LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL- levonorgestrel and ethinyl estradiol and ethinyl estradiol

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:

Mayne Pharma Inc.

INN (International Name):

LEVONORGESTREL

Composition:

LEVONORGESTREL 0.15 mg

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets is indicated for use by females of reproductive age to prevent pregnancy. Do not prescribe levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets to women 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 and Precautions (5.1)]. Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions (5.1)]. Have cerebrovascular disease [see Warnings and Precautions (5.1)]. Have coronary artery disease [see Warnings and Precautions (5.1)]. Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions (5.1)]. Have inherited or acquired h

Product summary:

Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets are available as round, film-coated, unscored, biconvex tablets debossed with TV on one side, packaged in an Extended-Cycle Tablet Dispenser, each containing a 13-week supply of the tablets in the following order: Box of 1 Extended-Cycle Tablet Dispenser NDC 51862-489-65 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL-
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
MAYNE PHARMA INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEVONORGESTREL AND ETHINYL
ESTRADIOL TABLETS AND ETHINYL ESTRADIOL TABLETS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS AND
ETHINYL ESTRADIOL
TABLETS.
LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS AND ETHINYL ESTRADIOL
TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1982
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_
WOMEN OVER 35 YEARS OLD WHO SMOKE SHOULD NOT USE LEVONORGESTREL AND
ETHINYL ESTRADIOL TABLETS AND
ETHINYL ESTRADIOL TABLETS. (4)
CIGARETTE SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS
FROM COMBINATION ORAL
CONTRACEPTIVE (COC) USE. (4)
RECENT MAJOR CHANGES
Contraindications (4) 8/2017
Warnings and Precautions (5.4) 8/2017
INDICATIONS AND USAGE
Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol
tablets is an estrogen/progestin COC indicated for use by
women to prevent pregnancy. (1)
DOSAGE AND ADMINISTRATION
Take one tablet daily by mouth at the same time every day for 91 days
(2)
Take tablets in the order directed on the Extended-Cycle Tablet
Dispenser (2)
DOSAGE FORMS AND STRENGTHS
Levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol
tablets consists of 91 tablets in the following order (3):
42 light pink tablets containing 0.15 mg levonorgestrel and 0.02 mg
ethinyl estradiol,
21 pink tablets containing 0.15 mg of levonorgestrel and 0.025 mg
ethinyl estradiol, and
21 purple tablets containing 0.15 mg of levonorgestrel and 0.03 mg
ethinyl estradiol, and
7 yellow tablets containing 0.01 mg of ethinyl estradiol. (3)
CONTRAINDICATIONS
A high risk of arterial or venous thrombotic diseases (4)
Undiagnosed abnormal uterine bleeding (4)
Breast cancer or other estrogen- or progestin-sens