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
MARLISSA® (levonorgestrel and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pregnancy. MARLISSA® (levonorgestrel and ethinyl estradiol tablets) is contraindicated in females who are known to have the following conditions: MARLISSA® (MĀR-LIS-SĂ) (Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg) Important Information about taking MARLISSA® (levonorgestrel and ethinyl estradiol tablets) Before you start taking MARLISSA® (levonorgestrel and ethinyl estradiol tablets): When should I start taking MARLISSA® (levonorgestrel and ethinyl estradiol tablets)? If you start taking MARLISSA® (levonorgestrel and ethinyl estradiol tablets) and you have not used a hormonal birth control method before: If you start taking MARLISSA® (levonorgestrel and ethinyl estradiol tablets) and you are switching from another birth control pill: If you start taking MARLISSA® (levonorgestrel and ethinyl estradiol tablets) and previously used a vaginal ring: If you start taking MARLISSA® (levonorgestrel and ethinyl estradiol tablets) and previously used a transdermal patch: If you start taking MARLISSA® (levonorgestrel and ethinyl estradiol tablets) and you are switching from a progestin-only method such as an implant or injection: If you start taking MARLISSA® (levonorgestrel and ethinyl estradiol tablets) and you are switching from an intrauterine device or system (IUD or IUS): Keep a calendar to track your period: If this is the first time you are taking birth control pills, read, “When should I start taking MARLISSA® (levonorgestrel and ethinyl estradiol tablets)? ” above. Follow these instructions for either a Sunday Start or a Day 1 Start . Instructions for using your MARLISSA® (levonorgestrel and ethinyl estradiol tablets) Pill Dispenser: Sunday Start: You will use a Sunday Start if your healthcare provider told you to take your first pill on a Sunday. Day 1 Start: You will use a Day 1 Start if your doctor told you to take your first pill (Day 1) on the first day of your period . What should I do if I miss any MARLISSA® (levonorgestrel and ethinyl estradiol tablets) pills? If you miss 1 pill in Weeks 1, 2, or 3, follow these steps: If you miss 2 pills in Week 1 or Week 2 of your pack, follow these steps: If you miss 2 pills in a row in Week 3, or you miss 3 or more pills in a row during Weeks 1, 2, or 3 of the pack, follow these steps: If you have any questions or are unsure about the information in this leaflet, call your healthcare provider. This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration. Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Questions? 1 (888) 721-7115 www.glenmarkpharma-us.com June 2022
MARLISSA® (levonorgestrel and ethinyl estradiol tablets, USP 0.15 mg/0.03 mg) is available in carton of 3 blisters, each containing 28 tablets (NDC 68462-388-29): Each blister contains: 21 Active Tablets: Light orange to orange color, round, biconvex, uncoated tablets with ‘A5’ debossed on one side. 7 Inert Tablets: Light pink to pink color, round, biconvex, uncoated tablets with ‘A6’ debossed on one side. 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. Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Questions? 1 (888) 721-7115 www.glenmarkpharma-us.com June 2022
Abbreviated New Drug Application
MARLISSA- LEVONORGESTREL AND ETHINYL ESTRADIOL GLENMARK PHARMACEUTICALS INC., USA ---------- MARLISSA (LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS, USP 0.15 MG/0.03 MG) RX ONLY WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs, including MARLISSA , are contraindicated in women who are over 35 years of age and smoke [see CONTRAINDICATIONS and WARNINGS (1)]. DESCRIPTION MARLISSA (levonorgestrel and ethinyl estradiol tablets) is a combination oral contraceptive (COC) consisting of 21 light orange to orange color MARLISSA (levonorgestrel and ethinyl estradiol tablets), each containing 0.15 mg of levonorgestrel, USP, a totally synthetic progestogen, and 0.03 mg of ethinyl estradiol, USP, an estrogen and 7 light pink to pink inert tablets (without hormones). The structural formulas for the active components are: LEVONORGESTREL, USP C H O MW: 312.4 Levonorgestrel, USP is chemically d(-)-13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4- en-20-yn-3-one ® ® ® ® 21 28 2 ETHINYL ESTRADIOL, USP C H O MW: 296.4 Ethinyl Estradiol, USP is 19-nor-17α-pregna-1,3,5(10)-trien-20-yne-3, 17-diol. Each light orange to orange color active tablet contains the following inactive ingredients: FD&C Yellow no. 6, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polacrilin potassium, povidone and talc. Each light pink to pink inert tablet contains the following inactive ingredients: D&C Red no. 30, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polacrilin potassium, povidone and talc. CLINICAL PHARMACOLOGY Combination oral contraceptives prevent pregnancy primarily by suppressing ovulation. INDICATIONS AND USAGE MARLISSA (levonorgestrel and ethinyl estradiol tablets) is indicated for use by females of reproductive potential to prevent pre 阅读完整的文件