MARLISSA- 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:

A-S Medication Solutions

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

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 68462-388-29): 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 [phone] www.glenmarkpharma.com/usa May 2019

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MARLISSA- LEVONORGESTREL AND ETHINYL ESTRADIOL
A-S MEDICATION SOLUTIONS
----------
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
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
®
®
®
®
21
28
2
20
24
2
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 use by f