Hope After six months of trying, 60 percent of couples will conceive without medical assistance, according to Resolve, the National Infertility Association. Of those who require medical assistance, 65 percent will give birth. Up to 90 percent of infertility cases are successfully treated with drug therapy or surgery, and only three percent need advanced technologies like IVF to conceive. If you find you can t get pregnant, don t give up hope. Stay encouraged, and get support. Live in the present moment as much as possible, and strive to maintain a positive outlook. The odds are in your favor that you ll eventually conceive and go on to have a healthy, happy baby. legit


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important Erbitux Generic Name: Cetuximab Class: Antineoplastic Agents VA Class: AN900 Chemical Name: Disulfide with human-mouse monoclonal C225 κ-chain anti-(human epidermal growth factor receptor) (human-mouse monoclonal C225 γ1-chain) immunoglobulin G1 dimer CAS Number: 205923-56-4 Overview Side Effects Dosage Professional Interactions More Pregnancy Warnings Breastfeeding Warnings User Reviews Support Group Q & A Compare Alternatives Pricing & Coupons Warning(s) Infusion-related Effects Severe infusion-related effects (rarely fatal) reported in about 3% of patients. 1 6 If severe infusion-related effects occur, discontinue cetuximab immediately and permanently . 1 (See Infusion-related Effects under Cautions.) Cardiopulmonary Arrest Cardiopulmonary arrest and/or sudden death reported in 2% of patients with squamous cell carcinoma of the head and neck receiving cetuximab in combination with radiation therapy. 1 (See Cardiopulmonary Arrest under Cautions.) Closely monitor serum electrolytes (including magnesium, potassium, and calcium) during and after cetuximab therapy. 1 (See Electrolyte Disorders under Cautions.) Introduction Antineoplastic agent; a recombinant chimeric (human-murine) monoclonal antibody that binds to epidermal growth factor receptors (EGFR). 1 6 7 Slideshow The Ferocity of Chemotherapy - Does The End Justify The Means? Uses for Erbitux Colorectal Cancer Used in combination with irinotecan for the treatment of EGFR-expressing metastatic colorectal cancer that is refractory to irinotecan-based chemotherapy. 1 2 3 19 Indication for use in combination with irinotecan is based on objective response rates; currently no data demonstrating clinical benefit (e.g., improvement in disease-related symptoms, increased survival). 1 Used as a single agent for the treatment of EGFR-expressing metastatic colorectal cancer in patients with disease that has failed treatment with both irinotecan-based and oxaliplatin-based regimens. 1 Also used as a single agent for the treatment of EGFR-expressing metastatic colorectal cancer in patients who are intolerant of irinotecan-based chemotherapy. 1 11 Retrospective subset analyses of metastatic colorectal cancer trials have not shown a treatment benefit for EGFR inhibitors (e.g., cetuximab, panitumumab) in patients whose tumors had KRAS (also called K-ras ) mutations in codon 12 or 13. 1 28 33 34 37 43 ASCO 28 and some clinicians 31 36 38 39 40 41 42 43 recommend that all patients with metastatic colorectal cancer who are potential candidates for EGFR inhibitor therapy have their tumor tested for KRAS mutations 28 31 36 38 39 40 41 42 43 in a Clinical Laboratory Improvement Amendments (CLIA)-accredited laboratory. 28 31 If KRAS mutation in codon 12 or 13 is detected, use of cetuximab is not recommended. 1 28 31 36 Under investigation for use in combination with chemotherapy regimens (e.g., irinotecan/fluorouracil/leucovorin [FOLFIRI], oxaliplatin/fluorouracil/leucovorin [FOLFOX]) for the first-line † treatment of metastatic colorectal cancer. 20 21 Head and Neck Cancer Used in combination with radiation therapy for initial treatment of locally or regionally advanced squamous cell carcinoma of the head and neck, particularly in patients who cannot tolerate platinum-based chemotherapy with radiation therapy. 1 13 Platinum-based chemotherapy with radiation therapy is current standard of care for treatment of advanced head and neck cancer. 13 Used as a single agent for the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck when previous platinum-based chemotherapy has failed. 1 12 Under investigation for use in combination with other antineoplastic agents (e.g., cisplatin), with or without radiation therapy, † for the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck. 5 14 15 16 17 18 Non-small Cell Lung Cancer (NSCLC) Use in combination with chemotherapy as first-line therapy for advanced (stage IIIB [with malignant pleural effusion] or IV [metastatic]) NSCLC † is not fully established because of equivocal evidence; 10024 additional studies needed to validate predictive tumor biomarkers and identify subgroups of patients with previously untreated advanced NSCLC who might derive clinical benefit (e.g., prolonged progression-free survival, prolonged overall survival, improved quality of life) from the addition of cetuximab to chemotherapy. 10017 10021 10022 10023 Erbitux Dosage and Administration General To minimize risk of infusion-related reactions, 4 premedicate with an antihistamine (e.g., diphenhydramine hydrochloride 50 mg) IV 30 60 minutes prior to initial cetuximab dose. 1 Administer antihistamine prior to subsequent doses as clinically indicated based on occurrence and severity of previous reactions. 1 Administration IV Administration Administer by IV infusion. 1 7 Do not administer by rapid IV injection, such as IV push or bolus . 1 Solution should be clear and colorless and may contain small amounts of easily visible, white, amorphous particulates. 1 Do not shake vials. 1 Contains no preservative; discard any unused portion of vial. 1 Use infusion pump or syringe pump to administer. 1 Administer drug through a low-protein-binding 0.22- mc m inline filter. 1 Monitor patients for infusion reactions during and for 1 hour following each infusion. 1 7 10 If infusion reaction requiring treatment occurs, monitor until event has resolved. 1 10 Dilution Do not dilute solution. 1 Rate of Administration Initial IV dose: Administer over 2 hours. 1 Subsequent weekly doses: Administer over 1 hour. 1 Infusion rate should not exceed 10 mg/minute. 1 Dosage Adults Colorectal Cancer Cetuximab or Cetuximab/Irinotecan for EGFR-Expressing Metastatic Disease IV Initial cetuximab dose of 400 mg/m 2 , followed by 250 mg/m 2 once weekly until disease progression or unacceptable toxicity occurs. 1 6 7 Head and Neck Cancer Cetuximab/Radiation Combination Therapy for Locally or Regionally Advanced Disease IV Initial dose of 400 mg/m 2 administered 1 week prior to initiation of first course of radiation therapy. 1 Then, 250 mg/m 2 once weekly for duration of radiation therapy (6 7 weeks); a median of 8 doses was administered in clinical studies. 1 Cetuximab administration should be completed 1 hour prior to radiation therapy. 1 Monotherapy for Recurrent or Metastatic Disease IV Initial dose of 400 mg/m 2 , followed by 250 mg/m 2 once weekly until disease progression or unacceptable toxicity occurs. 1 Dosage Modification for Toxicity and Contraindications to Continued Therapy Infusion-related Reactions If grade 1 or 2 or nonserious grade 3 or 4 infusion-related reaction occurs, reduce infusion rate by 50%. 1 6 If serious infusion-related reaction (requiring medical intervention and/or hospitalization) occurs, discontinue therapy immediately and permanently . 1 Dermatologic Toxicity If severe (grade 3 or 4) acneiform rash occurs, temporarily delay therapy; reduce subsequent doses or discontinue therapy depending on patient's response as follows: 1 Cetuximab Dosage Modification for Severe Acneiform Rash1 Occurrence of Severe Acneiform Rash Intervention Outcome Cetuximab Dosage First occurrence Delay infusion for 1 2 weeks Improvement Continue subsequent weekly dose of 250 mg/m 2 No improvement Discontinue cetuximab Second occurrence Delay infusion for 1 2 weeks Improvement Reduce subsequent weekly dose to 200 mg/m 2 No improvement Discontinue cetuximab Third occurrence Delay infusion for 1 2 weeks Improvement Reduce subsequent weekly dose to 150 mg/m 2 No improvement Discontinue cetuximab Fourth occurrence Discontinue cetuximab Pulmonary Toxicity If acute onset or worsening of pulmonary symptoms occurs, interrupt therapy. 