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:

Glenmark Pharmaceuticals Inc., USA

INN (International Name):

LEVONORGESTREL

Composition:

LEVONORGESTREL 0.15 mg

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): 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 [phone] www.glenmarkpharma-us.com June 2022

Product summary:

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 [phone] www.glenmarkpharma-us.com June 2022

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

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