PORTIA- levonorgestrel and ethinyl estradiol kit

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)

可用日期:

Teva Pharmaceuticals USA, Inc.

INN（国际名称）:

LEVONORGESTREL

组成:

LEVONORGESTREL 0.15 mg

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Portia (levonorgestrel and ethinyl estradiol tablets USP) is indicated for use by females of reproductive potential to prevent pregnancy. Portia (levonorgestrel and ethinyl estradiol tablets USP) is contraindicated in females who are known to have the following conditions: - A high risk of arterial or venous thrombotic diseases. Examples include women who are known to: - Smoke, if over age 35 [see BOXED WARNING and WARNINGS (1) ]. - Have current or history of deep vein thrombosis or pulmonary embolism [see WARNINGS (1) ]. - Have cerebrovascular disease [see WARNINGS (1) ]. - Have coronary artery disease [see WARNINGS (1) ]. - Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see WARNINGS (1) ]. - Have inherited or acquired hypercoagulopathies [see WARNINGS (1) ]. - Have uncontrolled hypertension or hypertension with vascular disease [see WARNINGS (3) ]. - Have diabetes mellitus and are over ag

產品總結:

Portia® (levonorgestrel and ethinyl estradiol tablets USP, 0.15 mg/ 0.03 mg) 28 tablets are packaged in cartons of six blister cards (NDC 0555-9020-58), each card containing 28 tablets: 21 Active Tablets: Pink, round, film-coated, biconvex, unscored active tablets, debossed with stylized b on one side and 992 on the other side. 7 Inert Tablets: White, round, biconvex, unscored inert tablets, debossed with stylized b on one side and 208 on the other side. Store at 20º to 25°C (68° to 77º F) (See USP Controlled Room Temperature). Keep this and all medications out of the reach of children. Teva Pharmaceuticals USA, Inc. North Wales, PA 19454 Rev. G 11/2022

授权状态:

Abbreviated New Drug Application

产品特点

PORTIA- LEVONORGESTREL AND ETHINYL ESTRADIOL
TEVA PHARMACEUTICALS USA, INC.
----------
PORTIA
(LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS USP)
RX ONLY
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR
EVENTS
CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS
FROM COMBINATION ORAL CONTRACEPTIVE (COC) USE. THIS RISK INCREASES
WITH
AGE, PARTICULARLY IN WOMEN OVER 35 YEARS OF AGE, AND WITH THE NUMBER
OF
CIGARETTES SMOKED. FOR THIS REASON, COCS, INCLUDING PORTIA, ARE
CONTRAINDICATED IN WOMEN WHO ARE OVER 35 YEARS OF AGE AND SMOKE [SEE
CONTRAINDICATIONS AND WARNINGS (1)].
DESCRIPTION
Portia (levonorgestrel and ethinyl estradiol tablets USP) is a
combination oral
contraceptive (COC) consisting of 21 pink active tablets, each
containing 0.15 mg of
levonorgestrel, USP, a synthetic progestin and 30 mcg of ethinyl
estradiol, USP, an
estrogen, and 7 white inert tablets (without hormones).
The structural formulas for the active components are:
LEVONORGESTREL, USP
C
H O M.W. 312.45
Levonorgestrel, USP is chemically 18,19-Dinorpregn-4-en-20-yn-3-one,
13-ethyl-17-
hydroxy-,(17α)-(-)-.
ETHINYL ESTRADIOL, USP
C
H O M.W. 296.40
®
_®_
21
28
2
C
H O M.W. 296.40
Ethinyl Estradiol, USP is 19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3,
17-diol.
Each pink active tablet contains the following inactive ingredients:
anhydrous lactose,
hypromellose, magnesium stearate, and microcrystalline cellulose. The
ingredients in the
film-coating include FD&C blue no. 1 aluminum lake, FD&C red no. 40
aluminum lake,
hypromellose, polyethylene glycol, polysorbate 80, and titanium
dioxide.
Each white inert tablet contains the following inactive ingredients:
anhydrous lactose,
hypromellose, magnesium stearate, and microcrystalline cellulose.
CLINICAL PHARMACOLOGY
Combination oral contraceptives prevent pregnancy primarily by
suppressing ovulation.
INDICATIONS AND USAGE
Portia (levonorgestrel and ethinyl estradiol tablets USP) is indicated
for use by females of
reproductive potential to prevent pregnancy.
CONTRAINDICATIONS
Portia (