DANAZOL capsule

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Lannett Company, Inc.

Designación común internacional (DCI):

DANAZOL

Composición:

DANAZOL 50 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Endometriosis. Danazol capsules are indicated for the treatment of endometriosis amenable to hormonal management. 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 function. - Pregnancy (see WARNINGS ). - Breast feeding. - Porphyria-Danazol capsules 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.

Resumen del producto:

Danazol Capsules USP, 50 mg are available as maize opaque/white opaque capsules imprinted with logo "LANNETT" on the cap and "1392" on the body and are supplied in: Bottles of 100 (NDC 0527-1392-01) Danazol Capsules USP, 100 mg are available as maize opaque/maize opaque capsules imprinted with logo "LANNETT" on the cap and "1368" on the body and are supplied in: Bottles of 100 (NDC 0527-1368-01) Danazol Capsules USP, 200 mg are available as orange opaque/orange opaque capsules imprinted with logo "LANNETT" on the cap and "1369" on the body and are supplied in: Bottles of 60 (NDC 0527-1369-06) Bottles of 100 (NDC 0527-1369-01) Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in a well-closed container with a child-resistant closure as defined in the USP. Distributed by: Lannett Company, Inc. Philadelphia, PA 19136 CIB70495E Rev. 04/20

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

DANAZOL- DANAZOL CAPSULE
LANNETT COMPANY, INC.
----------
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-_d_]-
isoxazol-17-ol. The
molecular formula is C
H
NO . It has a molecular weight of 337.46 and the following
structural formula:
Danazol capsules for oral administration contain 50 mg, 100 mg or 200
mg danazol.
_Inactive Ingredients:_ 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.
CLINICAL PHARMACOLOGY
Danazol suppresses the pituitary-ovarian axis. This suppression is
probably a
22
27
2
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 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 anothe