LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL kit

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Mylan Pharmaceuticals Inc.

DCI (Denominação Comum Internacional):

ETHINYL ESTRADIOL

Composição:

ETHINYL ESTRADIOL 0.02 mg

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are indicated for use by females of reproductive potential 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 COCs 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. Contraceptive hormones and/or metabolites are present in human milk. COCs can red

Resumo do produto:

Levonorgestrel and Ethinyl Estradiol Tablets, USP and Ethinyl Estradiol Tablets, USP are available in an Extended-Cycle Tablet Blister Pack that contains 84 round, white to off-white tablets and 7 round, light peach tablets. Each white to off-white tablet (debossed with 214 on one side and other side plain) contains 0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol. Each light peach tablet (debossed with 215 on one side and other side plain) contains 0.01 mg ethinyl estradiol. Carton of 2 pouches NDC 0378-7284-90; each pouch contains 91 tablets Extended-Cycle Tablet Blister Pack. Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] The tablets should not be removed from the protective blister packaging to avoid damage to the product. The blister pack should be kept in the foil pouch until dispensed to the patient.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

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
Contraindications, Pregnancy (4) Removed 01/2023
Warnings and Precautions, Malignant Neoplasms (5.11) 04/2022
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
Take one tablet daily by mouth at the same time every day for 91 days
in the order directed on the blister
pack. (2)
DOSAGE FORMS AND STRENGTHS
Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol
tablets consist of 84 white to off-white
tablets containing 0.1 mg levonorgestrel and 0.02 mg ethinyl
estradiol, and 7 light peach tablets
containing 0.01 mg ethinyl estradiol. (3)
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)
A high risk of arterial or venous thrombotic diseases (4)
Undiagnosed abnormal uterine bleeding (4)
Breast cancer (4)
Liver tumors or liver disease, acute viral hep