Danazol Rx only
DESCRIPTION
Danazol, USP is a synthetic steroid derived from ethisterone. It is a white to pale yellow crystalline powder, practically insoluble or insoluble in water, and sparingly soluble in alcohol. Chemically, danazol, USP is 17?-Pregna-2,4-dien-20-yno [2,3-d ]-isoxazol-17-ol, which has the following structural formula:
Structural Formula
(click image for full-size original)
C22 H27 NO2 M.W. 337.46
C22 H27 NO2 M.W. 337.46
Danazol Capsules USP for oral administration, contain 50 mg, 100 mg or 200 mg of danazol, USP. In addition, each capsule contains the following inactive ingredients: black iron oxide, D&C yellow no. 10, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40 aluminum lake, gelatin, lactose monohydrate, magnesium stearate, pharmaceutical glaze, propylene glycol, sodium starch glycolate, stearic acid and titanium dioxide
The 50 mg and 100 mg capsule shells also contain FD&C yellow no. 6.
The 200 mg capsule shell also contains FD&C red no. 40 and D&C red no. 28.
CLINICAL PHARMACOLOGY
Danazol suppresses the pituitary-ovarian axis. This suppression is probably a combination of depressed hypothalamic-pituitary response to lowered estrogen production, the alteration of sex steroid metabolism, and interaction of danazol with sex hormone receptors. The only other demonstrable hormonal effect is weak androgenic activity. Danazol depresses the output of both follicle-stimulating hormone (FSH) and luteinizing hormone (LH). INDICATIONS AND USAGE
Endometriosis
Danazol Capsules USP are indicated for the treatment of endometriosis amenable to hormonal management.
Fibrocystic Breast Disease
Most cases of symptomatic fibrocystic breast disease may be treated by simple measures (e.g., padded brassieres and analgesics).
In infrequent patients, symptoms of pain and tenderness may be severe enough to warrant treatment by suppression of ovarian function. Danazol Capsules USP are usually effective in decreasing nodularity, pain, and tenderness. It should be stressed to the patient that this treatment is not innocuous in that it involves considerable alterations of hormone levels and that recurrence of symptoms is very common after cessation of therapy.
Hereditary Angioedema
Danazol Capsules USP are indicated for the prevention of attacks of angioedema of all types (cutaneous, abdominal, laryngeal) in males and females.