DROSPIRENONE AND ETHINYL ESTRADIOL kit

Страна: Соединенные Штаты

Язык: английский

Источник: NLM (National Library of Medicine)

Активный ингредиент:

DROSPIRENONE (UNII: N295J34A25) (DROSPIRENONE - UNII:N295J34A25), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)

Доступна с:

Mylan Pharmaceuticals Inc.

ИНН (Международная Имя):

DROSPIRENONE

состав:

DROSPIRENONE 3 mg

Тип рецепта:

PRESCRIPTION DRUG

Терапевтические показания :

Drospirenone and ethinyl estradiol tablets, 3 mg/0.03 mg are indicated for use by females of reproductive potential to prevent pregnancy. Drosperinone and ethinyl estradiol tablets are contraindicated in females who are known to have or develop the following conditions: There is no use for contraception in pregnancy; therefore, drospirenone and ethinyl estradiol tablets should be discontinued during pregnancy. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to CHCs before conception or during early pregnancy. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4 percent and 15 to 20 percent, respectively. A retrospective database study of women in Norway, that included 44,734 pregnancies of which 368 were women who inadvertently took drospirenone/ethinyl estradiol during the fir

Обзор продуктов:

Drospirenone and Ethinyl Estradiol Tablets USP, 3 mg/0.03 mg are available in a carton of three pouches, each pouch contains a blister of 28 tablets. Each blister pack contains 28 uncoated tablets in the following order: NDC 0378-7300-53, carton of 3 pouches, each pouch containing a blister of 28 tablets. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Статус Авторизация:

Abbreviated New Drug Application

Характеристики продукта

DROSPIRENONE AND ETHINYL ESTRADIOL- DROSPIRENONE AND ETHINYL
ESTRADIOL
MYLAN PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DROSPIRENONE AND
ETHINYL ESTRADIOL TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS.
DROSPIRENONE AND ETHINYL ESTRADIOL TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 2001
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
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RECENT MAJOR CHANGES
Dosage and Administration (2.3) 5/2023
Contraindications, Pregnancy (4) Removed 5/2023
Warnings and Precautions, (5.11) Removed 5/2023
INDICATIONS AND USAGE
Drospirenone and ethinyl estradiol tablets are a combination of
drospirenone, a progestin, and ethinyl
estradiol, an estrogen, indicated for use by females of reproductive
potential to prevent pregnancy. (1)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Drospirenone and ethinyl estradiol tablets consist of 28 uncoated,
biconvex tablets in the following order
(3):
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
The most frequent adverse reactions (≥ 2%) are premenstrual syndrome
(13.2%), headache /migraine
(10.7%), breast pain/tenderness/discomfort (8.3%), nausea/vomiting
(4.5%), abdominal
pain/tenderness/discomfort (2.3%), mood changes (2.3%). (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MYLAN AT 1-877-446-3679
(1-877-4-INFO-
RX) OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH
DRUG INTERACTIONS
Drugs or herbal products that induce certain enzymes (for example,
CYP3A4) may decrease the
effectiveness of COCs or increase breakthrough bleeding. Counsel
patients to use a back-up or alternative
method of contraception when enzyme inducers are used with COCs. (7.1)
USE IN SPECIFIC POPULATIONS
Lactation: Can reduce milk production in breast-feeding females (8.2)
SEE 17 FOR PATIEN