Drugs & Vitamins

Premphase Active Ingredients: Conjugated Estrogens and Medroxyprogesterone Representative Names: Premphase, Prempro Available Product Images: What are conjugated estrogens; medroxyprogesterone tablets? What should I tell my health care provider before I take this medicine? How should I take this medicine? What if I miss a dose? What drug(s) may interact with conjugated estrogens; medroxyprogesterone? What side effects may I notice from taking conjugated estrogens; medroxyprogesterone? What should I watch for while taking conjugated estrogens; medroxyprogesterone? Where can I keep my medicine? What are conjugated estrogens; medroxyprogesterone tablets? (Back to top) CONJUGATED ESTROGENS; MEDROXYPROGESTERONE (Prempro™, Premphase™) tablets are a mixture of estrogen hormones combined with a progestin hormone. Estrogens are essential for maintaining normal female functions. Conjugated estrogens can help relieve symptoms of the menopause (hot flashes, night sweats, mood changes, and vaginal dryness and irritation), and also help to prevent the onset of osteoporosis (weak thin bones). Medroxyprogesterone (a progestin) is helpful in reducing overgrowth of the lining of the uterus (the endometrium), which may help reduce your risk of endometrial cancer. Medroxyprogesterone is added to either all tablets in the prescription (Prempro™), or it is added only for days 15—28 of the prescription cycle (Premphase™). Medroxyprogesterone is effective either way. Generic conjugated estrogens; medroxyprogesterone tablets are not yet available. What should I tell my health care provider before I take this medicine? (Back to top) They need to know if you have any of these conditions: •asthma •blood vessel disease, blood clotting disorder, or suffered a stroke •breast, cervical, endometrial, ovarian or uterine cancer •diabetes •endometriosis •fibroids in the womb •heart disease •high blood lipids or cholesterol •high blood pressure •high level of calcium in the blood •low level of calcium in the blood •hysterectomy •kidney disease •liver disease •mental depression •migraine •porphyria •systemic lupus erythematosus (SLE) •thyroid disease •tobacco smoker •vaginal bleeding •an unusual or allergic reaction to estrogens, medroxyprogesterone, other hormones, medicines, foods, dyes, or preservatives •pregnant or trying to get pregnant •breast-feeding How should I take this medicine? (Back to top) Take conjugated estrogen; medroxyprogesterone tablets by mouth. Follow the directions on the prescription label. Swallow the tablet with a drink of water. Take the tablets with food. Take your doses at regular intervals, at the same time each day. Do not take your medicine more often than directed. For Premphase™: You will take one tablet daily. Your prescription will have two blister cards of 14 tablets each. The first card contains 14 maroon tablets that are taken on days 1—14. The second card contains 14 blue tablets that are taken on days 15—28 of each cycle. For Prempro™: You will take one tablet daily. Your prescription will have two blister cards of 14 tablets each. All tablets in the cards are of the same strength. •For all uses of this medicine: Before starting this medication, read the paper on your prescription provided by your pharmacist or health care professional. This paper will tell you about the specific product you are taking. Make certain you understand the instructions. Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed. What if I miss a dose? (Back to top) If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses. What drug(s) may interact with conjugated estrogens; medroxyprogesterone? (Back to top) •anastrozole •barbiturates or benzodiazepines used for inducing sleep or treating seizures (convulsions) •bosentan •bromocriptine •carbamazepine •cimetidine •cyclosporine •dantrolene •exemestane •medications for diabetes •methotrexate •griseofulvin •hydrocortisone, cortisone, or prednisolone •isoniazid (INH) •letrozole •methotrexate •mineral oil •phenytoin •raloxifene or tamoxifen •rifabutin, rifampin, or rifapentine •testolactone •thyroid hormones •topiramate •tricyclic antidepressants •warfarin Tell your prescriber or health care professional about all other medicines you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines. What side effects may I notice from taking conjugated estrogens; medroxyprogesterone? (Back to top) Side effects that you should report to your prescriber or health care professional as soon as possible: •breakthrough bleeding and spotting •breast enlargement, tenderness, unusual discharge or milk production •chest pain •confusion, forgetfulness •leg, arm or groin pain •nausea, vomiting •severe headaches •stomach or abdominal pain (severe) •sudden shortness of breath •swelling of the hands, feet or ankles, or rapid weight gain •vision or speech problems •yellowing of the eyes or skin Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome): •change in sexual desire •diarrhea •mild stomach upset •mood changes, anxiety, depression, frustration, anger, or emotional outbursts •increased or decreased appetite •skin rash, acne, or brown spots on the face •tiredness •urinary incontinence •vaginal yeast infection (irritation and white discharge) •weight gain What should I watch for while taking conjugated estrogens; medroxyprogesterone? (Back to top) Visit your prescriber or health care professional for regular checks on your progress. You should have a complete check-up every 6 months. You will need a regular breast and pelvic exam and "Pap" smear while on conjugated estrogens-medroxyprogesterone therapy. You should also discuss the need for regular mammograms with your health care professional, and follow his or her guidelines for these tests. Conjugated estrogens-medroxyprogesterone can make your body retain fluid, making your fingers, hands, or ankles swell. Your blood pressure can go up. Contact your prescriber or health care professional if you feel you are retaining fluid. If you have any reason to think you are pregnant; stop taking conjugated estrogens-medroxyprogesterone at once and contact your prescriber or health care professional. Tobacco smoking increases the risk of getting a blood clot or having a stroke while you are taking conjugated estrogens, especially if you are more than 35 years old. You are strongly advised not to smoke. If you wear contact lenses and notice visual changes, or if the lenses begin to feel uncomfortable, consult your eye care specialist. If you are going to have elective surgery, you may need to stop taking your estrogens one month beforehand. Consult your health care professional for advice prior to scheduling the surgery. Where can I keep my medicine? (Back to top) Keep out of the reach of children in a container that small children cannot open. Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date. Last Updated:05/02/2006 CLINICAL PHARMACOLOGY© GOLD STANDARD MULTIMEDIA INC, ALL RIGHTS RESERVED

Note: The above information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist, or other healthcare professional. It should not be construed to indicate that the use of the product is safe, appropriate, or effective for you. Consult your healthcare professional before taking the product.