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:

Amneal Pharmaceuticals NY LLC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Levonorgestrel and ethinyl estradiol tablets are indicated for use by females of reproductive potential to prevent pregnancy. Levonorgestrel and ethinyl estradiol tablets are contraindicated in females who are known to have or develop the following conditions: - A high risk of arterial or venous thrombotic diseases. Examples include women who are known to: Smoke, if over age 35 [see BOXED WARNING and WARNINGS (1)]. Have current or history of deep vein thrombosis or pulmonary embolism [see WARNINGS (1)]. Have cerebrovascular disease [see WARNINGS (1)]. Have coronary artery disease [see WARNINGS (1)]. Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see WARNINGS (1)]. Have inherited or acquired hypercoagulopathies [see WARNINGS (1)]. Have uncontrolled hypertension or hypertension with vascular disease [see WARNINGS (4)]. Have diabetes mellitus and are over age 35, diabetes mellitus with hy

Product summary:

Levonorgestrel and ethinyl estradiol tablets USP, 0.15 mg/0.03 mg are available as follows: NDC 60219-1554-6                Blister Pack of 28 Tablets 21 active tablets - white, round, biconvex, film-coated tablet, debossed with ‘C5’ on one side. 7 inert tablets - yellow, round, biconvex, film-coated tablet, debossed with ‘C2’ on one side. Store at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature]. References available upon request. Made in Germany Distributed by: Amneal Pharmaceuticals of New York, LLC Brookhaven, NY  11719 Rev. 02-2022-03

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LEVONORGESTREL AND ETHINYL ESTRADIOL- LEVONORGESTREL AND ETHINYL
ESTRADIOL
AMNEAL PHARMACEUTICALS NY LLC
----------
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 levonorgestrel and ethinyl estradiol
tablets, are
contraindicated in women who are over 35 years of age and smoke [see
CONTRAINDICATIONS and WARNINGS (1)].
DESCRIPTION
21 white levonorgestrel and ethinyl estradiol tablets, USP each
containing 0.15 mg of
levonorgestrel, USP, (d(-)-13
beta-ethyl-17-alpha-ethinyl-17-beta-hydroxygon-4-en-3-
one), a totally synthetic progestogen, and 0.03 mg of ethinyl
estradiol, USP, (19-nor-
17α-pregna-1,3,5 (10)-trien-20-yne-3,17-diol), and 7 yellow inert
tablets. The inactive
ingredients present in both tablets are lactose monohydrate, magnesium
stearate,
microcrystalline cellulose, and polacrilin potassium. White tablets
are coated with Aqua
Polish White 014.17 MS which contains hydrogenated cottonseed oil,
hydroxypropylcellulose, hydroxypropylmethylcellulose, talc and
titanium dioxide. Yellow
inert tablets are coated with Aqua Polish Yellow 024.15 MS which
contains hydrogenated
cottonseed oil, hydroxypropylcellulose, hydroxypropylmethylcellulose,
ferric oxide red,
ferric oxide yellow, talc, and titanium dioxide.
CLINICAL PHARMACOLOGY
Combination oral contraceptives prevent pregnancy primarily by
suppression ovulation.
INDICATIONS AND USAGE
Levonorgestrel and ethinyl estradiol tablets are indicated for use by
females of
reproductive potential to prevent pregnancy.
CONTRAINDICATIONS
Levonorgestrel and ethinyl estradiol tablets are contraindicated in
females who are
known to have or develop the following conditions:
A high risk of arterial or venous thrombotic diseases. Exa