BEKYREE- desogestrel and ethinyl estradiol and ethinyl estradiol kit

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U), DESOGESTREL (UNII: 81K9V7M3A3) (DESOGESTREL - UNII:81K9V7M3A3)

Disponible desde:

Lupin Pharmaceuticals, Inc.

Designación común internacional (DCI):

ETHINYL ESTRADIOL

Composición:

ETHINYL ESTRADIOL 0.02 mg

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Bekyree (desogestrel and ethinyl estradiol tablets USP and ethinyl estradiol tablets USP) are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Oral contraceptives are highly effective. Table II lists the typical accidental pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates. Adapted from Hatcher et al., 1998, Ref#1. Oral contraceptives should not be used in women who currently have the following conditions: - Thrombophlebitis or thromboembolic disorders - A past history of deep vein thrombophlebitis or thromboembolic disorders - Cerebral vascular or coronary artery disease - Known or suspected carcinoma of the breast - Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia - Un

Resumen del producto:

Bekyree (desogestrel and ethinyl estradiol tablets USP and ethinyl estradiol tablets USP) are available in cartons (NDC 68180-879-13) containing three pouches, each pouch (NDC 68180-879-11) containing a wallet of 28 tablets (NDC 68180-879-11). Each wallet (28 tablets) contains in the following order: Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

BEKYREE - DESOGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
LUPIN PHARMACEUTICALS, INC.
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BEKYREE™
DESOGESTREL AND ETHINYL ESTRADIOL TABLETS USP, 0.15 MG/0.02 MG AND
ETHINYL ESTRADIOL TABLETS USP,
0.01 MG
RX ONLY
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV INFECTION (AIDS) AND
OTHER SEXUALLY TRANSMITTED DISEASES.
DESCRIPTION
Bekyree™ (desogestrel and ethinyl estradiol tablets USP and ethinyl
estradiol tablets USP) provide an
oral contraceptive regimen of 21 white round biconvex tablets each
containing 0.15 mg desogestrel (13-
ethyl-11-methylene-18,19-dinor-17 alpha-pregn-4-en- 20-yn-17-ol), 0.02
mg ethinyl estradiol (19-nor-
17 alpha-pregna-1,3,5 (10)-trien-20-yne-3,17-diol), and inactive
ingredients which include colloidal
silicon dioxide, corn starch, lactose monohydrate, magnesium stearate,
povidone, stearic acid, talc,
vitamin E and opadry white, a film coating made of hypromellose,
polyethylene glycol, and titanium
dioxide, followed by 2 inert green round biconvex tablets with the
following inactive ingredients: corn
starch, lactose monohydrate, magnesium stearate, and opadry green, a
film coating made of D&C
Yellow No. 10 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C
Yellow No. 6 Aluminum
Lake, hypromellose, polyethylene glycol, and titanium dioxide. Bekyree
also contains 5 yellow round
biconvex tablets containing 0.01 mg ethinyl estradiol (19-nor-17
alpha-pregna-1,3,5 (10)-trien-20-yne-
3,17-diol) and inactive ingredients which include colloidal silicon
dioxide, corn starch, lactose
monohydrate, magnesium stearate, povidone, stearic acid, talc, vitamin
E and opadry yellow, a film
coating made of FD&C Yellow No. 5 Aluminum Lake, hypromellose, iron
oxide yellow, polyethylene
glycol, and titanium dioxide. The molecular weights for desogestrel
and ethinyl estradiol are 310.5 and
296.40 respectively. The structural formulas are as follows:
Desogestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.02 mg meet
USP Dissolution Test 2.
CLINICAL PHARMACOLOGY
Comb