Precautions and warnings

Danazol can cause your body to retain extra fluid. Because of this, people with certain conditions—like epilepsy, migraine, heart or kidney problems, polycythemia, and high blood pressure—should be closely monitored while taking Danazol. It should also be used carefully in people with diabetes.

Since Danazol has sometimes caused mild liver problems (shown by higher liver enzyme levels), your doctor should regularly check your liver function. Finally, Danazol may make symptoms worse in people with acute intermittent porphyria.

Drug Interactions

Higher amounts of ciclosporin, warfarin, carbamazepine, and tacrolimus may be found in the blood.
Serious Risk: Diabetic patients may have a greater chance of developing insulin resistance, which can be life-threatening.

Contraindications

Do not use if you have allergies to the medication, are pregnant or breastfeeding, have porphyria, blood clot disorders, unexplained vaginal bleeding, or severe kidney, heart, or liver problems.

Mode of actions

Danazol works by lowering the release of certain hormones (FSH and LH) from the pituitary gland. This helps shrink and reduce endometrial tissue, slows the growth of abnormal breast tissue, and also decreases the number of hereditary angioedema attacks.

Dosage & Administration

Adult: PO: 200-800 mg/day in 2 divided doses for 3-6 mth, up to 9 mth if needed. It is recommended that danazol therapy in adult females should start on the first day of the menstrual cycle with an adjustment of dosage made subsequently to achieve amenorrhoea or the desired effect.

In endometrosis : The initial dose is 400 mg daily usually continued for 6 months. If symptoms do not resolve, the dose can be increased to 800 mg daily but the total course should not exceed 9 months.

Benign breast disease: Severe cyclical mastalgia. The recommended initial dose for severe cyclical mastalgia is 200-300 mg daily for 3-6 month. In several studies, the initial dose was either 200 mg or 300 mg daily, which was reduced after either 1 or 2 months if a clinically useful response had occurred.

Benign, multiple or recurrent breast disease: The recommended initial dose for this indication is 300 mg daily for 3-6 months.

Menorrhagia: In menorrhagia, daily doses of 100-200 mg have been found effective but 200 mg daily is usually sufficient to reduce menstrual blood flow to acceptable levels. The recommended initial dose is 200 mg daily for 3 months.

Gynecomastia: Adults, 300-600 mg daily. Adolescents, 200-300 mg daily.

Preoperative thinning of the endometrium before hysteroscopic endometrial ablation: Danazol induces endometrial atrophy and is currently recommended at doses of 400-800 mg daily for up to 3 months preoperatively.

Pregnancy & Lactation

This medicine must not be used during pregnancy. It can be absorbed through the skin and lungs caused can damage your unborn child’s organs and cause congenital disabilities. Strict two effective types of birth control starting one month before and during treatment and for three years after stopping this medicine. Discuss with your doctors if you are not sure which types of birth control are effective for you. You must need to take pregnancy tests regularly during your treatment with this medicine and for at least three years after taking this medicine. If it seems that you do become pregnant stop taking this medicine and call your doctor immediately. If you really become pregnant, miss a menstrual period, or have sex without using two forms of birth control. In some cases, your doctor can prescribe emergency contraception to prevent pregnancy. People on this medicine should not donate blood during the treatment and for three years afterward.

This medicine is also contraindicated breast milk. Breastfeeding is not recommended while using this medication and for three years afterward.

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