Jane S. Ricciuti, RPh, MS


October 21, 2003

In This Article

Oral Contraceptives

(levonorgestrel/ethinyl estradiol) Tablets

Manufacturer: Barr Laboratories

Drug Approval Classification: Original New Drug Application (Approval Date: 9/5/03)

Indication: Seasonale (levonorgestrel/ethinyl estradiol) is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.

Dosing: The dosage of Seasonale is 1 pink (active) tablet daily for 84 consecutive days, followed by 7 days of white (inert) tablets.

Clinical Summary: Seasonale is an extended-cycle oral contraceptive consisting of 84 pink active tablets each containing 0.15 mg of levonorgestrel, a synthetic progestogen, 0.03 mg of ethinyl estradiol, and 7 white inert tablets (without hormones).

In a 1-year controlled clinical trial, 4 pregnancies occurred in women 18-35 years of age during 809 completed 91-day cycles of Seasonale during which no backup contraception was used. This represents an overall use-efficacy (typical user efficacy) pregnancy rate of 1.98 per 100 women-years of use.

Seasonale (levonorgestrel/ethinyl estradiol) Tablets Labeling