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matches Ciclodan Generic Name: Ciclopirox Cream (SYE kloe PIR ox) Brand Name: Ciclodan Overview Side Effects Dosage Professional Pregnancy More Breastfeeding Warnings User Reviews Support Group Q & A Pricing & Coupons Uses of Ciclodan: It is used to treat fungal infections of the skin. What do I need to tell my doctor BEFORE I take Ciclodan? If you have an allergy to ciclopirox or any other part of Ciclodan (ciclopirox cream). If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs. This medicine may interact with other drugs or health problems. Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor. Slideshow A Joint Effort: A Provider's Guide To Orthopedic Pain Options What are some things I need to know or do while I take Ciclodan? Tell all of your health care providers that you take Ciclodan. This includes your doctors, nurses, pharmacists, and dentists. Talk with your doctor before you use other drugs or products on your skin. This medicine may cause harm if swallowed. If this medicine is swallowed, call a doctor or poison control center right away. Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using Ciclodan while you are pregnant. Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby. How is this medicine (Ciclodan) best taken? Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely. Use as you have been told, even if your signs get better. To gain the most benefit, do not miss doses. Do not take Ciclodan by mouth. Use on your skin only. Keep out of your mouth, nose, and eyes (may burn). Wash your hands before and after use. Do not wash your hands after use if putting this on your hand. Clean affected part before use. Make sure to dry well. Put a thin layer on the affected skin and rub in gently. Do not use coverings (bandages, dressings) unless told to do so by the doctor. What do I do if I miss a dose? Put on a missed dose as soon as you think about it. If it is close to the time for your next dose, skip the missed dose and go back to your normal time. Do not put on 2 doses or extra doses. Dosage Information (comprehensive) What are some side effects that I need to call my doctor about right away? WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect: Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat. Irritation where this medicine is used. Swelling. Blisters or sores. Oozing or bleeding. Burning. Redness. What are some other side effects of Ciclodan? All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away. These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch. Side Effects (complete list) If OVERDOSE is suspected: If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened. How do I store and/or throw out Ciclodan? Store at room temperature. Store in a dry place. Do not store in a bathroom. Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets. Check with your pharmacist about how to throw out unused drugs. Consumer Information Use and Disclaimer If your symptoms or health problems do not get better or if they become worse, call your doctor. Do not share your drugs with others and do not take anyone else's drugs. Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor. Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins. Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Ciclodan, please talk with your doctor, nurse, pharmacist, or other health care provider. If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened. This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Ciclodan. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Ciclodan. Review Date: December 6, 2017 Next Side Effects Print this page Add to My Med List More about Ciclodan (ciclopirox topical) Side Effects During Pregnancy or Breastfeeding Dosage Information Support Group Pricing & Coupons 1 Review Add your own review/rating Consumer resources Ciclodan Ciclodan Kit Ciclodan Topical (Advanced Reading) Other brands: Penlac , Loprox , Penlac Nail Lacquer , CNL8 Nail , ... +2 more Professional resources Ciclodan (FDA) Ciclodan Cream (FDA) Ciclopirox Olamine (AHFS Monograph) Related treatment guides Cutaneous Candidiasis Onychomycosis, Fingernail Onychomycosis, Toenail Seborrheic Dermatitis ... +4 more Drug Status Rx Availability Prescription only B Pregnancy Category No proven risk in humans N/A CSA Schedule Not a controlled drug Ciclodan Rating 1 User Review 10 /10 1 User Review 10 Rate it! Related Drugs Seborrheic Dermatitis prednisone , hydrocortisone topical , ketoconazole topical , dexamethasone , Decadron , Deltasone , More... Onychomycosis, Toenail terbinafine , Lamisil , ciclopirox topical , Penlac , itraconazole , Jublia , More... Tinea Corporis clotrimazole topical , ketoconazole topical , Lotrisone , terbinafine topical , Lamisil , More... Onychomycosis, Fingernail terbinafine , Lamisil , ciclopirox topical , Penlac , itraconazole , griseofulvin , More... 4 more conditions... and cannot


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unfavorable Sinarest Nasal these days

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Photo :Sinarest Nasal

always Sinarest Nasal Generic Name: oxymetazoline (Nasal route) ox-i-me-TAZ-oh-leen Overview Side Effects Dosage Interactions Pregnancy More Breastfeeding Warnings User Reviews Support Group Q & A Commonly used brand name(s) In the U.S. 4-Way Long Lasting Afrin Duramist Plus Duration Genasal Mucinex Full Force Mucinex Moisture Smart Nasacon Nasin Neo-Synephrine 12 Hour Nostrilla NRS-Nasal Relief Sinarest Nasal Vicks Sinex 12 Hour Available Dosage Forms: Solution Spray Therapeutic Class: Decongestant Chemical Class: Imidazoline Slideshow Seasonal Allergies: Top Prevention Tips Uses For Sinarest Nasal Oxymetazoline is used for the temporary relief of nasal (of the nose) congestion or stuffiness caused by hay fever or other allergies, colds, or sinus trouble. This medicine may also be used for other conditions as determined by your doctor. This medicine is available without a prescription. Before Using Sinarest Nasal In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered: Allergies Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully. Pediatric Children may be especially sensitive to the effects of oxymetazoline. This may increase the chance of side effects during treatment. Geriatric Many medicines have not been tested in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information about the use of oxymetazoline in the elderly. Breast Feeding There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding. Interactions with Medicines Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines. Amineptine Amitriptyline Amitriptylinoxide Amoxapine Carteolol Carvedilol Clomipramine Desipramine Dibenzepin Doxepin Fentanyl Citrate Furazolidone Imipramine Iproniazid Isocarboxazid Labetalol Levobunolol Linezolid Lofepramine Melitracen Methylene Blue Metipranolol Moclobemide Nadolol Nialamide Nortriptyline Opipramol Oxprenolol Penbutolol Phenelzine Pindolol Practolol Procarbazine Propranolol Protriptyline Rasagiline Safinamide Selegiline Sotalol Tianeptine Timolol Tranylcypromine Trimipramine Interactions with Food/Tobacco/Alcohol Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco. Other Medical Problems The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially: Dryness in nose or High blood pressure or Tachycardia (fast heart rate) or Trouble urinating from an enlarged prostate May make these conditions worse. Proper Use of oxymetazoline This section provides information on the proper use of a number of products that contain oxymetazoline. It may not be specific to Sinarest Nasal. Please read with care. To use the nose drops: Blow your nose gently. Tilt the head back while standing or sitting up, or lie down on a bed and hang the head over the side. Place the drops into each nostril and keep the head tilted back for a few minutes to allow the medicine to spread throughout the nose. Rinse the dropper with hot water and dry with a clean tissue. Replace the cap right after use. To avoid spreading a cold or infection, do not use the container for more than one person and throw the container away after your cold is better. To use the nose spray: Blow your nose gently. With the head upright, spray the medicine into each nostril. Sniff briskly while squeezing the bottle quickly and firmly. If needed, blow the nose gently again and repeat the spray process until the total dose is used. Rinse the tip of the spray bottle with hot water, taking care not to suck water into the bottle, and dry with a clean tissue. Replace the cap right after use. To avoid spreading a cold or infection, do not use the container for more than one person and throw the container away after your cold is better. Use this medicine only as directed. Do not use more of it, do not use it more often, and do not use it for longer than 3 days without checking with your doctor. To do so may make your runny or stuffy nose worse and may increase the chance of side effects. Dosing The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so. The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine. For nasal dosage form (nose drops or spray): For nasal congestion or stuffiness: Adults and children 6 years of age and older Use 2 or 3 drops or sprays of 0.05% solution in each nostril every ten to twelve hours. Do not use more than two times in twenty four hours. Children up to 6 years of age Use and dose must be determined by your doctor. Missed Dose If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses. Storage Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children. Do not keep outdated medicine or medicine no longer needed. Sinarest Nasal Side Effects Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Check with your doctor immediately if any of the following side effects occur: Blurred vision fast, irregular, or pounding heartbeat headache, dizziness, drowsiness, or lightheadedness high blood pressure increase in runny or stuffy nose nervousness trembling trouble in sleeping weakness Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: Burning, dryness, or stinging inside of nose sneezing Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. Side Effects (complete list) The information contained in the Truven Health Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you. The use of the Truven Health products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Truven Health and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, TRUVEN HEALTH MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Truven Health does not assume any responsibility or risk for your use of the Truven Health products. Copyright 2017 Truven Health Analytics, Inc. All Rights Reserved. Next Side Effects Print this page Add to My Med List More about Sinarest Nasal (oxymetazoline nasal) Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Interactions Support Group En Espaรฑol 0 Reviews Add your own review/rating Drug class: nasal antihistamines and decongestants Consumer resources Sinarest Nasal Other brands: Afrin , Nostrilla , Afrin Sinus , Zicam Sinus Relief , ... +22 more Professional resources Other Formulations Sinarest Sinus Related treatment guides Nasal Congestion} Drug Status OTC Availability Over the counter C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Drug Class Nasal antihistamines and decongestants Related Drugs Nasal Congestion sodium chloride nasal , epinephrine topical , pseudoephedrine , phenylephrine , Afrin , doxylamine , Sudafed Congestion , Claritin-D , loratadine / pseudoephedrine , Loratadine-D 24 Hour , Saline Nasal Mist , oxymetazoline nasal , Nostrilla , Neo-Synephrine , Sudafed 12-Hour , SudoGest , Ayr Saline Nasal , Loratadine-D 12 Hour , naphazoline nasal , tetrahydrozoline nasal , Ocean , More... Sinarest Nasal Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! Help and Support Looking for answers? Ask a question or go join the Sinarest Nasal support group to connect with others who have similar interests.} } normal


