Nazione: Stati Uniti
Lingua: inglese
Fonte: NLM (National Library of Medicine)
LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)
Preferreed Pharmaceuticals Inc.
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): Figure A 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 MAR
MARLISSA® (levonorgestrel and ethinyl estradiol tablets USP, 0.15 mg/0.03 mg) is available in cartons of 3 blister cards, each containing 28 tablets (NDC 68788-6339-2) Each blister card 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° to 25°C (68° to 77°F) excursions permitted to 15°C to 30°C (59° to 86° F). [See USP controlled room temperature]. Protect from light. References available upon request. Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403 513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Questions? 1 (888)721-7115 www.glenmarkpharma.com/usa May 2019
Abbreviated New Drug Application
MARLISSA- LEVONORGESTREL AND ETHINYL ESTRADIOL PREFERREED PHARMACEUTICALS INC. ---------- 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 ETHINYL ESTRADIOL USP C H O MW: 296.4 ® ® ® ® 21 28 2 20 24 2 Ethinyl Estradiol 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 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 30, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polacrilin potassium, povidone and talc. Each orange tablets contains FD&C yellow No. 6 as a color additive. CLINICAL PHARMACOLOGY Combination oral contraceptives prevent pregnancy primarily by suppressing ovulation. INDICATIONS AND USAGE MARLISSA (levonorgestrel and ethinyl estradiol tablets) is indicated for u Leggi il documento completo