LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL kit

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Mylan Pharmaceuticals Inc.

INN (الاسم الدولي):

LEVONORGESTREL

تركيب:

LEVONORGESTREL 0.15 mg

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are indicated for use by females of reproductive age to prevent pregnancy. Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are contraindicated in females who are known to have or develop the following conditions: Risk Summary There is no use for contraception in pregnancy; therefore, levonorgestrel and ethinyl estradiol tablets 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. Risk Summary Contraceptive hormones and/or metabolites are present in human milk. CHCs

ملخص المنتج:

How Supplied Levonorgestrel and ethinyl estradiol tablets, USP and ethinyl estradiol tablets, USP are available as round, unscored, biconvex tablets, packaged in an Extended-Cycle Tablet Blister Pack, each containing a 13-week supply of the tablets in the following order: Pouch of 1 Extended-Cycle Tablet Blister Pack NDC 0378-7316-85 Carton for 1 pouch of 1 Extended-Cycle Tablet Blister Pack NDC 0378-7316-85 Storage and Handling Store at 20° to 25° C (68° to 77° F). [See USP Controlled Room Temperature.]

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL-
LEVONORGESTREL AND ETHINYL ESTRADIOL 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
LEVONORGESTREL AND
ETHINYL ESTRADIOL TABLETS, AND ETHINYL ESTRADIOL TABLETS, SAFELY AND
EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR LEVONORGESTREL AND ETHINYL ESTRADIOL
TABLETS, AND
ETHINYL ESTRADIOL TABLETS.
LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS, AND ETHINYL ESTRADIOL
TABLETS, FOR
ORAL USE
INITIAL U.S. APPROVAL: 1982
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_.
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RECENT MAJOR CHANGES
INDICATIONS AND USAGE
Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol
tablets are a combination of
levonorgestrel, a progestin, and ethinyl estradiol, an estrogen,
indicated for use by females of reproductive
potential to prevent pregnancy. (1)
DOSAGE AND ADMINISTRATION
•
DOSAGE FORMS AND STRENGTHS
Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol
tablets consist of 91 tablets in the
following order (3):
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS AND ETHINYL ESTRADIOL
TABLETS ARE
CONTRAINDICATED IN WOMEN OVER 35 YEARS OLD WHO SMOKE. (4)
CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS
FROM
COMBINATION ORAL CONTRACEPTIVE (COC) USE. (4)
Contraindications, Pregnancy (4) Removed 08/2022
Take one tablet daily by mouth at the same time every day for 91 days
in the order directed on the
blister pack. (2)
42 white to off-white tablets containing 0.15 mg levonorgestrel and
0.02 mg ethinyl estradiol,
21 light peach tablets containing 0.15 mg of levonorgestrel and 0.025
mg ethinyl estradiol, and
21 bluish green tablets containing 0.15 mg of levonorgestrel and 0.03
mg ethinyl estradiol, and
7 yellow tablets containing 0.01 mg of et