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aimed toward Aygestin Generic Name: progestin (Oral route, Parenteral route, Vaginal route) Commonly used brand name(s) In the U.S. Aygestin Camila Crinone Errin First-Progesterone VGS Jolivette Megace Megace ES Next Choice Ovrette Plan B Prochieve Prometrium In Canada Alti-Mpa Megace Os Option 2 Available Dosage Forms: Tablet Suspension Capsule, Liquid Filled Gel/Jelly Cream Kit Suppository Capsule Uses For Aygestin Progestins are hormones. They are used by both men and women for different purposes. Progestins are prescribed for several reasons: To properly regulate the menstrual cycle and treat unusual stopping of the menstrual periods (amenorrhea). Progestins work by causing changes in the uterus. After the amount of progestins in the blood drops, the lining of the uterus begins to come off and vaginal bleeding occurs (menstrual period). Progestins help other hormones start and stop the menstrual cycle. . To help a pregnancy occur during egg donor or infertility procedures in women who do not produce enough progesterone. Also, progesterone is given to help maintain a pregnancy when not enough of it is made by the body. To prevent estrogen from thickening the lining of the uterus (endometrial hyperplasia) in women around menopause who are being treated with estrogen for ovarian hormone therapy (OHT). OHT is also called hormone replacement therapy (HRT) and estrogen replacement therapy (ERT). To treat pain that is related to endometriosis, a condition where the endometrial tissue which lines the uterus becomes displaced in other female organs. To treat a condition called endometriosis, to help prevent endometrial hyperplasia, or to treat unusual and heavy bleeding of the uterus (dysfunctional uterine bleeding) by starting or stopping the menstrual cycle. To help treat cancer of the breast, kidney, or uterus. Progestins help change the cancer cell's ability to react to other hormones and proteins that cause tumor growth. In this way, progestins can stop the growth of a tumor. To test the body's production of certain hormones such as estrogen. To treat loss of appetite and severe weight or muscle loss in patients with acquired immunodeficiency syndrome (AIDS) or cancer by causing certain proteins to be produced that cause increased appetite and weight gain. Progestins may also be used for other conditions as determined by your doctor. Depending on how much and which progestin you use or take, a progestin can have different effects. For instance, high doses of progesterone are necessary for some women to continue a pregnancy while other progestins in low doses can prevent a pregnancy from occurring. Other effects include causing weight gain, increasing body temperature, developing the milk-producing glands for breast-feeding, and relaxing the uterus to maintain a pregnancy. Progestins can help other hormones work properly. Progestins may help to prevent anemia (low iron in blood), too much menstrual blood loss, and cancer of the uterus. Progestins are available only with your doctor's prescription. Before Using Aygestin Allergies Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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 Although there is no specific information comparing use of progestins in children or teenagers with use in other age groups, this medicine is not expected to cause different side effects or problems in children or teenagers than it does in adults. Geriatric This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults. Pregnancy Progesterone, a natural hormone that the body makes during pregnancy, has not caused problems. In fact, it is sometimes used in women to treat a certain type of infertility and to aid in egg donor or infertility procedures. Other progestins have not been studied in pregnant women. Be sure to tell your doctor if you become pregnant while using any of the progestins. It is best to use some kind of birth control method while you are receiving progestins in high doses. High doses of progestins are not recommended for use during pregnancy since there have been some reports that they may cause birth defects in the genitals (sex organs) of a male fetus. Also, some of these progestins may cause male-like changes in a female fetus and female-like changes in a male fetus, but these problems usually can be reversed. Low doses of progestins, such as those doses used for contraception, have not caused major problems when used accidentally during pregnancy. Breast Feeding Although progestins pass into the breast milk, they have not been shown to cause problems in nursing babies. However, progestins may change the quality or amount (increase or decrease) of the mother's breast milk. It may be necessary for you to take another medicine or to stop breast-feeding during treatment. Be sure you have discussed the risks and benefits of the medicine with your doctor. 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 any of these medicines, 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 medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take. Boceprevir Dofetilide Tranexamic Acid Using medicines in this class 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. Amobarbital Aprepitant Aprobarbital Bosentan Butabarbital Butalbital Carbamazepine Ceritinib Conivaptan Dabrafenib Darunavir Dexamethasone Efavirenz Eliglustat Enzalutamide Eslicarbazepine Acetate Eterobarb Etravirine Felbamate Fosphenytoin Griseofulvin Heptabarbital Hexobarbital Idelalisib Isotretinoin Lesinurad Lixisenatide Lumacaftor Mephobarbital Methohexital Mitotane Modafinil Nafcillin Netupitant Nevirapine Oxcarbazepine Pentobarbital Phenobarbital Phenytoin Pitolisant Prednisone Primidone Rifabutin Rifampin St John's Wort Sugammadex Theophylline Thiopental Tizanidine Topiramate Ulipristal 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 medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially: Asthma or Epilepsy (or history of) or Heart or circulation problems or Kidney disease (severe) or Migraine headaches Progestins may cause fluid retention which may cause these conditions to become worse. Bleeding problems, undiagnosed, such as blood in the urine or changes in vaginal bleeding May make diagnosis of these problems more difficult. Blood clots, or history of or Breast cancer, or history of or Deep vein thrombosis (blood clot in the leg), active or history of or Heart attack, active or history of or Liver disease, including jaundice, or history of or Pulmonary embolism (clot in the lung), active or history of or Stroke , active or history of or Venous thromboembolism (clot in the veins), or history of Progestins should not be used in patients with these conditions. Breast disease (such as breast lumps or cysts), history of May make this condition worse for diseases that do not react in a positive way to progestins. Diabetes mellitus May cause an increase in your blood sugar and a change in the amount of medicine you take for diabetes; progestins in high doses are more likely to cause this problem. Memory loss (dementia) May make this condition worse. Vision changes This medicine may cause changes in vision; your medicine may need to be stopped if these conditions become worse. Proper Use of progestin This section provides information on the proper use of a number of products that contain progestin. It may not be specific to Aygestin. Please read with care. To make the use of a progestin as safe and reliable as possible, you should understand how and when to take it and what effects may be expected. Progestins usually come with patient directions. Read them carefully before taking or using this medicine. Take this medicine only as directed by your doctor. Do not take more of it and do not take it for a longer time than your doctor ordered . To do so may increase the chance of side effects. Try to take the medicine at the same time each day to reduce the possibility of side effects and to allow it to work better. Progestins are often given together with certain medicines. If you are using a combination of medicines, make sure that you take each one at the proper time and do not mix them. Ask your health care professional to help you plan a way to remember to take your medicines at the right times. Dosing The dose medicines in this class 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 these medicines. 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 medroxyprogesterone For oral dosage form (tablets): For controlling unusual and heavy bleeding of the uterus (dysfunctional uterine bleeding) or treating unusual stopping of menstrual periods (amenorrhea): Adults and teenagers 5 to 10 milligrams (mg) per day for five to ten days as directed by your doctor. For preparing the uterus for the menstrual period: Adults and teenagers 10 milligrams (mg) per day for five or ten days as directed by your doctor. For preventing estrogen from thickening the lining of the uterus (endometrial hyperplasia) when taking estrogen for ovarian hormone therapy in postmenopausal women: Adults When taking estrogen each day on Days 1 through 25: Oral, 5 to 10 milligrams (mg) of medroxyprogesterone per day for ten to fourteen or more days each month as directed by your doctor. Or, your doctor may want you to take 2.5 or 5 mg per day without stopping. Your doctor will help decide the number of tablets that is best for you and when to take them. For intramuscular injection dosage form: For treating cancer of the kidneys or uterus: Adults and teenagers At first, 400 to 1000 milligrams (mg) injected into a muscle as a single dose once a week. Then, your doctor may lower your dose to 400 mg or more once a month. For subcutaneous injection dosage form: For treating pain related to endometriosis: Adults and teenagers 104 milligrams (mg) injected under the skin of the anterior thigh or abdomen every three months (12 to 14 weeks) for not more than 2 years. For megestrol For oral dosage form (suspension): For treating loss of appetite (anorexia), muscles (cachexia), or weight caused by acquired immunodeficiency syndrome (AIDS): Adults and teenagers 800 milligrams (mg) a day for the first month. Then your doctor may want you to take 400 or 800 mg a day for three more months. For oral dosage form (tablets): For treating cancer of the breast: Adults and teenagers 160 milligrams (mg) a day as a single dose or in divided doses for two or more months. For treating cancer of the uterus: Adults and teenagers 40 to 320 milligrams (mg) a day for two or more months. For treating loss of appetite (anorexia), muscles (cachexia), or weight caused by cancer: Adults and teenagers 400 to 800 milligrams (mg) a day. For norethindrone For oral dosage form (tablets): For controlling unusual and heavy bleeding of the uterus (dysfunctional uterine bleeding) or treating unusual stopping of menstrual periods (amenorrhea): Adults and teenagers 2.5 to 10 milligrams (mg) a day from Day 5 through Day 25 (counting from the first day of the last menstrual cycle). Or, your doctor may want you to take the medicine only for five to ten days as directed. For treating endometriosis: Adults and teenagers At first, 5 milligrams (mg) a day