Prescribing Information
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What do the Experts Say?
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Safety

Well tolerated and well trusted

Next Choice® is a safe, effective option for women in their childbearing years.

It is a progestin-only (levonorgestrel) emergency contraceptive. Levonorgestrel is a commonly prescribed and clinically trusted progestin.

The safety profile of Next Choice was superior to the levonorgestrel and ethinyl estradiol (Yuzpe) regimen for nausea and vomiting. In a clinical trial, a 27% reduction in nausea (50% vs 23%) and a 13% reduction in vomiting (19% vs 6%) was demonstrated over the Yuzpe regimen.

The most common side effects associated with the use of Next Choice include nausea, abdominal pain, fatigue, headache, menstrual changes, dizziness, breast tenderness, vomiting, and diarrhea. Although women should return to a normal menstruation after taking Next Choice, they should be informed that their next period may be heavier or lighter, earlier or later. A clinical trial showed that most women (87%) had their next menstrual period within 7 days. Additionally, patients should be advised that if their period is more than 1 week late, they may be pregnant. If your patient reports severe abdominal pain, her pregnancy may be ectopic and require immediate medical care.

If a patient vomits within 1 hour of taking Next Choice, only you can determine if a replacement dose will be needed. It is very important that you advise your patients to promptly call you if such an event occurs.

Important Safety Information

Next Choice® should not be used by women with a known or suspected pregnancy. Women who become pregnant or complain of lower abdominal pain after taking Next Choice should be evaluated for ectopic pregnancy. Next Choice is not effective in terminating an existing pregnancy, and does not protect against STI/HIV. Next Choice may alter the next expected menses, however, if menses is delayed beyond 1 week, pregnancy should be considered. The most common adverse reactions in the clinical trial were menstrual changes (26%), nausea (23%), abdominal pain (18%), fatigue (17%), headache (17%), dizziness (11%), and breast tenderness (11%).

To report side effects of prescription drugs to the FDA, visit fda.gov/medwatch or call 1-800-FDA-1088.

For more information about Next Choice, please call our Medical Communications Department at 866-9WATSON.

This Web site is intended for United States Prescribers, Pharmacists & Consumers.