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Danazol

Brands: Cyclomen, Danol

 

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 interactions 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 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.

 

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; dcreased libido

Hematologic: reversible erythrocyctosis, 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, increase 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, tests, and herbs mentioned above.

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