1 If interstitial lung disease is confirmed, permanently discontinue therapy. 1 Special Populations No special population dosage recommendations at this time. 4 Cautions for Erbitux Contraindications No known contraindications according to manufacturer. 1 Warnings/Precautions Warnings Infusion-related Effects Potential for serious infusion-related effects (e.g., rapid airway obstruction [bronchospasm, stridor, hoarseness], hypotension, shock, loss of consciousness, MI, cardiac arrest). 1 (See Infusion-related Effects in Boxed Warning.) Infusion-related effects are severe (grade 3 or 4) in 2 5% of patients; fatal in less than 1 in 1000 patients. 1 Approximately 90% of severe reactions occur in association with initial cetuximab infusion despite premedication with antihistamines. 1 Monitor for signs of infusion reactions during and for 1 hour following each cetuximab infusion in a setting where resuscitation equipment and agents necessary to treat anaphylaxis are readily available. 1 7 10 For patients experiencing infusion reactions requiring treatment, monitor until event has resolved. 1 10 If grade 1 or 2 or nonserious grade 3 or 4 infusion-related reaction occurs, reduce infusion rate by 50%. 1 If serious infusion-related effects occur, discontinue cetuximab immediately and permanently and initiate appropriate therapy (e.g., epinephrine, corticosteroids, IV antihistamines, bronchodilators, oxygen). 1 Cardiopulmonary Arrest Cardiopulmonary arrest and/or sudden death reported in patients with or without CAD, arrhythmia, and/or CHF receiving cetuximab/radiation combination therapy for treatment of squamous cell carcinoma of the head and neck. 1 (See Cardiopulmonary Arrest in Boxed Warning.) Carefully consider use of cetuximab and radiation therapy for treatment of head and neck cancer in patients with a history of CAD, CHF, or arrhythmias. 1 Closely monitor serum electrolytes, including magnesium, potassium, and calcium, during and following cetuximab therapy. 1 Serious cardiotoxicity requiring discontinuance of therapy also reported in patients with squamous cell carcinoma of the head and neck receiving cetuximab in combination with cisplatin and radiation therapy (see Use in Combination with Radiation Therapy and Cisplatin under Cautions). 1 Pulmonary Effects Interstitial lung disease, interstitial pneumonitis (fatal in one case), and exacerbation of preexisting fibrotic lung disease reported. 1 4 6 If acute onset or exacerbation of pulmonary manifestations occurs, interrupt therapy. 1 If interstitial lung disease is confirmed, permanently discontinue therapy. 1 Use in Combination with Radiation Therapy and Cisplatin Safety of combination regimen consisting of cetuximab, radiation therapy, and cisplatin not established. 1 Serious cardiotoxicity and death (secondary to pneumonia or unknown cause) reported in patients receiving this combination for treatment of locally advanced squamous cell carcinoma of the head and neck. 1 Electrolyte Disorders Electrolyte abnormalities, including hypomagnesemia, hypocalcemia, and hypokalemia, have occurred. 1 Hypomagnesemia reported in 55% of patients; severe (grade 3 or 4) in 6 17% of patients. 1 Onset of hypomagnesemia and accompanying electrolyte abnormalities may occur from days to months following initiation of therapy. 1 10 Manifestations of hypomagnesemia may include fatigue and hypocalcemia. 23 Monitor for hypomagnesemia, hypocalcemia, and hypokalemia during and for ≥8 weeks following completion of therapy. 1 Replete electrolytes as necessary; IV replacement therapy indicated in severe cases. 1 10 23 Sensitivity Reactions Dermatologic Effects Acneiform rash reported in 76 88% of patients; severe in 1 17%. 1 Generally appears within first 2 weeks of therapy and may resolve following discontinuance; however, may persist beyond 28 days. 1 Skin drying/fissuring, 1 paronychial inflammation, 1 infectious sequelae (e.g., abscess formation, blepharitis, conjunctivitis, keratitis, cheilitis, cellulitis, Staphylococcus aureus sepsis), 1 and hypertrichosis 1 24 reported. 1 Fatal toxic epidermal necrolysis also reported. 27 Monitor for possible dermatologic effects and infectious complications. 1 If severe acneiform rash occurs, reduce dosage or discontinue therapy. 1 (See Dermatologic Toxicity under Dosage and Administration.) Limit sun exposure. 1 (See Advice to Patients.) General Precautions EGFR Expression and Response In clinical trials for colorectal cancer, testing for evidence of EGFR expression was required. 1 However, some authorities state that routine EGFR expression testing is not recommended in patients with colorectal cancer and that patients should not be included or excluded from cetuximab therapy based solely on EGFR test results. 31 Because expression of EGFR has been detected in nearly all head and neck cancers, EGFR testing was not required in these clinical trials. 1 Therapy Monitoring Monitor for dermatologic toxicity and infectious sequelae. 1 Periodically monitor for hypomagnesemia and accompanying hypocalcemia and hypokalemia during and for ≥8 weeks following completion of therapy. 1 10 Immunologic Effects Nonneutralizing anticetuximab antibodies detected in about 5% of patients. 1 Incidence of antibody development not fully established, but there appears to be no effect on safety and efficacy of the drug. 1 Specific Populations Pregnancy Category C. 1 Lactation Not known whether cetuximab is distributed into milk, but potential exists for distribution of IgG antibodies into milk. 1 Discontinue nursing or the drug; if nursing is interrupted, do not resume for at least 60 days following last dose (due to long half-life). 1 (See Half-life under Pharmacokinetics.) Pediatric Use Safety and efficacy not established in pediatric patients. 1 Geriatric Use In patients receiving monotherapy or combination therapy for colorectal cancer, no overall differences in safety and efficacy relative to younger adults. 1 Insufficient experience in patients ≥65 years of age with head and neck cancer to determine whether they respond differently than younger adults. 1 Common Adverse Effects Dermatologic effects (e.g., rash, pruritus, nail changes), headache, diarrhea, infection. 1 Combination therapy with irinotecan in patients with advanced colorectal cancer: Acneiform rash, asthenia/malaise, diarrhea, nausea. 1 Monotherapy in patients with advanced colorectal cancer: Rash/desquamation, fatigue, abdominal pain, pain, dry skin, dyspnea, constipation. 1 In combination with radiation therapy in patients with head and neck cancer: Acneiform rash; radiation dermatitis; weight loss; asthenia; nausea; elevated ALT, AST, and alkaline phosphatase. 1 Interactions for Erbitux Specific Drugs and Therapies Drug or Therapy Interaction Comments Cisplatin Pharmacokinetic interaction unlikely 1 7 Serious cardiotoxicity and death reported with concomitant use of cetuximab, cisplatin, and radiation 1 Docetaxel Pharmacokinetic interaction unlikely 1 7 Fluorouracil Pharmacokinetic interaction unlikely 1 7 Irinotecan Pharmacokinetic interaction unlikely 1 7 Radiation therapy Increased risk of cardiopulmonary arrest, sudden death, and/or adverse dermatologic effects (e.g., acneiform rash) 1 Increased risk of late radiation toxicities 1 Use concomitantly with caution in patients with history or clinical evidence of CAD, CHF, or arrhythmias 1 (see Cardiopulmonary Arrest under Cautions) Erbitux Pharmacokinetics Pharmacokinetics similar between patients with squamous cell carcinoma of the head and neck and those with colorectal cancer. 1 Elimination Elimination Route Systemic clearance believed to be through internalization of cetuximab-EGFR complex on hepatocytes and skin. 7 Half-life 112 hours following multiple dosing. 1 6 Special Populations Clearance increases with increasing body surface area. 1 Decreased clearance observed in women. 1 No effect on safety profile; effect on efficacy not elucidated. 1 Stability Storage Parenteral Injection 2 8 C. 1 Do not freeze. 1 Preparations in infusion containers are chemically and physically stable for up to 8 hours at 20 25 C or up to 12 hours at 2 8 C. 1 Discard any unused portion after 8 hours (if stored at 20 25 C) or after 12 hours (if stored at 2 8 C). 1 Actions Antineoplastic agent; a recombinant chimeric (human-murine) monoclonal antibody containing human framework regions and murine Fv regions. 