Country: Bandaríkin
Tungumál: enska
Heimild: NLM (National Library of Medicine)
LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)
Glenmark Pharmaceuticals Inc., USA
LEVONORGESTREL
LEVONORGESTREL 0.15 mg
PRESCRIPTION DRUG
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
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
Abbreviated New Drug Application
LEVONORGESTREL AND ETHINYL ESTRADIOL- LEVONORGESTREL AND ETHINYL ESTRADIOL GLENMARK PHARMACEUTICALS INC., USA ---------- 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._ • • 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 • • 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 • • • • • WARNINGS AND PRECAUTIONS • • • • • 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 Lestu allt skjalið