Danazol

Danazol is a gonadotropin inhibitor that suppresses the pituitary-ovarian axis, possibly by inhibiting the output of pituitary gonadotropins. Danazol also depresses the preovulatory surge in output of FSH and LH, thereby reducing ovarian estrogen production. Danazol may also directly inhibit ovarian steroidogenesis; bind to androgen, progesterone, and glucocorticoid receptors; bind to sex-hormone-binding globulin and corticosteroid-binding globulin; and increase the metabolic clearance rate of progesterone. In endometriosis, as a consequence of suppression of ovarian function, danazol causes both normal and ectopic endometrial tissues to become inactive and atrophic.

• Endometriosis
• Benign breast disease (fibrocystic breast disease)
• Menorrhagia
• Gynecomastia
• Hereditary angioedema
• Preoperative thinning of the endometrium before hysteroscopic endometrial ablation

As a gonadotropin inhibitor, danazol suppresses the pituitary-ovarian axis possibly by inhibiting the output of pituitary gonadotropins. Danazol also depresses the preovulatory surge in output of FSH and LH, thereby reducing ovarian estrogen production. Danazol may also directly inhibit ovarian steroidogenesis; bind to androgen, progesterone, and glucocorticoid receptors; bind to sex-hormone-binding globulin and corticosteroid-binding globulin; and increase the metabolic clearance rate of progesterone.

Danazol inhibits pituitary gonadotropin output, suppressing FSH and LH surges, thereby reducing ovarian estrogen production and causing endometrial tissue atrophy.

Adult - Endometriosis: 200-800 mg daily in 2-4 divided doses, adjusted to achieve amenorrhoea, usually for 6 months (up to 9 months in some cases).

Adult - Menorrhagia: 100-200 mg daily, 200 mg daily for 3 months is usually sufficient.

Adult - Benign breast disease: 100-400 mg daily in 2 divided doses for 3-6 months.

Adult - Gynecomastia: 400 mg daily in up to 4 divided doses for 6 months (adolescents: 200 mg daily, increased to 400 mg if no response after 2 months).

Adult - Hereditary angioedema: Initially 200 mg 2-3 times daily, reduced thereafter according to response.

Adult - Preoperative endometrial thinning: 400-800 mg daily for 3-6 weeks.

Take with or without food, but it is better to take it at a fixed time. Swallow the tablet whole, do not chew, crush or break it. In women of child-bearing potential, treatment should start during menstruation, preferably on the first day.

If you miss a dose of Danazol, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose. Do not double the dose.

Common Side Effects:

• Hoarseness of voice
• Hair loss
• Weight gain
• Acne
• Abnormal hair growth on face and body (women)
• Voice change
• Itchy scalp
• Swelling
• Sore throat
• Menstrual irregularities
• Vaginal dryness and irritation
• Flushing
• Reduction in breast size

Serious Side Effects:

• Virilization (voice changes, hirsutism, clitoral hypertrophy)
• Benign intracranial hypertension (headache, visual disturbances)
• Thromboembolic events
• Leukopenia, thrombocytopenia
• Insulin resistance
• Liver function changes

• May affect your ability to drive (dizziness, spinning feeling, changes in eyesight).
• If signs of virilization occur (voice changes or hirsutism), therapy should be stopped immediately.
• Caution in cardiac, hepatic or renal impairment, diabetes, hypertension, migraine, history of thrombosis.
• Use non-hormonal contraceptive methods to avoid pregnancy.
• Regular monitoring of liver function tests is advised.

• Pregnancy and breast-feeding
• Impaired hepatic, renal, or cardiac function
• Porphyria
• Thromboembolic disease
• Androgen-dependent tumor
• Undiagnosed abnormal vaginal bleeding
• Hypersensitivity to danazol

Insulin: Patients taking danazol may show increased insulin resistance.

Ciclosporin, warfarin, carbamazepine, tacrolimus: Serum levels may be increased.

Anticonvulsants (phenytoin, phenobarbital): Danazol may affect plasma concentrations.

Antihypertensives: Danazol may oppose the action of antihypertensive agents.

It is unsafe to consume alcohol with Danazol (may cause nausea or shortness of breath).

Pregnancy Category X. Danazol is highly unsafe during pregnancy. Risk of virilization of a female fetus. Seek your doctor's advice.

Danazol is unsafe during breastfeeding. Data suggests that the drug may cause toxicity to the baby.

Danazol is not used in children (except adolescents with gynecomastia).

No specific dosage adjustment is necessary for elderly patients. However, caution should be exercised.

Renal impairment: Use with caution. May not be advised in severe kidney disease. Dose adjustment may be needed.

Hepatic impairment: Use with caution. Not recommended in severe liver disease. Regular monitoring of liver function tests is advised.

No adequate information on overdose is available. Overdose may lead to virilization, liver toxicity, and other side effects. Seek medical attention.

Keep below 30°C temperature, away from light & moisture. Keep out of reach of children.

Danazol