1 6 7 Mechanism of antineoplastic effects in vivo unknown. 1 However, cetuximab binds specifically to EGFR (HER1, c-ERbB-1) on both normal and tumor cells and competitively blocks cellular action of EGF and other ligands (e.g., transforming growth factor [TGF]-α). 1 6 35 Binding to EGFR blocks phosphorylation and activation of receptor-associated kinases, resulting in inhibition of cell growth, induction of apoptosis (programmed cell death), and decreased matrix metalloproteinase and vascular endothelial growth factor production. 1 6 35 Signal transduction through EGFR leads to activation of the wild-type (nonmutated) KRAS gene. 1 35 36 37 However, the presence of an activating somatic mutation of the KRAS gene (mutated KRAS ) in a cancer cell can lead to dysregulation of signaling pathways and resistance to EGFR inhibitor therapy (e.g., cetuximab, panitumumab). 1 35 36 37 Can mediate antibody-dependent cellular cytotoxicity (ADCC) against certain tumor types in vitro. 1 Inhibits growth and survival of animal tumor cells that express EGFR. 1 In xenograft models for human tumors in mice, addition of cetuximab to radiation therapy, irinotecan, or irinotecan/fluorouracil regimen resulted in increased antitumor effect compared with radiation therapy or chemotherapy alone. 1 Advice to Patients Risk of infusion-related effects and adverse cardiopulmonary, pulmonary, and dermatologic effects. 1 Advise patients to report signs and symptoms of infusion reactions (e.g., fever, chills, difficulty breathing). 1 Importance of advising patients to use sunscreen and hats and limit sun exposure during and for 2 months following the last dose of cetuximab to avoid exacerbation of adverse dermatologic effects. 1 Necessity of advising men and women to use an effective method of contraception during and for 6 months following the last dose of cetuximab. 1 Advise pregnant women of risk to fetus and/or potential risk for loss of pregnancy. 1 Advise women to avoid breast-feeding during and for 60 days following the last dose of cetuximab. 1 Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses (e.g., arrhythmias, CAD, CHF). 1 Importance of informing patients of other important precautionary information. 1 (See Cautions.) Preparations Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. Cetuximab (Recombinant) Routes Dosage Forms Strengths Brand Names Manufacturer Parenteral Injection, for IV infusion only 2 mg/mL (100 and 200 mg) Erbitux Bristol-Myers Squibb AHFS DI Essentials. Copyright 2017, Selected Revisions April 28, 2015. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. † Use is not currently included in the labeling approved by the US Food and Drug Administration. References 1. Bristol-Myers Squibb Company. Erbitux (cetuximab) prescribing information. Princeton, NJ: 2010 Sep. 2. Saltz LB, Meropol NJ, Loehrer PJ et al. Phase II trial of cetuximab in patients with refractory colorectal cancer that expresses the epidermal growth factor receptor. J Clin Oncol . 2004; 22:1201-8. [PubMed 14993230] 3. Cunningham D, Humblet Y, Siena S et al. Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer. N Engl J Med . 2004; 351:337-45. [PubMed 15269313] 4. Bristol-Myers Squibb, Princeton, NJ: Personal communication. 5. Burtness B, Goldwasser MA, Flood W et al. Phase III randomized trial of cisplatin plus placebo compared with cisplatin plus cetuximab in metastatic/recurrent head and neck cancer: an Eastern Cooperative Oncology Group study. J Clin Oncol . 2005; 23:8646-54. [PubMed 16314626] 6. Anon. Two new drugs for colon cancer. Med Lett Drugs Ther. 2004; 46:46-7. 7. Reynolds NA, Wagstaff AJ. Cetuximab: in the treatment of metastatic colorectal cancer. Drugs . 2004; 64:109-18. [PubMed 14723561] 8. Food and Drug Administration. Orphan designations pursuant to Section 526 of the Federal Food and Cosmetic Act as amended by the Orphan Drug Act (P.L. 97-414). Rockville, MD; 2004 Sep 16. From FDA web site (). 9. Bonner JA, Harari PM, Giralt J et al. Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck. N Engl J Med . 2006; 354:567-78. [PubMed 16467544] 10. Rowinsky EK, Smyth AC. Dear healthcare provider letter regarding important drug warning for Erbitux (cetuximab). ImClone Systems and Bristol Myers Squibb; 2005 Sep 13. 11. Anon. Drugs of choice for cancer. Treat Guidel Med Lett . 2003; 1:41-52. [PubMed 15529105] 12. Vermorken JB, Trigo J, Hitt R et al. Open-label, uncontrolled, multicenter phase II study to evaluate the efficacy and toxicity of cetuximab as a single agent in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck who failed to respond to platinum-based therapy. J Clin Oncol . 2007; 25:2171-7. [PubMed 17538161] 13. Posner MR, Wirth LJ. Cetuximab and radiotherapy for head and neck cancer. N Engl J Med . 2006; 354:634-6. [PubMed 16467552] 14. Baselga J, Trigo JM, Bourhis J et al. Phase II multicenter study of the antiepidermal growth factor receptor monoclonal antibody cetuximab in combination with platinum-based chemotherapy in patients with platinum-refractory metastatic and/or recurrent squamous cell carcinoma of the head and neck. J Clin Oncol . 2005; 23:5568-77. [PubMed 16009950] 15. Herbst RS, Arquette M, Shin DM et al. Phase II multicenter study of the epidermal growth factor receptor antibody cetuximab and cisplatin for recurrent and refractory squamous cell carcinoma of the head and neck. J Clin Oncol . 2005; 23:5578-87. [PubMed 16009949] 16. Vermorken JB, Mesia R, Rivera F et al. Platinum-based chemotherapy plus cetuximab in head and neck cancer. N Engl J Med . 2008; 359:1116-27. [PubMed 18784101] 17. Pfister DG, Su YB, Kraus DH et al. Concurrent cetuximab, cisplatin, and concomitant boost radiotherapy for locoregionally advanced, squamous cell head and neck cancer: a pilot phase II study of a new combined-modality paradigm. J Clin Oncol . 2006; 24:1072-8. [PubMed 16505426] 18. Ang KK, protocol chair. Phase III randomized study of concurrent accelerated fractionated radiotherapy and cisplatin with versus without cetuximab in patients with stage III or IV squamous cell carcinoma of the oropharynx, hypopharynx, or larynx. Protocol ID: RTOG-0522. Last modified: 8/24/2006. National Cancer Institute: Clinical Trials (database). 19. Saltz L, Rubin M, Hochster H et al. Cetuximab (IMC-C225) plus irinotecan (CPT-11) is active in CPT-11-refractory colorectal cancer (CRC) that expresses epidermal growth factor receptor (EGFR). Proc ASCO . 2001; Abstract No. 7. 20. Venook A, Niedzwiecki D, Hollis D et al. Phase III study of irinotecan/5FU/LV (FOLFIRI) or oxaliplatin/5FU/LV (FOLFOX) cetuximab for patients (pts) with untreated metastatic adenocarcinoma of the colon or rectum (MCRC): CALGB 80203 preliminary results. Proc ASCO . 2006; Abstract No. 3509. 21. Venook A, protocol chair. Phase III randomized study of cetuximab and/or bevacizumab in combination with either oxaliplatin, fluorouracil, and leucovorin calcium (FOLFOX) or irinotecan hydrochloride, fluorouracil, and leucovorin calcium (FOLFIRI) in patients with previously untreated metastatic adenocarcinoma of the colon or rectum. Protocol ID: CALGB-C80405. Last modified: 8/24/2006. National Cancer Institute: Clinical Trials (database). 22. Chung KY, Shia J, Kemeny NE et al. Cetuximab shows activity in colorectal cancer patients with tumors that do not express the epidermal growth factor receptor by immunohistochemistry. J Clin Oncol . 2005; 23:1803-10. [PubMed 15677699] 23. Schrag D, Chung KY, Flombaum C et al. Cetuximab therapy and symptomatic hypomagnesemia. J Natl Cancer Inst . 2005; 97:1221-4. [PubMed 16106027] 24. Montagut C, Grau JJ, Grimalt R et al. Abnormal hair growth in a patient with head and neck cancer treated with the anti-epidermal growth factor receptor monoclonal antibody cetuximab. J Clin Oncol . 2005; 23:5273-5. [PubMed 16051981] 25. Jonker DJ, O Callaghan CJ, Karapetis CS et al. Cetuximab for the treatment of colorectal cancer. N Engl J Med . 2007; 357:2040-8. [PubMed 18003960] 26. Lièvre A, Bachet JB, Boige V et al. KRAS mutations as an independent prognostic factor in patients with advanced colorectal cancer treated with cetuximab. J Clin Oncol . 2008; 26:374-9. 27. Lin WL, Lin WC, Yang JY et al. Fatal toxic epidermal necrolysis associated with cetuximab in a patient with colon cancer. J Clin Oncol . 