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Danazol USP

Danazol-100 100 mg 2X10 Capsule
Danazol-200 200 mg 1X10 Capsule


Danazol is a preparation of Danazol. It is a weak impeded androgen with associated anabolic properties. It inhibits gonadotropin-releasing hormone and gonadotropin secretion. This suppresses menstruation, inhibits ovulation and causes regressive change in the vaginal smear and atrophic change in the endometrium. Danazol has no estrogenic or progestogenic properties .

Danazol-100: Each capsule contains Danazol USP 100 mg. Danazol-200: Each capsule contains Danazol USP 200 mg.

Danazol is indicated for the following treatment •Endometriosis •Benign breast disease •Severe cyclical mastalgia •Menorrhagia •Gynaecomastia • Preoperative thinning of the endometrium before hysteroscopic endometrial ablation

Dosage and Administration: Usually given in up to 4 divided doses; in women of child-bearing potential, treatment should start during menstruation, preferably on first day. Endometriosis: 200—800 mg daily in up to 4 divided doses, adjusted to achieve amenorrhoea, usually for 6 months (up to 9 months in some cases). Menorrhagia: In menorrhagia daily doses of 100-200 mg have been found effective but 200 mg daily for 3 months is usually sufficient to reduce menstrual blood flow to acceptable levels. Severe cyclical mastalgia:100-400 mg daily usually for 3-6 months. Benign breast cysts: 300 mg daily usually for 3-6 months. Gynaecomastia: 400 mg daily in up to 4 divided doses for 6 months (adolescents 200 mg daily, increased to 400 mg daily if no response after 2 months). For pre-operative thinning of endometrium: 400 mg-800 mg daily in up to 4 divided doses for 3-6 weeks.

Weight gain, Acne, Flushing, Sweating, Voice changes (hoarseness, change in pitch), abnormal growth of body hair (in Women), vaginal dryness/ irritation, or decreased breast size may occur.

Cardiac, hepatic or renal impairment, elderly, polycythaemia, epilepsy, diabetes mellitus, hypertension, migraine, lipoprotein disorder, history of thrombosis or thromboembolic disease. If signs of virilization occur,e.g. voice changes or hirsutism, therapy should be stopped immediately.

Pregnancy: Pregnancy Category-X. Pregnant Women: The drug should not be given to pregnant women, because of risk of virilization of a female fetus, particularly when high doses are given for several weeks. Lactating mother: Patients taking the drug should not breast feed.

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 ant diabetic drugs.Danazol may raise the plasma levels of cyclosporine and tacrolimus, leading to an increase of the renal toxicity of these drugs. Danazol can increase the calcemic response to synthetic vitamin D analogs in primary hypoparathyroidism.

Store at room temperature away from light and moisture. Keep away from children and pets.

Danazol is contraindicated in Pregnancy and breast feeding, Impaired hepatic, Renal or cardiac function, Thromboembolic disease, Androgen-dependent tumor, Abnormal vaginal bleeding, Hypersensitivity to Danazol etc.

Danazol-100: Each box contains 2 x 10 capsules in alu-alu blister pack. Danazol-200: Each box contains 1 x 10 capsules in alu-alu blister pack.