Drospirenone And Ethinyl Estradiol Prescribing Information
Dosage and Administration 5/2023
Contraindications, Pregnancy Removed 5/2023
Warnings and Precautions Removed 5/2023
Drospirenone and ethinyl estradiol tablets are a combination of drospirenone, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to:
• Prevent pregnancy.• Treat symptoms of premenstrual dysphoric disorder (PMDD) for females of reproductive potential who choose to use an oral contraceptive for contraception.• Treat moderate acne for women at least 14 years old only if the patient desires an oral contraceptive for birth control.
• Take one tablet daily by mouth at the same time every day.• Tablets must be taken in the order directed on the blister pack.
Drospirenone and ethinyl estradiol tablets, USP are available in blister packs.
Each blister pack (28 uncoated tablets) contains in the following order:
• 24 yellow tablets each containing 3 mg drospirenone (DRSP) and 0.02 mg ethinyl estradiol (EE)• 4 green inert tablets
Safety and efficacy of drospirenone and ethinyl estradiol tablets has been established in women of reproductive age. Efficacy is expected to be the same for postpubertal adolescents under the age of 18 and for users 18 years and older. Use of this product before menarche is not indicated.