for two weeks. Then, your doctor may increase your dose slowly up to 15 mg a day for six to nine months. Let your doctor know if your menstrual period starts. Your doctor may want you to take more of the medicine or may want you to stop taking the medicine for a short period of time. For progesterone For oral dosage form (capsules): For preventing estrogen from thickening the lining of the uterus (endometrial hyperplasia) when taking estrogen for ovarian hormone therapy in postmenopausal women: Adults 200 milligrams (mg) per day at bedtime for 12 continuous days per 28-day cycle of estrogen treatment each month. For treating unusual stopping of menstrual periods (amenorrhea): Adults 400 milligrams (mg) per day at bedtime for ten days. For vaginal dosage form (gel): For treating unusual stopping of menstrual periods (amenorrhea): Adults and teenagers 45 milligrams (mg) (one applicatorful of 4% gel) once every other day for up to six doses. Dose may be increased to 90 mg (one applicatorful of 8% gel) once every other day for up to six doses if needed. For use with infertility procedures: Adults and teenagers 90 milligrams (mg) (one applicatorful of 8% gel) one or two times a day. If pregnancy occurs, treatment can continue for up to ten to twelve weeks. For injection dosage form: For controlling unusual and heavy bleeding of the uterus (dysfunctional uterine bleeding) or treating unusual stopping of menstrual periods (amenorrhea): Adults and teenagers 5 to 10 milligrams (mg) a day injected into a muscle for six to ten days. Or, your doctor may want you to receive 100 or 150 mg injected into a muscle as a single dose. Sometimes your doctor may want you first to take another hormone called estrogen. If your menstrual period starts, your doctor will want you to stop taking the medicine. For vaginal dosage form (suppositories): For maintaining a pregnancy (at ovulation and at the beginning of pregnancy): Adults and teenagers 25 mg to 100 milligrams (mg) (one suppository) inserted into the vagina one or two times a day beginning near the time of ovulation. Your doctor may want you to receive the medicine for up to eleven weeks. 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. For all progestins, except for progesterone capsules for postmenopausal women: If you miss a dose of this medicine, take the missed dose 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. For progesterone capsules for postmenopausal women: If you miss a dose of 200 mg of progesterone capsules at bedtime, take 100 mg in the morning then go back to your regular dosing schedule. If you take 300 mg of progesterone a day and you miss your morning and evening doses, you should not take the missed dose. Return to your regular dosing schedule. Storage Keep out of the reach of children. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Do not keep outdated medicine or medicine no longer needed. Precautions While Using Aygestin It is very important that your doctor check your progress at regular visits . This will allow for your dosage to be adjusted and for any unwanted effects to be detected. These visits will usually be every 6 to 12 months, but some doctors require them more often. The Prometrium capsules contain peanut oil. If you have an allergy to peanuts, make sure your doctor knows this before you take this brand of progestin. Progestins may cause some people to become dizzy. For oral or vaginal progesterone, dizziness or drowsiness may occur 1 to 4 hours after taking or using it. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert. Unusual or unexpected vaginal bleeding of various amounts may occur between your regular menstrual periods during the first 3 months of use. This is sometimes called spotting when slight, or breakthrough menstrual bleeding when heavier. If this should occur, continue on your regular dosing schedule. Check with your doctor : If unusual or unexpected vaginal bleeding continues for an unusually long time. If your menstrual period has not started within 45 days of your last period. Missed menstrual periods may occur. If you suspect a pregnancy, you should stop taking this medicine immediately and call your doctor . Your doctor will let you know if you should continue taking the progestin. If you are scheduled for any laboratory tests, tell your health care professional that you are taking a progestin. Progestins can change certain test results. In some patients, tenderness, swelling, or bleeding of the gums may occur. Brushing and flossing your teeth carefully and regularly and massaging your gums may help prevent this. See your dentist regularly to have your teeth cleaned. Check with your medical doctor or dentist if you have any questions about how to take care of your teeth and gums, or if you notice any tenderness, swelling, or bleeding of your gums. You will need to use a birth control method while taking progestins for noncontraceptive use if you are fertile and sexually active . If you are using vaginal progesterone, avoid using other vaginal products for 6 hours before and for 6 hours after inserting the vaginal dose of progesterone. Since it is possible that certain doses of progestins may cause temporary thinning of the bones by changing your hormone balance, it is important that your doctor know if you have an increased risk of osteoporosis. Some things that can increase your risk for having osteoporosis include cigarette smoking, abusing alcohol, taking or drinking large amounts of caffeine, and having a family history of osteoporosis or easily broken bones. Some medicines, such as glucocorticoids (cortisone-like medicines) or anticonvulsants (seizure medicine), can also cause thinning of the bones. However, it is thought that progestins can help protect against osteoporosis in postmenopausal women. Aygestin Side Effects Along with their needed effects, progestins used in high doses sometimes cause some unwanted effects such as blood clots, heart attacks, and strokes, or problems of the liver and eyes. Although these effects are rare, some of them can be very serious and cause death. It is not clear if these problems are due to the progestin. They may be caused by the disease or condition for which progestins are being used. The following side effects may be caused by blood clots. Although not all of these side effects may occur, if they do occur they need immediate medical attention. Get emergency help immediately if any of the following side effects occur: Rare Symptoms of blood clotting problems, usually severe or sudden, such as: headache or migraine loss of or change in speech, coordination, or vision numbness of or pain in chest, arm, or leg unexplained shortness of breath Check with your doctor as soon as possible if any of the following side effects occur: More common Changes in vaginal bleeding (increased amounts of menstrual bleeding occurring at regular monthly periods, lighter vaginal bleeding between menstrual periods, heavier vaginal bleeding between regular monthly periods, or stopping of menstrual periods) symptoms of blood sugar problems (dry mouth, frequent urination, loss of appetite, or unusual thirst) Less common Mental depression skin rash unexpected or increased flow of breast milk Rare For megestrol During chronic treatment Backache dizziness filling or rounding out of the face irritability mental depression nausea or vomiting unusual decrease in sexual desire or ability in men unusual tiredness or 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: More common Abdominal pain or cramping bloating or swelling of ankles or feet blood pressure increase (mild) dizziness drowsiness (progesterone only) headache (mild) mood changes nervousness pain or irritation at place of injection site swelling of face, ankles, or feet unusual or rapid weight gain Less common Acne breast pain or tenderness brown spots on exposed skin, possibly long-lasting hot flashes loss or gain of body, facial, or scalp hair loss of sexual desire trouble in sleeping Not all of the side effects listed above have been reported for each of these medicines, but they have been reported for at least one of them. All of the progestins are similar, so any of the above side effects may occur with any of these medicines. After you stop using this medicine, your body may need time to adjust. The length of time this takes depends on the amount of medicine you were using and how long you used it. During this period of time check with your doctor if you notice the following side effect: For megestrol Dizziness nausea or vomiting unusual tiredness or weakness Delayed return to fertility stopping of menstrual periods unusual menstrual bleeding (continuing) 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. Print this page 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.} Recently Approved Lonhala Magnair Lonhala Magnair (glycopyrrolate) is a long-acting muscarinic antagonist (LAMA) bronchodilator for... Ozempic Ozempic (semaglutide) is a glucagon-like peptide-1 (GLP-1) analog administered once-weekly for the... Ogivri Ogivri (trastuzumab-dkst) is a HER2 / neu receptor antagonist biosimilar to Herceptin indicated for... Sublocade Sublocade (buprenorphine) is a once-monthly injectable partial opioid agonist formulation for the... More Help and Support Looking for answers? 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the correct There is no reliable diagnostic test for obsessive-compulsive disorder ( OCD ). The diagnosis is usually based on a thorough face-to-face interview conducted by an experienced mental health professional. Perhaps someday, as we learn more about the underlying biology of OCD, there will be genetic markers or characteristic patterns on brain scans that will confirm diagnosis. But we are not there yet. On the other hand, obtaining some medical tests may be appropriate to rule out neurological conditions that may produce obsessive-compulsive symptoms. Take our OCD Screening Quiz For example, consider a person who shows symptoms of OCD for the first time after a head injury at the age of 45. It would be reasonable to explore the possibility that an acute injury to the brain might have caused the symptoms of OCD. Another example is a 10-year-old girl who suddenly develops concerns about germs and begins washing her hands incessantly. She also displays jerking movements of her arms. These symptoms appear one month after having had a suspected strep throat. Although such onset is not typical of OCD, there is reason to believe that some cases may be precipitated by an abnormal reaction of the immune system to an untreated upper respiratory infection. Sue Swedo, MD, of the National Institute of Mental Health has coined the term PANDAS to refer to this variety of OCD. Most cases of OCD begin inconspicuously and gradually become more apparent over many months or years. It is only in retrospect that one looks back and recognizes some of the early signs of the illness. Nevertheless, there are some things you can do to determine if you have OCD. In fact, the majority of individuals who are diagnosed as having OCD first make the diagnosis themselves. The process of discovering OCD often starts with watching a TV talk show or