Brand Name for Norgestimate 0.25 mg/Ethinyl Estradiol 0.035 mg
The combined oral contraceptive containing norgestimate 0.25 mg and ethinyl estradiol 0.035 mg is marketed under several brand names, with the most commonly referenced being Ortho-Cyclen (now discontinued in the US) and Cilest (in Europe), though multiple generic formulations are currently available in the United States. 1, 2
Product Specifications
The FDA-approved formulation consists of 1:
- 21 active blue tablets each containing 0.25 mg norgestimate and 0.035 mg ethinyl estradiol
- 7 green placebo tablets (inert)
- Total of 28 tablets per cycle pack
Clinical Context
This specific dose combination represents a monophasic, low-dose combined oral contraceptive that has been available since its initial FDA approval in 1989 1. The formulation is indicated for:
- Contraception - primary indication 1
- Acne vulgaris treatment - FDA-approved for women who desire oral contraception 3, 4
Current Availability
All formulations containing this dose combination are now available as generics in the United States 4. The original brand name Ortho-Cyclen has been largely replaced by generic equivalents, though the formulation remains identical 1.
European studies historically referred to this combination as Cilest 2, though regional availability varies by country.
Key Prescribing Information
According to FDA labeling 1:
- One tablet taken daily at the same time each day
- Tablets must be taken in the order directed on the blister pack
- No skipping or delaying of tablet intake
- Contraindicated in women over 35 years who smoke due to cardiovascular risk
The norgestimate component is a third-generation progestin with negligible androgenic activity, which contributes to its favorable metabolic profile and effectiveness in treating acne 4, 2, 5.