2008; 26:2779-80. [PubMed 18509187] 28. Allegra CJ, Jessup JM, Somerfield MR et al. American Society of Clinical Oncology provisional clinical opinion: testing for KRAS gene mutations in patients with metastatic colorectal carcinoma to predict response to anti-epidermal growth factor receptor monoclonal antibody therapy. J Clin Oncol . 2009; 27:2091-6. [PubMed 19188670] 29. Cunningham D, Humblet Y, Siena S et al. Cetuximab monotherapy and cetuximab plus irinotecan in irinotecan-refractory metastatic colorectal cancer. N Engl J Med . 2004; 351:337-45. [PubMed 15269313] 30. Italiano A, Follana P, Caroli FX et al. Cetuximab shows activity in colorectal cancer patients with tumors for which FISH analysis does not detect an increase in EGFR gene copy number. Ann Surg Oncol . 2008; 15:649-54. [PubMed 17987340] 31. National Comprehensive Cancer Network (NCCN). Clinical practice guidelines in oncology; colon cancer. Version 2.2009. Accessed from the NCCN website: http://www.nccn.org/professionals/physician_gls/PDF/colon.pdf 32. Pirker R, Pereira JR, Szczesna A et al. Cetuximab plus chemotherapy in patients with advanced non-small-cell lung cancer (FLEX): an open-label randomised phase III trial. Lancet . 2009; 373:1525-31. [PubMed 19410716] 33. Van Cutsem E, Lang I, Moiseyenko V et al. KRAS status and efficacy in the first-line treatment of patients with metastatic colorectal cancer (mCRC) treated with FOLFIRI with or without cetuximab: the CRYSTAL experience. Proceedings of the 44th Annual Meeting of ASCO, Chicago, IL, 2008 May 30 Jun 3. Abstr. No. 2. 34. Bokemeyer C, Bondarenko I, Hartmann JT et al. KRAS status and efficacy of first-line treatment of patients with metastatic colorectal cancer (mCRC) with FOLFOX with or without cetuximab: the OPUS experience. Proceedings of the 44th Annual Meeting of ASCO, Chicago, IL 2008 May 30 Jun 3. Abstr. No. 4000. 35. Chang DZ, Kumar V, Ma Y et al. Individualized therapies in colorectal cancer: KRAS as a marker for response to EGFR-targeted therapy. J Hematol Oncol . 2009; 2:18. [PubMed 19386128] 36. Normanno N, Tejpar S, Morgillo F et al. Implications for KRAS status and EGFR-targeted therapies in metastatic CRC. Nat Rev Clin Oncol . 2009; 6:519-27. [PubMed 19636327] 37. Bristol-Myers Squibb. Erbitux (cetuximab) solution for intravenous infusion prescribing information. Princeton, NJ: 2009 Jul. 38. Freeman DJ, Juan T, Reiner M et al. Association of K-ras mutational status and clinical outcomes in patients with metastatic colorectal cancer receiving panitumumab alone. Clin Colorectal Cancer . 2008; 7:184-90. [PubMed 18621636] 39. Santini D, Loupakis F, Vincenzi B et al. High concordance of KRAS status between primary colorectal tumors and related metastatic sites: implications for clinical practice. Oncologist . 2008; 13:1270-5. [PubMed 19056857] 40. Di Nicolantonio F, Martini M, Molinari F et al. Wild-type BRAF is required for response to panitumumab or cetuximab in metastatic colorectal cancer. J Clin Oncol . 2008; 26:5705-12. [PubMed 19001320] 41. Peeters M, Balfour J, Arnold D. Review article: panitumumab--a fully human anti-EGFR monoclonal antibody for treatment of metastatic colorectal cancer. Aliment Pharmacol Ther . 2008; 28:269-81. [PubMed 19086328] 42. Weber J, McCormack PL. Panitumumab in metastatic colorectal cancer with wild-type KRAS . BioDrugs . 2008; 22:403-11. [PubMed 18998757] 43. Amado RG, Wolf M, Peeters M et al. Wild-type KRAS is required for panitumumab efficacy in patients with metastatic colorectal cancer. J Clin Oncol . 2008; 26:1626-34. [PubMed 18316791] 10001. Pirker R, Szczesna A, von Pawel J et al. FLEX: a randomized, multicenter, phase III study of cetuximab in combination with cisplatin/vinorelbine (CV) versus CV alone in the first-line treatment of advanced non-small cell lung cancer (NSCLC). Proceedings of 44th Annual Meeting of ASCO, Chicago, IL, 2008 May 30-June 3. Abstract No. 3. 10002. Lynch T, Patel T, Dreisbach L et al. A randomized multicenter phase III study of cetuximab (Erbitux) in combination with taxane/carboplatin versus taxane/carboplatin alone as first-line treatment for patients with advanced/metastatic non-small cell lung cancer (NSCLC): BMS 099. Presented at the 12th World Congress on lung cancer. 2007 Sept 2-6. Seoul, Korea. Abstract No. B3-03. 10003. ImClone Systems Inc. Erbitux Phase 3 BMS 099 lung cancer study secondary endpoint update: overall survival results announced. New York, NY; 2008 Aug 29. Press release. 10004. Herbst RS, Chansky K, Kelly K et al. A phase II randomized selection trial evaluating concurrent chemotherapy plus cetuximab or chemotherapy followed by cetuximab in patients with advanced non-small cell lung cancer (NSCLC): final report of SWOG 0342. Proceedings of the 43rd Annual Meeting of ASCO, 2007 Chicago, IL, June 1-5. Abstract No. 7545. 10005. Hirsch FR, Herbst RS, Olsen C, et al. Increased EGFR gene copy number detected by fluorescent in situ hybridization predicts outcome in non-small cell lung cancer patients treated with cetuximab and chemotherapy. J Clin Oncol. 2008; 26:3351-57. 10006. Butts CA, Bodkin D, Middleman ELet al. Randomized phase II study of gemcitabine plus cisplatin, with or without cetuximab, as first-line therapy for patients with advanced or metastatic non-small cell lung cancer. J Clin Oncol. 2007; 25:5777-84. [PubMed 18089875] 10007. Ettinger DS. Clinical implications of EGFR expression in the development and progression of solid tumors: focus on non-small cell lung cancer. The Oncologist. 2006; 11:358-73. [PubMed 16614231] 10008. Sequist LV, Bell DW, Lynch TL et al. Molecular predictors of response to epidermal growth factor receptor antagonists in non-small cell lung cancer. J Clin Oncol. 2007; 25:587-95. [PubMed 17290067] 10009. Hanna S, Lilenbaum R, Ansari R et al. Phase II trial of cetuximab in patients with previously treated non-small cell lung cancer. J Clin Oncol. 2006; 24:5253-5257. [PubMed 17114658] 10010. Ciardiello F and Tortora G. EGFR antagonists in cancer treatment. N Engl J Med. 2008; 358:1160-74. [PubMed 18337605] 10011. AHFS Oncology Expert Committee reviewers comments (personal observations). 10012. Schiller JH, Harrington D, Belani C et al. Comparison of four chemotherapy regimens for advanced non-small cell lung cancer. N Engl J Med. 2002; 346: 92-8. [PubMed 11784875] 10013. Socinski MA, Crowell R, Hensing TE, et al. Treatment of non-small cell lung cancer, stage IV: ACCP evidence-based clinical practice guidelines (2nd edition). Chest. 2007;132:277-289. 10014. Sandler A Gray R, Perry M et al. Paclitaxel-carboplatin alone or with bevacizumab for non-small cell lung cancer. N Engl J Med. 2006; 355:2542-50. [PubMed 17167137] 10015. Chung KI, Shia J, Kemeny N et al. Cetuximab shows activity in colorectal cancer patients with tumors that do not express the epidermal growth factor receptor by immunohistochemistry. J Clin Oncol. 2005; 23:1803-10. [PubMed 15677699] 10016. O'Byrne KJ, Gatzemeier U, Bondarenko I et al. Molecular biomarkers in non-small-cell lung cancer: a retrospective analysis of data from the phase 3 FLEX study. Lancet Oncol . 2011; 12:795-805. [PubMed 21782507] 10017. Khambata-Ford S, Harbison CT, Hart LL et al. Analysis of potential predictive markers of cetuximab benefit in BMS099, a phase III study of cetuximab and first-line taxane/carboplatin in advanced non-small-cell lung cancer. J Clin Oncol . 2010; 28:918-27. [PubMed 20100958] 10018. Pirker R, Pereira JR, von Pawel J et al. EGFR expression as a predictor of survival for first-line chemotherapy plus cetuximab in patients with advanced non-small-cell lung cancer: analysis of data from the phase 3 FLEX study. Lancet Oncol . 2012; 13:33-42. [PubMed 22056021] 100 enough