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it should [1%:<1% Injection:> <1% Cervical Cap with spermicides: 20 to 40% IUD: 1 to 2% Condom alone (male): 14% Diaphragm with Condom alone (female): 21% spermicides: 20% Periodic abstinence: 25% Spermicides alone: 26% Withdrawal: 19% Vaginal sponge: 20 to 40% No methods: 85% Female sterilization:> <1% WHO SHOULD NOT TAKE ORAL CONTRACEPTIVES Cigarette smoking increases the risk of serious cardiovascular side effects from oral contraceptive use. This risk increases with age and with heavy smoking (15 or more cigarettes per day) and is quite marked in women over 35 years of age. Women who use oral contraceptives are strongly advised not to smoke. Some women should not use the pill. For example, you should not take the pill if you are pregnant or think you may be pregnant. You should also not use the pill if you have any of the following conditions: A history of heart attack or stroke Blood clots in the legs (thrombophlebitis), lungs (pulmonary embolism), or eyes A history of blood clots in the deep veins of your legs Chest pain (angina pectoris) Known or suspected breast cancer or cancer of the lining of the uterus, cervix or vagina Unexplained vaginal bleeding (until a diagnosis is reached by your doctor) Yellowing of the whites of the eyes or of the skin (jaundice) during pregnancy or during previous use of the pill Liver tumor (benign or cancerous) Known or suspected pregnancy Tell your health care provider if you have ever had any of these conditions. Your health care provider can recommend a safer method of birth control. OTHER CONSIDERATIONS BEFORE TAKING ORAL CONTRACEPTIVES Tell your health care provider if you have or have had: Breast nodules, fibrocystic disease of the breast, an abnormal breast x-ray or mammogram Diabetes Elevated cholesterol or triglycerides High blood pressure Migraine or other headaches or epilepsy Mental depression Gallbladder, heart or kidney disease History of scanty or irregular menstrual periods Women with any of these conditions should be checked often by their health care provider if they choose to use oral contraceptives. Also, be sure to inform your doctor or health care provider if you smoke or are on any medications. RISKS OF TAKING ORAL CONTRACEPTIVES 1. Risk of developing blood clots Blood clots and blockage of blood vessels are one of the most serious side effects of taking oral contraceptives and can cause death or serious disability. In particular, a clot in the legs can cause thrombophlebitis and a clot that travels to the lungs can cause a sudden blocking of the vessel carrying blood to the lungs. Rarely, clots occur in the blood vessels of the eye and may cause blindness, double vision, or impaired vision. If you take oral contraceptives and need elective surgery, need to stay in bed for a prolonged illness or have recently delivered a baby, you may be at risk of developing blood clots. You should consult your doctor about stopping oral contraceptives three to four weeks before surgery and not taking oral contraceptives for two weeks after surgery or during bed rest. You should also not take oral contraceptives soon after delivery of a baby. It is advisable to wait for at least four weeks after delivery if you are not breast feeding or four weeks after a second trimester abortion. If you are breast feeding, you should wait until you have weaned your child before using the pill. (See also the section on Breast Feeding in General Precautions.) The risk of circulatory disease in oral contraceptive users may be higher in users of high-dose pills and may be greater with longer duration of oral contraceptive use. In addition, some of these increased risks may continue for a number of years after stopping oral contraceptives. The risk of abnormal blood clotting increases with age in both users and nonusers of oral contraceptives, but the increased risk from the oral contraceptive appears to be present at all ages. For women aged 20 to 44, it is estimated that about 1 in 2,000 using oral contraceptives will be hospitalized each year because of abnormal clotting. Among nonusers in the same age group, about 1 in 20,000 would be hospitalized each year. For oral contraceptive users in general, it has been estimated that in women between the ages of 15 and 34 the risk of death due to a circulatory disorder is about 1 in 12,000 per year, whereas for nonusers the rate is about 1 in 50,000 per year. In the age group 35 to 44, the risk is estimated to be about 1 in 2,500 per year for oral contraceptive users and about 1 in 10,000 per year for nonusers. 2. Heart attacks and strokes Oral contraceptives may increase the tendency to develop strokes (stoppage or rupture of blood vessels in the brain) and angina pectoris and heart attacks (blockage of blood vessels in the heart). Any of these conditions can cause death or serious disability. Smoking greatly increases the possibility of suffering heart attacks and strokes. Furthermore, smoking and the use of oral contraceptives greatly increase the chances of developing and dying of heart disease. 3. Gallbladder disease Oral contraceptive users probably have a greater risk than nonusers of having gallbladder disease, although this risk may be related to pills containing high doses of estrogens. 4. Liver tumors In rare cases, oral contraceptives can cause benign but dangerous liver tumors. These benign liver tumors can rupture and cause fatal internal bleeding. In addition, some studies report an increased risk of developing liver cancer. However, liver cancers are rare. 5. Cancer of the reproductive organs and breasts There is conflict among studies regarding breast cancer and oral contraceptive use. Some studies have reported an increase in the risk of developing breast cancer particularly at a younger age. The increased risk appears to be related to duration of use. The majority of studies have found no overall increase in the risk of developing breast cancer. A meta-analysis of 54 studies found a small increase in the frequency of having breast cancer diagnosed for women who were currently using combined oral contraceptives or had used them within the past ten years. This increase in the frequency of breast cancer diagnosis within ten years of stopping use, was generally accounted for by cancers localized to the breast. There was no increase in the frequency of having breast cancer diagnosed ten or more years after cessation of use. Some studies have found an increase in the incidence of cancer of the cervix in women who use oral contraceptives. However, this finding may be related to factors other than the use of oral contraceptives. There is insufficient evidence to rule out the possibility that the pill may cause such cancers. ESTIMATED RISK OF DEATH FROM A BIRTH CONTROL METHOD OR PREGNANCY All methods of birth control and pregnancy are associated with a risk of developing certain diseases which may lead to disability or death. An estimate of the number of deaths associated with different methods of birth control and pregnancy has been calculated and is shown in the following table. ANNUAL NUMBER OF BIRTH-RELATED OR METHOD-RELATED DEATHS ASSOCIATED WITH CONTROL OF FERTILITY PER 100,000 NONSTERILE WOMEN, BY FERTILITY CONTROL METHOD ACCORDING TO AGE Method of control and outcome 15-19 20-24 25-29 30-34 35-39 40-44 No fertility control methods* 7.0 7.4 9.1 14.8 25.7 28.2 Oral contraceptives non-smoker** 0.3 0.5 0.9 1.9 13.8 31.6 Oral contraceptives smoker** 2.2 3.4 6.6 13.5 51.1 117.2 IUD** 0.8 0.8 1.0 1.0 1.4 1.4 Condom* 1.1 1.6 0.7 0.2 0.3 0.4 Diaphragm/spermicide* 1.9 1.2 1.2 1.3 2.2 2.8 Periodic abstinence* 2.5 1.6 1.6 1.7 2.9 3.6 * Deaths are birth-related. **Deaths are method-related. In the above table, the risk of death from any birth control method is less than the risk of childbirth, except for oral contraceptive users over the age of 35 who smoke and pill users over the age of 40 even if they do not smoke. It can be seen in the table that for women aged 15 to 39, the risk of death was highest with pregnancy (7-26 deaths per 100,000 women, depending on age). Among pill users who do not smoke, the risk of death was always lower than that associated with pregnancy for any age group, although over the age of 40, the risk increases to 32 deaths per 100,000 women, compared to 28 associated with pregnancy at that age. However, for pill users who smoke and are over the age of 35, the estimated number of deaths exceeds those for other methods of birth control. If a woman is over the age of 40 and smokes, her estimated risk of death is four times higher (117/100,000 women) than the estimated risk associated with pregnancy (28/100,000 women) in that age group. The suggestion that women over 40 who do not smoke should not take oral contraceptives is based on information from older, higher-dose pills. An Advisory Committee of the FDA discussed this issue in 1989 and recommended that the benefits of low-dose oral contraceptive use by healthy, nonsmoking women over 40 years of age may outweigh the possible risks. WARNING SIGNALS If any of these adverse effects occur while you are taking oral contraceptives, call your doctor immediately: Sharp chest pain, coughing of blood, or sudden shortness of breath (indicating a possible clot in the lung) Pain in the calf (indicating a possible clot in the leg) Crushing chest pain or heaviness in the chest (indicating a possible heart attack) Sudden severe headache or vomiting, dizziness or fainting, disturbances of vision or speech, weakness, or numbness in an arm or leg (indicating a possible stroke) Sudden partial or complete loss of vision (indicating a possible clot in the eye) Breast lumps (indicating possible breast cancer or fibrocystic disease of the breast; ask your doctor or health care provider to show you how to examine your breasts) Severe pain or tenderness in the stomach area (indicating a possibly ruptured liver tumor) Difficulty in sleeping, weakness, lack of energy, fatigue, or change in mood (possibly indicating severe depression) Jaundice or a yellowing of the skin or eyeballs, accompanied frequently by fever, fatigue, loss of appetite, dark colored urine, or light colored bowel movements (indicating possible liver problems) SIDE EFFECTS OF ORAL CONTRACEPTIVES 1. Vaginal bleeding Irregular vaginal bleeding or spotting may occur while you are taking the pills. Irregular bleeding may vary from slight staining between menstrual periods to breakthrough bleeding which is a flow much like a regular period. Irregular bleeding occurs most often during the first few months of oral contraceptive use, but may also occur after you have been taking the pill for some time. Such bleeding may be temporary and usually does not indicate any serious problems. It is important to continue taking your pills on schedule. If the bleeding occurs in more than one cycle or lasts for more than a few days, talk to your doctor or health care provider. 2. Contact lenses If you wear contact lenses and notice a change in vision or an inability to wear your lenses, contact your doctor or health care provider. 3. Fluid retention Oral contraceptives may cause edema (fluid retention) with swelling of the fingers or ankles and may raise your blood pressure. If you experience fluid retention, contact your doctor or health care provider. 4. Melasma A spotty darkening of the skin is possible, particularly of the face, which may persist. 5. Other side effects Other side effects may include nausea and vomiting, change in appetite, headache, nervousness, depression, dizziness, loss of scalp hair, rash, and vaginal infections. If any of these side effects bother you, call your doctor or health care provider. GENERAL PRECAUTIONS 1. Missed periods and use of oral contraceptives before or during early pregnancy There may be times when you may not menstruate regularly after you have completed taking a cycle of pills. If you have taken your pills regularly and miss one menstrual period, continue taking your pills for the next cycle but be sure to inform your health care provider before doing so. If you have not taken the pills daily as instructed and missed a menstrual period, you may be pregnant. If you missed two consecutive menstrual periods, you may be pregnant. Check with your health care provider immediately to determine whether you are pregnant. Do not continue to take oral contraceptives until you are sure you are not pregnant, but continue to use another method of contraception. There is no conclusive evidence that oral contraceptive use is associated with an increase in birth defects, when taken inadvertently during early pregnancy. Previously, a few studies had reported that oral contraceptives might be associated with birth defects, but these findings have not been seen in more recent studies. Nevertheless, oral contraceptives or any other drugs should not be used during pregnancy unless clearly necessary and prescribed by your doctor. You should check with your doctor about risks to your unborn child of any medication taken during pregnancy. 2. While breast feeding If you are breast feeding, consult your doctor before starting oral contraceptives. Some of the drug will be passed on to the child in the milk. A few adverse effects on the child have been reported, including yellowing of the skin (jaundice) and breast enlargement. In addition, combination oral contraceptives may decrease the amount and quality of your milk. If possible, do not use combination oral contraceptives while breast feeding. You should use another method of contraception since breast feeding provides only partial protection from becoming pregnant and this partial protection decreases significantly as you breast feed for longer periods of time. You should consider starting combination oral contraceptives only after you have weaned your child completely. 3. Laboratory tests If you are scheduled for any laboratory tests, tell your doctor you are taking birth control pills. Certain blood tests may be affected by birth control pills. 