ORTHO TRI-CYCLEN(r) LO (norgestimate/ethinyl estradiol) Tablets, the new low- dose version of the most prescribed birth control pill, is now available by prescription. Recently approved by the U.S. Food and Drug Administration (FDA), ORTHO TRI-CYCLEN LO contains a combination of hormones -- 25 micrograms (mcg) of estrogen and the progestin, norgestimate -- that offers excellent efficacy, tolerability and cycle control. Like other oral contraceptives, ORTHO TRI-CYCLEN LO is highly effective when taken correctly.
ORTHO TRI-CYCLEN LO is manufactured and will be marketed by Ortho-McNeil Pharmaceutical, Inc., the leader in the U.S. contraceptive market and maker of ORTHO TRI-CYCLEN(r) (norgestimate/ethinyl estradiol) Tablets. ORTHO TRI-CYCLEN, the nation's #1 prescribed birth control pill, was the first to be approved by the FDA to treat moderate acne and help maintain clearer skin.
"ORTHO TRI-CYCLEN LO offers a new degree of choice for women who use oral contraceptives," said Ronald T. Burkman, M.D., Baystate Medical Center, Department of Obstetrics and Gynecology, Springfield, Mass. "With norgestimate and 25 micrograms of estrogen, ORTHO TRI-CYCLEN LO offers effective contraception and excellent cycle control. This new option is important to me because many of my patients report breakthrough bleeding and spotting as the primary reason for discontinuing their pill use."
Research shows that almost 50 percent of women who stop using the Pill do so because of side effects often related to the dose and type of hormones in the Pill. Breakthrough bleeding is the number one reason women stop taking the Pill; it is inconvenient, sometimes embarrassing, and can be distressing for women who don't realize it is a potential side effect of the Pill. Many women who stop taking the Pill often use a less reliable method of birth control or no method at all, which can result in an unplanned pregnancy. Among those who discontinue the Pill, more than 600,000 unintended pregnancies occur each year in the United States according to a 1995 study published in the Journal of Reproductive Medicine.
ORTHO TRI-CYCLEN LO is a triphasic birth control pill. It provides a daily dose of 25 mcg of estrogen for 21 days and three different doses of the progestin, norgestimate (180 mcg daily/days 1-7; 215 mcg daily/days 8-14; 250 mcg daily/days 15-21). The last seven days contain no active ingredients. Norgestimate is unique to ORTHO TRI-CYCLEN LO, ORTHO TRI-CYCLEN and ORTHO-CYCLEN. It is a progestin with more than 10 years of proven clinical performance. By lowering the serum levels of free testosterone in a woman's body, the low androgenic profile of norgestimate is associated with low rates of weight gain, acne and facial hair growth.
ORTHO TRI-CYCLEN LO can be used with the ORTHO PERSONAL PAK(tm) Tablet Dispensers, the only collection of fashionably discreet birth control pill packaging. Women may choose from six designs, including two, limited edition compacts created by fashion designer Nicole Miller.
ORTHO TRI-CYCLEN LO will be priced competitively based on other branded contraceptives.
ORTHO TRI-CYCLEN LO, ORTHO TRI-CYCLEN and ORTHO-CYCLEN Tablets are indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception.
ORTHO TRI-CYCLEN can be a good choice for women 15 or over with mild to moderate acne, who have reached menstruation, are seeking contraception, have no known contraindications to birth control pills, and are unresponsive to topical acne medication.
Oral contraceptives are not for everybody. Most side effects of the Pill are not serious and those that are, occur infrequently. Serious risks, which can be life threatening, include blood clots, stroke, and heart attacks, and are increased if you smoke cigarettes. Cigarette smoking increases the risk of serious cardiovascular side effects,
especially if you're over 35. Women who use oral contraceptives are strongly advised not to smoke. 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.
You should talk to your doctor or health care professional about how this risk relates to your use of the Pill. Some women should not use the Pill, including women who have blood clots, certain cancers, a history of heart attack or stroke, as well as those who are or may be pregnant. The Pill does not protect against HIV or sexually transmitted diseases.
Ortho-McNeil is a pioneer and a leader in contraception and women's health care. Ortho-McNeil offers the broadest range of prescription birth control options, including the first transdermal contraceptive patch, ten birth control pills, a leading intrauterine device (IUD) and diaphragms. The company also markets prescription pharmaceutical products in other therapeutic categories, including central nervous system, urology, infectious disease, analgesics and wound healing.
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