news segment, or reading a newspaper, magazine or internet article, like you are doing right now. Awareness about OCD grew following a 1987 segment on OCD broadcast by the ABC-TV network program 20/20. That coverage triggered a cascade of media attention on OCD that stimulated clinical and research activity and galvanized an advocacy movement culminating in the formation of the Obsessive Compulsive Foundation, Inc. Many people with OCD felt alone until they witnessed the story of someone like themselves. They thought they were losing their mind until they realized they were suffering from a legitimate brain-based illness. They didn t know how to describe their experience until they heard it described by someone else who gave it a name. They finally had hope because scientists were making progress in squelching this unwelcome ruler of their inner domain. It often takes people a long time to seek out help for OCD, even after they learn it is a treatable illness. Individuals may call years after viewing an OCD story on Oprah or 20/20 to ask for a consultation. When asked why it took so long, the reason given is usually embarrassment. The symptoms of OCD can be so disagreeable and so private that they are very difficult to share with anyone, including loved ones and trained professionals. A simple device used to reduce the shame of sharing such sensitive material is a checklist featuring examples of obsessive-compulsive behavior. Although it is best to do this in person, some people prefer to fill out a questionnaire initially on their own. Sometimes the examples seem absurd and one can t imagine how anyone in her right mind could have such thoughts or engage in such ludicrous behaviors. Other times, the questions are right on target and it feels like the checklist was written just for the individual completing it. To experienced clinicians, none of the thoughts or behaviors of OCD seem odd or outlandish. They are products of the disorder, the hiccups of the brain as Judith Rapoport, MD, once called them. The symptoms of OCD don t influence a clinician s perception of the person so afflicted any more than pus from an infected wound would make a physician feel that the patient is morally decayed. APA Reference Goodman, W. (2017). How Do I Know If I Have Obsessive-Compulsive Disorder?. Psych Central . Retrieved on November 30, 2017, from https://psychcentral.com/disorders/ocd/how-do-i-know-if-i-have-obsessive-compulsive-disorder/ Hot Topics Today 1 How to Understand Gaslighting 2 Mobile Apps Can Help Manage and Support Mental, Emotional Health 3 Eating Nuts May Strengthen Some Brain Waves 4 Bipolar or Depression? Heart Test May Help Tell the Difference 5 Boosting Brain Activity May Buffer Against Anxiety Most Popular News Mobile Apps Can Help Manage and Support Mental, Emotional Health For Older Women, Every Movement Counts Toward Health Bipolar or Depression? Heart Test May Help Tell the Difference Boosting Brain Activity May Buffer Against Anxiety Eating Nuts May Strengthen Some Brain Waves Join Over 195,000 Subscribers to Our Weekly Newsletter Find a Therapist Enter ZIP or postal code the child


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hind lights Encora PM tablets Description Encora is a prescription vitamin and mineral nutritional supplement with essential fatty acids consisting of two capsules and two tablets on each blister card designated for AM and PM oral administration as follows: AM tablet is an oval-shaped, light pink film-coated tablet containing the following ingredients: Calcium (calcium carbonate)400 mg Vitamin D 3 (cholecalciferol)200 IU Vitamin C (as Ester-C † )25 mg Folic Acid, USP2 mg Vitamin B 6 (pyridoxine hydrochloride, USP)25 mg PM tablet is an oval-shaped, purple film-coated tablet containing the following ingredients: Calcium (calcium carbonate)600 mg Vitamin D 3 (cholecalciferol)600 IU Vitamin C (as Ester-C † )25 mg Folic acid, USP0.5 mg Vitamin B 6 (pyridoxine hydrochloride, USP)12.5 mg AM and PM capsule is a pink soft gelatin capsule containing the following ingredients: Essential Fatty Acids (omega-3)650 mg DHA and EPA550 mg ‡ a - Linolenic acid (ALA)100 mg Linoleic acid (LA)10 mg Vitamin E (dl-alpha-tocopheryl acetate)50 IU † Ester-C is a patented pharmaceutical grade material consisting of calcium ascorbate and calcium threonate. Ester-C is a licensed trademark of Zila Nutraceuticals, Inc. ‡ Eicosapentaenoic acid (EPA) to docosahexaenoic acid (DHA) ratio is approximately 2.7:1 Inactive Ingredients : Tablets: acacia, butylated hydroxyanisole, butylated hydroxytoluene, colloidal silicon dioxide, corn starch, croscarmellose sodium, D&C Red No. 27 aluminum lake, hydrolyzed gelatin, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium lauryl sulfate, stearic acid, sucrose, talc, titanium dioxide, and vegetable oil. The AM tablet also contains FD&C Blue No. 2 aluminum lake. The PM tablet also contains FD&C Blue No. 1 aluminum lake. Capsule: D&C Red No. 33, ethyl vanillin, FD&C Red No. 40, gelatin, glycerine, soybean oil and titanium dioxide. Indications and Usage Encora is a patented formulation indicated to provide calcium, essential fatty acids, folic acid and other vitamins and minerals for daily nutritional and health supplementation. Contraindications This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. Warnings Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B 12 is deficient. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive. Allergy Alert: This product contains soy. Precautions General Do not exceed recommended dosage. The calcium content should be considered before prescribing for patients with kidney stones. Encora should be used with caution in patients with known sensitivity or allergy to fish. Pediatric Use Safety and effectiveness in pediatric patients have not been established. Geriatric Use Clinical studies of this product did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, relfecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Adverse Reactions Allergic sensitization has been reported following both oral and parenteral administration of folic acid. Dosage and Administration Encora is a morning and evening oral dosing regimen, supplied in unit-dose blister cards each containing an AM dose of 1 soft gelatin capsule and 1 light pink tablet and a PM dose of 1 soft gelatin capsule and 1 purple tablet. Encora 's patented dosing regimen, consisting of an "AM" dose taken in the morning and a "PM" dose taken at night, should be followed for improved nutrient absorption potential, or as prescribed by your physician. How Supplied Encora is supplied in a 30-day unit-of-use dispensing carton containing 30 blister cards of 2 tablets and 2 capsules each (NDC 64011-166-36). Encora AM tablets are oval-shaped, light pink film-coated tablets, embossed "Ther-Rx" on one side and "147" with a partial bisect on the other side. The PM tablet are oval-shaped, purple film-coated tablets, debossed "Ther-Rx" on one side and "161" with a partial bisect on the other side. Encora capsules are pink soft gelatin capsules, imprinted "Ther-Rx 148" on one side in purple ink. Store at controlled room temperature 25 C (77 F); excursions permitted to 15 -30 C (59 -86 F). [See USP Controlled Room Temperature.] Avoid excessive heat above 40 C (104 F). Avoid freezing. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Mktd. by Ther-Rx Corp., St. Louis, MO 63044 U.S. Patent Nos. 4,822,816; 5,070,085; 5,945,123; 6,197,329; 6,214,379; 6,228,388; 6,258,846; 6,375,956; 6,576,666. Other U.S. Patents Pending. P4889 05/05 PRODUCT PHOTO(S): NOTE: These photos can be used only for identification by shape, color, and imprint. They do not depict actual or relative size. The product samples shown here have been supplied by the manufacturer. While every effort has been made to assure accurate reproduction, please remember that any visual identification should be considered preliminary. In cases of poisoning or suspected overdosage, the drug's identity should be verified by chemical analysis. Print this page FDA Consumer Updates Depression: FDA-Approved Medications May Help Dealing with ADHD: What You Need to Know Making Decisions for Your Health: Getting the Info You Need FDA: Cutting-Edge Technology Sheds Light on Antibiotic Resistance More FDA updates will give you


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that wrong Featured News Video: video: CVS Health to Acquire Aetna; Combination to Provide Consumers with a Better Experience, Reduced Costs and Improved Access to Health Care Experts in Homes and Communities Across the Country Video: video: By the Numbers: The State of Health Care in the United States Frustrated by the U.S. health care system, Americans want change, yet remain optimistic about its future outlook. Video: video: On Target: What the New Hypertension Guidelines Mean New hypertension guidelines could mean lifestyle and medication changes for consumers. CVS Health tools and experts can help. Load more Press Releases Enter keywords Select year Year -Year 2017 2016 2015 2014 2013 2012 2011 2010 2009 2008 2007 12.06.17 CVS Pharmacy Launches Free, Same-Day Prescription Delivery in Manhattan 12.03.17 CVS Health to Acquire Aetna; Combination to Provide Consumers with a Better Experience, Reduced Costs and Improved Access to Health Care Experts in Homes and Communities Across the Country 11.30.17 Meningitis B Vaccine Available to Students, Faculty and Staff at UMass Amherst 11.30.17 CVS Health Reminds Families It's Not Too Late to Get Their Flu Shot During National Influenza Vaccination Week 11.30.17 New CVS Health Survey Reveals Majority of Americans Want Change to Improve the State of U.S. Health Care 11.28.17 CVS Health Launches "Real-Time Benefits," Providing Access to Actionable Information Across All Points of Care 11.21.17 CVS Pharmacy's Exclusive Black Friday and Cyber Monday promotions help customers save time and money, and find joy in the little things that matter most 11.14.17 CVS Health Commits to Hiring 5,000 New Apprentices by 2022, Expands States Participating in the Program 11.09.17 CVS Health Earns Perfect Score in 2018 Corporate Equality Index 11.09.17 CVS Health Makes Overdose-Reversal Drug Available Without Individual Prescription at CVS Pharmacy Locations in Delaware 11.09.17 CVS Health Makes Overdose-Reversal Drug Available Without Individual Prescription at CVS Pharmacy Locations in Oklahoma 11.09.17 CVS Health Makes Overdose-Reversal Drug Available Without Individual Prescription at CVS Pharmacy Locations in Michigan 11.08.17 CVS Health Joins with the National Consortium of State-Operated Comprehensive Rehabilitation Centers to Help More Americans with Disabilities Find Meaningful Employment 11.06.17 CVS Pharmacy to Bring Prescriptions Right to Customers' Doors with Nationwide Next-Day Delivery and Same-Day Delivery in Select Markets 11.06.17 CVS Health Reports Third Quarter Results 11.02.17 CVS Health Offering Hepatitis A Vaccine to Broward County Residents Following Increase in Local Cases of the Illness 11.02.17 CVS Pharmacy to Host 45 Free Community Health Screenings in Houston 11.01.17 CVS Health Foundation Awards $1 Million Dollars in Grants to Eight Cancer Centers to Increase Smoking Cessation Resources in the Oncology Setting 10.30.17 CVS Health to Support Researchers Who Stand Up To Cancer with In-Store Fundraising Campaign 10.27.17 CVS Health Corporation To Hold Third Quarter 2017 Conference Call Load more CVS Health Impact Dashboard Explore the impact CVS Health is having across the U.S. in the CVS Health Impact Dashboard Connect with us Facebook Twitter YouTube LinkedIn Tweets Loading... Leadership Our team of executives have a wealth of experience across the health care spectrum. View bios Email News Alerts Want to receive updates about CVS Health? Sign up for email news alerts Media Gallery Find logos and other CVS Health assets changes