4. Drug interactions Certain drugs may interact with birth control pills to make them less effective in preventing pregnancy or cause an increase in breakthrough bleeding. Such drugs include rifampin, drugs used for epilepsy such as barbiturates (for example, phenobarbital), anticonvulsants such as carbamazepine (Tegretol is one brand of this drug), phenytoin (Dilantin is one brand of this drug), phenylbutazone (Butazolidin is one brand), and possibly certain antibiotics. Hormonal contraceptives may interact with lamotrigine (LAMICTAL ), an anticonvulsant used for epilepsy. This may increase the risk of seizures so your healthcare professional may need to adjust the dose of lamotrigine. You may need to use additional contraception when you take drugs which can make oral contraceptives less effective. 5. Sexually transmitted diseases This product (like all oral contraceptives) is intended to prevent pregnancy. It does not protect against transmission of HIV (AIDS) and other sexually transmitted diseases such as chlamydia, genital herpes, genital warts, gonorrhea, hepatitis B, and syphilis. HOW TO TAKE THE PILL IMPORTANT POINTS TO REMEMBER BEFORE YOU START TAKING YOUR PILLS: 1. BE SURE TO READ THESE DIRECTIONS: Before you start taking your pills. Anytime you are not sure what to do. 2. THE RIGHT WAY TO TAKE THE PILL IS TO TAKE ONE PILL EVERY DAY AT THE SAME TIME. If you miss pills you could get pregnant. This includes starting the pack late. The more pills you miss, the more likely you are to get pregnant. 3. MANY WOMEN HAVE SPOTTING OR LIGHT BLEEDING, OR MAY FEEL SICK TO THEIR STOMACH DURING THE FIRST 1-3 PACKS OF PILLS. If you feel sick to your stomach, do not stop taking the pill. The problem will usually go away. If it doesn t go away, check with your doctor or clinic. 4. MISSING PILLS CAN ALSO CAUSE SPOTTING OR LIGHT BLEEDING, even when you make up these missed pills. On the days you take 2 pills to make up for missed pills, you could also feel a little sick to your stomach. 5. IF YOU HAVE VOMITING OR DIARRHEA, for any reason or IF YOU TAKE SOME MEDICINES, including some antibiotics, your pills may not work as well. Use a back-up method (such as condoms, foam or sponge) until you check with your doctor or clinic. 6. IF YOU HAVE TROUBLE REMEMBERING TO TAKE THE PILL, talk to your doctor or clinic about how to make pill-taking easier or about using another method of birth control. 7. IF YOU HAVE ANY QUESTIONS OR ARE UNSURE ABOUT THE INFORMATION IN THIS LEAFLET, call your doctor or clinic. BEFORE YOU START TAKING YOUR PILLS 1. DECIDE WHAT TIME OF DAY YOU WANT TO TAKE YOUR PILL. It is important to take it at about the same time every day. 2. LOOK AT YOUR PILL PACK TO SEE THAT IT HAS 28 PILLS. The 28-pill pack has 21 active pills (with hormones) to take for 3 weeks. This is followed by 1 week of reminder light green pills (without hormones). Alyacen 1/35: There are 21 peach active pills and 7 light green reminder pills 3. ALSO FIND: 1) where on the pack to start taking pills, 2) in what order to take the pills. 3) see pill package diagram above. 4. BE SURE YOU HAVE READY AT ALL TIMES: ANOTHER KIND OF BIRTH CONTROL (such as condoms, foam or sponge) to use as a back-up in case you miss pills. AN EXTRA, FULL PILL PACK. WHEN TO START THE FIRST PACK OF PILLS You have a choice of which day to start taking your first pack of pills. Decide with your doctor or clinic which is the best day for you. Pick a time of day which will be easy to remember. SUNDAY START: Alyacen 1/35: Take the first active peach pill of the first pack on the Sunday after your period starts , even if you are still bleeding. If your period begins on Sunday, start the pack the same day. Use another method of birth control as a back-up method if you have sex anytime from the Sunday you start your first pack until the next Sunday (7 days). DAY 1 START: Alyacen 1/35: Take the first active peach pill of the first pack during the first 24 hours of your period. 1. Pick the day label strip that starts with the first day of your period (this is the day you start bleeding or spotting, even if it is almost midnight when the bleeding begins). 2. Place this day label strip on the tablet blister card over the area that has the days of the week (starting with Sunday) imprinted in the plastic. Note : If the first day of your period is a Sunday, you can skip steps #1 and #2. You will not need to use a back-up method of birth control, since you are starting the pill at the beginning of your period. WHAT TO DO DURING THE MONTH 1. TAKE ONE PILL AT THE SAME TIME EVERY DAY UNTIL THE PACK IS EMPTY. Do not skip pills even if you are spotting or bleeding between monthly periods or feel sick to your stomach (nausea). Do not skip pills even if you do not have sex very often. 2. WHEN YOU FINISH A PACK OR SWITCH YOUR BRAND OF PILLS: Start the next pack on the day after your last light green reminder pill. Do not wait any days between packs. WHAT TO DO IF YOU MISS PILLS Alyacen 1/35: If you MISS 1 peach active pill: 1. Take it as soon as you remember. Take the next pill at your regular time. This means you may take 2 pills in 1 day. 2. You do not need to use a back-up birth control method if you have sex. If you MISS 2 peach active pills in a row in WEEK 1 OR WEEK 2 of your pack: 1. Take 2 pills on the day you remember and 2 pills the next day. 2. Then take 1 pill a day until you finish the pack. 3. You MAY BECOME PREGNANT if you have sex in the 7 days after you miss pills. You MUST use another birth control method (such as condoms, foam or sponge) as a back-up for those 7 days. If you MISS 2 peach active pills in a row in THE 3RD WEEK : 1. If you are a Sunday Starter: Keep taking 1 pill every day until Sunday. On Sunday, THROW OUT the rest of the pack and start a new pack of pills that same day. If you are a Day 1 Starter: THROW OUT the rest of the pill pack and start a new pack that same day. 2. You may not have your period this month but this is expected. However, if you miss your period 2 months in a row, call your doctor or clinic because you might be pregnant. 3. You MAY BECOME PREGNANT if you have sex in the 7 days after you miss pills. You MUST use another birth control method (such as condoms, foam or sponge) as a back-up for those 7 days. If you MISS 3 OR MORE peach active pills in a row (during the first 3 weeks): 1. If you are a Sunday Starter: Keep taking 1 pill every day until Sunday. On Sunday, THROW OUT the rest of the pack and start a new pack of pills that same day. If you are a Day 1 Starter: THROW OUT the rest of the pill pack and start a new pack that same day. 2. You may not have your period this month but this is expected. However, if you miss your period 2 months in a row, call your doctor or clinic because you might be pregnant. 3. You MAY BECOME PREGNANT if you have sex in the 7 days after you miss pills. You MUST use another birth control method (such as condoms, foam or sponge) as a back-up method for those 7 days. A REMINDER FOR THOSE ON 28-DAY PACKS: If you forget any of the 7 light green reminder pills in Week 4: THROW AWAY the pills you missed. Keep taking 1 pill each day until the pack is empty. You do not need a back-up method. FINALLY, IF YOU ARE STILL NOT SURE WHAT TO DO ABOUT THE PILLS YOU HAVE MISSED: Use a BACK-UP METHOD anytime you have sex. KEEP TAKING ONE ACTIVE PILL EACH DAY until you can reach your doctor or clinic. PREGNANCY DUE TO PILL FAILURE Combination Oral Contraceptives The incidence of pill failure resulting in pregnancy is approximately one percent (i.e., one pregnancy per 100 women per year) if taken every day as directed, but more typical failure rates are about 3%. If failure does occur, the risk to the fetus is minimal. PREGNANCY AFTER STOPPING THE PILL There may be some delay in becoming pregnant after you stop using oral contraceptives, especially if you had irregular menstrual cycles before you used oral contraceptives. It may be advisable to postpone conception until you begin menstruating regularly once you have stopped taking the pill and desire pregnancy. There does not appear to be any increase in birth defects in newborn babies when pregnancy occurs soon after stopping the pill. OVERDOSAGE Serious ill effects have not been reported following ingestion of large doses of oral contraceptives by young children. Overdosage may cause nausea and withdrawal bleeding in females. In case of overdosage, contact your health care provider or pharmacist. OTHER INFORMATION Your health care provider will take a medical and family history before prescribing oral contraceptives and will examine you. The physical examination may be delayed to another time if you request it and the health care provider believes that it is a good medical practice to postpone it. You should be reexamined at least once a year. Be sure to inform your health care provider if there is a family history of any of the conditions listed previously in this leaflet. Be sure to keep all appointments with your health care provider, because this is a time to determine if there are early signs of side effects of oral contraceptive use. Do not use the drug for any condition other than the one for which it was prescribed. This drug has been prescribed specifically for you; do not give it to others who may want birth control pills. HEALTH BENEFITS FROM ORAL CONTRACEPTIVES In addition to preventing pregnancy, use of combination oral contraceptives may provide certain benefits. They are: menstrual cycles may become more regular blood flow during menstruation may be lighter and less iron may be lost. Therefore, anemia due to iron deficiency is less likely to occur. pain or other symptoms during menstruation may be encountered less frequently ectopic (tubal) pregnancy may occur less frequently noncancerous cysts or lumps in the breast may occur less frequently acute pelvic inflammatory disease may occur less frequently oral contraceptive use may provide some protection against developing two forms of cancer: cancer of the ovaries and cancer of the lining of the uterus. If you want more information about birth control pills, ask your doctor/health care provider or pharmacist. They have a more technical leaflet called the Professional Labeling, which you may wish to read. The professional labeling is also published in a book entitled Physicians Desk Reference, available in many book stores and public libraries. Manufactured by: Glenmark Generics Ltd. Colvale-Bardez, Goa 403 513, India Manufactured for: Glenmark Generics Inc., USA Mahwah, NJ 07430 Questions? 1 (888)721-7115 www.glenmarkgenerics.com March 2012 Alyacen 1/35 - Carton Label Alyacen 1/35 - Pouch Label Alyacen 1/35 - Blister Pack Alyacen 1/35 norethindrone and ethinyl estradiol kit Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68462-394 Packaging # Item Code Package Description 1 NDC:68462-394-29 3 BLISTER PACK in 1 CARTON 1 NDC:68462-394-84 1 KIT in 1 BLISTER PACK Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 21 Part 2 7 Part 1 of 2 Alyacen 1/35 norethindrone and ethinyl estradiol tablet Product Information Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength NORETHINDRONE (NORETHINDRONE) NORETHINDRONE 1 mg ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 0.035 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE FD&C YELLOW NO. 6 ANHYDROUS LACTOSE LACTOSE MONOHYDRATE MAGNESIUM STEARATE STARCH, CORN TALC Product Characteristics Color PINK (Peach) Score no score Shape ROUND (flat faced , beveled edged) Size 7mm Flavor Imprint Code A1 Contains Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091634 01/19/2012 Part 2 of 2 Alyacen 1/35 inert tablet Product Information Route of Administration ORAL DEA Schedule Inactive Ingredients Ingredient Name Strength D&C YELLOW NO. 10 FD&C BLUE NO. 2 LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE TALC STARCH, CORN Product Characteristics Color GREEN (light green) Score no score Shape ROUND (flat faced , beveled edged) Size 7mm Flavor Imprint Code A2 Contains Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091634 01/19/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA091634 01/19/2012 Labeler - Glenmark Generics Inc.,USA (835917282) Establishment Name Address ID/FEI Operations Glenmark Generics Limited 677318665 ANALYSIS(68462-394), MANUFACTURE(68462-394) Revised: 03/2012 Glenmark Generics Inc.,USA Next Interactions Print this page Add to My Med List More about Alyacen 1/35 (ethinyl estradiol / norethindrone) Side Effects During Pregnancy Dosage Information Drug Images Drug Interactions Support Group Pricing & Coupons 7 Reviews Add your own review/rating Drug class: contraceptives Consumer resources Professional resources Norethindrone, Ethinyl Estradiol and Ferrous Fumarate (FDA) Other brands: Lo Loestrin Fe , Microgestin Fe 1/20 , Loestrin 24 Fe , Necon 1/35 , ... +72 more Related treatment guides Birth Control> ]} 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 X Pregnancy Category Not for use in pregnancy N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Manufacturer Glenmark Pharmaceuticals Inc., USA Drug Class Contraceptives Sex hormone combinations Related Drugs contraceptives medroxyprogesterone , Provera , Depo-Provera , norethindrone , Mirena , Nexplanon sex hormone combinations Prempro , Lo Loestrin Fe , Estratest , Microgestin Fe 1 / 20 , Activella , Loestrin 24 Fe Birth Control medroxyprogesterone , Provera , Depo-Provera , norethindrone , Mirena , Nexplanon , Sprintec , levonorgestrel , NuvaRing , Ortho Tri-Cyclen , Yasmin , Yaz , TriNessa , Aviane , Lo Loestrin Fe , Apri , Alesse , Mononessa , Microgestin Fe 1 / 20 , Camila , Xulane , Seasonique , Lutera , Levora , Ortho Evra , More... Alyacen 1 / 35 Rating 7 User Reviews 4.0 /10 7 User Reviews 4.0 Rate it! Alyacen 1 / 35 Images Alyacen 1 / 35 ethinyl estradiol 0.035 mg / norethindrone 1 mg (A1 ) View larger images} } a designated


