Levonorgestrel Dailymed

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 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.

Levonorgestrel tablets, 0.75 mg are contraindicated for use in the case of known or suspected 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.

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, 0.75 mg. 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, 0.75 mg.

Levonorgestrel tablets, 0.75 mg are not effective in terminating an existing pregnancy.

Levonorgestrel tablets, 0.75 mg are not effective in terminating an existing pregnancy.

Some women may experience spotting a few days after taking levonorgestrel tablets, 0.75 mg. 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.

A physical examination is not required prior to prescribing levonorgestrel tablets, 0.75 mg. 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, 0.75 mg.

A physical examination is not required prior to prescribing levonorgestrel tablets, 0.75 mg. 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, 0.75 mg.

A rapid return of fertility is likely following treatment with levonorgestrel tablets, 0.75 mg for emergency contraception; therefore, routine contraception should be continued or initiated as soon as possible following use of levonorgestrel tablets, 0.75 mg to ensure ongoing prevention of pregnancy.

A rapid return of fertility is likely following treatment with levonorgestrel tablets, 0.75 mg for emergency contraception; therefore, routine contraception should be continued or initiated as soon as possible following use of levonorgestrel tablets, 0.75 mg to ensure ongoing prevention of 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.

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 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.

Emergency contraceptive pills are not effective if a woman is already pregnant. Levonorgestrel tablets, 0.75 mg are believed to act as an emergency contraceptive principally by preventing ovulation or fertilization (by altering tubal transport of sperm and/or ova). In addition, it may inhibit implantation (by altering the endometrium). It is not effective once the process of implantation has begun.

Emergency contraceptive pills are not effective if a woman is already pregnant. Levonorgestrel tablets, 0.75 mg are believed to act as an emergency contraceptive principally by preventing ovulation or fertilization (by altering tubal transport of sperm and/or ova). In addition, it may inhibit implantation (by altering the endometrium). It is not effective once the process of implantation has begun.

Absorption No specific investigation of the absolute bioavailability of levonorgestrel in humans has been conducted. However, literature indicates that levonorgestrel is rapidly and completely absorbed after oral administration (bioavailability about 100%) and is not subject to first pass metabolism. After a single dose of levonorgestrel (0.75 mg) administered to 16 women under fasting conditions, the maximum serum concentrations of levonorgestrel were 14.1 + 7.7 ng/mL (mean + SD)  at an average of 1.6 + 0.7 hours. Cmax = maximum concentration Tmax = time to maximum concentration CL = clearance Vd = volume of distribution t ½ = elimination half life AUCinf = area under the drug concentration curve from time 0 to infinity Mean (± SD) Cmax (ng/mL) Tmax (h) CL (L/h) Vd (L) t ½ (h) AUCinf ( ng/mL.h)  Levonorgestrel 14.1 (7.7) 1.6 (0.7) 7.7 (2.7) 260.0 24.4 (5.3) 123.1 (50.1) Effect of Food: The effect of food on the rate and the extent of levonorgestrel absorption following single oral administration of levonorgestrel tablets, 0.75 mg have not been evaluated. Distribution The apparent volume of distribution of levonorgestrel is reported to be approximately 1.8 L/kg. It is about 97.5 to 99% protein-bound, principally to sex hormone binding globulin (SHBG) and, to a lesser extent, serum albumin. Metabolism Following absorption, levonorgestrel is conjugated at the 17β-OH position to form sulfate conjugates and, to a lesser extent, glucuronide conjugates in plasma. Significant amounts of conjugated and unconjugated 3α, 5β-tetrahydrolevonorgestrel are also present in plasma, along with much smaller amounts of 3α, 5α-tetrahydrolevonorgestrel and 16βhydroxylevonorgestrel. Levonorgestrel and its phase I metabolites are excreted primarily as glucuronide conjugates. Metabolic clearance rates may differ among individuals by several-fold, and this may account in part for the wide variation observed in levonorgestrel concentrations among users. Excretion About 45% of levonorgestrel and its metabolites are excreted in the urine and about 32% are excreted in feces, mostly as glucuronide conjugates. Specific Populations Pediatric This product is not intended for use in the pediatric (pre-menarcheal) population, and pharmacokinetic data are not available for this population. Geriatric This product is not intended for use in postmenopausal women and pharmacokinetic data are not available for this population. Race No formal studies have evaluated the effect of race on pharmacokinetics of levonorgestrel tablets, 0.75 mg. 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 [see USE IN SPECIFIC POPULATIONS (8.6)]. Hepatic Impairment No formal studies were conducted to evaluate the effect of hepatic disease on the disposition of levonorgestrel tablets, 0.75 mg. Renal Impairment No formal studies were conducted to evaluate the effect of renal disease on the disposition of levonorgestrel tablets, 0.75 mg. Drug-Drug Interactions No formal drug-drug interaction studies were conducted with levonorgestrel tablets, 0.75 mg [see DRUG INTERACTIONS (7)].

  Take levonorgestrel tablet, 0.75 mg as soon as possible and not more than 72 hours after unprotected intercourse or a known or suspected contraceptive failure.   If you vomit within two hours of taking either tablet, immediately contact your healthcare provider to discuss whether to take another tablet.   Seek medical attention if you experience severe lower abdominal pain 3 to 5 weeks after taking levonorgestrel tablet, 0.75 mg, in order to be evaluated for an ectopic pregnancy.   After taking levonorgestrel tablet, 0.75 mg, consider the possibility of pregnancy if your period is delayed more than one week beyond the date you expected your period.   Do not use levonorgestrel tablet, 0.75 mg as routine contraception.   Levonorgestrel tablets, 0.75 mg are not effective in terminating an existing pregnancy.   Levonorgestrel tablet, 0.75 mg does not protect against HIV-infection (AIDS) and other sexually transmitted diseases/infections.   For women younger than age 17 years, levonorgestrel tablets, 0.75 mg are available only by prescription.