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Pronunciation: DAN-uh-ZOLE
Class: Sex hormone

Trade Names

Danazol
- Capsules 50 mg
- Capsules 100 mg
- Capsules 200 mg

Cyclomen (Canada)

Pharmacology

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

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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

Endometriosis
Adults

PO 800 mg/day in 2 divided doses.

Fibrocystic Breast Disease
Adults

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

Hereditary Angioedema
Adults

PO 200 mg 2 or 3 times daily.

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

Anticoagulants

May increase anticoagulant effects.

Carbamazepine

May increase carbamazepine concentration.

Cyclosporine

May increase cyclosporine levels, thus increasing risk of nephrotoxicity.

Insulin

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 function impairment.

Miscellaneous

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

Precautions

Warnings

Pregnancy

Contraindicated in pregnancy. Negative pregnancy test must be obtained immediately prior to therapy. Nonhormonal method of contraception is recommended during therapy.

Intracranial hypertension

Benign intracranial hypertension (pseudotumor cerebri) has been reported. Screen for early signs of intracranial hypertension (eg, headache, nausea, vomiting, visual disturbances).

Peliosis hepatitis and benign hepatic adenoma

Peliosis hepatitis and benign hepatic adenoma have been observed with long-term use.

Thromboembolism and thrombotic events

Thromboembolism and thrombotic events have been reported, including life-threatening or fatal strokes.


Pregnancy

Category X .

Lactation

Drug contraindicated in breast-feeding women.

Children

Safety and efficacy not established.

Hepatic Function

Hepatic function impairment 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 adverse reactions 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.

Copyright © 2009 Wolters Kluwer Health.

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