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Photo :Lubricants

the variety Home Getting Pregnant Conception Lubricants Lubricants If you've been trying to conceive (TTC) but have nothing to show for months of trying, it's time to take a closer look at your love life to see if you can identify the barrier between you and that baby. It may be as simple as having sex at a more fertile time of your cycle, or abstaining from sex for a couple of days so your partner's sperm count can rebuild. Or the problem may be your lubricant. Pleasure And Pain Vaginal dryness can be a fact of life for some women, and applying a lubricant can make the difference between pleasure and pain during a lovemaking session. But many women don't realize that most lubricants can harm sperm. That said, while most water-based lubricants are hostile to sperm, in no way should they be considered adequate contraception. Lubricants are not spermicides and do not protect you against pregnancy. Most of them do have an adverse affect on sperm, though, and it's important to be aware of this issue when planning conception. There is one lubricant on the market that is designed not to harm sperm. This lubricant is called Pre-Seed and is available in several countries. Pre-Seed is the only water-based lubricant that is a safe substitute for a woman's own vaginal secretions when trying to conceive. Canola Oil The idea that lubricants are harmful to sperm is not a new one. A study performed back in 1996 measured the harmful effects of the various types of commercial lubricants on sperm motility and longevity. Some of the lubricants studied include K-Y Jelly, Touch, Replens, and Astroglide. In addition to these lubricants, two oils were tested, among them regular kitchen-quality canola oil. The various preparations and substances were mixed with sperm and the effects were measured at intervals of 1, 15, 30, and 60 minutes. All of the four commercial preparations tested in the study proved to inhibit sperm motility within the space of an hour at a rate of 60-100%. This result is comparable with that of the most common spermicidal agents containing nonoxynol-9. Nonoxynol-9 is found in most contraceptive foams, jellies, and creams. Of the various lubricants tested, only canola oil was found to have no measurable impact on sperm, though most couples would find the oil stains bedding and is messy to use. The results of the 1996 study were published in International Journal of Fertility and Menopausal Studies. At least one independent chemist has made the suggestion that the lubricants may be too saline and that this salinity, added to the fact of preservatives and a PH balance that is different from that of female humans may be the reason for their adverse affect on sperm. A possible alternative may be found in a homemade option created from natural ingredients found in your own kitchen. Some popular options include egg whites, glycerin, or ground flax seed cooked in water. Sperm Friendly It's unfortunate that the manufacturers producing commercial lubricants have not addressed the problem of sperm damage incurred during the use of their products. Pre-Seed is the only commercial lubricant available that is designed to imitate a woman's own cervical mucus and is therefore a sperm-friendly product. The lubricant is still not in wide distribution so you may need to search the internet for a source. Login to comment Log in or sign up Forgot Password? Username: Password: CANCEL (0 Comments) Login to add a comment Post a comment You must be logged in to comment. respectable


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effective r the hematologic toxicities or where otherwise noted. Table 5 - Treatment Emergent Adverse Reactions Regardless of Relationship to Treatment in Patients Receiving Docetaxel as Monotherapy for Non-Small Cell Lung Cancer Previously Treated with Platinum-Based Chemotherapy * * Normal Baseline LFTs: Transaminases   1.5 times ULN or alkaline phosphatase   2.5 times ULN or  isolated elevations  of transaminases or alkaline phosphatase up to 5 times ULN   Febrile  Neutropenia: ANC grade 4 with fever >38 C with intravenous antibiotics and/or hospitalization.   Not Applicable;   Not Done   COSTART term and grading system   Adverse Reaction Docetaxel 75 mg/m 2 n=176 %  Best Supportive Care n=49 % Vinorelbine/ Ifosfamide n=119 %  Neutropenia Any Grade 3/4  84 65  14 12  83 57 Leukopenia Any Grade 3/4  84 49  6 0  89 43 Thrombocytopenia Any Grade 3/4  8 3  0 0  8 2 Anemia Any Grade 3/4  91 9  55 12  91 14 Febrile Neutropenia    6  NA    1 Infection Any Grade 3/4  34 10  29 6  30 9 Treatment Related Mortality  3  NA    3 Hypersensitivity Reactions Any Grade 3/4   6 3   0 0   1 0 Fluid Retention Any Severe  34 3  ND     23 3 Neurosensory Any Grade 3/4  23 2  14 6  29 5 Neuromotor Any Grade 3/4  16 5  8 6  10 3 Skin Any Grade 3/4  20 1  6 2  17 1 Gastrointestinal Nausea Any Grade 3/4 Vomiting Any Grade 3/4 Diarrhea Any Grade 3/4   34 5  22 3  23 3   31 4  27 2  6 0   31 8  22 6  12 4 Alopecia 56 35 50 Asthenia Any Severe    53 18  57 39  54 23 Stomatitis Any Grade 3/4  26 2  6 0  8 1 Pulmonary Any Grade 3/4  41 21  49 29  45 19 Nail Disorder Any Severe    11 1  0 0  2 0 Myalgia Any Severe    6 0  0 0  3 0 Arthralgia Any Severe    3 0  2 0  2 1 Taste Perversion Any Severe    6 1  0 0  0 0 Combination therapy with docetaxel in chemotherapy-naรฏve advanced unresectable or metastatic NSCLC Table 6 presents safety data from two arms of an open label costs

effective r the hematologic toxicities or where otherwise noted. Table 5 - Treatment Emergent Adverse Reactions Regardless of Relationship to Treatment in Patients Receiving Docetaxel as Monotherapy for Non-Small Cell Lung Cancer Previously Treated with Platinum-Based Chemotherapy * * Normal Baseline LFTs: Transaminases 1.5 times ULN or alkaline phosphatase 2.5 times ULN or isolated elevations of transaminases or alkaline phosphatase up to 5 times ULN Febrile Neutropenia: ANC grade 4 with fever >38 C with intravenous antibiotics and/or hospitalization. Not Applicable; Not Done COSTART term and grading system Adverse Reaction Docetaxel 75 mg/m 2 n=176 % Best Supportive Care n=49 % Vinorelbine/ Ifosfamide n=119 % Neutropenia Any Grade 3/4 84 65 14 12 83 57 Leukopenia Any Grade 3/4 84 49 6 0 89 43 Thrombocytopenia Any Grade 3/4 8 3 0 0 8 2 Anemia Any Grade 3/4 91 9 55 12 91 14 Febrile Neutropenia 6 NA 1 Infection Any Grade 3/4 34 10 29 6 30 9 Treatment Related Mortality 3 NA 3 Hypersensitivity Reactions Any Grade 3/4 6 3 0 0 1 0 Fluid Retention Any Severe 34 3 ND 23 3 Neurosensory Any Grade 3/4 23 2 14 6 29 5 Neuromotor Any Grade 3/4 16 5 8 6 10 3 Skin Any Grade 3/4 20 1 6 2 17 1 Gastrointestinal Nausea Any Grade 3/4 Vomiting Any Grade 3/4 Diarrhea Any Grade 3/4 34 5 22 3 23 3 31 4 27 2 6 0 31 8 22 6 12 4 Alopecia 56 35 50 Asthenia Any Severe 53 18 57 39 54 23 Stomatitis Any Grade 3/4 26 2 6 0 8 1 Pulmonary Any Grade 3/4 41 21 49 29 45 19 Nail Disorder Any Severe 11 1 0 0 2 0 Myalgia Any Severe 6 0 0 0 3 0 Arthralgia Any Severe 3 0 2 0 2 1 Taste Perversion Any Severe 6 1 0 0 0 0 Combination therapy with docetaxel in chemotherapy-naรฏve advanced unresectable or metastatic NSCLC Table 6 presents safety data from two arms of an open label costs

