openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Warnings sections page 1 of 1 · 1 matching rows.
warnings and cautions
5 WARNINGS AND PRECAUTIONS Ectopic pregnancy: Women who become pregnant or complain of lower abdominal pain after taking Next Choice One Dose TM tablet should be evaluated for ectopic pregnancy. ( 5.1 ) Next Choice One Dose TM tablet is not effective in terminating an existing pregnancy. ( 5.2 ) Effect on menses: Next Choice One Dose TM tablet may alter the next expected menses. If menses is delayed beyond 1 week, pregnancy should be considered. ( 5.3 ) STI/HIV: Next Choice One Dose TM tablet does not protect against STI/HIV. ( 5.4 ) Contains FD&C Yellow #6 as a color additive. 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 Next Choice One Dose TM . 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 Next Choice One Dose TM . 5.2 Existing Pregnancy Next Choice One Dose TM is not effective in terminating an existing pregnancy. 5.3 Effect on Menses Some women may experience spotting a few days after taking Next Choice One Dose TM . 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 Next Choice One Dose TM does 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 Next Choice One Dose TM . 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 Next Choice One Dose TM . 5.6 Fertility Following Discontinuation A rapid return of fertility is likely following treatment with Next Choice One Dose TM for emergency contraception; therefore, routine contraception should be continued or initiated as soon as possible following use of Next Choice One Dose TM to ensure ongoing prevention of pregnancy. 5.7 Presence of FD&C Yellow #6 Next Choice One Dose TM contains FD&C Yellow #6 as a color additive.
6 ADVERSE REACTIONS The most common adverse reactions (≥10%) in clinical trials included heavier menstrual bleeding (31%), nausea (14%), lower abdominal pain (13%), fatigue (13%), headache (10%), and dizziness (10%) ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Watson Laboratories, Inc. at 1-800-272-5525 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. Levonorgestrel tablet was studied in a randomized, double-blinded multicenter clinical trial. In this study, all women who had received at least one dose of study medication were included in the safety analysis: 1,379 women in the levonorgestrel tablet group (1 dose of 1.5 mg levonorgestrel), and 1,377 women in the levonorgestrel tablets group (2 doses of 0.75 mg levonorgestrel taken 12 hours apart). The mean age of women given levonorgestrel tablet was 27 years. The racial demographic of those enrolled was 54% Chinese, 12% Other Asian or Black, and 34% were Caucasian in each treatment group. 1.6% of women in the levonorgestrel tablet group and 1.4% in levonorgestrel tablets group were lost to follow-up. The most common adverse events (>10%) in the clinical trial for women receiving levonorgestrel tablet included heavier menstrual bleeding (30.9%), nausea (13.7%), lower abdominal pain (13.3%), fatigue (13.3%), and headache (10.3%). Table 1 lists those adverse events that were reported in > 4% of levonorgestrel tablet users. Table 1: Adverse Events in > 4% of Women, by % Frequency Most Common Adverse Events (MedDRA) Levonorgestrel N=1359 (%) Heavier Menstrual Bleeding 30.9 Nausea 13.7 Lower abdominal pain 13.3 Fatigue 13.3 Headache 10.3 Dizziness 9.6 Breast tenderness 8.2 Delay of menses (> 7 days) 4.5 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of levonorgestrel tablets (2 doses of 0.75 mg levonorgestrel taken 12 hours apart). 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