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:

Naari Pte Limited

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 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 (1)]. - Have uncontrolled hypertension or hypertension with vascular disease [see

Product summary:

Levonorgestrel and Ethinyl Estradiol Tablets USP 0.15 mg/0.03 mg are available in blister pack, containing 28 Tablets: The blister packs of 3 are available in box (NDC 79929-003-05). Store at 20º to 25°C (68° to 77º F) [See USP Controlled Room Temperature]. Manufactured For: Naari Pte Limited 36 Robinson Road, #13-01 City House, Singapore 068877 Issued November 2021

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LEVONORGESTREL AND ETHINYL ESTRADIOL- LEVONORGESTREL AND ETHINYL
ESTRADIOL
NAARI PTE LIMITED
----------
LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS USP 0.15MG/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
Levonorgestrel and Ethinyl Estradiol Tablets USP are a combination
oral contraceptive
(COC) consisting of 21 light-orange active tablets, each containing
0.15 mg of
levonorgestrel, a synthetic progestin and 30 mcg of ethinyl estradiol,
an estrogen, and 7
pink inert tablets (without hormones).
The structural formulas for the active components are:
Levonorgestrel is chemically 18, 19-Dinorpregn-4-en-20-yn-3-one,
13-ethyl-17-hydroxy-
,(17α)-(-)-.
Ethinyl Estradiol is 19-nor-17α-pregna-1, 3, 5(10)-trien-20-yne-3,
17-diol.
Each light-orange active tablet contains the following inactive
ingredients: lactose
monohydrate, FD&C Yellow No. 6, microcrystalline cellulose, povidone
K-30, polacrilin
potassium and magnesium stearate.
Each pink inert tablet contains the following inactive ingredients:
lactose monohydrate,
FD&C Red no. 40 aluminum lake, microcrystalline cellulose, povidone
K-30,
croscarmellose sodium and magnesium stearate.
CLINICAL PHARMACOLOGY
Combination oral contraceptives prevent pregnancy primarily by
suppressing 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 the following conditions:
A high risk of arterial or venous throm