music r the hematologic toxicities or where otherwise noted. Table 5 - Treatment Emergent Adverse Reactions Regardless of Relationship to Treatment in Patients Receiving Docetaxel as Monotherapy for Non-Small Cell Lung Cancer Previously Treated with Platinum-Based Chemotherapy * * Normal Baseline LFTs: Transaminases 1.5 times ULN or alkaline phosphatase 2.5 times ULN or isolated elevations of transaminases or alkaline phosphatase up to 5 times ULN Febrile Neutropenia: ANC grade 4 with fever >38 C with intravenous antibiotics and/or hospitalization. Not Applicable; Not Done COSTART term and grading system Adverse Reaction Docetaxel 75 mg/m 2 n=176 % Best Supportive Care n=49 % Vinorelbine/ Ifosfamide n=119 % Neutropenia Any Grade 3/4 84 65 14 12 83 57 Leukopenia Any Grade 3/4 84 49 6 0 89 43 Thrombocytopenia Any Grade 3/4 8 3 0 0 8 2 Anemia Any Grade 3/4 91 9 55 12 91 14 Febrile Neutropenia 6 NA 1 Infection Any Grade 3/4 34 10 29 6 30 9 Treatment Related Mortality 3 NA 3 Hypersensitivity Reactions Any Grade 3/4 6 3 0 0 1 0 Fluid Retention Any Severe 34 3 ND 23 3 Neurosensory Any Grade 3/4 23 2 14 6 29 5 Neuromotor Any Grade 3/4 16 5 8 6 10 3 Skin Any Grade 3/4 20 1 6 2 17 1 Gastrointestinal Nausea Any Grade 3/4 Vomiting Any Grade 3/4 Diarrhea Any Grade 3/4 34 5 22 3 23 3 31 4 27 2 6 0 31 8 22 6 12 4 Alopecia 56 35 50 Asthenia Any Severe 53 18 57 39 54 23 Stomatitis Any Grade 3/4 26 2 6 0 8 1 Pulmonary Any Grade 3/4 41 21 49 29 45 19 Nail Disorder Any Severe 11 1 0 0 2 0 Myalgia Any Severe 6 0 0 0 3 0 Arthralgia Any Severe 3 0 2 0 2 1 Taste Perversion Any Severe 6 1 0 0 0 0 Combination therapy with docetaxel in chemotherapy-naรฏve advanced unresectable or metastatic NSCLC Table 6 presents safety data from two arms of an open label involved
 
Photo :r the hematologic toxicities or where otherwise noted. Table 5 - Treatment Emergent Adverse Reactions Regardless of Relationship to Treatment in Patients Receiving Docetaxel as Monotherapy for Non-Small Cell Lung Cancer Previously Treated with Platinum-Based Chemotherapy * * Normal Baseline LFTs: Transaminases 1.5 times ULN or alkaline phosphatase 2.5 times ULN or isolated elevations of transaminases or alkaline phosphatase up to 5 times ULN Febrile Neutropenia: ANC grade 4 with fever >38 C with intravenous antibiotics and/or hospitalization. Not Applicable; Not Done COSTART term and grading system Adverse Reaction Docetaxel 75 mg/m 2 n=176 % Best Supportive Care n=49 % Vinorelbine/ Ifosfamide n=119 % Neutropenia Any Grade 3/4 84 65 14 12 83 57 Leukopenia Any Grade 3/4 84 49 6 0 89 43 Thrombocytopenia Any Grade 3/4 8 3 0 0 8 2 Anemia Any Grade 3/4 91 9 55 12 91 14 Febrile Neutropenia 6 NA 1 Infection Any Grade 3/4 34 10 29 6 30 9 Treatment Related Mortality 3 NA 3 Hypersensitivity Reactions Any Grade 3/4 6 3 0 0 1 0 Fluid Retention Any Severe 34 3 ND 23 3 Neurosensory Any Grade 3/4 23 2 14 6 29 5 Neuromotor Any Grade 3/4 16 5 8 6 10 3 Skin Any Grade 3/4 20 1 6 2 17 1 Gastrointestinal Nausea Any Grade 3/4 Vomiting Any Grade 3/4 Diarrhea Any Grade 3/4 34 5 22 3 23 3 31 4 27 2 6 0 31 8 22 6 12 4 Alopecia 56 35 50 Asthenia Any Severe 53 18 57 39 54 23 Stomatitis Any Grade 3/4 26 2 6 0 8 1 Pulmonary Any Grade 3/4 41 21 49 29 45 19 Nail Disorder Any Severe 11 1 0 0 2 0 Myalgia Any Severe 6 0 0 0 3 0 Arthralgia Any Severe 3 0 2 0 2 1 Taste Perversion Any Severe 6 1 0 0 0 0 Combination therapy with docetaxel in chemotherapy-naรฏve advanced unresectable or metastatic NSCLC Table 6 presents safety data from two arms of an open label

benefit from randomized controlled trial (TAX326) that enrolled patients with unresectable stage IIIB or IV non-small cell lung cancer and no history of prior chemotherapy. Adverse reactions were described using the NCI Common Toxicity Criteria except where otherwise noted. Table 6 - Adverse Reactions Regardless of Relationship to Treatment in Chemotherapy- Naรฏve Advanced Non-Small Cell Lung Cancer Patients Receiving Docetaxel in Combination with Cisplatin * Replaces NCI term Allergy COSTART term and grading system. Adverse Reaction Docetaxel 75 mg/m2 + Cisplatin 75 mg/m2 n=406 % Vinorelbine 25 mg/m2 + Cisplatin 100 mg/m2 n=396 % Neutropenia Any Grade 3/4 91 74 90 78 Febrile Neutropenia 5 5 Thrombocytopenia Any Grade 3/4 15 3 15 4 Anemia 89 94 Any Grade 3/4 7 25 Infection 35 37 Any Grade 3/4 8 8 Fever in absence of infection 33 29 Any Grade 3/4 < 1 1 Hypersensitivity Reaction * 12 4 Any Grade 3/4 3 < 1 Fluid Retention 54 42 Any All severe or life-threatening events 2 2 Pleural effusion Any 23 22 All severe or life-threatening events 2 2 Peripheral edema Any 34 18 All severe or life-threatening events <1> <1 Weight gain Any 15 9 All severe or life-threatening events> <1> <1 Neurosensory Any 47 42 Grade 3/4 4 4 Neuromotor Any 19 17 Grade 3/4 3 6 Skin Any 16 14 Grade 3/4> <1 1 Nausea Any 72 76 Grade 3/4 10 17 Vomiting Any 55 61 Grade 3/4 8 16 Diarrhea Any 47 25 Grade 3/4 7 3 Anorexia Any 42 40 All severe or life-threatening events 5 5 Stomatitis Any 24 21 Grade 3/4 2 1 Alopecia Any 75 42 Grade 3> <1 0 Asthenia Any 74 75 All severe or life-threatening events 12 14 Nail Disorder Any 14> <1 All severe events> <1 0 Myalgia Any 18 12 All severe events> <1> <1 Deaths within 30 days of last study treatment occurred in 31 patients (7.6%) in the docetaxel+cisplatin arm and 37 patients (9.3%) in the vinorelbine+cisplatin arm. Deaths within 30 days of last study treatment attributed to study drug occurred in 9 patients (2.2%) in the docetaxel+cisplatin arm and 8 patients (2%) in the vinorelbine+cisplatin arm. The second comparison in the study most valuable


any one r the hematologic toxicities or where otherwise noted. Table 5 - Treatment Emergent Adverse Reactions Regardless of Relationship to Treatment in Patients Receiving Docetaxel as Monotherapy for Non-Small Cell Lung Cancer Previously Treated with Platinum-Based Chemotherapy * * Normal Baseline LFTs: Transaminases 1.5 times ULN or alkaline phosphatase 2.5 times ULN or isolated elevations of transaminases or alkaline phosphatase up to 5 times ULN Febrile Neutropenia: ANC grade 4 with fever >38 C with intravenous antibiotics and/or hospitalization. Not Applicable; Not Done COSTART term and grading system Adverse Reaction Docetaxel 75 mg/m 2 n=176 % Best Supportive Care n=49 % Vinorelbine/ Ifosfamide n=119 % Neutropenia Any Grade 3/4 84 65 14 12 83 57 Leukopenia Any Grade 3/4 84 49 6 0 89 43 Thrombocytopenia Any Grade 3/4 8 3 0 0 8 2 Anemia Any Grade 3/4 91 9 55 12 91 14 Febrile Neutropenia 6 NA 1 Infection Any Grade 3/4 34 10 29 6 30 9 Treatment Related Mortality 3 NA 3 Hypersensitivity Reactions Any Grade 3/4 6 3 0 0 1 0 Fluid Retention Any Severe 34 3 ND 23 3 Neurosensory Any Grade 3/4 23 2 14 6 29 5 Neuromotor Any Grade 3/4 16 5 8 6 10 3 Skin Any Grade 3/4 20 1 6 2 17 1 Gastrointestinal Nausea Any Grade 3/4 Vomiting Any Grade 3/4 Diarrhea Any Grade 3/4 34 5 22 3 23 3 31 4 27 2 6 0 31 8 22 6 12 4 Alopecia 56 35 50 Asthenia Any Severe 53 18 57 39 54 23 Stomatitis Any Grade 3/4 26 2 6 0 8 1 Pulmonary Any Grade 3/4 41 21 49 29 45 19 Nail Disorder Any Severe 11 1 0 0 2 0 Myalgia Any Severe 6 0 0 0 3 0 Arthralgia Any Severe 3 0 2 0 2 1 Taste Perversion Any Severe 6 1 0 0 0 0 Combination therapy with docetaxel in chemotherapy-naรฏve advanced unresectable or metastatic NSCLC Table 6 presents safety data from two arms of an open label absolutely everyone
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Photo :Tagrisso

