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warnings and cautions
5 WARNINGS AND PRECAUTIONS Ectopic Pregnancy: Women who become pregnant or complain of lower abdominal pain after taking Levonorgestrel tablets should be evaluated for ectopic pregnancy. ( 5.1 ) Levonorgestrel tablets are not effective in terminating an existing pregnancy. ( 5.2 ) Effect on menses: Levonorgestrel tablets may alter the next expected menses. If menses is delayed beyond 1 week, pregnancy should be considered. ( 5.3 ) STI/HIV: Levonorgestrel tablets do not protect against STI/HIV. ( 5.4 ) 5.1 Ectopic Pregnancy Ectopic pregnancies account for approximately 2% of all reported pregnancies. Up to 10% of pregnancies reported in clinical studies of routine use of progestin-only contraceptives are ectopic. A history of ectopic pregnancy is not a contraindication to use of this emergency contraceptive method. Healthcare providers, however, should consider the possibility of an ectopic pregnancy in women who become pregnant or complain of lower abdominal pain after taking Levonorgestrel tablets. A follow-up physical or pelvic examination is recommended if there is any doubt concerning the general health or pregnancy status of any woman after taking Levonorgestrel tablets. 5.2 Existing Pregnancy Levonorgestrel tablets are not effective in terminating an existing pregnancy. 5.3 Effects on Menses Some women may experience spotting a few days after taking Levonorgestrel tablets. Menstrual bleeding patterns are often irregular among women using progestin-only oral contraceptives and women using levonorgestrel for postcoital and emergency contraception. If there is a delay in the onset of expected menses beyond 1 week, consider the possibility of pregnancy. 5.4 STI/HIV Levonorgestrel tablets do not protect against HIV infection (AIDS) or other sexually transmitted infections (STIs). 5.5 Physical Examination and Follow-up A physical examination is not required prior to prescribing Levonorgestrel tablets. A follow-up physical or pelvic examination is recommended if there is any doubt concerning the general health or pregnancy status of any woman after taking Levonorgestrel tablets. 5.6 Fertility Following Discontinuation A rapid return of fertility is likely following treatment with Levonorgestrel tablets for emergency contraception; therefore, routine contraception should be continued or initiated as soon as possible following use of Levonorgestrel tablets to ensure ongoing prevention of pregnancy.
6 ADVERSE REACTIONS The most common adverse reactions (≥ 10%) in the clinical trial included menstrual changes (26%), nausea (23%), abdominal pain (18%), fatigue (17%), headache (17%), dizziness (11%) and breast tenderness (11%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alvogen at 1-866-770-3024 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. A double-blind, controlled clinical trial in 1,955 evaluable women compared the efficacy and safety of Levonorgestrel tablets (one 0.75 mg tablet of levonorgestrel taken within 72 hours of unprotected intercourse, and one tablet taken 12 hours later) to the Yuzpe regimen (two tablets each containing 0.25 mg levonorgestrel and 0.05 mg ethinyl estradiol, taken within 72 hours of intercourse, and two tablets taken 12 hours later). The most common adverse events (>10%) in the clinical trial for women receiving Levonorgestrel tablets included menstrual changes (26%), nausea (23%), abdominal pain (18%), fatigue (17%), headache (17%), dizziness (11%), and breast tenderness (11%). Table 1 lists those adverse events that were reported in ≥ 5% of Levonorgestrel tablets users. Table 1. Adverse Events in ≥ 5% of Women, by % Frequency Levonorgestrel tablets N = 977(%) Nausea 23.1 Abdominal Pain 17.6 Fatigue 16.9 Headache 16.8 Heavier Menstrual Bleeding 13.8 Lighter Menstrual Bleeding 12.5 Dizziness 11.2 Breast Tenderness 10.7 Vomiting 5.6 Diarrhea 5.0 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of Levonorgestrel tablets. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Gastrointestinal Disorders Abdominal Pain, Nausea, Vomiting General Disorders and Administration Site Conditions Fatigue Nervous System Disorders Dizziness, Headache Reproductive System and Breast Disorders Dysmenorrhea, Irregular Menstruation, Oligomenorrhea, Pelvic Pain