BLISOVI FE 1.5/30- norethindrone acetate and ethinyl estradiol kit

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U), NORETHINDRONE ACETATE (UNII: 9S44LIC7OJ) (NORETHINDRONE - UNII:T18F433X4S)

Dostupno od:

Lupin Pharmaceuticals, Inc.

INN (International ime):

ETHINYL ESTRADIOL

Sastav:

ETHINYL ESTRADIOL 0.03 mg

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Blisovi Fe 1.5/30 is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Oral contraceptives are highly effective. Table I 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 methods can result in lower failure rates. Adapted from RA Hatcher et al, Reference 7. 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 - Undiagnosed abnormal genital bleeding - Cholestatic jaundice of

Proizvod sažetak:

Blisovi Fe 1.5/30 (28 Tablets) (norethindrone acetate and ethinyl estradiol tablets USP, 1.5 mg/0.03 mg; and ferrous fumarate tablets) are available in a wallet (NDC 68180-866-11) containing 28 tablets packed in a pouch (NDC 68180-866-11). Such three pouches are packaged in a carton (NDC 68180-866-13). Each wallet contains 28 tablets, as follows: Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

BLISOVI FE 1.5/30 - NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
LUPIN PHARMACEUTICALS, INC.
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BLISOVI™ FE 1.5/30
(NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS USP AND FERROUS
FUMARATE TABLETS*)
1.5 MG/0.03 MG
*FERROUS FUMARATE TABLETS ARE NOT USP FOR DISSOLUTION
BLISOVI™ FE 1.5/30
(NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLETS USP AND FERROUS
FUMARATE TABLETS*)
1.5 MG/0.03 MG
*Ferrous fumarate tablets are not USP for dissolution
BLISOVI™ FE 1.5/30
Each pink tablet contains 1.5 mg norethindrone acetate and 30 mcg
ethinyl estradiol.
Each brown placebo tablet contains 75 mg ferrous fumarate.
RX ONLY
PATIENTS SHOULD BE COUNSELED THAT THIS PRODUCT DOES NOT PROTECT
AGAINST HIV INFECTIONS (AIDS) AND OTHER SEXUALLY TRANSMITTED DISEASES.
DESCRIPTION
BLISOVI FE 1.5/30 is progestogen-estrogen combination.
Blisovi Fe 1.5/30 provides a continuous dosage regimen consisting of
21 oral contraceptive tablets and
seven ferrous fumarate tablets. The ferrous fumarate tablets are
present to facilitate ease of drug
administration via a 28-day regimen, are non-hormonal, and do not
serve any therapeutic purpose.
Each pink tablet contains norethindrone acetate
(17α-ethinyl-19-nortestosterone acetate), 1.5 mg; ethinyl
estradiol (17α-ethinyl-1,3,5(10)-estratriene-3,17β-diol), 30 mcg.
Each pink tablet contains the following inactive ingredients: acacia,
confectioner's sugar, corn starch,
FD & C red no. 40, lactose monohydrate, magnesium stearate and talc.
Each brown tablet contains ferrous fumarate, magnesium stearate,
microcrystalline cellulose, povidone,
sodium starch glycolate, and sucrose.
The ferrous fumarate tablets do not serve any therapeutic purpose.
CLINICAL PHARMACOLOGY
Combination oral contraceptives act by suppression of gonadotropins.
Although the primary mechanism
of this action is inhibition of ovulation, other alterations include
changes in the cervical mucus (which
increase the difficulty of sperm entry into the uterus) and the
endometrium (which reduce the likelihood
of implantation).
PHARMA