Each tablet contains Levonorgestrel 1.5 mg.
PHARMACOLOGY: Pharmacodynamics: Pregnancy may be prevented through several mechanisms: Thickening of cervical mucus, which inhibits sperm through the uterus and sperm survival, inhibits ovulation from a negative feedback mechanism on the hypothalamus, leading to reduced secretion of follicle stimulating hormone (FSH) and luteinizing hormone (LH); altering the endometrium, which may affect implantation. Levonorgestrel is not effective once the implantation process has begun.
Pharmacokinetics: Absorption: Levonorgestrel is rapidly and completely absorbed after oral administration (Bioavailability about 100%) and is not subjected to first pass metabolism.
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: Levonorgestrel is conjugated at the 17 beta-OH position to form sulfate conjugates and glucuronide conjugates in plasma. Significant amounts of conjugated and unconjugated 3 alpha, 5 beta-tetrahydrolevonorgestrel are also present in plasma, along with much smaller amounts of 3 alpha, 5 alpha-tetrahydrolevonorgestrel and 16 beta hydroxylevonorgestrel. Levonorgestrel and its phase I metabolites are excreted primarily as glucuronide conjugates.
Excretion: About 45% of levonorgestrel and its metabolites are excreted in the urine and about 32% are excreted in feces, mostly as glucuronide conjugates.
To prevent pregnancy in the case of: Sexually assaulted victims; Known or suspected contraceptive failure, incorrect or emergency cases such as condom leak, miscount safe period, intrauterine device used failure, disregard of contraceptive injection or over 3 days late of taking oral contraceptives.
Take 1 tablet as soon as possible within 72 hours after unprotected intercourse or a known or suspected contraceptive failure. If vomiting occurs within 2 hours of taking the tablets, consider repeating the dose.
The efficacy is better if levonorgestrel is taken as directed as soon as possible after unprotected intercourse.
OVERDOSE AND TREATMENT: There are no data on overdosage of levonorgestrel. However, the acute overdosage of oral contraceptives reportedly results in nausea, vomiting, and withdrawal bleeding.
1. Do not use for regular birth control.
2. Do not use in pregnancy.
3. Hypersensitivity to levonorgestrel or any component of the formulation.
4. Do not use in women with vaginal bleeding.
1. Consult the physicians or pharmacists before using this drug.
2. Do not use as regular prevention of pregnancy. Repeated use may cause serious effects.
3. This drug has no efficacy for abortion and cannot protect against sexually transmitted diseases.
4. Consult the physician if any abnormal symptoms occur, especially lack of menstruation.
Effect on menses: Menstrual bleeding patterns are often irregular among women using progestin-only oral contraceptives and in clinical studies of levonorgestrel for postcoital and emergency contraceptive use. Some women may experience spotting a few days after taking levonorgestrel. If there is a delay in the onset of menses beyond 1 week, consider the possibility of pregnancy.
Sexually transmitted disease: Levonorgestrel does not protect against HIV infection (AIDS) and other sexually transmitted diseases.
Carbohydrate metabolism: The effects of levonorgestrel on carbohydrate metabolism are unknown. Some users of progestin-only contraceptives may experience slight deterioration in glucose tolerance, with increases in plasma insulin; however, women with diabetes mellitus who use progestin-only oral contraceptive do not generally experience changes in their insulin requirements. Nonetheless, monitor diabetic women while they are taking levonorgestrel.
Use in Pregnancy: Ectopic pregnancy: Consider a history of ectopic pregnancy a contraindication of using the emergency contraceptive method. However, be alert to the possibility of an ectopic pregnancy in women who become pregnant or complain of lower abdominal pain after taking levonorgestrel.
Pregnancy may occur despite the correct use of this drug.
Pregnancy: Category X. Many studies have found no 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 oral contraceptives have not demonstrated significant adverse effects. Levonorgestrel is not effective in terminating an existing pregnancy.
Ectopic pregnancy: Consider a history of ectopic pregnancy a contraindication of using the emergency contraceptive method. However, be alert to the possibility of an ectopic pregnancy in women who become pregnant or complain of lower abdominal pain after taking levonorgestrel.
Pregnancy may occur despite the correct use of this drug.
Lactation: Small amounts of progestin pass into the breast milk of women taking progestin-only oral contraceptives for long-term contraception. However, no adverse effects caused by progestin-only oral contraceptives have been found on breast-feeding performance, either in the quality or quantity of the milk, or on the health, growth, or development of the infant.
Central Nervous System: Fatigue, headache, dizziness.
Gastrointestinal System: Nausea, abdominal pain, vomiting.
Genitourinary System: Breast tenderness, dysmenorrhea, irregular menses, pelvic pain.
Drugs affecting Hepatic Microsomal Enzymes: Concomitant use of oral contraceptives and the inducers of hepatic microsomal cytochrome P-450 (CYP) enzyme may decrease contraceptive efficacy and increase breakthrough bleeding. The inducer of hepatic microsomal enzymes including barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampicin, topiramate and St. John's wort.
Antiretroviral agents: Concomitant use of oral contraceptives and some HIV-protease inhibitors or nonnucleoside reverse transcriptase inhibitors may reduce the efficacy of the oral contraceptives.
G03AC03 - levonorgestrel ; Belongs to the class of progestogens. Used as systemic contraceptives.
Madonna One tab 1.5 mg
1's
Sign Out