hurries up [0.1:<0.001 Objective Response Rate Objective Response Rate 65% 29% (95% CI) # (59%, 70%) (21%, 37%) Complete response 1% 1% Partial response 63% 27% P-value> <0.001 Duration of Response (DoR) Median Duration of Response in months (95% CI) 11.0 (8.6, 12.6) 4.2 (3.0, 5.9) Figure 1. Kaplan-Meier Curves of PFS by Investigator Assessment in AURA3 In a sensitivity analysis of PFS according to blinded independent central review, median PFS was 11 months in the Tagrisso arm compared to 4.2 months in the chemotherapy arm (HR 0.28; 95% CI: 0.20, 0.38). CNS Metastases Efficacy Data in AURA3 A BICR assessment of CNS efficacy by RECIST 1.1 in the subgroup of 46/419 (11%) patients identified to have measurable CNS lesions on a baseline brain scan are summarized in Table 5. Table 5. CNS Efficacy by BICR in Patients with Measurable CNS Lesions at Baseline Brain Scan in AURA3 * According to RECIST v1.1. Based on confirmed response. Based on patients with response only; DoR defined as the time from the date of first documented response (complete response or partial response) until progression or death event. Efficacy Parameter Tagrisso N=30 Chemotherapy N=16 CNS Objective Response Rate * CNS Objective Response Rate 57% 25% (95% CI) (37%, 75%) (7%, 52%) Complete response 7% 0% Partial response 50% 25% CNS Duration of Response Median Duration of Response, Months (Range) NR (1.4, 12.5) 5.7 (1.4, 5.7) NR Not Reached Pretreated T790M Positive NSCLC Patients AURA Extension and AURA2 The efficacy of Tagrisso was demonstrated in two multicenter, single-arm, open-label clinical trials, AURA Extension and AURA2, in patients with metastatic EGFR T790M mutation-positive NSCLC who had progressed on prior systemic therapy, including an EGFR TKI. All patients were required to have EGFR T790M mutation-positive NSCLC as detected by the cobas EGFR mutation test and received Tagrisso 80 mg once daily. The major efficacy outcome measure of both trials was ORR according to RECIST v1.1 as evaluated by a Blinded Independent Central Review (BICR). Duration of response (DOR) and Progression-Free Survival (PFS) were additional outcome measures. AURA Extension and AURA2 population characteristics were: median age 63 years (range 35 to 89), female (68%), White (36%), Asian (60%), never smoker (72%), World Health Organization (WHO) performance status 0 (37%) or 1 (63%), adenocarcinoma histology (96%), 1 prior line of therapy [EGFR-TKI treatment only, second line, chemotherapy-naรฏve] (31%), 2 or more prior lines of therapy (69%). Fifty-nine percent (59%) of patients had extra-thoracic visceral metastasis including 39% with CNS metastases (identified by CNS lesion site at baseline, medical history, and/or prior surgery and/or prior radiotherapy to CNS metastases) and 29% with liver metastases. 47% of patients had metastatic bone disease. Somatic EGFR mutations in addition to T790M were exon 19 deletion (68%), L858R (29%), G719X (2%), and S768I (2%). Efficacy results by BICR from AURA Extension and AURA2 are summarized in Table 6. The majority (96%) of patients with confirmed objective responses had ongoing responses ranging from 1.1 to 5.6 months after a median duration of follow-up of 4.2 months for AURA Extension and 4.0 months for AURA2. Table 6. Efficacy Results by BICR in AURA Extension and AURA2 * Pooled analysis of AURA Extension and AURA2 Objective response rate according to RECIST v1.1. Efficacy Parameter Study 1 (N=201) Study 2 (N=210) Overall * (N=411) Objective Response Rate (95% CI) 57% (50, 64) 61% (54, 68) 59% (54, 64) Complete Response 0 1% 0.5% Partial Response 57% 60% 59% In a separate dose finding part of AURA Extension, 63 patients with centrally confirmed T790M-positive NSCLC progressed on prior systemic therapy, including an EGFR TKI were administered Tagrisso 80 mg. In these patients, the BICR-confirmed objective response rate was 51% (32/63) and the median duration of response was 12.4 months from the time of first documented response. How Supplied/Storage and Handling 80 mg tablets: beige, oval and biconvex tablet marked with AZ 80 on one side and plain on the reverse and are available in bottles of 30 (NDC 0310-1350-30). 40 mg tablets: beige, round and biconvex tablet marked with AZ 40 on one side and plain on the reverse and are available in bottles of 30 (NDC 0310-1349-30). Store Tagrisso bottles at 25 C (77 F). Excursions permitted to 15-30 C (59-86 F) [see USP Controlled Room Temperature]. Patient Counseling Information Advise the patient to read the FDA-approved patient labeling (Patient Information). Interstitial Lung Disease/Pneumonitis Inform patients of the risks of severe or fatal ILD, including pneumonitis. Advise patients to contact their healthcare provider immediately to report new or worsening respiratory symptoms [see Warnings and Precautions (5.1) ] . QTc Interval Prolongation Inform patients of symptoms that may be indicative of significant QTc prolongation including dizziness, lightheadedness, and syncope. Advise patients to report these symptoms and to inform their physician about the use of any heart or blood pressure medications [see Warnings and Precautions (5.2) ] . Tagrisso can cause cardiomyopathy. Advise patients to immediately report any signs or symptoms of heart failure to their healthcare provider [see Warnings and Precautions (5.3) ] . Keratitis Advise patients to contact their healthcare provider immediately if they develop eye symptoms (eye inflammation, lacrimation, light sensitivity, eye pain, red eye or changes in vision) [see Warnings and Precautions (5.4) ] . Embryo-Fetal Toxicity Tagrisso can cause fetal harm if taken during pregnancy. Advise pregnant women of the potential risk to a fetus. Advise females to inform their healthcare provider if they become pregnant or if pregnancy is suspected, while taking Tagrisso [see Warnings and Precautions (5.3) and Use in Specific Populations (8.1) ] . Females and Males of Reproductive Potential Advise females of reproductive potential to use effective contraception during treatment with Tagrisso and for 6 weeks after the final dose [see Use in Specific Populations (8.3) ] . Advise males to use effective contraception during treatment and for 4 months after the final dose of Tagrisso [see Use in Specific Populations (8.3) ] . Lactation Advise women not to breastfeed during treatment with Tagrisso and for 2 weeks after the final dose [see Use in Specific Populations (8.2) ] . Distributed by: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850 Tagrisso is a registered trademark of the AstraZeneca group of companies. AstraZeneca 2017 Patient Information Tagrisso ( tuh-GRISS-oh ) (osimertinib) tablets What is the most important information I should know about Tagrisso? Tagrisso may cause serious side effects, including: lung problems. Tagrisso may cause lung problems that may lead to death. Symptoms may be similar to those symptoms from lung cancer. Tell your doctor right away if you have any new or worsening lung symptoms, including trouble breathing, shortness of breath, cough, or fever. heart problems, including heart failure. Tagrisso may cause heart problems that may lead to death. Your doctor should check your heart function before you start taking Tagrisso and during treatment as needed. Tell your doctor right away if you have any of the following signs and symptoms of a heart problem: feeling like your heart is pounding or racing, shortness of breath, swelling of your ankles and feet, feeling lightheaded. eye problems. Tagrisso may cause eye problems. Tell your doctor right away if you have symptoms of eye problems which may include watery eyes, sensitivity to light, eye pain, eye redness, or vision changes. Your doctor may send you to see an eye specialist (ophthalmologist) if you get eye problems with Tagrisso. See What are the possible side effects of Tagrisso? for more information about side effects. What is Tagrisso? Tagrisso is a prescription medicine used to treat non-small cell lung cancer (NSCLC). Tagrisso may be used when your non-small cell lung cancer has spread to other parts of the body and: has a certain type of abnormal epidermal growth factor receptor (EGFR) gene, called T790M, and you have had previous treatment with an EGFR tyrosine kinase inhibitor medicine and it has stopped working. Your doctor will perform a test to make sure that Tagrisso is right for you. It is not known if Tagrisso is safe and effective in children. Before taking Tagrisso, tell your doctor about all of your medical conditions, including if you: have lung or breathing problems. have heart problems, including a condition called long QTc syndrome. have problems with your electrolytes, such as sodium, potassium, calcium or magnesium. have a history of eye problems. are pregnant or plan to become pregnant. Tagrisso can harm your unborn baby. Tell your doctor right away if you become pregnant during treatment with Tagrisso or think you may be pregnant. Females who are able to become pregnant should use effective birth control during treatment with Tagrisso and for 6 weeks after the final dose of Tagrisso. Males who have female partners that are able to become pregnant should use effective birth control during treatment with Tagrisso and for 4 months after the final dose of Tagrisso. are breastfeeding or plan to breastfeed. It is not known if Tagrisso passes into your breast milk. Do not breastfeed during treatment with Tagrisso and for 2 weeks after your final dose of Tagrisso. Talk to your doctor about the best way to feed your baby during this time. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, or herbal supplements. Especially tell your doctor if you take a heart or blood pressure medicine. How should I take Tagrisso? Take Tagrisso exactly as your doctor tells you to take it. Your doctor may change your dose, temporarily stop, or permanently stop treatment with Tagrisso if you have side effects. Take Tagrisso 1 time each day. You can take Tagrisso with or without food. If you miss a dose of Tagrisso, do not make up for the missed dose. Take your next dose at your regular time. If you cannot swallow Tagrisso tablets whole: place your dose of Tagrisso in a container that contains 60 mL (2 ounces) of water. Do not use carbonated water or any other liquids. stir the Tagrisso tablet and water until the Tagrisso tablet is in small pieces (the tablet will not completely dissolve). Do not crush, heat, or use ultrasound to prepare the mixture. drink the Tagrisso and water mixture right away. add 120 mL to 240 mL (4 to 8 ounces) of water into the container and drink to make sure that you take your full dose of Tagrisso. What are the possible side effects of Tagrisso? Tagrisso may cause serious side effects, including: See What is the most important information I should know about Tagrisso? The most common side effects of Tagrisso are: diarrhea rash dry skin changes in your nails, including: redness, tenderness, pain, inflammation, brittleness, separation from nailbed, and shedding of nails tiredness Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Tagrisso. For more information, ask your doctor or pharmacist. 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 Tagrisso? Store Tagrisso at room temperature between 68 F to 77 F (20 C to 25 C). Safely throw away medicine that is out of date or that you no longer need. Keep Tagrisso and all medicines out of the reach of children. General information about the safe and effective use of Tagrisso. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Tagrisso for a condition for which it was not prescribed. Do not give Tagrisso to other people, even if they have the same symptoms you have. It may harm them. You can ask your doctor or pharmacist for information about Tagrisso that is written for a healthcare professional. What are the ingredients in Tagrisso? Active ingredient: osimertinib Inactive ingredients: mannitol, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, and sodium stearyl fumarate. Tablet coating contains: polyvinyl alcohol, titanium dioxide, macrogol 3350, talc, ferric oxide yellow, ferric oxide red and ferric oxide black. For more information, go to www.Tagrisso.com or call 1-800-236-9933. Distributed by: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850 AstraZeneca 2017 This Patient Information has been approved by the U.S. Food and Drug Administration. Revised: 2017 Tagrisso osimertinib 40 mg NDC 0310- 1349 -30 30 Tablets Each tablet contains 40 mg osimertinib. USUAL ADULT DOSAGE: See Prescribing Information. WARNING: As with all medications, keep out of the reach of children. Store at room temperature between 68 F to 77 F (20 C to 25 C). Rx only AstraZeneca Tagrisso osimertinib 80 mg NDC 0310- 1350 -30 30 Tablets Each tablet contains 80 mg osimertinib. USUAL ADULT DOSAGE: See Prescribing Information. WARNING: As with all medications, keep out of the reach of children. Store at room temperature between 68 F to 77 F (20 C to 25 C). Rx only AstraZeneca Tagrisso osimertinib tablet, film coated Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0310-1349 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OSIMERTINIB (OSIMERTINIB) OSIMERTINIB 40 Inactive Ingredients Ingredient Name Strength MANNITOL CELLULOSE, MICROCRYSTALLINE SODIUM STEARYL FUMARATE POLYVINYL ALCOHOL TITANIUM DIOXIDE POLYETHYLENE GLYCOL 3350 TALC FERRIC OXIDE YELLOW FERRIC OXIDE RED FERROSOFERRIC OXIDE HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED Product Characteristics Color BROWN (beige) Score no score Shape ROUND (biconvex) Size 9mm Flavor Imprint Code AZ;40 Contains Packaging # Item Code Package Description 1 NDC:0310-1349-30 30 TABLET, FILM COATED in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA208065 11/13/2015 Tagrisso osimertinib tablet, film coated Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0310-1350 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OSIMERTINIB (OSIMERTINIB) OSIMERTINIB 80 Inactive Ingredients Ingredient Name Strength MANNITOL CELLULOSE, MICROCRYSTALLINE SODIUM STEARYL FUMARATE POLYVINYL ALCOHOL TITANIUM DIOXIDE POLYETHYLENE GLYCOL 3350 TALC FERRIC OXIDE YELLOW FERRIC OXIDE RED FERROSOFERRIC OXIDE HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED Product Characteristics Color BROWN (beige) Score no score Shape OVAL (biconvex) Size 15mm Flavor Imprint Code AZ;80 Contains Packaging # Item Code Package Description 1 NDC:0310-1350-30 30 TABLET, FILM COATED in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA208065 11/13/2015 Labeler - AstraZeneca Pharmaceuticals LP (054743190) Registrant - AstraZeneca PLC (230790719) Revised: 10/2017 AstraZeneca Pharmaceuticals LP Next Interactions Print this page Add to My Med List More about Tagrisso (osimertinib) Side Effects During Pregnancy Dosage Information Drug Images Drug Interactions Support Group Pricing & Coupons En Espaรฑol 0 Reviews Add your own review/rating Drug class: EGFR inhibitors Consumer resources Tagrisso Tagrisso (Advanced Reading) Professional resources Tagrisso (AHFS Monograph) Related treatment guides Non-Small Cell Lung Cancer> ]} 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 N/A CSA Schedule Not a controlled drug 2 years Approval History FDA approved 2015 Manufacturer AstraZeneca Drug Class EGFR inhibitors Related Drugs EGFR inhibitors Tarceva , Erbitux , erlotinib , cetuximab , Vectibix , gefitinib Non-Small Cell Lung Cancer Avastin , methotrexate , Taxol , Opdivo , cisplatin , Taxotere , Tarceva , Keytruda , paclitaxel , nivolumab , gemcitabine , Gemzar , Abraxane , docetaxel , Alimta , bevacizumab , pembrolizumab , pemetrexed , erlotinib , Trexall , Tecentriq , crizotinib , Cyramza , atezolizumab , More... Tagrisso Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! Tagrisso Images Tagrisso 40 mg (AZ 40 ) View larger images} } looking ahead to


