国家: 美国
语言: 英文
来源: 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
Ashlyna is indicated for use by females of reproductive potential to prevent pregnancy. Ashlyna is 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. 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 time but is less likely to occur once breastf
Ashlyna® (Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg and Ethinyl Estradiol Tablets, USP 0.01 mg) are available in extended-cycle tablet dispensers, each containing a 13-week supply of tablets: 84 light blue to blue tablets, each containing 0.15 mg of levonorgestrel, USP and 0.03 mg ethinyl estradiol, USP and 7 light yellow to yellow tablets, each containing 0.01 mg of ethinyl estradiol, USP. The light blue to blue tablets are round, film-coated, biconvex, unscored tablets debossed with ‘E1’ on one side. The light yellow to yellow tablets are round, biconvex, film-coated, unscored tablets debossed with ‘D8’ on one side. 1 carton containing 2 individual pouches. Inside each pouch is 1 extended-cycle tablet dispenser containing 84 light blue to blue tablets and 7 light yellow to yellow tablets NDC 68462-646-93 Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light.
Abbreviated New Drug Application
ASHLYNA- LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL GLENMARK PHARMACEUTICALS INC., USA ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ASHLYNA SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ASHLYNA. ASHLYNA (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_ • • RECENT MAJOR CHANGES Contraindications, Pregnancy (4) Removed 01/2023 Warnings and Precautions, Malignant Neoplasms (5.2) 04/2022 INDICATIONS AND USAGE Ashlynais 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 Ashlyna (Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg and Ethinyl Estradiol Tablets, USP 0.01 mg) consists of 84 light blue to blue tablets containing 0.15 mg levonorgestrel, USP and 0.03 mg ethinyl estradiol, USP and 7 light yellow to yellow tablets containing 0.01 mg ethinyl estradiol, USP. (3) CONTRAINDICATIONS • • • • • WARNINGS AND PRECAUTIONS • • • • • • • ® ASHLYNA IS CONTRAINDICATED IN WOMEN OVER 35 YEARS OLD WHO SMOKE. CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS FROM COMBINATION ORAL CONTRACEPTIVE (COC) USE. ® 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 hepatitis or decompensated cirrhosis (4) Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (4) Vascular risks: Stop if a thrombotic or thromboembolic event occurs. S 阅读完整的文件