DANAZOL capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Teva Pharmaceuticals USA, Inc.

INN (International Name):

DANAZOL

Composition:

DANAZOL 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Danazol capsules are indicated for the treatment of endometriosis amenable to hormonal management. Danazol capsules are indicated for the prevention of attacks of angioedema of all types (cutaneous, abdominal, laryngeal) in males and females. Danazol should not be administered to patients with: - Undiagnosed abnormal genital bleeding. - Markedly impaired hepatic, renal, or cardiac function. - Pregnancy. (See WARNINGS .) - Breastfeeding. - Porphyria - Danazol can induce ALA synthetase activity and hence porphyrin metabolism. - Androgen-dependent tumor. - Active thrombosis or thromboembolic disease and history of such events. - Hypersensitivity to danazol.

Product summary:

Danazol capsules, USP are available as follows: 50 mg: Yellow opaque cap/white opaque body capsule. Imprinted with black ink stylized barr  633 . Available in bottles of 100 (NDC 0555-0633-02) capsules. 100 mg: Yellow opaque cap/yellow clear body capsule. Imprinted with black ink stylized barr 634 . Available in bottles of 100 (NDC 0555-0634-02) capsules. 200 mg: Orange opaque cap/orange clear body capsule. Imprinted with black ink stylized barr 635 . Available in bottles of 60 (NDC 0555-0635-09) and 100 (NDC 0555-0635-02) capsules. Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Keep this and all medications out of the reach of children. Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. D 10/2022

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DANAZOL- DANAZOL CAPSULE
TEVA PHARMACEUTICALS USA, INC.
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DANAZOL CAPSULES, USP
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 17α-Pregna-2,4-dien-20-yno
[2,3-_d_]-isoxazol-17-ol,
which has the following structural formula:
C
H
NO 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
22
27
2
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 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 be another mechanism by which it
facilitates
regression of the disease.
In the treatment of endometriosis, danazol alters the normal and