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Danazol

Trade Names:
Danazol
- Capsules 50 mg
- Capsules 100 mg
- Capsules 200 mg

Mechanism of Action

Pharmacology

Suppresses pituitary-ovarian axis by inhibiting output of pituitary gonadotropins; has weak, dose-related androgenic activity with no estrogenic or progestational activity.

Pharmacokinetics

Absorption

Extent of availability and C _max increase 3- to 4-fold, respectively, following food. T _max delayed by 30 min after food.

Indications and Usage

Treatment of endometriosis; symptomatic treatment of fibrocystic breast disease; prevention of attacks of hereditary angioedema.

Unlabeled Uses

Treatment of precocious puberty, gynecomastia, and menorrhagia; treatment of idiopathic immune thrombocytopenia, lupus-associated thrombocytopenia, and autoimmune hemolytic anemia.

Contraindications

Pregnancy; lactation; undiagnosed abnormal genital bleeding; markedly impaired hepatic, renal, or cardiac function.

Dosage and Administration

PO 800 mg/day in 2 divided doses.

PO 100 to 400 mg/day in 2 divided doses.

PO 200 mg bid to tid.

General Advice

• Give medication with food or milk to minimize GI irritation.

Storage/Stability

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

Drug Interactions

May increase anticoagulant effects.

May increase carbamazepine concentration.

May increase cyclosporine levels, thus increasing risk of nephrotoxicity.

Diabetic patients may need increased insulin doses.

Laboratory Test Interactions

May interfere with tests for determination of testosterone, androstenedione, and dehydroepiandrosterone levels.

Adverse Reactions

Dermatologic

Acne; mild hirsutism; oily skin or hair.

GI

Gastroenteritis.

Hepatic

Jaundice; elevated LFT results; hepatic dysfunction.

Miscellaneous

Edema; decreased breast size; deepening of voice; weight gain; flushing; sweating; vaginitis; nervousness; emotional lability; amenorrhea; anovulation; breakthrough bleeding.

Precautions

Pregnancy

Category X .

Lactation

Drug contraindicated in nursing women.

Children

Safety and efficacy not established.

Hepatic Function

Hepatic dysfunction may occur; observe patient; monitor LFTs periodically.

Androgenic effects

May not be reversible even when drug is discontinued.

Carcinoma of breast

Exclude before treatment of fibrocystic breast disease.

Fluid retention

Carefully observe patients who cannot tolerate edema (eg, those with epilepsy, cardiac/renal dysfunction, migraine).

Long-term experience

Limited. Similar drugs have been associated with serious toxicity (eg, cholestatic jaundice, peliosis hepatitis). Use lowest effective dose and consider decreasing dose or withdrawing therapy periodically.

Patient Information

• Caution patient that this medication must not be taken during pregnancy or when pregnancy is possible. Advise patient to use reliable form of birth control while taking this drug.
• Remind patient to take medication with food or milk to minimize GI upset.
• Instruct patient to notify health care provider if masculinizing effects occur (eg, abnormal facial hair or other fine body hair growth, deepening of voice, acne, clitoral enlargement, testicular atrophy, decrease in breast size). Inform patient that most of these side effects will cease after drug is discontinued; however, some changes may be irreversible (eg, permanent voice changes have occurred because of structural changes in larynx).
• Inform patient to notify health care provider if change in libido occurs because this may indicate toxicity.
• Instruct patient to eat low-sodium diet to prevent fluid retention and to notify health care provider of any signs of edema.
• Advise women being treated for fibrocystic breast disease to notify health care provider of any nodule that persists or enlarges during treatment. Review proper technique for breast self-examination.
• Caution patient not to discontinue drug abruptly.
• Advise patient to notify health care provider of irregular menses. Explain that amenorrhea usually occurs but that menstruation usually resumes 2 to 3 mo after termination of therapy.
• Explain that drug-induced anovulation is reversible within 2 to 3 mo of discontinuation of therapy.