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steady Meet the 15 Students Changing Mental Health on Campus freshmen

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Photo :Meet the 15 Students Changing Mental Health on Campus

negative September 19, 2017 By Kelly Davis, MHA National Manager of Peer Advocacy, Supports, and Services Mental Health America is proud to announce the members of its first ever Collegiate Mental Health Innovation Council (CMHIC). CMHIC is made up of 15 students and recent graduates from across the country who are moving beyond awareness and taking action to address mental health in their campus communities. Members will contribute to a report on their programs and the student perspective on how to create comprehensive, sustainable, and engaging mental health services and supports on campus. Click on each photo to read about their work. Carter Kofman, University of Wisconsin-Madison Carter Kofman is a person in long-term recovery, which means he has not used drugs or alcohol since September 5th, 2014; he is also a person who lives with mental health conditions. As a recent graduate of the University of Wisconsin-Madison, he is currently working in the recovery field with the goal of making mental health and addiction recovery resources more accessible. While attending UW-Madison, he had the opportunity to serve as chair of the Collegiate Recovery Community, Live Free, and advocated for access to recovery resources, the dismantling of stigma, and education related to addiction and recovery. He believes that addressing the intersections of addiction and mental health conditions is crucial to supporting life in recovery, especially for young people and college students who experience unique challenges and opportunities in school settings. As a member of the Collegiate Mental Health Innovation Council, he hopes to increase the availability of a wide range of resources for students so there no longer needs to be a choice between recovery and a college education. Cody Semrau, Colgate University Semrau is the Founder & CEO of BetterMynd, an online mental health and teletherapy platform for college campuses. Cody graduated from Colgate University in 2014 where he received a degree in Political Science and Creative Writing. While a senior at Colgate, Cody experienced his own mental health issues, which has inspired him to make mental health resources more accessible and more transparent for all college students. Cody has a passion for social entrepreneurship and in using technology to improve the well-being of young adults. Gabby Frost, Drexel University Gabby is 19-years-old and a sophomore Music Industry major at Drexel University in Philadelphia, Pennsylvania. She is also the founder and CEO of Buddy Project, a non-profit organization aiming to prevent suicide and raise awareness for mental health. Buddy Project recently launched a Campus Rep program in March 2017 to give students across the globe the opportunity to spread awareness for mental health on their middle school, high school, and college campuses. Gabby is currently a member of Hack Harassment's Advisory Board, Crisis Text Line's Youth Advisory Council, and the Real Time Academy of Short Form Arts & Sciences. She is also a sister of the Alpha Sigma Alpha sorority and an ambassador for Clover Letter. Helmi Henkin, The University of Alabama Helmi Henkin is a senior psychology and French major at The University of Alabama from Menlo Park, California. Mental health is her greatest passion and she pursues advocacy in mental health related causes whenever she can. She participates in local advocacy as NAMI Tuscaloosa's Ending the Silence Program Coordinator and Connection Support Group Facilitator, and as NAMI Alabama's Smarts Advocacy Training co-coordinator. Every year she raises money for her local Out of the Darkness Walk and speaks to legislators about the importance of increased funding for mental health resources as an AFSP Field Advocate. Through her involvement in on campus research, volunteer work as a Crisis Text Line Crisis Counselor, and internships in London and Bali, she has gained clinical experience in the mental health field as well. She is currently on the Board for NAMI Alabama. Last year she served on the Jed Foundation's Student Advisory Council and she cannot wait to be a part of Mental Health America's Collegiate Mental Health Innovation Council this year. Jalyn Radziminski, Emory University Born and raised in Fort Wayne, Indiana, Jalyn Radziminski is a rising senior at Emory University double majoring in linguistics and human rights. Jalyn is an activist recognized by Humanity in Action who dedicates a lot of her work addressing issues surrounding mental health for people of color and mass incarceration. Through her experience leading groups MERGE, Multi-Ethnic Racial Group at Emory, and Theta Nu Xi Multicultural Sorority Inc., Jalyn addresses the necessity of building bonds between people of different races, cultures, religions backgrounds, and lifestyles as well as promoting the acknowledgement of intersections of identity. She promotes mental health awareness for people of color as the founder of her university's Black Mental Health Ambassadors program and creates mental health vlogs on her YouTube channel, "CouraJAYus". Kenna Chick, Georgetown University Kenna Chick is currently a sophomore at the School of Foreign Service at Georgetown University. Her greatest passion is mental health policy and advocacy, especially on destigmatizing mental illness and removing barriers to treatment. She plans on creating her own major in Global Mental Health Legislation, studying different cultural values and traditions and how they impact mental health legislation in different countries. As the current Chair of the Georgetown University Student Association Mental Health Health Policy Team, she is working on many projects that focus on destigmatizing, educating, and eliminating barriers to access to mental health resources. One of the projects is to implement off-campus therapy stipends, as psychotherapy in the DC area is notoriously expensive and the University s services are short-term. In addition to that, she is the Director of Outreach for Project Lighthouse, an anonymous peer to peer chat-line that provides information about campus resources and peer support. Finally, she is on the Youth Advisory Board of the Steve Fund (a group that aims to destigmatize mental health and increases access to services for people of color in college) and Young Mind Advocacy s Generation Bold (a group that focuses on mental health care for transition-aged youth). Maggie Skoch, University of Notre Dame; Stritch School of Medicine at Loyola University Chicago Maggie Skoch received her BA in Theology/Arts and Letters Pre-Health at the University of Notre Dame in 2016. She currently attends Stritch School of Medicine at Loyola University Chicago, where she is pursuing a concurrent MD/MA in Bioethics and Health Policy with the intent to practice psychiatry. After her own experience with a mental illness, Maggie became an active advocate for student mental health at Notre Dame, working as an intern in the Division of Student Affairs and serving as the President of Notre Dame s NAMI chapter. She received The Jed Foundation s Student Voice of Mental Health Award in 2016 as a result of this work. Mahima Verma, University of Southern California Mahima is a recent graduate of the University of Southern California with a B.A. in History. She is a first generation Indian American woman and is passionate about singing and writing. Health advocacy became a core part of her college experiences this past year as she struggled with PTSD and depression and side-effects of psychiatric medicine. As she found it very difficult to communicate my health and supportive needs to friends, family, and faculty and secure adequate mental health services on and off campus, Mahima began self-advocating by sharing her story of recovery from anorexia nervosa from ages of 13-19 in spoken word poetry, music videos, and talks with student government. Her advocacy was surprisingly heard across multiple campuses in California and led her to an opportunity to lead a college mental health organization (Active Minds at USC). These experiences have motivated her lifelong commitment to bettering access to young adult mental and physical health services, especially in South Asian American communities she was raised in. As a member of MHA's Collegiate Mental Health Innovation Council, Mahima looks forward to creating settings for students and campus professionals to have long-term conversations on wellness and peer support and to work together to establish adequate health services on campus. Max Rothman, University of Michigan Max Rothman is a rising senior from Los Angeles, California who is pursuing a major in Economics and a minor in Business at the University of Michigan. Max has dedicated much of his time on campus to mental health initiatives and organizations including Wolverine Support Network (WSN), Central Student Government Mental Health Task Force, Athletes Connected, and Greek Life Mental Health Chairs. Currently, in his role as Director of Program Development for WSN, he is working on the national expansion of the organization to universities around the country. Max is also a tennis enthusiast who is on the University of Michigan Club Tennis team and has just started a tennis podcast. Miana Bryant, East Carolina University Miana Bryant is a senior at East Carolina University pursuing a Bachelor of Arts in Psychology and Criminal Justice. She is the president and founder of the 4x award winning Mental Elephant, an organization focused on spreading awareness about mental illnesses in adolescents. The Mental Elephant has over 200 active members, and hosts mental health events every month on different campuses. Her passion for mental health stemmed from her own personal battles with depression and anxiety throughout her adolescence. Though wounded, Miana turned her pain into The Mental Elephant in order to reach other people around the globe that battle the same problems. Peggy Wunderlich, Southeastern Community College (West Burlington, IA) Peggy Wunderlich is a returning student at Southeastern Community College (SCC) pursuing a degree in Interactive and Social Media Marketing. Her passion is helping others, especially advocating for mental health and education. Peggy believes in having a positive impact in our society and paying it forward. She has acquired her Associate of Arts degree from SCC in West Burlington, Iowa and has completed additional studies at Iowa State University in Ames, Iowa. Currently, Peggy is serving on the Alumni Association Board at SCC and has been the Iowa Region Phi Theta Kappa Alumni Fundraiser Coordinator for the past four years (PTK is a two year International Honor Society for Community Colleges). Peggy has received a PTK Outstanding Leadership and Community Service Award. Also, she was selected to the 2010 All-Iowa Academic Team in recognition of scholarly achievements presented by the Iowa Community Colleges, the Coca-Cola Scholars Foundation, and Phi Theta Kappa Honor Society. Peggy has been awarded two PTK International Alumni Appreciation Awards, which she was nominated for her actions and support given to others and to the organization. Priya Sridhar, University of North Carolina Chapel Hill Shivpriya [Priya] Sridhar is a rising sophomore at UNC Chapel Hill and Robertson Scholar at UNC-CH and Duke University, where she is pursuing degrees in Public Policy and Global Health. During her freshman year, she founded the UNC-CH Mental Health Ambassadors chapter to promote conversation around mental health, destigmatize mental illness, facilitate support networks, and present educative programming on the campus of UNC Chapel Hill Priya believes that as students, we all should achieve a basic knowledge and set of skills to deal with the augmented threat to good mental health on campus. Most recently, Priya interned at Orleans Public Defenders as a client advocate, where she addressed the medical, mental health, and re-entry needs of inmates in New Orleans. Priya is certified in Mental Health First Aid USA, was a 2015 Bezos Scholar at the Aspen Institute, and a 2017 Conference Delegate at the Global Festival of Ideas for Sustainable Development. In her spare time, she enjoys playing violin for her church, running, and reading. Sam Orley, University of Michigan Sam Orley is a Senior at the University of Michigan's Ross School of Business and the Executive Director of Wolverine Support Network (WSN), one of the nation's first collegiate peer-to-peer support models. Since inception, WSN has held over 1,000 peer-led groups dedicated to mental health and well-being, and is now actively expanding its model to high schools and other colleges across the country. He is inspired by his brother's legacy to drive positive social and environmental impact in his community and across the world, with past experiences relating to sustainable energy systems, healthy living and urban challenges. At the University of Michigan, he is also involved with the Detroit Revitalization and Business Initiative and the Center for Positive Organizations. Satvik Sethi, State University of New York at Binghamton Satvik Sethi is an international sophomore from India majoring in Business Administration and Management at the State University of New York at Binghamton. With his vision of making the world happier, Satvik has started a social entrepreneurial venture called Runaway that aims to promote mental health awareness and help those in need of emotional support. He has also undertaken many social initiatives that focus on rural empowerment, mental health, and collaborative learning by leading social service projects in schools, colleges and villages in association with various national and international organizations. In his free time, Satvik enjoys writing poetry, composing music and seeking new adventures. Leah Goodman, University of Chicago at Illinois Leah Goodman is a licensed occupational therapist, clinical doctoral student and certified yoga instructor from Miami, Florida. She graduated with a BS in psychology from the University of Florida, an MA in occupational therapy from the University of Southern California, and will receive her clinical doctorate in occupational therapy (OTD) from the University of Illinois at Chicago in December 2017. At UIC, Leah contributes to a research team that explores community participation disparities for people with disabilities. Her current doctoral work focuses on supportive, mental health and disability services for university students. Leah strongly believes in the value of integrating wellbeing into higher education, and is passionate about making college an accessible and positive experience for all students. Learn more about the Collegiate Mental Health Innovation Council by clicking here. Tags: mental health life on campus college student collegiate mental health innovation council CMHIC university Mental Health America Blog is certain