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flesh presser clindamycin and tretinoin (Topical application route) klin-da-MYE-sin FOS-fate, TRET-i-noin Overview Side Effects Dosage Professional Interactions More Pregnancy Warnings User Reviews Support Group Q & A Pricing & Coupons Commonly used brand name(s) In the U.S. Veltin Ziana Available Dosage Forms: Gel/Jelly Therapeutic Class: Antiacne Chemical Class: Clindamycin Slideshow Newborn Baby Health: 8 Woes From Cradle Cap And Colic To Whooping Cough Uses For clindamycin and tretinoin Clindamycin and tretinoin topical is used to treat acne. It works by killing the bacteria that cause acne and by keeping the skin pores (tiny openings on the skin's surface) clear. clindamycin and tretinoin is available only with your doctor's prescription. Before Using clindamycin and tretinoin 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 clindamycin and tretinoin, the following should be considered: Allergies Tell your doctor if you have ever had any unusual or allergic reaction to clindamycin and tretinoin 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 Appropriate studies have not been performed on the relationship of age to the effects of clindamycin and tretinoin topical in children younger than 12 years of age. Safety and efficacy have not been established. Geriatric Appropriate studies on the relationship of age to the effects of clindamycin and tretinoin topical have not been performed in the geriatric population. However, no geriatric-specific problems have been documented to date. Pregnancy Pregnancy Category Explanation All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. 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 clindamycin and tretinoin, 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 clindamycin and tretinoin 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. Erythromycin 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 clindamycin and tretinoin. Make sure you tell your doctor if you have any other medical problems, especially: Colitis caused by antibiotics, history of or Crohn's disease or Ulcerative colitis Should not be used in patients with these conditions. Proper Use of clindamycin and tretinoin It is very important that you use clindamycin and tretinoin only as directed . Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause your skin to become too dry or irritated. You may need to use clindamycin and tretinoin for several weeks or months before your skin starts to look better. Applying extra medicine will not make it work faster. clindamycin and tretinoin is for use on the skin only . Do not get it in your eyes, mouth, nose, on the corners of your nose, or vagina. Do not use it on skin areas that have cuts, scrapes, or burns. If it does get on these areas, rinse it off right away. clindamycin and tretinoin comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions. To use: Wash your hands with soap and water before and after using clindamycin and tretinoin. Before applying clindamycin and tretinoin, wash your face with warm water and a mild soap, rinse well, and pat dry. Apply just enough medicine to lightly cover the affected areas, and rub it in gently but well. A pea-sized amount is enough to cover the whole face. You should not wash your face too often, 2 or 3 times a day is enough. Washing your face too often may dry your skin and make the acne worse. Dosing The dose of clindamycin and tretinoin 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 clindamycin and tretinoin. 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 topical dosage form (gel): For acne: Adults and teenagers Apply to the affected area(s) of the skin once a day, at bedtime. Children younger than 12 years of age Use and dose must be determined by your doctor. Missed Dose If you miss a dose of clindamycin and tretinoin, apply 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. 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. Ask your healthcare professional how you should dispose of any medicine you do not use. Precautions While Using clindamycin and tretinoin It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Stop using clindamycin and tretinoin and call your doctor right away if you start having severe, watery diarrhea or bloody diarrhea. This could be a sign of a serious side effect. Do not take any medicine for diarrhea without checking first with your doctor. Some medicines may make your diarrhea worse or make it last longer. clindamycin and tretinoin may make your skin more sensitive to sunlight, wind, and cold weather. Use a sunscreen when you are outdoors. Avoid sunlamps and tanning beds. You may need to wear protective clothing, such as a hat. Skin reactions can occur when you use clindamycin and tretinoin, such as dryness, redness, peeling, burning, or stinging. Stop using clindamycin and tretinoin and call your doctor right away if your skin becomes very red, swollen, blistered, or crusted. clindamycin and tretinoin may also cause a temporary change in skin color (lighter or darker). Talk to your doctor if this concerns you. Tell your doctor if you are planning to have a surgery before using clindamycin and tretinoin. clindamycin and tretinoin may affect how certain anesthesia medicines (medicines used during surgery to make you numb) work. Do not use any other medicines on the treated skin areas without asking your doctor. Avoid using any skin care products that can dry or irritate your skin. These include rough skin cleansers, soaps, or products that contain alcohol, spices, or lime. clindamycin and tretinoin 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: More common Dryness and peeling of the skin flushing or redness of the skin itching unusually warm skin Less common Burning or stinging at the site of application changes in the color of the skin fever stomach cramps, tenderness, or pain watery or bloody diarrhea 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: Less common Cough dry skin headaches muscle aches pain and tenderness around the eyes and cheekbones shortness of breath or troubled breathing sore throat stuffy or runny nose tightness of the chest or wheezing unusual tiredness or weakness 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 clindamycin/tretinoin topical Side Effects During Pregnancy Dosage Information Drug Interactions Support Group Pricing & Coupons En Espaรฑol 108 Reviews Add your own review/rating Drug class: topical acne agents Consumer resources Clindamycin and tretinoin topical Clindamycin and Tretinoin Other brands: Veltin , Ziana Professional resources Clindamycin and Tretinoin Gel (FDA) Clindamycin and Tretinoin (Wolters Kluwer) Related treatment guides Acne} Antibiotics 101 Everything you need to know about antibiotics: List of Common Antibiotics & Types Antibiotics & Drinking Alcohol - Is it Safe? Antibiotics For UTI - What Are My Options? Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Manufacturer Teva Pharmaceuticals USA, Inc. Drug Class Topical acne agents Related Drugs Acne doxycycline , clindamycin topical , erythromycin topical , minocycline , tretinoin topical , tetracycline topical , dapsone topical , Accutane , Vibramycin , Retin-A , isotretinoin , Minocin , Ortho Tri-Cyclen , Yasmin , Monodox , adapalene topical , Yaz , TriNessa , Epiduo , Claravis , Benzaclin , Tazorac , Differin , Adoxa , More... Clindamycin / tretinoin topical Rating 108 User Reviews 7.4 /10 108 User Reviews 7.4 Rate it! Related Questions & Answers Clindamycin/Tretinoin - I've only used them one time so Far.. and my face is peeling very badly? Read more questions} } most fashionable


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problem Aygestin Generic Name: norethindrone (nor eth IN drone) Brand Name: Aygestin, Camila, Errin, Jolivette, Nor-QD, Nora-Be, Ortho Micronor Overview Side Effects Dosage Professional Interactions More Pregnancy Warnings Breastfeeding Warnings User Reviews Drug Images Support Group Q & A Pricing & Coupons What is Aygestin (norethindrone)? Norethindrone is a form of progesterone, a female hormone. Norethindrone prevents ovulation (the release of an egg from an ovary). This medication also causes changes in your cervical mucus and uterine lining, making it harder for sperm to reach the uterus and harder for a fertilized egg to attach to the uterus. Norethindrone is used for birth control (contraception) to prevent pregnancy. Norethindrone is also used to treat menstrual disorders, endometriosis, or abnormal vaginal bleeding caused by a hormone imbalance. Norethindrone may also be used for other purposes not listed in this medication guide. Slideshow Endometriosis: A Healthcare Professional's Guide What is the most important information I should know about Aygestin (norethindrone)? This medication can cause birth defects in an unborn baby. Do not use if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment. Do not use this medication if you have any of the following conditions: a history of stroke or blood clot, circulation problems, breast cancer, abnormal vaginal bleeding, liver disease, or if you have recently had an incomplete miscarriage or abortion. You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions. Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35. Norethindrone does not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to help protect yourself from these diseases. What should I discuss with my healthcare provider before using Aygestin (norethindrone)? This medication can cause birth defects. Do not use if you are pregnant. Tell your doctor right away if you become pregnant. Do not use this medication if you are allergic to norethindrone, or if you have: a history of a stroke, blood clot, or circulation problems; breast cancer; abnormal vaginal bleeding; or if you have recently had an incomplete miscarriage or abortion. Before using norethindrone, tell your doctor if you have any of the following conditions. You may need a dose adjustment or special tests to safely take norethindrone. high blood pressure or a history of heart disease; migraines; kidney disease; liver disease or liver cancer; a history of depression or mental illness; high cholesterol or triglycide (fatty acid) levels in your blood; asthma; or seizures or epilepsy. Norethindrone can pass into breast milk. Make sure your doctor knows if you are breast-feeding a baby while taking this medication. Taking hormones can increase your risk of blood clots, stroke, or heart attack, especially if you smoke and are older than 35. How should I take Aygestin (norethindrone)? Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label. You may need to use back-up birth control, such as condoms or a spermicide, when you first start using this medication. Follow your doctor's instructions. If you need to have any type of medical tests or surgery, or if you will be on bed rest, you may need to stop using this medication for a short time. Any doctor or surgeon who treats you should know that you are using norethindrone. Your doctor will need to see you on a regular basis while you are using this medication. Do not miss any appointments. Store this medication at room temperature away from moisture and heat. What happens if I miss a dose? Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose. Missing a pill increases your risk of becoming pregnant. If you are more than 3 hours late in taking your dose, use back-up birth control such as condoms or a spermicide for at least the next 48 hours. If you miss a period for two months in a row, call your doctor because you might be pregnant. What happens if I overdose? Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include nausea, vomiting, and vaginal bleeding. What should I avoid while taking Aygestin (norethindrone)? Do not smoke while using norethindrone, especially if you are older than 35. Smoking can increase your risk of blood clots, stroke, or heart attack caused by norethindrone. Norethindrone will not protect you from sexually transmitted diseases--including HIV and AIDS. Using a condom is the only way to protect yourself from these diseases. Aygestin (norethindrone) side effects Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects: sudden numbness or weakness, especially on one side of the body; sudden headache, confusion, pain behind the eyes, problems with vision, speech, or balance; pain or swelling in one or both legs; migraine headache; swelling in your hands or feet, rapid weight gain; symptoms of depression (sleep problems, weakness, mood changes); severe pelvic pain; chest pain or heavy feeling, pain spreading to the arm or shoulder, nausea, sweating, general ill feeling; or nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes). Less serious side effects may include: mild nausea, vomiting, bloating, stomach cramps; breast pain, swelling, or tenderness; dizziness; freckles or darkening of facial skin; increased acne or hair growth; changes in weight; vaginal itching or discharge; skin itching or rash; changes in your menstrual periods, decreased sex drive; or mild headache. This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088. Side Effects (complete list) What other drugs will affect Aygestin (norethindrone)? Some drugs can make norethindrone less effective, which may result in pregnancy. Before using norethindrone, tell your doctor if you are using any of the following drugs: griseofulvin (Fulvicin, Grisactin); rifampin (Rifadin, Rifater, Rifamate, Rimactane); St. John's wort; ketoconazole (Nizoral) or itraconazole (Sporanox); a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton); or HIV medicines such as amprenavir (Agenerase), atazanavir (Reyataz), tipranavir (Aptivus), indinavir (Crixivan), saquinavir (Invirase), lopinavir/ritonavir (Kaletra), fosamprenavir (Lexiva), ritonavir (Norvir), or nelfinavir (Viracept). There may be other drugs that can interact with norethindrone. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Next Side Effects Print this page Add to My Med List More about Aygestin (norethindrone) Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Images Drug Interactions Support Group Pricing & Coupons En Espaรฑol 5 Reviews Add your own review/rating Generic Availability Drug class: contraceptives Consumer resources Aygestin Aygestin (Advanced Reading) Other brands: Camila , Jolivette , Ortho Micronor , Heather , ... +8 more Professional resources Aygestin (AHFS Monograph) Aygestin (FDA) Related treatment guides Abnormal Uterine Bleeding Amenorrhea Endometriosis Where can I get more information? Your pharmacist can provide more information about norethindrone. 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: 1.11. Last reviewed: December 15, 2010 Date modified: December 03, 2017} 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 Teva Pharmaceuticals USA, Inc. Drug Class Contraceptives Progestins Related Drugs Abnormal Uterine Bleeding Premarin , megestrol , Megace , medroxyprogesterone , Provera , Depo-Provera , norethindrone , conjugated estrogens , More... Amenorrhea progesterone , medroxyprogesterone , Provera , Depo-Provera , Prometrium , norethindrone , Camila , Jolivette , More... Endometriosis medroxyprogesterone , leuprolide , Provera , Depo-Provera , Lupron Depot , norethindrone , Sprintec , Zoladex , More... Aygestin Rating 5 User Reviews 6.0 /10 5 User Reviews 6.0 Rate it! Aygestin Images Aygestin 5 mg (5 AYGESTIN ) View larger images Related Questions & Answers Problems with bleeding, getting pregnant,etc.? I have been prescribed 10mg Aygestin for 2 months & have been on it about 3 weeks to try to shrink? How long can I safely take Aygestin for? Have been taking Aygestin (Norethindrone 5mg) from 1 - 14 days every 3 months to precipitate a? Aygestin - I have been on norethindrone for 14 years. when I first started taking it a few monthsi? Read more questions} } discover


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hold The student who asked to see me looks exhausted. I m used to sleepy students. It s an occupational hazard of teaching the 8:30 a.m. class. But I ve been worried about this young man for several weeks. He seems to be fighting especially hard to keep his head from hitting the desk during every class. Ironically, we ve been covering sleep disorders in our psychology seminar and he sent me an urgent request for an appointment. Now at my office in the late afternoon, he doesn t look much better. Were you serious that people sometimes feel so paralyzed when they wake up that they can t move? he asks. Is it really true that people can hear voices just because they are sleep-deprived? How about seeing ghosts and spirits? Yes. Yes. And yes, I tell him. Those are all symptoms of sleep disorders. He lets out a big sigh. He seems very, very relieved. I thought maybe I was going insane. My student s sanity is not in question, at least not yet. However, his chronic insomnia is causing him more and more trouble. What he had thought were paranormal experiences or symptoms of mental illness are most likely a consequence of inadequate and frequently interrupted sleep. Untreated, his health, his ability to think clearly, and his capacity to make good judgments are likely to deteriorate. He s certainly not alone in his inability to get sufficient sleep. A recent study released by the Centers for Disease Control and Prevention found that 41 percent of Americans report that they have not had sufficient sleep for nearly 2 weeks of the past month. Only one third of adults report they get enough sleep every night. This doesn t surprise me. My clients and my friends regularly report lack of sufficient sleep; sometimes with near-disastrous consequences. Stress, financial pressures, overuse of technology, (did I mention stress?) and the conventional wisdom that people don t really need as much sleep as once was believed are all conspiring to increase our expectations for productivity and decrease our time relaxing, recovering, and sleeping. One man I know let s call him Ted awoke in his car as he was being shaken by a local police officer. He d pulled into a driveway, thinking it was his own, and promptly fallen asleep. Alarmed by the presence of a strange car idling in their yard at 3 a.m., the homeowners had called the police. My friend had driven 100 miles to get home after a long day of meetings to avoid having to pay for a hotel room. He could have paid with his life and the lives of others. Trying to meet the demands of work and responsibilities to family sometimes makes people take chances. Alex drove 15 hours straight rather than stop for rest, pushing to get home in time for his daughter s birthday. During the last hour, he kept seeing phantom vehicles bearing down on him, only to evaporate like mist. Freaked by the hallucinations and obsessed with getting home, he pushed on. Fortunately, he was traveling in the wee hours of the morning when few others were on the road. In a somber moment, he acknowledges that wrapping himself around a tree would not have been a wonderful birthday surprise for his daughter. But at the time, he d been just stressing about getting home. He made it but, like Ted, it was more a matter of luck than skill that got him there. Financial pressures sometimes make people give up on sleep. Ciel is a hardworking single mom who is doing her best both to support her kids and increase her prospects for a better job by going to school. She works third shift as an awake overnight staff member at a residential school for troubled teens. The overnighter pays better than day work and she can study when the residents are asleep. She gets off at 7:00 a.m., takes an 8:00 and a 9:30 college class and gets home at about 11:30. She sleeps until 3:30 when the kids come home. The hours from 3:30 to 7:30 are dedicated to doing household chores , having dinner with her children, and getting them started on homework. If she s lucky, she fits in another nap from 8:00 10:00. She is getting only about 6 hours in a 24-hour period and that 6 hours is neither continuous nor predictable. If a child is home sick, if a school project requires more mom-time to get done, if she s behind on laundry, she often sacrifices even more hours of sleep. Her persistence in both meeting her goals and being there for her kids is admirable. But the quality of her work, her parenting , and her life in general suffers. Not too surprisingly, she collapsed during the holidays and ended up in a hospital for acute exhaustion. She slept for the first 26 hours of her hospital stay! Technology can also be blamed for disrupting our sleep. The constant input of emails, texts, and social networking, video and online games, and TV on demand, all the time, puts the brain into a constant active state. A brain that s wired up has difficulty settling down when it s time to sleep. Often enough, a person who tosses and turns trying to get to sleep gives up and goes back to the computer! So much for quieting the unquiet mind! For these many reasons, the average American is getting slightly more than six and a half hours of sleep a night. That s a drop from an average of eight hours a night 50 100 years ago. Although it is true that not everyone needs the same amount of sleep, most of us do need 8 9 hours of rest. The reduction of over an hour on average means that many people are losing almost a complete cycle of restorative sleep. The result is the increase of sleep disorders and related illness. More and more people are showing up in clinical offices with symptoms of narcolepsy, sleep paralysis, night terrors, sleep phase disorders, or chronic insomnia. Often psychiatric disorders like depression and anxiety are secondary to insufficient sleep, as are medical diseases like hypertension, high cholesterol, and diabetes. Like my student, many people are in denial about the impact of their sleep habits on their general health and wellbeing or have resigned themselves to a pattern of inadequate sleep. Others have convinced themselves that they really don t need more than 5 or 6 hours of sleep to be at their best and scold themselves for being tired. Still others have developed dependence on over-the-counter sleep aids or think that getting extra sleep on the weekends compensates for inadequate sleep during the week. Nightly restorative sleep is essential to wellbeing, productivity, and creativity. If you are among the millions of people who are simply depriving themselves of rest, give yourself the gift of a good night s sleep. If you ve developed a sleep disorder, a visit to a sleep clinic or to a clinician trained in treating sleep disorders can result in a plan for re-establishing healthful and restorative sleep. Ah to sleep. More important: To sleep enough. It s what the body and mind really needs. Related Articles About Marie Hartwell-Walker, Ed.D. Dr. Marie Hartwell-Walker is licensed as both a psychologist and marriage and family counselor. She specializes in couples and family therapy and parent education. She writes regularly for Psych Central as well as Psych Central's Ask the Therapist feature. She is author of the insightful parenting e-book, Tending the Family Heart . Check out her book, Unlocking the Secrets of Self-Esteem . View all posts by Marie Hartwell-Walker, Ed.D. 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anyone Sleep-Deprived Nation the baby
