DANAZOL capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DANAZOL (UNII: N29QWW3BUO) (DANAZOL - UNII:N29QWW3BUO)

Available from:

Carilion Materials Management

INN (International Name):

DANAZOL

Composition:

DANAZOL 200 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Endometriosis Danazol capsules 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 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 are indicated for the prevention of attacks of angioedema of all types (cutaneous, abdominal, laryngeal) in males and females. Danazol capsules should not be administered to patients with: - Undiagnosed abnormal genital bleeding. - Markedly impaired hepatic, renal, or cardiac functi

Product summary:

NDC:68151-2298-0 in a PACKAGE of 1 CAPSULES

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DANAZOL- DANAZOL CAPSULE
CARILION MATERIALS MANAGEMENT
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DANAZOL CAPSULES, USP RX ONLY
DESCRIPTION
Danazol 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 is
17α-Pregna-2, 4-dien-20-yno [2, 3- ]-isoxazol-17-ol. The molecular
formula is C H NO . It has a
molecular weight of 337.46 and the following structural formula: _d_
Danazol capsules for oral administration contain 50 mg, 100 mg, or 200
mg danazol.
anhydrous lactose, lactose monohydrate, magnesium stearate,
pregelatinized starch, sodium lauryl
sulfate, talc. Capsule shells for 200 mg danazol contain D&C Yellow
#10, FD&C Red #40, D&C Red
#28, gelatin, and titanium dioxide. Capsule shells for 50 mg and 100
mg danazol contain D&C Yellow #
10, FD&C Red # 40, gelatin, and titanium dioxide. The capsule
imprinting ink contains: shellac glaze in
ethanol, iron oxide black, n-butyl alcohol, propylene glycol, ethanol,
methanol, FD&C Blue No. 2
Aluminum Lake, FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 1 Aluminum
Lake, and D&C
Yellow No. 10 Aluminum Lake. _Inactive Ingredients:_
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).
Recent evidence suggests a direct inhibitory effect at gonadal sites
and a binding of danazol to
receptors of gonadal steroids at target organs. In addition, danazol
has been shown to significantly
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decrease IgG, IgM and IgA levels, as well as phospholipid and IgG
isotope autoantibodies in patients
with endometriosis and associated elevations of autoantibodies,
suggesting this could