Nazol Capsules

Endometriosis. Danazol capsules are indicated for the treatment of endometriosis amenable to hormonal management. Hereditary Angioedema. Danazol capsules are indicated for the prevention of attacks of angioedema of all types (cutaneous, abdominal, laryngeal) in males and females.

The following events have been reported in association with the use of danazol capsules: 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. …

Danazol capsules should not be administered to patients with: Undiagnosed abnormal genital bleeding. Markedly impaired hepatic, renal, or cardiac function. Pregnancy (see WARNINGS ). Breast feeding. Porphyria-Danazol capsules 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.

PRECAUTIONS Because danazol capsules may cause some degree of fluid retention, conditions that might be influenced by this factor, such as epilepsy, migraine, or cardiac or renal dysfunction, polycythemia and hypertension require careful observation. Use with caution in patients with diabetes mellitus. Since hepatic dysfunction manifested by modest increases in serum transaminases levels has been reported in patients treated with danazol capsules, periodic liver function tests should be performed (see WARNINGS and ADVERSE REACTIONS ). Administration of danazol has been reported to cause exacerbation of the manifestations of acute intermittent porphyria (see CONTRAINDICATIONS ). …