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beginning Compound W Generic Name: salicylic acid topical (SAL i SIL ik AS id TOP ik al) Brand Name: Acnevir, Compound W, DermalZone, Dermarest Psoriasis Skin Treatment, Dr Scholl's Callus Removers, Dr Scholl's Clear Away Wart Remover, Dr Scholl's Corn Removers, Freezone Corn Remover, Keralyt, Mediplast, Oxy Face Scrub, Salex, Scalpicin Scalp Relief, Stri-Dex, UltraSal-ER, Wart Remover Overview Side Effects Dosage Interactions Reviews More Support Group Q & A Compare Alternatives What is Compound W (salicylic acid topical)? There are many brands and forms of salicylic acid available. Not all brands are listed on this leaflet. Salicylic acid is a keratolytic (peeling agent). Salicylic acid causes shedding of the outer layer of skin. Salicylic acid topical (for the skin) is used in the treatment of acne, dandruff, seborrhea, or psoriasis, and to remove corns, calluses, and warts. Salicylic acid topical may also be used for purposes not listed in this medication guide. Slideshow Acne Advice: Skin Care Solutions For Both Teens and Adults Alike What is the most important information I should know about Compound W (salicylic acid topical)? Salicylic acid topical can cause a rare but serious allergic reaction or severe skin irritation. Stop using this medicine and get emergency medical help if you have: hives, itching; difficult breathing, feeling light-headed; or swelling of your face, lips, tongue, or throat. What should I discuss with my healthcare provider before using Compound W (salicylic acid topical)? You should not use salicylic acid topical if you are allergic to it. Do not give this medication to a child or teenager with a fever, flu symptoms, or chicken pox. Salicylic acid can cause Reye's syndrome, a serious and sometimes fatal condition in children. Ask a doctor or pharmacist if it is safe for you to use this medicine if you have other medical conditions, especially: liver or kidney disease; diabetes; or blood circulation problems. It is not known whether salicylic acid topical will harm an unborn baby. Do not use this medicine without a doctor's advice if you are pregnant. It is not known whether salicylic acid topical passes into breast milk or if it could harm a nursing baby. Do not use this medicine without a doctor's advice if you are breast-feeding a baby. This medicine should not be used on a child younger than 2 years old. How should I use Compound W (salicylic acid topical)? Salicylic acid topical is available in many different forms, such as liquid, gel, lotion, cream, ointment, foam, soap, shampoo, cloth pads, and skin patches. Use the medicine exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Salicylic acid topical can cause a rare but serious allergic reaction or severe skin irritation. Before you start using this medicine, you may choose to apply a "test dose" to see if you have a reaction. Apply a very small amount of the medicine to 1 or 2 small acne areas every day for 3 days in a row. If there is no reaction, begin using the full prescribed amount on the 4th day. Do not take this medicine by mouth. It is for use only on your skin. Gently clean and dry the affected area. When treating warts or calluses, you may gently remove any loose tissue with a soft brush, wash cloth, or nail file. Soak the skin for 5 minutes before applying the medicine. You may need to shake the foam or lotion before use. Follow all directions on the product label. Cut the skin patch to fit the area you are treating. Follow all directions on your medication label about how long to wear the skin patch. Use salicylic acid topical regularly to get the most benefit. It may take up to several days before your symptoms improve. Call your doctor if your symptoms do not improve, or if they get worse while using salicylic acid topical. Do not use salicylic acid topical to treat any skin condition that has not been checked by your doctor. Store at room temperature away from moisture and heat. Keep the foam canister away from open flame or high heat. The canister may explode if it gets too hot. Do not puncture or burn an empty aerosol canister. What happens if I miss a dose? Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose. What happens if I overdose? An overdose of salicylic acid is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication. What should I avoid while using Compound W (salicylic acid topical)? Wart remover medicine may be flammable. Do not use near high heat or open flame such as a burning candle. Wash the medicine off your hands before handling a hair styling appliance (such as a curling or straightening iron). High heat could cause the medicine to ignite and burn your skin. Do not smoke until the gel has completely dried on your skin. Avoid getting this medication in your eyes, nose, mouth, rectum, or vagina. If this does happen, rinse with water. Do not use the medicine on sunburned, windburned, dry, chapped, irritated, or broken skin. Avoid using other medications on the areas you treat with salicylic acid topical unless your doctor tells you to. Compound W (salicylic acid topical) side effects Salicylic acid topical can cause a rare but serious allergic reaction or severe skin irritation. These reactions may occur just a few minutes after you apply the medicine, or within a day or longer afterward. Stop using this medicine and get emergency medical help if you have signs of an allergic reaction : hives, itching; difficult breathing, feeling light-headed; swelling of your face, lips, tongue, or throat. Stop using salicylic acid topical and call your doctor at once if you have: severe headache, ringing in your ears, problems with hearing, thinking problems; severe stomach pain, vomiting, or diarrhea; a light-headed feeling, like you might pass out; shortness of breath; or severe burning, dryness, or irritation of the skin. Common side effects may include: minor skin irritation, rash, or peeling; or changes in the color of treated skin (usually whitening). This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Side Effects (complete list) What other drugs will affect Compound W (salicylic acid topical)? It is not likely that other drugs you take orally or inject will have an effect on topically applied salicylic acid. But many drugs can interact with each other. Tell each of your health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products. Next Side Effects Print this page Add to My Med List More about Compound W (salicylic acid topical) Side Effects Dosage Information Drug Interactions Compare Alternatives Support Group En Español 1 Review Add your own review/rating Drug class: topical acne agents Consumer resources Compound W One-Step Wart Remover Topical (Advanced Reading) Compound W Plus Topical (Advanced Reading) Compound W Topical (Advanced Reading) Other brands: Duofilm , Salacyn , Salicylic Acid Cleansing Bar , KeralytGel , ... +48 more Professional resources Salicylic Acid (AHFS Monograph) Salicylic Acid Solution (FDA) Related treatment guides Warts Acne Where can I get more information? Your pharmacist can provide more information about salicylic acid topical. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed. Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist. Copyright 1996-2012 Cerner Multum, Inc. Version: 4.02. Date modified: December 03, 2017 Last reviewed: February 26, 2016} Drug Status Rx OTC Availability Rx and/or OTC C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Manufacturer Prestige Brands Drug Class Topical acne agents Topical keratolytics Related Drugs Warts salicylic acid topical , Duofilm , silver nitrate topical , Virasal , Wart Remover , UltraSal-ER , Tinamed Plantar , Duoplant , More... Acne doxycycline , clindamycin topical , erythromycin topical , minocycline , tretinoin topical , tetracycline , dapsone topical , Accutane , Vibramycin , Retin-A , isotretinoin , More... Compound W Rating 1 User Review 1 User Review Not Rated - Be the first! Related Questions & Answers What is Expiry date of elocom/fucidin mixture compound ? When using Compound W for a corn, are the skin layers supposed to fall off? Or are you supposed to? Will Aldara remove plantar warts? Compound W - how dangerous is it if you accidentaly put Comp W in your eyes? When do I know the wart is gone? I have used Compound W bandages a few different times, and just? Read more questions} } to surround


