LEVONORGESTREL AND ETHINYL ESTRADIOL kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Glenmark Pharmaceuticals Inc., USA

INN (International Name):

LEVONORGESTREL

Composition:

LEVONORGESTREL 0.15 mg

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Levonorgestrel and ethinyl estradiol tablets are indicated for use by females of reproductive potential to prevent pregnancy. Levonorgestrel 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 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. Risk Summary Contraceptive hormones and/or metabolites are present in human milk. COCs can reduce milk production in breastfeeding females. This reduction can occur at any

Product summary:

How Supplied Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg are available in Extended-Cycle Tablet Dispensers, each containing a 13-week supply of tablets: NDC 68462-672-95 – 1 carton containing 3 foil pouches. Inside each pouch is 1 Extended-Cycle Tablet Dispenser containing 84 light blue to blue tablets and 7 white to off-white tablets. Storage and Handling

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LEVONORGESTREL AND ETHINYL ESTRADIOL- LEVONORGESTREL AND ETHINYL
ESTRADIOL
GLENMARK PHARMACEUTICALS INC., USA
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEVONORGESTREL AND
ETHINYL ESTRADIOL TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS.
LEVONORGESTREL 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 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
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DOSAGE FORMS AND STRENGTHS
Levonorgestrel and Ethinyl Estradiol Tablets, USP consists of 84
round, light blue to blue tablets containing
0.15 mg of levonorgestrel, USP and 0.03 mg of ethinyl estradiol, USP
and 7 round, white to off-white inert
tablets. (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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LEVONORGESTREL 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. (5.1)
Contraindications, Pregnancy (4) Removed 01/2023
Warnings and Precautions, Malignant Neoplasms ( 5.11 ) 04/2022
Take one tablet daily by mouth at the same time every day for 91 days.
(2.1)
Take tablets in the order directed on the Extended-Cycle Tablet
Dispenser. (2.2)
A high risk of arterial or venous thrombotic diseases (4)
Liver tumors or liver disease, acute viral hepatitis or decompensated
cirrhosis (4)
Undiagnosed abnormal uterine bleeding (4)
Breast cancer (4)
Co-administration with Hepatitis C drug combinations containing
ombitasvir/paritaprevir/ritonavir, with
or without dasabu