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Danazol information from DrugsUpdate  

See Available Brands of Danazol in India

P - Contraindicated in pregnancy
L - Contraindicated in lactation
LI - Lab *

Danazol is a derivative of the synthetic steroid ethisterone, a modified testosterone. Also known as 17alpha-ethinyl testosterone. Before becoming available as a generic drug, Danazol was marketed as Danocrine in the United States. It was approved by the U.S. Food and Drug Administration (FDA) as the first drug to specifically treat endometriosis in the early 1970s. Although effective for endometriosis, its use is limited by its masculinizing side-effects.Its role as a treatment for endometriosis has been largely replaced by the GnRH agonists.

Pharmacodynamics

Pharmacokinetics

Danazol suppresses the pituitary-ovarian axis by reducing the release of follicle-stimulating hormone and luteinizing hormone. This causes the regression and atrophy of endometrial tissue, decreases growth rate of abnormal breast tissue and reduces attacks in hereditary angioedema. Onset Approximately 4 wk. Absorption Absorbed from the GI tract (oral); absorption increases if taken with food. Metabolism Hepatic (extensive); converted to 2-hydroxymethylethisterone. Excretion Via urine.

Danazol Indications / Danazol Uses

Information Not Available

Danazol Adverse Reactions / Danazol Side Effects

Oedema, wt gain, sweating, acne, hirsutism, flushing, oily skin or hair, deepening of the voice, clitoral hypertrophy, amenorrhoea, hepatic dysfunction, CNS or GI disturbances, benign intracranial hypertension, reduction in breast size, visual disturbances, elevated LFT values. Potentially Fatal: Thromboembolic events and fatal strokes have been reported.

Precautions

Because Danazol may cause some degree of fluid retention, conditions that might be influenced by this factor, such as epilepsy, migraine, or cardiac or renal dysfunction, require careful observation. Since hepatic dysfunction manifested by modest increases in serum transaminase levels has been reported in patients treated with Danazol, periodic liver function tests should be performed. Administration of Danazol has been reported to cause exacerbation of the manifestations of acute intermittent porphyria.

Special Precautions

Epilepsy, migraine; cardiac, hepatic, renal disorders. Severe hypertension, diabetes, polycythaemia, history of thrombosis; children.

Other Drug Interactions

Increased serum levels of ciclosporin, warfarin, carbamazepine and tacrolimus. Potentially Fatal: Increased incidence of insulin resistance in diabetic patients.

Other Interactions

Food Interactions:Increased conc with high fat meal.

Dosage

Oral Endometriosis Adult: 200-800 mg daily in 2 divided doses adjusted according to response, for 3-6 mth or if necessary, up to 9 mth. Oral Benign breast disorders Adult: Initially, 100-400 mg daily in 2 divided doses adjusted according to response and continued for 3-6 mth. Oral Gynaecomastia Adult: Male adolescents: Initially, 200 mg daily, may increase to 400 mg daily after 2 mth if no response occurs; adult men: Initial: 400 mg daily in up to 4 divided doses. Usual treatment duration: 6 mth. Child: Male adolescents: Initially, 200 mg daily increased to 400 mg after 2 mth if no response occurs. Treatment usually up to 6 months. Oral Hereditary angioedema Adult: Initially, 200 mg bid-tid reduced thereafter according to patient's response. Oral Preoperative thinning of the endometrium Adult: 400-800 mg daily, in up to 4 divided doses for 3-6 wk. Oral Menorrhagia Adult: 200 mg once daily. Review treatment 3 mth later.

Food(before/after)

May be taken with or without food. (Take consistently either always w/ or always without meals.)

List of Contraindications

Danazol and Pregnancy

Contraindicated in pregnancy. Category X: Studies in animals or human beings have demonstrated foetal abnormalities or there is evidence of foetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.

Danazol and Lactation

Contraindicated in lactation

Danazol and Children

Information Not Available

Danazol and Geriatic

Information Not Available

Danazol and Other Contraindications

Hypersensitivity, pregnancy, lactation, porphyria, thromboembolic disorders; undiagnosed genital bleeding, markedly impaired renal, cardiac or hepatic dysfunction.

Storage

Store drug in closed, light-resistant container at room temperature.

Lab interference

Store drug in closed, light-resistant container at room temperature.

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