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made in particular DermacinRx Therazole Pak Generic Name: clotrimazole and betamethasone dipropionate, zinc oxide Dosage Form: kit Indications and Usage for DermacinRx Therazole Pak Clotrimazole and betamethasone dipropionate cream is a combination of an azole antifungal and corticosteroid and is indicated for the topical treatment of symptomatic inflammatory tinea pedis, tinea cruris, and tinea corporis due to Epidermophyton floccosum, Trichophyton mentagrophytes, and Trichophyton rubrum in patients 17 years and older. DermacinRx Therazole Pak Dosage and Administration Treatment of tinea corporis or tinea cruris: Apply a thin film of clotrimazole and betamethasone dipropionate cream into the affected skin areas twice a day for one week. Do not use more than 45 grams per week. Do not use with occlusive dressings. If a patient shows no clinical improvement after 1 week of treatment with clotrimazole and betamethasone dipropionate cream, the diagnosis should be reviewed. Do not use longer than 2 weeks. Treatment of tinea pedis: Gently massage a sufficient amount of clotrimazole and betamethasone dipropionate cream into the affected skin areas twice a day for two weeks. Do not use more than 45 grams per week. Do not use with occlusive dressings. If a patient shows no clinical improvement after 2 week of treatment with clotrimazole and betamethasone dipropionate cream, the diagnosis should be reviewed. Do not use longer than 4 weeks. Clotrimazole and betamethasone dipropionate cream is for topical use only. It is not for oral, ophthalmic, or intravaginal use. Dosage Forms and Strengths Cream, 1%/0.05% (base). Each gram of clotrimazole and betamethasone dipropionate cream, USP contains 10 mg of clotrimazole, USP and 0.64 mg of betamethasone dipropionate USP, (equivalent to 0.5 mg of betamethasone) in a white to off-white hydrophilic cream. Contraindications None. Warnings and Precautions Effects on Endocrine System Clotrimazole and betamethasone dipropionate cream can cause reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or after withdrawal of treatment. Cushing s syndrome and hyperglycemia may also occur due to the systemic effect of corticosteroids while on treatment. Factors that predispose a patient to HPA axis suppression include the use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressing, altered skin barrier, liver failure, and young age. Because of the potential for systemic corticosteroid effects, patients may need to be periodically evaluated for HPA axis suppression. This may be done by using the adrenocorticotropic hormone (ACTH) stimulation test. In a small trial, clotrimazole and betamethasone dipropionate cream was applied using large dosages, 7 g daily for 14 days (twice a day) to the crural area of normal adult subjects. Three of the 8 normal subjects on whom clotrimazole and betamethasone dipropionate cream was applied exhibited low morning plasma cortisol levels during treatment. One of these subjects had an abnormal cosyntropin test. The effect on morning plasma cortisol was transient and subjects recovered 1 week after discontinuing dosing. In addition, 2 separate trials in pediatric subjects demonstrated adrenal suppression as determined by cosyntropin testing [see Use in Specific Populations (8.4) ]. If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid. Pediatric patients may be more susceptible to systemic toxicity due to their larger skin-surface-to-body mass ratios [see Use in Specific Populations (8.4) ]. Diaper Dermatitis The use of clotrimazole and betamethasone dipropionate cream in the treatment of diaper dermatitis is not recommended. Adverse Reactions Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical trials common adverse reaction reported for clotrimazole and betamethasone dipropionate cream was paresthesia in 1.9% of patients. Adverse reactions reported at a frequency less than 1% included rash, edema, and secondary infection. Postmarketing Experience Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following local adverse reactions have been reported with topical corticosteroids: itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, skin atrophy, striae, miliaria, capillary fragility (ecchymoses), telangiectasia, and sensitization (local reactions upon repeated application of product). Adverse reactions reported with the use of clotrimazole are: erythema, stinging, blistering, peeling, edema, pruritus, urticaria, and general irritation of the skin. USE IN SPECIFIC POPULATIONS Pregnancy Teratogenic Effects Pregnancy Category C There are no adequate and well-controlled studies with clotrimazole and betamethasone dipropionate cream in pregnant women. Therefore, clotrimazole and betamethasone dipropionate cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. There have been no teratogenic studies performed in animals or humans with the combination of clotrimazole and betamethasone dipropionate. Corticosteroids are generally teratogenic in laboratory animals when administered at relatively low dosage levels. Studies in pregnant rats with intravaginal doses up to 100 mg/kg (15 times the maximum human dose) revealed no evidence of fetotoxicity due to clotrimazole exposure. No increase in fetal malformations was noted in pregnant rats receiving oral (gastric tube) clotrimazole doses up to 100 mg/kg/day during gestation Days 6 to 15. However, clotrimazole dosed at 100 mg/kg/day was embryotoxic (increased resorptions), fetotoxic (reduced fetal weights), and maternally toxic (reduced body weight gain) to rats. Clotrimazole dosed at 200 mg/kg/day (30 times the maximum human dose) was maternally lethal, and therefore, fetuses were not evaluated in this group. Also in this study, doses up to 50 mg/kg/day (8 times the maximum human dose) had no adverse effects on dams or fetuses. However, in the combined fertility, teratogenicity, and postnatal development study described above, 50 mg/kg clotrimazole was associated with reduced maternal weight gain and reduced numbers of offspring reared to 4 weeks. Oral clotrimazole doses of 25, 50, 100, and 200 mg/kg/day (2 to 15 times the maximum human dose) were not teratogenic in mice. No evidence of maternal toxicity or embryotoxicity was seen in pregnant rabbits dosed orally with 60, 120, or 180 mg/kg/day (18 to 55 times the maximum human dose). Betamethasone dipropionate has been shown to be teratogenic in rabbits when given by the intramuscular route at doses of 0.05 mg/kg. This dose is approximately one-fifth the maximum human dose. The abnormalities observed included umbilical hernias, cephalocele, and cleft palates. Betamethasone dipropionate has not been tested for teratogenic potential by the dermal route of administration. Some corticosteroids have been shown to be teratogenic after dermal application to laboratory animals. Nursing Mothers Systemically administered corticosteroids appear in human milk and can suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids can result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when clotrimazole and betamethasone dipropionate cream is administered to a nursing woman. Pediatric Use The use of clotrimazole and betamethasone dipropionate cream in patients under 17 years of age is not recommended. Adverse events consistent with corticosteroid use have been observed in pediatric patients treated with clotrimazole and betamethasone dipropionate cream. In open-label trials, 17 of 43 (39.5%) evaluable pediatric subjects (aged 12 to 16 years old) using clotrimazole and betamethasone dipropionate cream for treatment of tinea pedis demonstrated adrenal suppression as determined by cosyntropin testing. In another open-label trial, 8 of 17 (47.1%) evaluable pediatric subjects (aged 12 to 16 years old) using clotrimazole and betamethasone dipropionate cream for treatment of tinea cruris demonstrated adrenal suppression as determined by cosyntropin testing. