Escapel (levonorgestrel) tablets 1.5 mg. №1

Description

Escapel Storage
active substance: levonorgestrel;

1 tablet contains levonorgestrel 1.5 mg;

Excipients: potato starch, colloidal anhydrous silica, magnesium stearate, talc, corn starch, lactose monohydrate.

Escapel Dosage form
Tablets.

Main physical and chemical properties: flat tablets of white or almost white color, chamfered, engraved “G00” on one side. The diameter of the tablets is about 8 mm.

Pharmacotherapeutic group
Sex hormones and modulators of the reproductive system. Emergency contraceptives. ATX code G03A D01.

Pharmacological properties

Pharmacodynamics.

The exact mechanism of action of the drug Escapel is unknown. At the recommended doses, levonorgestrel affects ovulation and fertilization if sexual intercourse took place in the preovulatory phase of the menstrual cycle, ie at the time of the highest probability of fertilization. At the started implantation, the drug is not effective.

Efficacy: According to a previous clinical study, 750 mcg of levonorgestrel (as two doses of 750 mcg taken at 12-hour intervals) prevents pregnancy in 85% of cases. Presumably, the more time elapsed between sexual intercourse and taking the drug, the lower its effectiveness (95% within the first 24 hours, 85% – in the period from 24 to 48 hours, and 58% – in the period from 48 to 72 hours).

According to a previous clinical study, 2 tablets of levonorgestrel 750 mcg, taken simultaneously (within 72 hours after unprotected intercourse), prevent pregnancy in 84% of cases. There were no differences in the frequency of pregnancy in women who took the drug on the third or fourth day after unprotected intercourse (p> 0.2).

Escapel Indication
For urgent oral contraception in the first 72 hours after sexual intercourse, during which no contraceptive methods were used or the method of contraception used was not reliable enough.

Contraindication
Hypersensitivity to any of the components of the drug, severe liver failure; pregnancy.

Interaction with other medicinal products and other forms of interaction
Levonorgestrel metabolism is enhanced by concomitant use of inducers of liver enzymes, mainly inducers of the enzyme system CYP3A4. Plasma levels of levonorgestrel (AUC) were reduced by approximately 50% when co-administered with efavirenz.

Medicines containing the following active substances may reduce the concentration of levonorgestrel in the blood plasma: barbiturates (including primidone); phenytoin; carbamazepine; herbal preparations containing Hypericum perforatum (perforated St. John’s wort); rifampicin; ritonavir; rifabutin; griseofulvin.

Women who have taken liver enzyme inducers in the last 4 weeks and who need emergency contraception should consider using non-hormonal emergency contraceptives (such as the intrauterine system, which contains copper). Taking a double dose of levonorgestrel (3000 mcg levonorgestrel for 72 hours after unprotected intercourse) is an alternative for those women who are unable or unwilling to use the intrauterine system containing copper, although this specific combination (double dose of levonorgestrel when using inducers microsomal liver enzymes) has not been studied.

Drugs containing levonorgestrel may increase the toxicity of cyclosporine by inhibiting its metabolism.