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the types Ciclodan Generic Name: ciclopirox topical (sye kloe PEER ox TOP i kal) Brand Name: Ciclodan, Ciclodan Kit, CNL8 Nail, Loprox, Pedipirox-4, Penlac Nail Lacquer Overview Side Effects Dosage Professional Pregnancy More Breastfeeding Warnings User Reviews Support Group Q & A Pricing & Coupons What is Ciclodan (ciclopirox topical)? Ciclopirox is an antifungal medicine that prevents fungus from growing on your skin. Ciclopirox topical (for the skin) cream, gel, and lotion formulations are used to treat skin infections such as athlete's foot, jock itch, ringworm, and yeast infections. Ciclopirox shampoo is used to treat seborrheic dermatitis, an inflammatory skin condition of the scalp. Ciclopirox nail lacquer is used to treat fungal infections of the toenails and fingernails. Ciclopirox topical may also be used for purposes not listed in this medication guide. Slideshow Inherited Risk: The BRCA Gene Explained What is the most important information I should know about Ciclodan (ciclopirox 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 Ciclodan (ciclopirox topical)? You should not use ciclopirox if you are allergic to it. To make sure ciclopirox topical is safe for you, tell your doctor if you have: diabetes; epilepsy or other seizure disorder; a weak immune system (caused by disease or by using certain medicines); or a condition for which you use steroid medication (including skin conditions or breathing disorders). Ciclopirox topical is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether ciclopirox topical passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby. Do not use this medicine on a child without medical advice. Ciclopirox shampoo and gel are not approved for use by anyone younger than 16 years old. Ciclopirox nail laquer is not approved for use by anyone younger than 12 years old. Ciclopirox cream and lotion are not approved for use by anyone younger than 10 years old. How should I use Ciclodan (ciclopirox topical)? Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions. Wash your hands before and after using this medication, unless you are using ciclopirox to treat a hand condition. To apply the cream, gel, or lotion: Clean and dry the affected area. Apply a small amount of the cream (usually twice daily) for 2 to 4 weeks. Follow your doctor's instructions. Do not use bandages or dressings that do not allow air to circulate (occlusive dressings) on areas treated with ciclopirox cream or lotion, unless otherwise directed by your doctor. Wear loose-fitting clothing (preferably cotton). If the infection does not clear up in 4 weeks, or if it appears to get worse, see your doctor. To use ciclopirox shampoo: Wet the hair and apply approximately 1 teaspoon (5 mL) of the shampoo to the scalp. Up to 2 teaspoons (10 mL) may be used for long hair. Lather and leave on the hair and scalp for 3 minutes. A timer may be used. Treatment should be repeated twice per week for 4 weeks, with a minimum of 3 days between applications. If no improvement is seen after 4 weeks of treatment, contact your doctor. It may take up to 4 weeks before your symptoms improve after using ciclopirox topical cream, gel, lotion, or shampoo. Keep using the medicine as directed and tell your doctor if your symptoms do not improve, or if they get worse. To use ciclopirox nail lacquer: Use on the nails and immediately surrounding skin only. Avoid contact with other areas. Remove any loose nail or nail material using nail clippers or a nail file. Apply ciclopirox nail lacquer once daily (preferably at bedtime) to all affected nails with the applicator brush provided. Apply the lacquer evenly over the entire nail. Where possible, apply the nail lacquer to the underside of the nail and to the skin beneath it. Allow the lacquer to dry (approximately 30 seconds) before putting on socks or stockings. After applying the medication, wait 8 hours before taking a bath or shower. Apply ciclopirox nail lacquer daily over the previous coat. Once a week, remove the nail lacquer with alcohol. Remove as much as possible of the damaged nail using nail clippers or nail a file. To prevent the screw cap from sticking to the bottle, do not allow the solution to get into the bottle treads. To prevent the solution from drying out, close the bottle tightly after every use. Treatment with ciclopirox nail lacquer may require several months before initial improvement of symptoms is noticed. Up to 48 weeks of daily application of the nail lacquer, monthly removal of the unattached infected nail by a health care professional, and weekly trimming by the patient may be required for complete treatment. Use this medicine 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. Store all forms of this medicine at room temperature away from moisture, heat, and light. Once a bottle of ciclopirox shampoo is opened, it should be used within 8 weeks. Ciclopirox nail lacquer is flammable. Avoid using near open flame, and do not smoke until the gel has completely dried on your skin. 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 ciclopirox topical 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 Ciclodan (ciclopirox topical)? Avoid contact with the eyes, nose, and inside of the mouth. If this does happen, rinse with water. Avoid using other medications on the areas you treat with ciclopirox topical unless your doctor tells you to. Do not use nail polish, artificial nails, or other cosmetic nail products on the nails treated with ciclopirox nail lacquer. 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. Ciclodan (ciclopirox 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 this medicine and call your doctor at once if you have: unusual or severe itching, redness, burning, dryness, or irritation of treated skin; or discoloration or other changes in the nails. Common side effects may include: mild burning, itching, or redness. 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 Ciclodan (ciclopirox topical)? Tell your doctor about all your current medicines and any you start or stop using, especially: an inhaled or topical steroid medicine; or seizure medication; It is not likely that other drugs you take orally or inject will have an effect on topically applied ciclopirox. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Next Side Effects Print this page Add to My Med List More about Ciclodan (ciclopirox topical) Side Effects During Pregnancy or Breastfeeding Dosage Information Support Group Pricing & Coupons 1 Review Add your own review/rating Consumer resources Ciclodan Kit Ciclodan Ciclodan Topical (Advanced Reading) Other brands: Penlac , Loprox , Penlac Nail Lacquer , CNL8 Nail , ... +2 more Professional resources Ciclodan (FDA) Ciclodan Cream (FDA) Ciclopirox Olamine (AHFS Monograph) Related treatment guides Cutaneous Candidiasis Onychomycosis, Fingernail Onychomycosis, Toenail Seborrheic Dermatitis ... +4 more Where can I get more information? Your pharmacist can provide more information about ciclopirox 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: 6.01. Date modified: December 03, 2017 Last reviewed: May 27, 2016} Drug Status Rx Availability Prescription only B Pregnancy Category No proven risk in humans N/A CSA Schedule Not a controlled drug Related Drugs Seborrheic Dermatitis prednisone , hydrocortisone topical , ketoconazole topical , dexamethasone , Decadron , Deltasone , More... Onychomycosis, Toenail terbinafine , Lamisil , ciclopirox topical , Penlac , itraconazole , Jublia , More... Tinea Corporis clotrimazole topical , ketoconazole topical , Lotrisone , terbinafine topical , Lamisil , More... Onychomycosis, Fingernail terbinafine , Lamisil , ciclopirox topical , Penlac , itraconazole , griseofulvin , More... 4 more conditions... Ciclodan Rating 1 User Review 10 /10 1 User Review 10 Rate it! Help and Support Looking for answers? Ask a question or go join the Ciclodan support group to connect with others who have similar interests.} } definitely


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