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression when they are treated with topical corticosteroids. They are, therefore also at greater risk of adrenal insufficiency during and/or after withdrawal of treatment. Pediatric patients may be more susceptible than adults to skin atrophy, including striae, when they are treated with topical corticosteroids. HPA axis suppression, Cushing s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids [see Warnings and Precautions (5.1) ]. Avoid use of clotrimazole and betamethasone dipropionate cream in the treatment of diaper dermatitis. Geriatric Use Clinical studies of clotrimazole and betamethasone dipropionate cream did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, greater sensitivity of some older individuals cannot be ruled out. The use of clotrimazole and betamethasone dipropionate cream under occlusion, such as in diaper dermatitis, is not recommended. Postmarket adverse event reporting for clotrimazole and betamethasone dipropionate cream in patients aged 65 and above includes reports of skin atrophy and rare reports of skin ulceration. Caution should be exercised with the use of these corticosteroid-containing topical products on thinning skin. DermacinRx Therazole Pak Description Clotrimazole and betamethasone dipropionate cream USP, 1%/0.05% (base), contains combinations of clotrimazole USP, an azole antifungal, and betamethasone dipropionate USP, a corticosteroid, for topical use. Chemically, clotrimazole, USP is 1-( o -Chloro-α,α-diphenylbenzyl)imidazole, with the molecular formula C 22 H 17 ClN 2 , a molecular weight of 344.84, and the following structural formula: Clotrimazole, USP is an odorless, white crystalline powder, insoluble in water and soluble in ethanol. Betamethasone dipropionate, USP has 9-Fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the molecular formula C 28 H 37 FO 7 , a molecular weight of 504.59, and the following structural formula: Betamethasone dipropionate, USP is a white to creamy-white, odorless crystalline powder, insoluble in water. Each gram of clotrimazole and betamethasone dipropionate cream, USP contains 10 mg clotrimazole, USP and 0.64 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone), in a white to off-white hydrophilic cream. Inactive ingredients: Ceteareth-30, cetyl alcohol, mineral oil, propylene glycol, purified water, sodium phosphate monobasic monohydrate, stearyl alcohol and white petrolatum; benzyl alcohol as preservative. DermacinRx Therazole Pak - Clinical Pharmacology Mechanism of Action Clotrimazole is an azole antifungal [see Clinical Pharmacology (12.4) ]. Betamethasone dipropionate is a corticosteroid. Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action for the treatment of tinea pedis, tinea cruris and tinea corporis is unknown. Pharmacodynamics Vasoconstrictor Assay Studies performed with clotrimazole and betamethasone dipropionate cream indicate that these topical combination antifungal/corticosteroids may have vasoconstrictor potencies in a range that is comparable to high-potency topical corticosteroids. However, similar blanching scores do not necessarily imply therapeutic equivalence. Pharmacokinetics Skin penetration and systemic absorption of clotrimazole and betamethasone dipropionate following topical application of clotrimazole and betamethasone dipropionate cream has not been studied. The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption of topical corticosteroids. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids [see Dosage and Administration (2) ] . Once absorbed through the skin, the pharmacokinetics of topical corticosteroids are similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile. Microbiology Mechanism of Action Clotrimazole, an azole antifungal agent, inhibits 14-α-demethylation of lanosterol in fungi by binding to one of the cytochrome P-450 enzymes. This leads to the accumulation of 14-α-methylsterols and reduced concentrations of ergosterol, a sterol essential for a normal fungal cytoplasmic membrane. The methylsterols may affect the electron transport system, thereby inhibiting growth of fungi. Activity In Vitro and In Vivo Clotrimazole has been shown to be active against most strains of the following dermatophytes, both in vitro and in clinical infections, Epidermophyton floccosum, Trichophyton mentagrophytes, and Trichophyton rubrum [see Indications and Usage (1) ]. Drug Resistance Strains of dermatophytes having a natural resistance to clotrimazole have not been reported. Resistance to azoles, including clotrimazole, has been reported in some Candida species. No single-step or multiple-step resistance to clotrimazole has developed during successive passages of Trichophyton mentagrophytes. Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment of Fertility There are no adequate laboratory animal studies with either the combination of clotrimazole and betamethasone dipropionate or with either component individually to evaluate carcinogenesis. Betamethasone was negative in the bacterial mutagenicity assay ( Salmonella typhimurium and Escherichia coli ) and in the mammalian cell mutagenicity assay (CHO/HGPRT). It was positive in the in vitro human lymphocyte chromosome aberration assay, and equivocal in the in vivo mouse bone marrow micronucleus assay. Reproductive studies with betamethasone dipropionate carried out in rabbits at doses of 1 mg/kg by the intramuscular route and in mice up to 33 mg/kg by the intramuscular route indicated no impairment of fertility except for dose-related increases in fetal resorption rates in both species. These doses are approximately 5- and 38-fold the maximum human dose based on body surface areas, respectively. In a combined study of the effects of clotrimazole on fertility, teratogenicity, and postnatal development, male and female rats were dosed orally (diet admixture) with levels of 5, 10, 25, or 50 mg/kg/day (approximately 1 to 8 times the maximum dose in a 60-kg adult based on body surface area) from 10 weeks prior to mating until 4 weeks postpartum. No adverse effects on the duration of estrous cycle, fertility, or duration of pregnancy were noted. Clinical Studies In clinical trials of tinea corporis, tinea cruris, and tinea pedis, subjects treated with clotrimazole and betamethasone dipropionate cream showed a better clinical response at the first return visit than subjects treated with clotrimazole cream. In tinea corporis and tinea cruris, the subject returned 3 to 5 days after starting treatment, and in tinea pedis, after 1 week. Mycological cure rates observed in subjects treated with clotrimazole and betamethasone dipropionate cream were as good as, or better than, in those subjects treated with clotrimazole cream. In these same clinical studies, patients treated with clotrimazole and betamethasone dipropionate cream showed better clinical responses and mycological cure rates when compared with subjects treated with betamethasone dipropionate cream. How Supplied/Storage and Handling Clotrimazole and betamethasone dipropionate cream, USP is available as follows: 15 gram tube in a carton (NDC 0472-0379-15) 45 gram tube in a carton (NDC 0472-0379-45) Store at 20 to 25 C (68 to 77 F); excursions permitted to 15 to 30 C (59 to 86 F) [See USP Controlled Room Temperature]. Patient Counseling Information See FDA-Approved Patient Labeling ( Patient Information ) Inform the patient of the following: Use clotrimazole and betamethasone dipropionate cream as directed by the physician. It is for external use only. Avoid contact with the eyes, the mouth, or intravaginally. Do not use clotrimazole and betamethasone dipropionate cream on the face or underarms. Do not use more than 45 grams of clotrimazole and betamethasone dipropionate cream per week. When using clotrimazole and betamethasone dipropionate cream in the groin area, patients should use the medication for 2 weeks only, and apply the cream sparingly. Patients should wear loose-fitting clothing. Notify the physician if the condition persists after 2 weeks. Do not use clotrimazole and betamethasone dipropionate cream for any disorder other than that for which it was prescribed. Do not bandage, cover or wrap the treatment area unless directed by the physician. Avoid use of clotrimazole and betamethasone dipropionate cream in the diaper area, as diapers or plastic pants may constitute occlusive dressing. Report any signs of local adverse reactions to the physician. Advise patients that local reactions and skin atrophy are more likely to occur with occlusive use or prolonged use. This medication is to be used for the full prescribed treatment time, even though the symptoms may have improved. Notify the physician if there is no improvement after 1 week of treatment for tinea cruris or tinea corporis, or after 2 weeks for tinea pedis. Manufactured by: G&W Laboratories, Inc. 111 Coolidge Street South Plainfield, NJ 07080 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA I600-5511/14A GW7100 Revised July 2016 PATIENT INFORMATION Clotrimazole (kloe trim' a zole) and Betamethasone Dipropionate (bay" ta meth' a sone dye proe' pee oh nate) Cream USP, 1%/0.05% (base) Important information: Clotrimazole and betamethasone dipropionate cream is for use on skin only. Do not use clotrimazole and betamethasone dipropionate cream in your eyes, mouth, or vagina. What is clotrimazole and betamethasone dipropionate cream? Clotrimazole and betamethasone dipropionate cream is a prescription medication used on the skin (topical) to treat fungal infections of the feet, groin, and body in people 17 years of age and older. Clotrimazole and betamethasone dipropionate cream is used for fungal infections that are inflamed and have symptoms of redness or itching. Clotrimazole and betamethasone dipropionate cream should not be used in children under 17 years of age. Before using clotrimazole and betamethasone dipropionate cream, tell your healthcare provider about all your medical conditions, including if you: are pregnant or plan to become pregnant. It is not known if clotrimazole and betamethasone dipropionate cream will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if clotrimazole and betamethasone dipropionate passes into your breast milk. