DANAZOL

DANAZOL (da'na-zole) Cyclomen  Classifications: androgen/anabolic steroid; Therapeutic: anabolic steroid Prototype: Testosterone Pregnancy Category: X

Availability

50 mg, 100 mg, 200 mg capsules

Action

Synthetic androgen steroid; derivative of testosterone with dose-related mild androgenic effects but no estrogenic or progestational activity. Suppresses pituitary output of FSH and LH, resulting in anovulation and associated amenorrhea.

Therapeutic Effect

Interrupts progress and pain of endometriosis by causing atrophy and involution of both normal and ectopic endometrial tissue.

Uses

Palliative treatment of endometriosis when alternative hormonal therapy is ineffective, contraindicated, or intolerable. Also used to treat fibrocystic breast disease and hereditary angioedema.

Unlabeled Uses

To treat precocious puberty, gynecomastia, menorrhagia, premenstrual syndrome (PMS), chronic immune thrombocytopenic purpura (ITP), autoimmune hemolytic anemia, hemophilia A and B.

Contraindications

Pregnancy (category X), lactation; children; undiagnosed abnormal genital bleeding; impaired renal, cardiac, or hepatic function; porphyria; vaginal bleeding.

Cautious Use

Migraine headache, epilepsy; seizure disorders; elderly.

Route & Dosage

Endometriosis Adult: PO 400 mg b.i.d. for 3–6 mo, start during menstruation or if pregnancy test is negative, may extended to 9 mo if necessary. Do not repeat regimen. Fibrocystic Breast Disease Adult: PO 100–400 mg in 2 divided doses, start during menstruation or if pregnancy test is negative Hereditary Angioedema Adult: PO 200 mg b.i.d. or t.i.d., may decrease by 50% at intervals of 1–3 mo or longer, start during menstruation or if pregnancy test is negative

Administration

Oral

• Start therapy during menstruation, or after a negative pregnancy test.
• Store capsules at 15°–30° C (59°–86° F) in tightly closed container.

Adverse Effects (≥1%)

Body as a Whole: Hypersensitivity (skin rashes, nasal congestion). Endocrine: Androgenic effects (acne, mild hirsutism, deepening of voice, oily skin and hair, hair loss, edema, weight gain, pitch breaks, voice weakness, decrease in breast size); hypoestrogenic effects (hot flashes; sweating; emotional lability; nervousness; vaginitis with itching, drying, burning, or bleeding; amenorrhea, irregular menstrual patterns); impairment in glucose tolerance. CNS: Dizziness, sleep disorders, fatigue, tremor, irritability. Special Senses: Conjunctival edema. CV: Elevated BP. GI: Gastroenteritis, hepatic damage (rare), increased LDL, decreased HDL. Urogenital: Decreased libido. Musculoskeletal: Joint lock-up, joint swelling.

Interactions

Herbal: Echinacea possibility of increased hepatotoxicity.

Pharmacokinetics

Elimination: Other pharmacokinetic information is not known. Half-Life: 4.5 h.

Nursing Implications

Assessment & Drug Effects

• Routine breast examinations should be carried out during therapy. Carcinoma of the breast should be ruled out prior to start of therapy for fibrocystic breast disease. Advise patient to report to physician if any nodule enlarges or becomes tender or hard during therapy.
• Because danazol may cause fluid retention, patients with cardiac or renal dysfunction, epilepsy, or migraine should be observed closely during therapy, as these problems could worsen. Monitor weight.
• Drug-induced edema may compress the median nerve, producing symptoms of carpal tunnel syndrome. If patient complains of wrist pain that worsens at night, paresthesias in radial palmar aspect of the hand and fingers, consult physician.
• Lab tests: Baseline and periodic liver function tests should be performed in all patients. Patients with diabetes (or history of) should have blood glucose tests.

Patient & Family Education

• Note: Pain and discomfort are usually relieved in 2 or 3 mo; the nodularity in 4–6 mo. Menses may be regular or irregular in pattern during therapy.
• Note: Drug-induced amenorrhea is reversible. Ovulation and cyclic bleeding usually return within 60–90 d after therapeutic regimen is discontinued as well as the potential for conception.
• Use a nonhormonal contraceptive during treatment because ovulation may not be suppressed until 6–8 wk after therapy is begun. If pregnancy occurs while taking this drug, discontinue danazol. Continue discussing the question of continuing the pregnancy considered.
• Report voice changes promptly. Stop drug to avoid permanent damage to voice. Virilizing adverse effects may persist even after drug therapy is terminated.

---

Common adverse effects in italic, life-threatening effects underlined; generic names in bold; classifications in SMALL CAPS; Canadian drug name; Prototype drug