Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
LEVONORGESTREL (UNII: 5W7SIA7YZW) (LEVONORGESTREL - UNII:5W7SIA7YZW)
Lupin Pharmaceuticals, Inc.
ORAL
PRESCRIPTION DRUG
Levonorgestrel tablets, 0.75 mg are progestin-only emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. To obtain optimal efficacy, the first tablet should be taken as soon as possible within 72 hours of intercourse. The second tablet should be taken 12 hours later. Levonorgestrel tablets, 0.75 mg are available only by prescription for women younger than age 17 years, and available over the counter for women 17 years and older. Levonorgestrel tablets, 0.75 mg are not indicated for routine use as a contraceptive. Levonorgestrel tablets, 0.75 mg are contraindicated for use in the case of known or suspected pregnancy. Many studies have found no harmful effects on fetal development associated with long-term use of contraceptive doses of oral progestins. The few studies of infant growth and development that have been conducted with progestin-only pills have not demonstrated significant adverse effects. In general, no adverse effects of progestin-only pills have been found on breastfeeding performance or on the health, growth or development of the infant. However, isolated post-marketing cases of decreased milk production have been reported. Small amounts of progestins pass into the breast milk of nursing mothers taking progestin-only pills for long-term contraception, resulting in detectable steroid levels in infant plasma. Safety and efficacy of progestin-only pills for long-term contraception have been established in women of reproductive age. Safety and efficacy are expected to be the same for postpubertal adolescents under the age of 16 and for users 16 years and older. Use of levonorgestrel tablets, 0.75 mg emergency contraception before menarche is not indicated. This product is not intended for use in postmenopausal women. No formal studies have evaluated the effect of race. However, clinical trials demonstrated a higher pregnancy rate in Chinese women with both levonorgestrel tablets, 0.75 mg and the Yuzpe regimen (another form of emergency contraception). The reason for this apparent increase in the pregnancy rate with emergency contraceptives in Chinese women is unknown. No formal studies were conducted to evaluate the effect of hepatic disease on the disposition of levonorgestrel tablets, 0.75 mg. No formal studies were conducted to evaluate the effect of renal disease on the disposition of levonorgestrel tablets, 0.75 mg. Levonorgestrel is not a controlled substance. There is no information about dependence associated with the use of levonorgestrel tablets, 0.75 mg.
Levonorgestrel Tablets, 0.75 mg are white to off white round biconvex tablets, debossed with "LU" on one side and "S24" on the other side. Levonorgestrel Tablets, 0.75 mg are available in a wallet containing 2 tablets (NDC 68180-851-11). Each wallet is packed in a carton (NDC 68180-851-13). Store Levonorgestrel Tablets, 0.75 mg at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). [see USP Controlled Room Temperature].
Abbreviated New Drug Application
LEVONORGESTREL- LEVONORGESTREL TABLET LUPIN PHARMACEUTICALS, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE LEVONORGESTREL TABLETS, 0.75 MG SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR LEVONORGESTREL TABLETS, 0.75 MG. LEVONORGESTREL TABLETS, 0.75 MG, FOR ORAL USE INITIAL U.S. APPROVAL: 1982 INDICATIONS AND USAGE Levonorgestrel tablets, 0.75 mg are progestin-only emergency contraceptive, indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. Levonorgestrel tablets, 0.75 mg are available only by prescription for women younger than age 17 years, and available over the counter for women 17 years and older. Levonorgestrel tablets, 0.75 mg are not intended for routine use as a contraceptive. (1) DOSAGE AND ADMINISTRATION The first tablet is taken orally as soon as possible within 72 hours after unprotected intercourse. The second tablet should be taken 12 hours after the first dose. Efficacy is better if levonorgestrel tablet, 0.75 mg is taken as soon as possible after unprotected intercourse. (2) DOSAGE FORMS AND STRENGTHS A total of two 0.75 mg tablets taken 12 hours apart as a single course of treatment. (3) CONTRAINDICATIONS Known or suspected pregnancy. (4) WARNINGS AND PRECAUTIONS Ectopic Pregnancy: Women who become pregnant or complain of lower abdominal pain after taking levonorgestrel tablets, 0.75 mg should be evaluated for ectopic pregnancy. (5.1) Levonorgestrel tablets, 0.75 mg are not effective in terminating an existing pregnancy. (5.2) Effect on menses: Levonorgestrel tablets, 0.75 mg may alter the next expected menses. If menses is delayed beyond 1 week, pregnancy should be considered. (5.3) STI/HIV: Levonorgestrel tablets, 0.75 mg does not protect against STI/HIV. (5.4) 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%), d Soma hati kamili