Vabon

Vabon

danazol

Manufacturer:

Biolab

Distributor:

Biopharm
Concise Prescribing Info
Contents
Danazol
Indications/Uses
Endometriosis, associated infertility, benign breast disease including gynaecomastia, mazoplasia & mastodynia, menorrhagia, primary constitutional precocious puberty & other similar endocrine disorders. Prophylaxis of hereditary angioedema.
Dosage/Direction for Use
Endometriosis Patient w/ moderate to severe disease or who are infertile Initially 800 mg daily in 2 divided doses. Patient w/ mild disease Initially 200-400 mg daily in 2 divided doses. Symptomatic management of fibrocystic breast disease 100-400 mg daily in 2 divided doses. Menorrhagia Adult 200 mg daily for 12 wk. May be increased to 400 mg daily. Primary constitutional precocious puberty Childn 100-200 mg daily according to age & wt. Prophylaxis of hereditary angioedema Initially 200 mg bid or tid. Maintenance dose: Decrease dose by ≥50% at intervals of 1-3 mth or longer after obtaining an initial response. May increase dose by up to 200 mg daily if attack occurs during treatment.
Administration
May be taken with or without food: Take consistently either always w/ or always w/o meals.
Contraindications
Abnormal genital bleeding of unknown etiology. Impaired cardiac function; porphyria. Hepatic & renal impairment. Pregnancy & lactation.
Special Precautions
Discontinue if signs & symptoms of pseudotumor cerebri develop. Patients w/ seizure disorders, migraine, or cardiac, renal or dysfunction. Liver peliosis, benign or malignant hepatic adenoma. Hepatotoxicity during long-term administration. Increased risk of CV disease eg, CAD, atherosclerosis. Periodically evaluate liver functions in all patients receiving treatment. Evaluate semen for vol, viscosity, & sperm count & motility every 3-4 mth during therapy, especially in adolescents. Carefully monitor for signs of virilization. Examine for the presence of papilledema. Rule out carcinoma before initiating treatment. Woman of childbearing age should use an effective, non-hormonal method of contraception during therapy. Contraindicated in woman who are or may become pregnant; lactation.
Adverse Reactions
Mild hirsutism, decreased breast size, voice changes, sore throat, acne, increased oiliness of skin or hair, hair loss, wt gain, edema, clitoral hypertrophy, testicular atrophy, flushing, sweating, emotional lability, vaginitis w/ itching, dryness, burning &/or bleeding, glucose intolerance; menstrual irregularities, hematuria, reduced spermatogenesis, abnormalities in semen vol, viscosity, sperm count & motility; cholestatic jaundice, liver peliosis, benign or malignant hepatic adenoma; benign intracranial HTN, headache, papilledema, anxiety, depression, dizziness, fainting, fatigue, Guillain-Barre syndrome, nervousness, seizures, sleep disorders, syncope, paresthesias, tremor, weakness; increased BP, thromboembolism, thrombotic or thrombophlebitic events; allergic reactions, urticaria, pruritus, petechiae, rash; gastroenteritis, appetite changes, nausea, vomiting, constipation, bleeding gum; muscle cramps or spasm, joint pain or swelling, locked joints, back, neck & leg pain, carpal tunnel syndrome; reversible erythrocytosis, leukocytosis, polycythemia, eosinophilia, leucopenia, increased erythrocyte & platelet counts; visual disturbances, conjunctival edema, cataracts; fever, chills, nasal congestion, pancreatitis.
Drug Interactions
Increased carbamazepine levels. Increased cyclosporine blood conc. Prolonged prothrombin time w/ warfarin. Interference w/ lab determinations of testosterone, androstenedione, dehydroepiandrosterone, CPK, glucose tolerance, glucagon, thyroid-binding & sex hormone-binding globulin, other plasma proteins, lipids & lipoproteins.
MIMS Class
Trophic Hormones & Related Synthetic Drugs
ATC Classification
G03XA01 - danazol ; Belongs to the class of antigonadotropins and similar agents.
Presentation/Packing
Form
Vabon cap 100 mg
Packing/Price
100's
Form
Vabon cap 200 mg
Packing/Price
100's
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