in the dead of night Signifor Injection it's critical

in the dead of night Signifor Injection it's critical

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Photo :Signifor Injection

foremost Signifor Injection Generic Name: pasireotide Dosage Form: injection Overview Side Effects Dosage Professional Interactions More Pregnancy Warnings User Reviews Support Group Q & A Pricing & Coupons 1 INDICATIONS AND USAGE Cushing s Disease SIGNIFOR is indicated for the treatment of adult patients with Cushing s disease for whom pituitary surgery is not an option or has not been curative. Slideshow Fertility Facts: Women's Fertility Issues Explained 2 DOSAGE AND ADMINISTRATION Recommended Dosage Range The recommended dosage range of SIGNIFOR is 0.3 to 0.9 mg by subcutaneous injection twice a day. The recommended initial dose is either 0.6 mg or 0.9 mg twice a day. Titrate dose based on response and tolerability. Patients should be evaluated for a treatment response [clinically meaningful reduction in 24-hour urinary free cortisol (UFC) levels and/or improvement in signs or symptoms of the disease] and should continue receiving therapy with SIGNIFOR as long as benefit is derived [see Clinical Studies (14)] . Maximum urinary free cortisol reduction is typically seen by two months of treatment [see Clinical Studies (14)] . For patients who are started on 0.6 mg twice a day, a dosage increase to 0.9 mg twice a day may be considered based on the response to the treatment, as long as the 0.6 mg dosage is well tolerated by the patient. Management of suspected adverse reactions may require temporary dose reduction of SIGNIFOR. Dose reduction by 0.3 mg decrements per injection is suggested. Recommendations Prior to Initiation of SIGNIFOR Prior to the start of SIGNIFOR, patients should have baseline levels of the following: fasting plasma glucose [see Warnings and Precautions (5.2)] hemoglobin A1c [see Warnings and Precautions (5.2)] liver tests [see Warnings and Precautions (5.4)] serum potassium and magnesium levels [see Warnings and Precautions (5.3)] Patients should also have a baseline electrocardiogram and gallbladder ultrasound [see Warnings and Precautions (5.3, 5.5)] . Treatment of patients with poorly controlled diabetes mellitus should be intensively optimized with anti-diabetic therapy prior to starting SIGNIFOR [see Warnings and Precautions (5.2)] . Dosage in Patients with Hepatic Impairment For patients with moderate hepatic impairment (Child-Pugh B), the recommended initial dosage is 0.3 mg twice a day and the maximum dosage is 0.6 mg twice a day. Avoid the use of SIGNIFOR in patients with severe hepatic impairment (Child-Pugh C) [see Use in Specific Populations (8.6)] . Important Administration Instructions Instruct patients to: Refer to the FDA-approved patient labeling (Instructions for Use) for detailed administration instructions. Prior to injection, visually inspect the product for particulate matter and discoloration. Do not use if particulates and/or discoloration are observed. Avoid injection in sites showing signs of inflammation or irritation. Prior to injection, gently pinch the skin at the injection site and hold the needle/syringe at an angle of approximately 45 degrees. Administer SIGNIFOR subcutaneously by self-injection into the top of the thigh or the abdomen. Avoid multiple subcutaneous injections at the same site within short periods of time. Use of the same injection site for two consecutive injections is not recommended. 3 DOSAGE FORMS AND STRENGTHS Injection: 0.3 mg/mL, 0.6 mg/mL, and 0.9 mg/mL in a single-dose, 1 mL colorless glass ampule. 4 CONTRAINDICATIONS None. 5 WARNINGS AND PRECAUTIONS Hypocortisolism Treatment with SIGNIFOR leads to suppression of adrenocorticotropic hormone (ACTH) secretion in Cushing s disease. Suppression of ACTH may lead to a decrease in circulating levels of cortisol and potentially hypocortisolism. Monitor and instruct patients on the signs and symptoms associated with hypocortisolism (e.g., weakness, fatigue, anorexia, nausea, vomiting, hypotension, hyponatremia or hypoglycemia). If hypocortisolism occurs, consider temporary dose reduction or interruption of treatment with SIGNIFOR, as well as temporary, exogenous glucocorticoid replacement therapy. Hyperglycemia and Diabetes Elevations in blood glucose levels have been seen in healthy volunteers and patients treated with SIGNIFOR. In the Phase III trial, the development of pre-diabetes and diabetes was observed [see Clinical Studies (14)] . In this trial, nearly all patients including those with normal glucose status at baseline, pre-diabetes, and diabetes developed worsening glycemia in the first two weeks of treatment. Cushing s disease patients with poor glycemic control (as defined by HbA1c values >8% while receiving anti-diabetic therapy) may be at a higher risk of developing severe hyperglycemia and associated complications, e.g., ketoacidosis. Because of this predictable adverse reaction, the glycemic status [fasting plasma glucose (FPG) or hemoglobin A1c (HbA1c)] should be assessed prior to starting treatment with SIGNIFOR. In patients with uncontrolled diabetes mellitus intensive anti-diabetic therapy should be optimized prior to treatment with SIGNIFOR. Self-monitoring of blood glucose and/or FPG assessments should be done every week for the first two to three months and periodically thereafter, as clinically appropriate, as well as over the first two to four weeks after any dose increase. After treatment discontinuation, glycemic monitoring (e.g., FPG or HbA1c) should be done according to clinical practice. Patients who were initiated on anti-diabetic therapy as a result of SIGNIFOR may require closer monitoring after discontinuation of SIGNIFOR, especially if the anti-diabetic therapy has a risk of causing hypoglycemia. If hyperglycemia develops in a patient treated with SIGNIFOR, the initiation or adjustment of anti-diabetic treatment per standard of care is recommended. The optimal treatment for the management of SIGNIFOR-induced hyperglycemia is not known. If uncontrolled hyperglycemia persists, despite appropriate medical management, the dose of SIGNIFOR should be reduced or discontinued. Bradycardia and QT Prolongation Bradycardia Bradycardia has been reported with the use of SIGNIFOR [see Adverse Reactions (6)] . Patients with cardiac disease and/or risk factors for bradycardia, such as history of clinically significant bradycardia, high-grade heart block, or concomitant use of drugs associated with bradycardia, should be carefully monitored. Dose adjustments of beta-blockers, calcium channel blockers, or correction of electrolyte disturbances may be necessary. QT Prolongation SIGNIFOR is associated with QT prolongation. In two thorough QT studies with SIGNIFOR, QT prolongation occurred at therapeutic and supra-therapeutic doses. SIGNIFOR should be used with caution in patients who are at significant risk of developing prolongation of QTc, such as those: with congenital long QT prolongation. with uncontrolled or significant cardiac disease including recent myocardial infarction, congestive heart failure, unstable angina or clinically significant bradycardia. on anti-arrhythmic therapy or other substances that are known to lead to QT prolongation. with hypokalemia and/or hypomagnesemia. A baseline ECG is recommended prior to initiating therapy with SIGNIFOR and monitoring for an effect on the QTc interval is advisable. Hypokalemia and hypomagnesemia must be corrected prior to SIGNIFOR administration and should be monitored periodically during therapy. Liver Test Elevations In the Phase III trial, 5% of patients had an ALT or AST level greater than 3 times the upper limit of normal (ULN). In the entire clinical development program of SIGNIFOR, there were 4 cases of concurrent elevations in ALT (alanine aminotransferase) greater than 3 x ULN and bilirubin greater than 2 x ULN: one patient with Cushing s disease and three healthy volunteers [see Adverse Reactions (6 )] . In these cases, total bilirubin elevations were seen either concomitantly or preceding the transaminase elevation. Monitoring of liver tests should be done after 1 to 2 weeks on treatment, then monthly for 3 months, and every 6 months thereafter. If ALT is normal at baseline and elevations of ALT of 3-5 times the ULN are observed on treatment, repeat the test within a week or within 48 hours if exceeding 5 times ULN. If ALT is abnormal at baseline and elevations of ALT of 3-5 times the baseline values are observed on treatment, repeat the test within a week or sooner if exceeding 5 times ULN. Tests should be done in a laboratory that can provide same-day results. If the values are confirmed or rising, interrupt SIGNIFOR treatment and investigate for probable cause of the findings, which may or may not be SIGNIFOR-related. Serial measures of ALT, aspartate aminotransferase, alkaline phosphatase, and total bilirubin, should be done weekly, or more frequently, if any value exceeds 5 times the baseline value in case of abnormal baselines or 5 times the ULN in case of normal baselines. If resolution of abnormalities to normal or near normal occurs, resuming treatment with SIGNIFOR may be done cautiously, with close observation, and only if some other likely cause has been found. Cholelithiasis Cholelithiasis has been frequently reported in clinical studies with SIGNIFOR [see Adverse Reactions (6)] . Ultrasonic examination of the gallbladder before, and at 6- to 12-month intervals during SIGNIFOR therapy is recommended. Monitoring for Deficiency of Pituitary Hormones As the pharmacological activity of SIGNIFOR mimics that of somatostatin, inhibition of pituitary hormones, other than ACTH, may occur. Monitoring of pituitary function (e.g., TSH/free T 4 , GH/IGF-1) should occur prior to initiation of therapy with SIGNIFOR and periodically during treatment should be considered as clinically appropriate. Patients who have undergone transsphenoidal surgery and pituitary irradiation are particularly at increased risk for deficiency of pituitary hormones. 