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take other corticosteroid medicines by mouth or use other products on your skin or scalp that contain corticosteroids. What should I avoid while using clotrimazole and betamethasone dipropionate cream? Clotrimazole and betamethasone dipropionate cream should not be used to treat diaper rash or redness. You should avoid applying clotrimazole and betamethasone dipropionate cream in the diaper area. How should I use clotrimazole and betamethasone dipropionate cream? Use clotrimazole and betamethasone dipropionate cream exactly as your healthcare provider tells you to use it. Use clotrimazole and betamethasone dipropionate cream for the prescribed treatment time, even if your symptoms get better. Do not use more than 45 grams of clotrimazole and betamethasone dipropionate cream in 1 week. Do not bandage, cover, or wrap the treated area unless your healthcare provider tells you to. Wear loose-fitting clothing if you use clotrimazole and betamethasone dipropionate cream in the groin area. Do not use clotrimazole and betamethasone dipropionate cream on your face or underarms (armpits). For treatment of fungal infections of the groin and body: Apply a thin layer of clotrimazole and betamethasone dipropionate cream to the affected skin area 2 times a day for 1 week. Tell your healthcare provider if the treated skin area does not improve after 1 week of treatment. Do not use clotrimazole and betamethasone dipropionate cream for longer than 2 weeks. For treatment of fungal infections of the feet: Apply a thin layer of clotrimazole and betamethasone dipropionate cream to the affected skin area 2 times a day for 2 weeks. Tell your healthcare provider if the treated skin area does not improve after 2 weeks of treatment. Do not use clotrimazole and betamethasone dipropionate cream longer than 4 weeks. Wash your hands after applying clotrimazole and betamethasone dipropionate cream. What are the possible side effects of clotrimazole and betamethasone dipropionate cream? Clotrimazole and betamethasone dipropionate cream may cause serious side effects, including: Clotrimazole and betamethasone dipropionate cream can pass through your skin. Too much clotrimazole and betamethasone dipropionate cream passing through your skin can cause your adrenal glands to stop working. Your healthcare provider may do blood tests to check for adrenal gland problems. The most common side effects of clotrimazole and betamethasone dipropionate cream include burning, tingling, rash, swelling, and infections. These are not all the possible side effects of clotrimazole and betamethasone dipropionate cream. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store clotrimazole and betamethasone dipropionate cream? Store clotrimazole and betamethasone dipropionate cream at room temperature between 68 F to 77 F (20 C to 25 C). Keep clotrimazole and betamethasone dipropionate cream and all medicines out of the reach of children. General information about the safe and effective use of clotrimazole and betamethasone dipropionate cream. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or healthcare provider for information about clotrimazole and betamethasone dipropionate cream that is written for health professionals. Do not use clotrimazole and betamethasone dipropionate cream for a condition for which it was not prescribed. Do not give clotrimazole and betamethasone dipropionate cream to other people, even if they have the same symptoms that you have. It may harm them. What are the ingredients in clotrimazole and betamethasone dipropionate cream? Active ingredients: clotrimazole, USP and betamethasone dipropionate, USP Inactive ingredients: Ceteareth-30, cetyl alcohol, mineral oil, propylene glycol, purified water, sodium phosphate monobasic monohydrate, stearyl alcohol and white petrolatum; benzyl alcohol as preservative. This Patient Information has been approved by the U.S. Food and Drug Administration. Manufactured by: G&W Laboratories, Inc. 111 Coolidge Street South Plainfield, NJ 07080 USA Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA I600-5511/14A GW7100 Revised July 2016 DermacinRx Zinc Oxide Skin Healing Paste Active ingredient Zinc Oxide 20.0% (3.0% as Calamine) Purpose Skin Protectant Uses for the treatment and/or prevention of diaper rash temporarily protects and helps relieve minor skin irritation and itching due to rashes Warnings For external use only Do not use on deep or puncture wounds animal bites serious burns When using this product do not get into eyes Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of childern. If swallowed, get medical help or contact a Poison Control Center right away. Directions cleanse skin with warm water and soap apply paste to area as needed for G-tubes, cleanse as above, apply thin layer and secure with drain sponge or product as directed Other information protect from freezing avoid excessive heat Inactive ingredients: Aleurites Moluccana Seed Oil, Aloe Barbadensis (Aloe Vera) Leaf Juice, Bisabolol, Calcium Pantothenate (Vitamin B5), Carthamus Tinctorius (Safflower) Oleosomes, Carthamus Tinctorius (Safflower) Seed Oil, Fragrance, Maltodextrin, Modified Corn Starch, Niacinamide (Vitamin B3), Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Petrolatum, Phenoxyethanol, Pyridoxine HCl (Vitamin B6), Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Hyaluronate, Sodium Starch Octenylsuccinate, Tocopheryl Acetate (Vitamin E), Zingiber Officinale (Ginger) Root Extract. DermacinRx Therazole Pak (kit carton) DERMACINRX THERAZOLE PAK clotrimazole and betamethasone dipropionate, zinc oxide kit Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:59088-893 Packaging # Item Code Package Description 1 NDC:59088-893-00 1 KIT in 1 CARTON Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 TUBE 15 g Part 2 30 PACKET 120 g Part 1 of 2 CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE clotrimazole and betamethasone dipropionate cream Product Information Item Code (Source) NDC:0472-0379 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOTRIMAZOLE (CLOTRIMAZOLE) CLOTRIMAZOLE 10 mg in 1 g BETAMETHASONE DIPROPIONATE (BETAMETHASONE) BETAMETHASONE 0.5 mg in 1 g Inactive Ingredients Ingredient Name Strength CETEARETH-30 CETYL ALCOHOL MINERAL OIL PROPYLENE GLYCOL WATER SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE STEARYL ALCOHOL PETROLATUM BENZYL ALCOHOL Packaging # Item Code Package Description 1 NDC:0472-0379-15 1 TUBE in 1 CARTON 1 15 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076002 Part 2 of 2 DERMACINRX ZINC OXIDE SKIN HEALING zinc oxide paste Product Information Item Code (Source) NDC:59088-563 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 200 mg in 1 g Inactive Ingredients Ingredient Name Strength KUKUI NUT OIL ALOE VERA LEAF .ALPHA.-BISABOLOL, (+/-)- CALCIUM PANTOTHENATE CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES SAFFLOWER OIL MALTODEXTRIN MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) NIACINAMIDE PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) PETROLATUM PHENOXYETHANOL PYRIDOXINE HYDROCHLORIDE SILICON DIOXIDE SODIUM ASCORBYL PHOSPHATE HYALURONATE SODIUM .ALPHA.-TOCOPHEROL ACETATE GINGER OIL Packaging # Item Code Package Description 1 NDC:59088-563-01 4 g in 1 PACKET Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA076002 08/09/2016 Labeler - PureTek Corporation (785961046) Revised: 09/2016 PureTek Corporation Print this page} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Recently Approved Lonhala Magnair Lonhala Magnair (glycopyrrolate) is a long-acting muscarinic antagonist (LAMA) bronchodilator for... 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