danazol
danazol
zol´), n brand name: Danocrine;
drug class: androgen, α-ethinyl testosterone derivative;
action: decreases FSH and LH output;
uses: endometriosis, prevention of hereditary angioedema, fibrocystic breast disease.
danazol
Cyclomen (CA)
Pharmacologic class: Androgen (synthetic)
Therapeutic class: Sex hormone
Pregnancy risk category X
FDA Boxed Warning
• Drug is contraindicated during pregnancy. Patient must have negative pregnancy test immediately before therapy starts, and should use nonhormonal contraceptive method during therapy.
• If patient becomes pregnant during therapy, discontinue drug and inform her of potential fetal risk.
• Drug may cause thromboembolism and thrombotic events, including life-threatening or fatal stroke.
• With long-term use, drug may cause peliosis hepatis and benign hepatic adenoma. Use lowest dosage that provides adequate protection.
• Drug has been linked to benign intracranial hypertension (pseudotumor cerebri). Screen for early signs and symptoms, including headache, nausea, vomiting, and visual disturbances.
Action
Suppresses pituitary-ovarian axis, probably through a combination of depressed hypothalamic-pituitary response to reduced estrogen production, altered sex hormone metabolism, and interaction with sex hormone receptors
Availability
Capsules: 50 mg, 100 mg, 200 mg
⊘Indications and dosages
➣ Moderate endometriosis amenable to hormonal management
Adults and adolescents: 400 mg P.O. b.i.d for up to 9 months. In milder cases, 100 to 200 mg P.O. b.i.d. initially, with dosage adjustments based on patient response.
➣ Fibrocystic breast disease
Adults and adolescents: 100 to 200 mg P.O. b.i.d. for 2 to 6 months
➣ Hereditary angioedema
Adults and adolescents: 200 mg P.O. two to three times daily. If possible, decrease dosage by 50% or less q 1 to 3 months. If acute angioedema attack occurs, increase dosage up to 200 mg/day.
Off-label uses
• Menorrhagia
• Precocious puberty
Contraindications
• Hypersensitivity to drug
• Abnormal GU tract bleeding
• Porphyria
• Severe hepatic, renal, or cardiac disease
• Pregnancy or breastfeeding
Precautions
Use cautiously in:
• coronary artery disease, conditions aggravated by edema
• mild to moderate hepatic disease
• children.
Administration
• Verify that patient isn't pregnant before initiating therapy. Start therapy during menstruation.
• Don't give to female of childbearing age unless she's willing and able to use barrier contraception during therapy.
• Give with food or milk.
| Route | Onset | Peak | Duration |
| P.O. (endometriosis) | Unknown | 6-8 wk | 60-90 days |
| P.O. (fibrocyst.) | 1 mo | 2-6 mo | 1 yr |
| P.O. (angioedema) | Unknown | 1-3 mo | Unknown |
Adverse reactions
CNS: headache, tremor, emotional lability, irritability, nervousness, anxiety, depression, sleep disorders, epilepsy exacerbation, benign intracranial hypertension
CV: increased blood pressure, palpitations, tachycardia, thrombotic events, myocardial infarction
EENT: cataracts, blurred vision, nasal congestion, papilledema
GI: nausea, vomiting, constipation, indigestion, gastroenteritis, anorexia, pancreatitis
GU: hematuria; amenorrhea; menstrual cycle disturbances (spotting, altered cycle); anovulation; vaginal dryness; changes in breast size; clitoral enlargement; testicular atrophy; abnormalities in semen volume, viscosity, mobility, and sperm count; decreased libido
Hematologic: reversible erythrocytosis, eosinophilia, polycythemia, thrombocytosis, leukocytosis, leukopenia, thrombocytopenia , splenic peliosis
Hepatic: cholestatic jaundice, peliosis hepatitis, hepatic adenoma, malignant hepatic tumor
Metabolic: increased insulin requirement (in diabetic patients)
Musculoskeletal: muscle cramps, spasms, pain, or fasciculations; joint pain and swelling; joint "lock-up"; pain in back, neck, or limbs; carpal tunnel syndrome
Skin: acne, hirsutism, oily skin, rash, photosensitivity, yellowing of skin and sclera, pigmentation changes, seborrhea, sweating
Other: weight gain, edema, deepening of voice, Stevens-Johnson syndrome
Interactions
Drug-drug. Carbamazepine: increased carbamazepine blood level
Cyclosporine, tacrolimus: increased blood levels of these drugs, increased risk of nephrotoxicity
Insulin, oral hypoglycemics: increased blood glucose level and insulin resistance, necessitating adjustment of insulin or oral hypoglycemic dosages
Warfarin: prolonged prothrombin time
Drug-diagnostic tests. Creatine kinase, glucagon, glucose, hepatic enzymes, low-density lipoproteins, plasma proteins, sex hormone-binding globulins: increased levels
Glucose tolerance, thyroid function: altered test results
High-density lipoproteins: decreased level
Patient monitoring
☞ Assess for early indications of benign intracranial hypertension, such as headache, nausea, vomiting, and visual disturbances. Screen for papilledema; if present, refer patient to neurologist immediately.
☞ Watch for hepatic problems. Long-term use is linked to peliosis hepatitis and hepatic tumors, which may be silent until complicated by acute, life-threatening intra-abdominal hemorrhage.
• Monitor patient for thromboembolism and thrombophlebitis.
• Check CBC with white cell differential and liver and kidney function test results regularly.
Patient teaching
• Advise female of childbearing age to use barrier contraception, because drug causes fetal abnormalities.
• Inform female patient that drug frequently causes amenorrhea after 6 to 8 weeks of therapy.
☞ Instruct female patient to report masculinizing effects, such as facial hair or deepening of voice.
• Tell male patient that drug may cause sperm reduction during therapy.
☞ Instruct patient to promptly report signs and symptoms of fluid retention (swelling of ankles, feet, or hands; difficulty breathing; sudden weight gain), change in urine or stool color, yellowing of eyes and skin, and easy bruising or bleeding.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.
danazol
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