ORTHO TRI-CYCLEN

ORTHO TRI-CYCLEN® (norgestimate/ethinyl estradiol) is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. In addition, it is the only oral contraceptive indicated in the United States for the treatment of moderate acne vulgaris in women 15 years of age or older, who have no known contraindication to oral contraceptive therapy, who desire contraception, who have begun menstruation and who are unresponsive to topical anti-acne medications. It is the first low-dose birth control pill with a noncontraceptive indication since the Pill was introduced over 35 years ago.

Research has demonstrated that ORTHO TRI-CYCLEN decreases the level of a hormone which contributes to the development of acne-producing agents, thus attacking the cause of the acne. In the clinical studies, ORTHO TRI-CYCLEN showed improvement of acne similar to that seen in studies looking at efficacy of benzoyl peroxide and topical or systemic antibiotics.

ORTHO TRI-CYCLEN treats acne with a combination of ethinyl estradiol, a synthetic estrogen, and norgestimate, a progestin. Two randomized, double-blind, placebo-controlled studies demonstrated that improvement of acne was reported during use of ORTHO TRI-CYCLEN in more than 80 percent of the studies' participants treated with ORTHO TRI-CYCLEN.

Serious as well as minor side effects have been reported with the use of oral contraceptives. Serious risks, which can be life threatening, include blood clots, stroke and heart attacks are increased if you smoke cigarettes. Some studies have reported an increase in the risk of developing breast cancer among women who use oral contraceptives. However, the majority of studies have found no overall increase in this risk. Some studies have reported an increase of developing breast cancer, particularly at a younger age. This increased relative risk appears to be related to duration of use. You should speak to your healthcare professional about how this risk relates to your use of the pill.

ORTHO TRI-CYCLEN, like all oral contraceptives, does not protect against HIV infection (AIDS) or other sexually transmitted diseases.

For information on Warnings, Precautions, and additional Adverse Reactions that may occur, regardless of drug relationship please see product package insert for full U.S. prescribing information.

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