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Drug Information For:
DANAZOL 50MG CAPSULES
Ingredient Name:DANAZOL (DA-na-zole)
Drug Manufacturer:BARR LABS
Common Uses:This medicine is a synthetic steroid used to treat certain types of endometriosis or fibrocystic breast disease. It is also used to prevent attacks of hereditary angioedema (HAE). It may also be used to treat other conditions as determined by your doctor.
Before Using This Medicine:WARNING: Do not use this medicine if you are pregnant. It may cause serious harm to a fetus. It is recommended that a pregnancy test be performed before starting this medicine. Effective, nonhormonal birth control measures, such as diaphragms and condoms, should be used while taking this medicine. Talk with your doctor about the use of effective birth control while you use this medicine. If you become pregnant while taking this medicine, stop use and contact your doctor right away. SERIOUS AND SOMETIMES FATAL blood clots (eg, stroke), increased pressure in the head, and liver problems have been reported with this use of this medicine. Notify your doctor immediately if you develop any of the following: calf or leg pain, redness, tenderness, or swelling; chest pain; fainting; headache; nausea or vomiting; shortness of breath; symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine, pale stools, stomach pain, loss of appetite, unusual tiredness); symptoms of stroke (eg, one-sided weakness, slurred speech, confusion); or vision changes. Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE if you are also taking simvastatin. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking anticoagulants (eg, warfarin), carbamazepine, cyclosporine, insulin or other diabetes medicine (eg, glipizide), sirolimus, certain statins (eg, atorvastatin, lovastatin), or tacrolimus. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including a history of the blood disease polycythemia, blood vessel problems, cancer (eg, breast cancer), diabetes, seizures, fluid retention (swelling), heart problems (eg, heart failure, heart disease), high blood pressure, high cholesterol levels, liver or kidney problems, migraines, allergies, pregnancy, or breast-feeding. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have undiagnosed abnormal vaginal bleeding; the blood disease porphyria; an androgen-dependent tumor; or severe liver, kidney, or heart problems. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have a blood clot, are at risk for blood clots, or have a history of blood clots or stroke, or if you are pregnant or are breast-feeding. Contact your doctor or pharmacist if you have any questions or concerns about taking this medicine.
How to Use This Medicine:Follow the directions for using this medicine provided by your doctor. This medicine may be taken on an empty stomach or with food. IF YOU ARE BEING TREATED for endometriosis or fibrocystic breast disease, you should begin treatment during menstruation. Endometriosis patients must take this medicine consistently for 3 to 6 months. It may be necessary to take this medicine for 9 months. STORE THIS MEDICINE at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly-closed container, away from heat, moisture, and light. Do not store in the bathroom. KEEP THIS MEDICINE out of the reach of children and away from pets. IF YOU MISS A DOSE OF THIS MEDICINE, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Cautions:DO NOT TAKE THIS MEDICINE if you have had an allergic reaction to it or if you are allergic to any ingredient in this product. DO NOT EXCEED THE RECOMMENDED DOSE without checking with your doctor. IT MAY TAKE SEVERAL MONTHS for this medicine to work. Do not stop using this medicine without checking with your doctor. Laboratory and/or medical tests, including liver function tests and complete blood cell counts, may be performed to monitor your progress or to check for side effects. KEEP ALL DOCTOR AND LABORATORY APPOINTMENTS while you are using this medicine. THIS MEDICINE MAY AFFECT CERTAIN LAB TEST RESULTS. Make sure laboratory personnel and your doctors know you use this medicine. BEFORE YOU HAVE ANY MEDICAL OR DENTAL TREATMENTS, EMERGENCY CARE, OR SURGERY, tell the doctor or dentist that you are taking this medicine. This medicine may cause dizziness. DO NOT DRIVE, OPERATE MACHINERY, OR DO ANYTHING ELSE THAT COULD BE DANGEROUS until you know how you react to this medicine. Using this medicine alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. IF YOU ARE TAKING THIS MEDICINE FOR FIBROCYSTIC BREAST DISEASE, you should have a breast exam before starting it. Contact your doctor right away if you experience new or persistent breast pain, tenderness, or lumps while taking this medicine. FOR WOMEN: DO NOT USE THIS MEDICINE if you are pregnant. It may cause harm to the fetus. Women who may become pregnant must have a negative pregnancy test before beginning treatment with this medicine. Avoid becoming pregnant while you are taking it. Use a barrier method of birth control, such as a condom or diaphragm, while taking this medicine. Talk with your doctor about the use of effective birth control while you use this medicine. IF YOU THINK YOU MAY BE PREGNANT, contact your doctor immediately. IT IS UNKNOWN IF THIS MEDICINE IS EXCRETED in breast milk. DO NOT BREAST-FEED while taking this medicine. DIABETES PATIENTS: This medicine may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.
Possible Side Effects:SIDE EFFECTS that may occur while taking this medicine include acne, changes in menstrual flow (eg, spotting), changes in semen volume, decrease in breast size, excessively oily skin, flushing, hair loss, mild weight gain, sweating, vaginal itching or dryness, or voice changes (eg, hoarseness, sore throat, change in pitch). If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience abnormal hair growth; burning, numbness, or tingling; calf or leg pain, redness, tenderness, or swelling; chest pain; dizziness; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; headache; mental or mood changes (eg mood swings, nervousness); nausea; red, swollen, blistered, or peeling skin; seizures; shortness of breath; sudden, unexplained weight gain; swelling of the hands, ankles, legs or feet; symptoms of liver problems (eg, yellowing of the skin or eyes, dark urine, pale stools, stomach pain, loss of appetite, unusual tiredness); symptoms of stroke (eg, one-sided weakness, slurred speech, confusion); unusual bleeding or bruising; vision problems; or vomiting. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; or swelling of the mouth, face, lips, or tongue. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Overdose:If overdose is suspected, contact your local poison control center or emergency room immediately.
Additional Information:DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. IF YOU WILL BE USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, be sure to obtain necessary refills before your supply runs out. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.
Copyright 2014 Wolters Kluwer Health, Inc.