6 ADVERSE REACTIONS Clinically significant adverse reactions that appear in other sections of the labeling include: Hypocortisolism [see Warnings and Precautions (5.1)] Hyperglycemia and Diabetes [see Warnings and Precautions (5.2)] Bradycardia and QT prolongation [see Warnings and Precautions (5.3)] Liver Test Elevations [see Warnings and Precautions (5.4)] Cholelithiasis [see Warnings and Precautions (5.5)] Pituitary Hormone Deficiency [see Warnings and Precautions (5.6)] Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice. A total of 162 Cushing s disease patients were exposed to SIGNIFOR in the Phase III study [see Clinical Studies (14)] . At study entry, patients were randomized to receive twice a day (b.i.d.) doses of either 0.6 mg or 0.9 mg of SIGNIFOR given subcutaneously. The mean age of patients was approximately 40 years old with a predominance of female patients (78%). The majority of the patients had persistent or recurrent Cushing s disease (83%) and few patients ( 5%) in either treatment group had received previous pituitary irradiation. The median exposure to the treatment was 10.4 months (0.03 37.8) with 68% of patients having at least six-months exposure. In the Phase III trial, adverse reactions were reported in 98% of patients. The most common adverse reactions (frequency 20% in either group) were diarrhea, nausea, hyperglycemia, cholelithiasis, headache, abdominal pain, fatigue, and diabetes mellitus. There were no deaths during the study. Serious adverse events were reported in 25% of patients. Adverse events leading to study discontinuation were reported in 17% of patients. Adverse reactions with an overall frequency higher than 5% are presented in Table 1 by randomized dose group and overall. Adverse reactions are ranked by frequency, with the most frequent reactions listed first. Table 1 - Adverse reactions [n (%)] with an overall frequency of more than 5% in the combined dose group in the Phase III study in Cushing s disease patients SIGNIFOR 0.6 mg bid N=82 SIGNIFOR 0.9 mg bid N=80 Overall N=162 Diarrhea 48 (59) 46 (58) 94 (58) Nausea 38 (46) 46 (58) 84 (52) Hyperglycemia 31 (38) 34 (43) 65 (40) Cholelithiasis 25 (30) 24 (30) 49 (30) Headache 23 (28) 23 (29) 46 (28) Abdominal pain 19 (23) 20 (25) 39 (24) Fatigue 12 (15) 19(24) 31 (19) Diabetes mellitus 13 (16) 16 (20) 29 (18) Injection site reactions 14 (17) 14 (18) 28 (17) Nasopharyngitis 10 (12) 11 (14) 21 (13) Alopecia 10 (12) 10 (13) 20 (12) Asthenia 13 (16) 5 (6) 18 (11) Glycosylated hemoglobin increased 10 (12) 8 (10) 18 (11) Alanine aminotransferase increased 11 (13) 6 (8) 17 (10) Gamma-glutamyl transferase increased 10 (12) 7 (9) 17 (10) Edema peripheral 9 (11) 8 (10) 17 (10) Abdominal pain upper 10 (12) 6 (8) 16 (10) Decreased appetite 7 (9) 9 (11) 16 (10) Hypercholesterolemia 7 (9) 9 (11) 16 (10) Hypertension 8 (10) 8 (10) 16 (10) Dizziness 8 (10) 7 (9) 15 (9) Hypoglycemia 12 (15) 3 (4) 15 (9) Type 2 diabetes mellitus 10 (12) 5 (6) 15 (9) Anxiety 5 (6) 9 (11) 14 (9) Influenza 9 (11) 5 (6) 14 (9) Insomnia 3 (4) 11 (14) 14 (9) Myalgia 10 (12) 4 (5) 14 (9) Arthralgia 5 (6) 8 (10) 13 (8) Pruritus 6 (7) 7 (9) 13 (8) Lipase increased 7 (9) 5 (6) 12 (7) Constipation 7 (9) 4 (5) 11 (7) Hypotension 5 (6) 6 (8) 11 (7) Vomiting 3 (4) 8 (10) 11 (7) Back pain 4 (5) 6 (8) 10 (6) Dry skin 5 (6) 5 (6) 10 (6) Electrocardiogram QT prolonged 5 (6) 5 (6) 10 (6) Hypokalemia 6 (7) 4 (5) 10 (6) Pain in extremity 6 (7) 4 (5) 10 (6) Sinus bradycardia 8 (10) 2 (3) 10 (6) Vertigo 4 (5) 6 (8) 10 (6) Abdominal distension 4 (5) 5 (6) 9 (6) Adrenal insufficiency 4 (5) 5 (6) 9 (6) Aspartate aminotransferase increased 6 (7) 3 (4) 9 (6) Blood glucose increased 6 (7) 3 (4) 9 (6) Other notable adverse reactions which occurred with a frequency less than 5% were: anemia (4%); blood amylase increased (2%) and prothrombin time prolonged (2%). Gastrointestinal Disorders Gastrointestinal disorders, predominantly diarrhea, nausea, abdominal pain and vomiting were reported frequently in the Phase III trial (see Table 1). These events began to develop primarily during the first month of treatment with SIGNIFOR and required no intervention. Hyperglycemia and Diabetes Hyperglycemia-related terms were reported frequently in the Phase III trial. For all patients, these terms included: hyperglycemia (40%), diabetes mellitus (18%), increased HbA1c (11%), and type 2 diabetes mellitus (9%). In general, increases in fasting plasma glucose (FPG) and hemoglobin A1c (HbA1c) were seen soon after initiation of SIGNIFOR and were sustained during the treatment period. In the SIGNIFOR 0.6 mg group, mean fasting plasma glucose (FPG) levels increased from 98.6 mg/dL at baseline to 125.1 mg/dL at Month 6. In the SIGNIFOR 0.9 mg group, mean fasting plasma glucose (FPG) levels increased from 97.0 mg/dL at baseline to 128.0 mg/dL at Month 6. In the SIGNIFOR 0.6 mg group, HbA1c increased from 5.8% at baseline to 7.2% at Month 6. In the SIGNIFOR 0.9 mg group, HbA1c increased from 5.8% at baseline to 7.3% at Month 6 [see Warning and Precautions (5.2)] . At one-month follow-up visits following discontinuation of SIGNIFOR, mean FPG and HbA1c levels decreased but remained above baseline values. Long-term follow-up data are not available. Elevated Liver Tests In the Phase III trial, there were transient mean elevations in aminotransferase values in patients treated with SIGNIFOR. Mean values returned to baseline levels by Month 4 of treatment. The elevations were not associated with clinical symptoms of hepatic disease. In the clinical development program of SIGNIFOR, there were 4 patients with concurrent elevations in ALT greater than 3 x ULN and bilirubin greater than 2 x ULN: one patient with Cushing s disease and three healthy volunteers [see Warnings and Precautions (5.4)] . In all four cases, the elevations were noted within the first 10 days of treatment. In all of these cases, total bilirubin elevations were seen either concomitantly or preceding the transaminase elevation. The patient with Cushing s disease developed jaundice. All four cases had resolution of the laboratory abnormalities with discontinuation of SIGNIFOR. Hypocortisolism Cases of hypocortisolism were reported in the Phase III study in Cushing s disease patients [see Adverse Reactions (6) and Clinical Studies (14)] . The majority of cases were manageable by reducing the dose of SIGNIFOR and/or adding low-dose, short-term glucocorticoid therapy [see Warnings and Precautions (5.1)] . Injection Site Reactions Injection site reactions were reported in 17% of patients enrolled in the Phase III trial in Cushing s disease. The events were most frequently reported as local pain, erythema, hematoma, hemorrhage, and pruritus. These events resolved spontaneously and required no intervention. Thyroid Function Hypothyroidism with the use of SIGNIFOR was reported for seven patients participating in the Phase III study in Cushing s disease. All seven patients presented with a TSH close to or below the lower limit at study entry which precludes establishing a conclusive relationship between the adverse event and the use of SIGNIFOR. Other Abnormal Laboratory Findings Asymptomatic and reversible elevations in lipase and amylase were observed in patients receiving SIGNIFOR in clinical studies. Pancreatitis is a potential adverse reaction associated with the use of somatostatin analogs due to the association between cholelithiasis and acute pancreatitis. For hemoglobin levels, mean decreases that remained within normal range were observed. Also, post-baseline elevations in PT and PTT were noted in 33% and 47% of patients, respectively. The PT and PTT elevations were minimal. These laboratory findings are of unclear clinical significance. 7 DRUG INTERACTIONS Effects of Other Drugs on SIGNIFOR Drugs that Prolong QT Co-administration of drugs that prolong the QT interval with SIGNIFOR may have additive effects on the prolongation of the QT interval. Caution is required when co-administering SIGNIFOR with drugs that may prolong the QT interval [see Warnings and Precautions (5.3)] . Effects of SIGNIFOR on Other Drugs Cyclosporine Concomitant administration of cyclosporine with pasireotide may decrease the relative bioavailability of cyclosporine and, therefore, dose adjustment of cyclosporine to maintain therapeutic levels may be necessary. Bromocriptine Co-administration of somatostatin analogues with bromocriptine may increase the blood levels of bromocriptine. Dose reduction of bromocriptine may be necessary. 8 USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. Reproduction studies have been performed in rats and rabbits which showed evidence of harm to the fetus due to pasireotide at therapeutic exposures. Animal reproduction studies are not always predictive of human response. Pasireotide should be used during pregnancy only if clearly needed. Dosing in rats before mating and continuing into gestation at exposures less than the human clinical exposure based on body surface area comparisons across species, resulted in adverse fertility effects including: statistically significant increased implantation loss and decreased viable fetuses, corpora lutea, and implantation sites. Abnormal cycles or acyclicity were observed at systemic exposure 5-fold higher than the maximum therapeutic exposure based on surface area, comparisons across species [see Nonclinical Toxicology (13.1)] . In embryofetal development studies in rats given 1, 5, and 10 mg/kg/day subcutaneously throughout organogenesis, maternal toxicity was observed at all doses, including the lowest dose tested which had exposures 4-times higher than that at the maximum therapeutic dose based on AUC comparisons across species. In embryofetal development studies in rabbits given 0.05, 1, and 5 mg/kg/day subcutaneously through organogenesis, maternal toxicity was observed at 1 mg/kg/day at an exposure 7-times higher than the maximum therapeutic exposure. Treatment related increased incidence of skeletal malformations were observed at 0.05 mg/kg/day, exposures less than the maximum therapeutic exposure based on AUC comparisons across species. In pre- and post-natal developmental studies in rats given subcutaneous doses of 2, 5, and 10 mg/kg/day during gestation through lactation and weaning, maternal toxicity was observed at all doses including the lowest dose (12-times higher than the maximum therapeutic dose based on surface area comparisons across species). Retardation of physiological growth, attributed to GH inhibition was observed at 2 mg/kg/day during a pre- and post-natal study in rats. After weaning, body weight gains in the rat pups (F1 generation) exposed to pasireotide were comparable to controls, showing reversibility of this developmental delay. Labor and Delivery No data in humans are available. Studies in rats have shown no effects on labor and delivery [see Nonclinical Toxicology (13.1)] . Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when SIGNIFOR is administered to a nursing woman [see Nonclinical Toxicology (13.1)] . Pasireotide was excreted into rat milk at levels 30% of the plasma level. As a risk to the breastfed child cannot be excluded, SIGNIFOR should not be used by the nursing mother. Pediatric Use Safety and effectiveness of SIGNIFOR have not been established in pediatric patients. Geriatric Use Clinical studies of SIGNIFOR did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy [see Clinical Pharmacology (12.3)]. Hepatic Impairment Dose adjustment is not required in patients with mild impaired hepatic function (Child-Pugh A), but is required for patients with moderately impaired hepatic function (Child-Pugh B) [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3)]. Avoid the use of SIGNIFOR in patients with severe hepatic impairment (Child-Pugh C). Renal Impairment No dosage adjustment of SIGNIFOR in patients with impaired renal function is required [see Clinical Pharmacology (12.3)]. 10 OVERDOSAGE No cases of overdosage have been reported in patients with Cushing s disease receiving SIGNIFOR subcutaneously. Doses up to 2.1 mg b.i.d. have been used in healthy volunteers with adverse reactions of diarrhea being observed at a high frequency. In the event of overdosage, it is recommended that appropriate supportive treatment be initiated, as dictated by the patient s clinical status, until resolution of the symptoms. Up-to-date information about the treatment of overdose can be obtained from a certified Regional Poison Center. 11 DESCRIPTION SIGNIFOR (pasireotide) injection is prepared as a sterile solution of pasireotide diaspartate in a tartaric acid buffer for administration by subcutaneous injection. SIGNIFOR is a somatostatin analog. Pasireotide diaspartate, chemically known as (2-Aminoethyl) carbamic acid (2R,5S,8S,11S,14R,17S,19aS)-11-(4-aminobutyl)-5-benzyl-8-(4-benzyloxybenzyl)-14-(1H-indol-3-ylmethyl)-4,7,10,13,16,19-hexaoxo-17-phenyloctadecahydro-3a,6,9,12,15,18-hexaazacyclopentacyclooctadecen-2-yl ester, di[(S)-2-aminosuccinic acid] salt, is a cyclohexapeptide with pharmacologic properties mimicking those of the natural hormone somatostatin. The molecular formula of pasireotide diaspartate is C 58 H 66 N 10 O 9 2 C 4 H 7 NO 4 and the molecular weight is 1313.41. The structural formula is: SIGNIFOR is supplied as a sterile solution in a single-dose, 1 mL colorless glass ampule containing pasireotide in 0.3 mg/mL, 0.6 mg/mL, or 0.9 mg/mL strengths for subcutaneous injection. Each glass ampule contains: 0.3 mg 0.6 mg 0.9 mg Pasireotide diaspartate 0.3762 * 0.7524 * 1.1286 * Mannitol 49.50 49.50 49.50 Tartaric acid 1.501 1.501 1.501 Sodium hydroxide ad pH 4.2 ad pH 4.2 ad pH 4.2 Water for injection ad 1 mL ad 1 mL ad 1 mL * corresponds to 0.3/0.6/0.9 mg pasireotide base Note: Each ampule contains an overfill of 0.1 mL to allow accurate administration of 1 mL from the ampule. 12 CLINICAL PHARMACOLOGY Mechanism of Action SIGNIFOR is an injectable cyclohexapeptide somatostatin analogue. Pasireotide exerts its pharmacological activity via binding to somatostatin receptors (SSTRs). Five human somatostatin receptor subtypes are known: SSTR 1, 2, 3, 4, and 5. These receptor subtypes are expressed in different tissues under normal physiological conditions. Corticotroph tumor cells from Cushing s disease patients frequently over-express SSTR5 whereas the other receptor subtypes are often not expressed or are expressed at lower levels. Pasireotide binds and activates the SSTRs resulting in inhibition of ACTH secretion, which leads to decreased cortisol secretion. The binding affinities of endogenous somatostatin and pasireotide are shown in Table 2. Table 2- Binding affinities of somatostatin (SRIF-14) and pasireotide to the five human somatostatin receptor subtypes (SSTR1-5) Compound SSTR1 SSTR2 SSTR3 SSTR4 SSTR5 Somatostatin (SRIF-14) 0.93 0.12 0.15 0.02 0.56 0.17 1.5 0.4 0.29 0.04 Pasireotide 9.3 0.1 1.0 0.1 1.5 0.3 > 100 0.16 0.01 Results are the mean SEM of IC 50 values expressed as nmol/l Pharmacodynamics Glucose Metabolism In a randomized, double-blind mechanism study conducted in healthy volunteers, the development of hyperglycemia with pasireotide at doses of 0.6 mg b.i.d. and 0.9 mg b.i.d. was related to significant decreases in insulin secretion as well as incretin hormones (i.e., glucagon-like peptide-1 [GLP-1] and glucose-dependent insulinotropic polypeptide [GIP]) [see Warnings and Precautions (5.2) and Adverse Reactions (6.1)] . Cardiac Electrophysiology QTcI interval was evaluated in a randomized, blinded, crossover study in healthy subjects investigating pasireotide doses of 0.6 mg b.i.d. and 1.95 mg b.i.d. The maximum mean (95% upper confidence bound) placebo-subtracted QTcI change from baseline was 12.7 (14.7) ms and 16.6 (18.6) ms, respectively. Both pasireotide doses decreased heart rate, with a maximum mean (95% lower confidence bound) placebo-subtracted change from baseline of -10.9 (-11.9) beats per minute (bpm) observed at 1.5 hours for pasireotide 0.6 mg bid, and -15.2 (-16.5) bpm at 0.5 hours for pasireotide 1.95 mg b.i.d. The supra-therapeutic dose (1.95 mg b.i.d) produced mean steady-state C max values 3.3-fold the mean C max for the 0.6 mg b.i.d dose in the study. Pharmacokinetics In healthy volunteers, pasireotide demonstrates approximately linear pharmacokinetics (PK) for a dose range from 0.0025 to 1.5 mg. In Cushing s disease patients, pasireotide demonstrates linear dose-exposure relationship in a dose range from 0.3 to 1.2 mg. Absorption and Distribution In healthy volunteers, pasireotide peak plasma concentration is reached within T max 0.25-0.5 hour. C max and AUC are dose-proportional following administration of single and multiple doses. No studies have been conducted to evaluate the absolute bioavailability of pasireotide in humans. Food effect is unlikely to occur since SIGNIFOR is administered via a parenteral route. In healthy volunteers, pasireotide is widely distributed with large apparent volume of distribution (V z /F >100 L). Distribution between blood and plasma is concentration independent and shows that pasireotide is primarily located in the plasma (91%). Plasma protein binding is moderate (88%) and independent of concentration. Pasireotide has low passive permeability and is likely to be a substrate of P-gp (P-glycoprotein), but the impact of P-gp on ADME (absorption, distribution, metabolism, excretion) of pasireotide is expected to be low. In clinical testing in healthy volunteers, P-gp inhibition (e.g., verapamil) did not affect the rate or extent of pasireotide availability. Pasireotide is not a substrate of efflux transporter BCRP (breast cancer resistance protein), influx transporter OCT1 (organic cation transporter 1), or influx transporters OATP (organic anion-transporting polypeptide) 1B1, 1B3, or 2B1. Metabolism and Excretion Pasireotide was shown to be metabolically stable in human liver and kidney microsomes systems. In healthy volunteers, pasireotide in its unchanged form is the predominant form found in plasma, urine, and feces. Somatropin may increase CYP450 enzymes and, therefore, suppression of growth hormone secretion by somatostatin analogs including pasireotide may decrease the metabolic clearance of compounds metabolized by CYP450 enzymes. Pasireotide is eliminated mainly via hepatic clearance (biliary excretion) with a small contribution of the renal route. In a human ADME study 55.9 6.63% of the radioactivity dose was recovered over the first 10 days post dosing, including 48.3 8.16% of the radioactivity in feces and 7.63 2.03% in urine. The clearance (CL/F) of pasireotide in healthy volunteers and Cushing s disease patients is ~7.6 L/h and ~3.8 L/h, respectively. Steady-state Pharmacokinetics: Following multiple subcutaneous doses, pasireotide demonstrates linear pharmacokinetics in the dose range of 0.05 to 0.6 mg once a day in healthy volunteers, and 0.3 mg to 1.2 mg twice a day in Cushing s disease patients. Based on the accumulation ratios of AUC, the calculated effective half-life (t 1/2,eff ) in healthy volunteers was approximately 12 hours (on average between 10 and 13 hours for 0.05, 0.2 and 0.6 mg once a day doses). Specific Populations: Population PK analyses of SIGNIFOR indicate that race, body weight, age, and gender do not have a clinically relevant influence on PK parameters. No dose adjustment is required for demographics. Hepatic Impairment In a clinical study in subjects with impaired hepatic function (Child-Pugh A, B and C), subjects with moderate and severe hepatic impairment (Child-Pugh B and C) showed significantly higher exposures than subjects with normal hepatic function. Upon comparison with the control group, AUC inf was increased by 12%, 56% and 42% and C max increased by 3%, 46% and 33%, respectively, in the mild, moderate and severe hepatic impairment groups [see Use in Specific Populations (8.6) and Dosage and Administration (2.3)]. Pediatric Patients No studies have been performed in pediatric patients [see Use in Specific Populations (8.4)]. Geriatric Patients No clinical pharmacology studies have been performed in geriatric patients. Renal Impairment Clinical pharmacology studies have not been performed in patients with impaired renal function. However, renal clearance has a minor contribution to the elimination of pasireotide in humans. Renal function is not expected to significantly impact the circulating levels of pasireotide [see Use in Specific Populations (8.7)]. Drug Interaction Studies There was no significant drug interaction between pasireotide and metformin, nateglinide or liraglutide. 13 NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis A life-time carcinogenicity study was conducted in rats and transgenic mice. Rats were given daily subcutaneous doses of pasireotide at 0.01, 0.05, 0.3 mg/kg/day for 104 weeks. There were no drug-related tumors in rats at exposures up to 7-fold higher than the maximum recommended clinical exposure at the 1.8 mg/day dose. Mice were given subcutaneous doses of pasireotide at 0.5, 1.0, 2.5 mg/kg/day for 26 weeks and did not identify any carcinogenic potential. Mutagenesis Pasireotide was not genotoxic in a battery of in vitro assays (Ames mutation test in Salmonella and Escherichia coli and mutation test in human peripheral lymphocytes). Pasireotide was not genotoxic in an in vivo rat bone marrow nucleus test. Impairment of Fertility Subcutaneous dosing at 0.1 mg/kg/day before mating and continuing into gestation in rats at exposures less than the human clinical exposure based on body surface area comparisons across species resulted in statistically significant increased implantation loss and decreased viable fetuses, corpora lutea, and implantation sites. Abnormal cycles or acyclicity were observed at 1 mg/kg/day (5-fold higher than the maximum therapeutic exposure based on surface ar prospective customers


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