Danazol Capsule

Danazol Capsule is used for: Endometriosis, Benign breast disorders, Gynaecomastia, Hereditary angioedema, Menorrhagia.

Oral Endometriosis Adult: 200-800 mg daily in 2 divided doses adjusted according to response, for 3-6 mth or if necessary, up to 9 mth. Benign breast disorders Adult: Initially, 100-400 mg daily in 2 divided doses adjusted according to response and continued for 3-6 mth. Gynaecomastia Adult: Male adolescents: Initially, 200 mg daily, may increase to 400 mg daily after 2 mth if no response occurs; adult men: Initial: 400 mg daily in up to 4 divided doses. Usual treatment duration: 6 mth. Child: Male adolescents: Initially, 200 mg daily increased to 400 mg after 2 mth if no response occurs. Treatment usually up to 6 months. Hereditary angioedema Adult: Initially, 200 mg bid-tid reduced thereafter according to patient's response. Preoperative thinning of the endometrium Adult: 400-800 mg daily, in up to 4 divided doses for 3-6 wk. Menorrhagia Adult: 200 mg once daily. Review treatment 3 mth later.

May be taken with or without food. Take consistently either always w/ or always w/o meals.

Hypersensitivity, pregnancy, lactation, porphyria, thromboembolic disorders; undiagnosed genital bleeding, markedly impaired renal, cardiac or hepatic dysfunction.

A sensitive test (eg, beta subunit test if available) capable of determining early pregnancy recommended immediately prior to start of therapy; non-hormonal method of contraception should be used during therapy If patient becomes pregnant while receiving therapy, administration of the drug should be discontinued and the patient should apprised of potential risk to fetus Experience with long-term therapy is limited; peliosis hepatis and benign hepatic adenoma observed with long-term use; peliosis hepatis and hepatic adenoma may be silent until complicated by acute, potentially life-threatening intraabdominal hemorrhage; the physician should be alert to this possibility Attempts should be made to determine the lowest dose that will provide adequate protection; if the drug was begun at a time of exacerbation of hereditary angioneurotic edema due to trauma, stress or other cause, periodic attempts to decrease or withdraw therapy should be considered Danazol has been associated with several cases of benign intracranial hypertension also known as pseudotumor cerebri; early signs and symptoms of benign intracranial hypertension include papilledema, headache, nausea, vomiting, and visual disturbances; patients with these symptoms should be screened for papilledema and, if present, the patients should be advised to discontinue danazol immediately and be referred to a neurologist for further diagnosis and care A temporary alteration of lipoproteins in the form of decreased high-density lipoproteins and possibly increased low-density lipoproteins reported during therapy These alterations may be marked, and prescribers should consider potential impact on risk of atherosclerosis and coronary artery disease in accordance with potential benefit of therapy to the patient Before initiating therapy of fibrocystic breast disease, carcinoma of the breast should be excluded; however, nodularity, pain, tenderness due to fibrocystic breast disease may prevent recognition of underlying carcinoma before treatment is begun If any nodule persists or enlarges during treatment, carcinoma should be considered and ruled out; patients should be watched closely for signs of androgenic effects some of which may not be reversible even when drug administration is stopped Because this drug may cause some degree of fluid retention, conditions that might be influenced by this factor, such as epilepsy, migraine, cardiac, or renal dysfunction, polycythemia, and hypertension require careful observation Use with caution in patients with diabetes mellitus; since hepatic dysfunction manifested by modest increases in serum transaminases levels reported in patients receiving therapy, periodic liver function tests should be performed Administration of this drug has been reported to cause exacerbation of manifestations of acute intermittent porphyria; laboratory monitoring of hematologic state should be considered

Pregnancy Exposure to drugs in utero may result in androgenic effects on the female fetus; clitoral hypertrophy, labial fusion, urogenital sinus defect, vaginal atresia, and ambiguous genitalia have been reported Administered orally to pregnant rats from the 6th through the 15th day of gestation at doses up to 250 mg/kg/day (7-15 times the human dose) did not result in drug-induced embryotoxicity or teratogenicity, nor differences in litter size, viability, or weight of offspring compared to controls In rabbits, the administration of this drug on days 6-18 of gestation at doses of 60 mg/kg/day and above (2-4 times the human dose) resulted in inhibition of fetal development Lactation Contraindicated in breastfeeding patients

Prolongation of prothrombin time occurs in patients stabilized on warfarin Therapy may cause an increase in carbamazepine levels in patients taking both drugs This drug can cause insulin resistance; use caution when using with antidiabetic drugs This drug may raise plasma levels of cyclosporin and tacrolimus, leading to an increase of renal toxicity of these drugs; monitoring of systemic concentrations of these drugs and appropriate dose adjustments may be needed when used concomitantly with danazol Danazol can increase the calcemic response to synthetic vitamin D analogs in primary hyperparathyroidism; the risk of myopathy and rhabdomyolysis is increased by concomitant administration of danazol with statins such as simvastatin, atorvastatin, and lovastatin; caution should be exercised if used concomitantly Potentially Fatal: Increased incidence of insulin resistance in diabetic patients. Contraindicated (2) fosaprepitant simvastatin Serious (42) acalabrutinib alprazolam aprepitant brigatinib bromocriptine cobimetinib colchicine cyclosporine deflazacort dihydroergotamine dihydroergotamine intranasal doxorubicin doxorubicin liposomal dronabinol eliglustat encorafenib entrectinib eplerenone ergotamine ibrutinib ivosidenib lonafarnib lovastatin methylergonovine naldemedine naloxegol nisoldipine olaparib pexidartinib pimozide pretomanid rivaroxaban selpercatinib tacrolimus tezacaftor tolvaptan ubrogepant vardenafil vemurafenib venetoclax vilazodone warfarin

Side effects of Danazol : Frequency Not Defined Intracranial hypertension,Increased blood pressure,Thromboembolism,Anxiety,Depression,Dizziness,Urticaria Androgenic Effects (common) Mild hirsutism,Decreased breast size,Voice changes,Sore throat, acne,Increased oiliness of skin or hair,Hair loss,Menstrual irregularities (common),Gastroenteritis,Nausea,Vomiting,Elevated LFTs,Joint pain,Muscle spasm Potentially Fatal: Thromboembolic events and fatal strokes have been reported.

Danazol suppresses the pituitary-ovarian axis by reducing the release of follicle-stimulating hormone and luteinizing hormone. This causes the regression and atrophy of endometrial tissue, decreases growth rate of abnormal breast tissue and reduces attacks in hereditary angioedema.

Danazol 100mg Capsule manufactured by Ibn Sina Pharmaceutical Ind. Ltd.. Its generic name is Danazol. Danazol is availble in Bangladesh. Farmaco BD drug index information on Danazol Capsule is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.