Danazol Danazol 50 Mg 1 Medication Summary
No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication?
This medication is described in FDA/DailyMed prescribing information. No separate FDA Medication Guide was found for this label. This summary is based on FDA/DailyMed prescribing information.
What is this medication used for?
Danazol should not be administered to patients with: Undiagnosed abnormal genital bleeding.Markedly impaired hepatic, renal, or cardiac function.Pregnancy. (See WARNINGS .)Breastfeeding.Porphyria - Danazol can induce ALA synthetase activity and hence porphyrin metabolism.Androgen-dependent tumor. Active thrombosis or thromboembolic disease and history of such events. Hypersensitivity to danazol.
What should I know before taking it?
Danazol should not be administered to patients with: Undiagnosed abnormal genital bleeding.Markedly impaired hepatic, renal, or cardiac function.Pregnancy. (See WARNINGS .)Breastfeeding.Porphyria - Danazol can induce ALA synthetase activity and hence porphyrin metabolism.Androgen-dependent tumor. Active thrombosis or thromboembolic disease and history of such events. Hypersensitivity to danazol.
What important warnings are listed?
Use of danazol in pregnancy is contraindicated. A sensitive test (e.g., beta subunit test if available) capable of determining early pregnancy is recommended immediately prior to start of therapy. Additionally a non-hormonal method of contraception should be used during therapy. If a patient becomes pregnant while taking danazol, administration of the drug should be discontinued and the patient should be apprised of the potential risk to the fetus. Exposure to danazol in utero may result in androgenic effects on the female fetus; reports of clitoral hypertrophy, labial fusion, urogenital sinus defect, vaginal atresia, and ambiguous genitalia have been received (see PRECAUTIONS, Pregnancy,.
How is this medication usually taken?
Danazol capsules, USP are available as follows: 50 mg: Yellow opaque cap/white opaque body capsule. Imprinted with black ink stylized barr 633. Available in bottles of 100 (NDC 0555-0633-02) capsules. 100 mg: Yellow opaque cap/yellow clear body capsule. Imprinted with black ink stylized barr 634. Available in bottles of 100 (NDC 0555-0634-02) capsules. 200 mg: Orange opaque cap/orange clear body capsule. Imprinted with black ink stylized barr 635. Available in bottles of 60 (NDC 0555-0635-09) and 100 (NDC 0555-0635-02) capsules. Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a.
What side effects are listed?
The following events have been reported in association with the use of danazol: Androgen like effects include weight gain, acne and seborrhea. Mild hirsutism, edema, hair loss, voice change, which may take the form of hoarseness, sore throat or of instability or deepening of pitch, may occur and may persist after cessation of therapy. Hypertrophy of the clitoris is rare. Other possible endocrine effects are menstrual disturbances including spotting, alteration of the timing of the cycle and amenorrhea. Although cyclical bleeding and ovulation usually return within 60 to 90 days after discontinuation of therapy with danazol, persistent amenorrhea has occasionally been reported. Flushing,.
What interactions are listed?
Prolongation of prothrombin time occurs in patients stabilized on warfarin. Therapy with danazol may cause an increase in carbamazepine levels in patients taking both drugs. Danazol can cause insulin resistance. Caution should be exercised when used with antidiabetic drugs. Danazol may raise the plasma levels of cyclosporin and tacrolimus, leading to an increase of the renal toxicity of these drugs. Monitoring of systemic concentrations of these drugs and appropriate dose adjustments may be needed when used concomitantly with danazol. Danazol can increase the calcemic response to synthetic vitamin D analogs in primary hypoparathyroidism. The risk of myopathy and rhabdomyolysis is increased.
Where can I find the official prescribing information?
Review the full prescribing information on DailyMed: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e19acee5-ff33-45a5-bbbf-801756bc59b4
⚠️ Disclaimer
This summary is for educational purposes only and is not medical advice. Always consult your doctor, pharmacist, or other licensed healthcare professional before starting, stopping, or changing any medicine. Read full medical disclaimer.