Uses of Endozol 200: - Heavy menstrual bleeding - Endometriosis - Benign fibrocystic breast disease Endometriosis, Benign breast disorders, Gynaecomastia, Hereditary angioedema, Menorrhagia. Hypersensitivity, pregnancy, lactation, porphyria, thromboembolic disorders; undiagnosed genital bleeding, markedly impaired renal, cardiac or hepatic dysfunction.

Drugs affecting (inhibiting) gonadotrophin

As a gonadotropin inhibitor, danazol suppresses the pituitary-ovarian axis possibly by inhibiting the output of pituitary gonadotropins. Danazol also depresses the preovulatory surge in output of follicle-stimulating hormone (FSH) and luteinizing hormone (LH), thereby reducing ovarian estrogen production. Danazol may also directly inhibits ovarian steroidogenesis; bind to androgen, progesterone, and glucocorticoid receptors; bind to sex-hormone-binding globulin and corticosteroid-binding globulin; and increases the metabolic clearance rate of progesterone. Another mechanism of action by which danazol may use to facilitate regression of endometriosis is by decreasing IgG, IgM, and IgA concentrations, as well as phospholipid and IgG isotope autoantibodies. In the treatment of endometriosis, as a consequence of suppression of ovarian function, danazol causes both normal and ectopic endometrial tissues to become inactive and atrophic. This leads to anovulation and associated amenorrhea. In fibrocystic breast disease, the exact mechanism of action of danazol is unknown, but may be related to suppressed estrogenic stimulation as a result of decreased ovarian production of estrogen. A direct effect on steroid receptor sites in breast tissue is also possible. This leads to a disappearance of nodularity, relief of pain and tenderness, and possibly changes in the menstrual pattern. In terms of hereditary angioedema, danazol corrects the underlying biochemical deficiency by increasing serum concentrations of the deficient C1 esterase inhibitor, resulting in increased serum concentrations of the C4 component of the complement system.

How to use Danazol: Take this medicine in the dose and duration as advised by your doctor. Do not chew, crush or break it. Danazol may be taken with or without food, but it is better to take it at a fixed time. Administration: May be taken with or without food. Take consistently either always w/ or always w/o meals. Adult Dose: 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.

Increased serum levels of ciclosporin, warfarin, carbamazepine and tacrolimus. Potentially Fatal: Increased incidence of insulin resistance in diabetic patients.

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

Common - Hoarseness of voice - Hair loss - Weight gain - Acne - Abnormal hair growth on a women face and body - Voice change - Itchy scalp - Swelling - Sore throat 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.

Category X: Studies in animals or human beings have demonstrated fetal abnormalities or there is evidence of fetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.

Precaution: Danazol may cause some degree of fluid retention, conditions that might be influenced by this factor, such as epilepsy, migraine, or 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 has been reported in patients treated with Danazol, periodic liver function tests should be performed Administration of danazol has been reported to cause exacerbation of the manifestations of acute intermittent porphyria. Lactation: enters breast milk/contraindicated

There have been no incidents of acute overdosage with Danazol and it is unlikely that any immediate serious reaction will be seen from a single excessive dose. In case of the acute overdosage, the drug should be removed by gastric lavage and the patient should be kept under observation.

Store at 15-30°C.

Drugs affecting (inhibiting) gonadotrophin

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.

Pregnancy Category: X Lactation: enters breast milk/contraindicated