Norgestimate and Ethinyl Estradiol

Dosage form: tablets
Drug class:Contraceptives

Medically reviewed by Drugs.com. Last updated on Jan 1, 2022.

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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 are contraindicated in women who are over 35 years of age and smoke [see CONTRAINDICATIONS (4)].

Indications and Usage for Norgestimate and Ethinyl Estradiol

Oral Contraceptive

Norgestimate and Ethinyl Estradiol Tablets, USP is indicated for use by females of reproductive potential to prevent pregnancy [see CLINICAL STUDIES (14)] .

Acne

Norgestimate and Ethinyl Estradiol Tablets, USP is indicated for the treatment of moderate acne vulgaris in females at least 15 years of age, who have no known contraindications to oral contraceptive therapy and have achieved menarche. Tri-Estarylla™ should be used for the treatment of acne only if the patient desires an oral contraceptive for birth control [see CLINICAL STUDIES ( 14)].