Drospirenone And Ethinyl Estradiol

Do not use drospirenone and ethinyl estradiol tablets if you smoke cigarettes and are over 35 years old. Smoking increases your risk of

serious cardiovascular side effects (heart and blood vessel problems) from birth control pills, including death from heart attack, blood clots or stroke.

This risk increases with age and the number of cigarettes you smoke.

Dosage and Administration (2.3) 5/2023

Contraindications, Pregnancy (4) Removed 5/2023

Warnings and Precautions, (5.11) Removed 5/2023

Drospirenone and Ethinyl Estradiol Tablets USP is a combination of drospirenone, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy.(1)

In case of severe vomiting or diarrhea, absorption may not be complete and additional contraceptive measures should be taken. If vomiting occurs within 3-4 hours after tablet-taking, this can be regarded as a missed tablet.

Drospirenone and ethinyl estradiol tablets consists of 28, biconvex tablets in the following order (3):

• 21 yellow film-coated tablets, each containing 3 mg drospirenone (DRSP) and 0.03 mg ethinyl estradiol (EE),
• 7 inert white tablets

Lactation: Can reduce milk production in breast-feeding females (8.2)