Escapel, pills 1.5mg, 1pc

Composition

1 tablet contains:

Active ingredient:

levonorgestrel 1.5 mg,

excipients:

potato starch 1 mg;

colloidal silicon dioxide 1 mg;

magnesium stearate 2 mg;

talc 5 mg;

corn starch 47 mg;

lactose monohydrate 142.5 mg

Pharmacological action

Escapel has a contraceptive, progestogenic, anti-estrogenic effect.

Pharmacodynamics

Levonorgestrel is a synthetic progestogen with a contraceptive effect, pronounced progestogenic and anti-estrogenic properties. With the recommended dosage regimen, levonorgestrel suppresses ovulation and fertilization if sexual contact occurred during the pre-ovulation phase, when the possibility of fertilization is greatest. It can also cause changes in the endometrium that prevent implantation. The drug is ineffective if implantation has already occurred.

Effectiveness. It is recommended to start taking Escapel as soon as possible (but no later than 72 hours) after sexual intercourse, if no protective measures have been applied. The more time elapsed between sexual intercourse and taking the drug, the lower its effectiveness (95% during the first 24 hours,85% – from 24 to 48 hours, and 58% – from 48 to 72 hours). At the recommended dose, levonorgestrel does not significantly affect blood clotting factors, fat and carbohydrate metabolism.

Pharmacokinetics

Levonorgestrel is rapidly and almost completely absorbed when taken orally. After taking one tablet of_Escapel, the serum cmax of the drug, equal to 18.5 ng / ml, is reached in 2 hours. After reaching cmax, the_{levonorgestrel}content decreases and T_1/2 is about 26 hours.

Levonorgestrel is excreted approximately equally by the kidneys and through the intestines exclusively in the form of metabolites. Levonorgestrel biotransformation corresponds to steroid metabolism. Levonorgestrel is hydroxylated in the liver, and its metabolites are excreted in the form of conjugated glucuronides Pharmacologically active metabolites of levonorgestrel are unknown.

Levonorgestrel binds to serum albumin and SHBG. Only 1.5% of the total dose is in free form, and 65% is associated with SHBG. Absolute bioavailability is 100% of the dose taken.

Indications

Emergency (post-coital) contraception (after unprotected sexual contact or if the method of contraception used is unreliable).

Use during pregnancy and lactation

Escapel should not be used during pregnancy.

If pregnancy occurred during the use of an emergency method of contraception, it should be borne in mind that, based on the available data, no adverse effect of the drug on the fetus was detected.

Levonorgestrel penetrates into the mother’s milk.

After taking the drug, breast-feeding should be stopped for 24 hours.

Contraindications

• hypersensitivity to any component of the drug Escapel;
• severe liver failure;
• patients with rare hereditary diseases, such as lactose intolerance, lactase deficiency or glucose-galactose malabsorption;
• pregnancy;
• adolescence (up to 16 years).

With caution: diseases of the liver or biliary tract; jaundice (including in the anamnesis); Crohn’s disease; lactation.

Side effects

Possible allergic reactions: hives, rash, itching, swelling of the face.

Transient side effects that occur with varying frequency (often ≥1/100,

Often-vomiting, diarrhea, dizziness, headache, breast tenderness, delayed menstruation (no more than 5-7 days), if menstruation is delayed for a longer period, it is necessary to exclude pregnancy; very often — nausea, fatigue, pain in the lower abdomen, acyclic spotting (bleeding).

Interaction

Simultaneous use of drugs that induce liver enzymes accelerates the metabolism of levonorgestrel.

The following drugs may reduce the effectiveness of levonorgestrel: amprecavil, lansoprazole, nevirapine, oxcarbazepine, tacrolimus, topiramate, tretinoin, barbiturates, including primidone, phenytoin and carbamazepine; drugs containing St. John’s wort (Hypericum perforatum), as well as rifampicin, ritonavir, ampicillin, tetracycline, rifabutin, griseofulvin.

Reduces the effectiveness of hypoglycemic and anticoagulant drugs (coumarin derivatives, phenindione). Increases plasma concentrations of corticosteroids. Women taking these medications should consult a doctor.

Drugs containing levonorgestrel may increase the risk of cyclosporine toxicity due to suppression of its metabolism.

How to take, course of use and dosage

Inside. 1 tablet should be taken as soon as possible, but no later than 72 hours after unprotected sexual intercourse. If vomiting occurs within 3 hours after taking the Escapel tablet, then you should take another 1 tablet of Escapel can be used at any time of the menstrual cycle. In the case of an irregular menstrual cycle, pregnancy should be excluded.

After taking an emergency contraceptive, local barrier contraceptive methods (such as a condom) should be used until the next menstrual period begins. The use of the drug for repeated unprotected sexual intercourse during one menstrual cycle is not recommended due to an increase in the frequency of acyclic spotting/bleeding.

Overdose

Symptoms: increased severity of side effects.

Treatment: symptomatic therapy. There is no specific antidote.

Special instructions

Escapel should be used exclusively for emergency contraception. Repeated use of the drug Escapel during one menstrual cycle is not recommended. Escapel should be taken as soon as possible, but no later than 72 hours after unprotected sexual intercourse. The effectiveness of emergency contraception with delayed use of the drug is significantly reduced.

The drug does not replace the use of permanent methods of contraception. In most cases, Escapel does not affect the nature of the menstrual cycle. However, acyclic spotting may occur and menstruation may be delayed for several days. If menstruation is delayed for more than 5-7 days and changes in its nature (scanty or abundant discharge), pregnancy should be excluded. The appearance of pain in the lower abdomen, fainting states may indicate an ectopic pregnancy.

Adolescents under 16 years of age in exceptional cases (including rape) need to consult a gynecologist to confirm pregnancy. After emergency contraception, it is recommended to consult a gynecologist to select the most appropriate method for permanent contraception.

Emergency contraception does not protect against sexually transmitted diseases.

In cases of gastrointestinal disorders (for example, Crohn’s disease), the effectiveness of the drug may decrease.

Effect of the drug on the ability to drive a car and work mechanisms. The effect of the drug on the ability to drive a car and mechanisms has not been studied.

Form of production

Tablets

Storage conditions

At a temperature of 15-25 °C.

Shelf

life is 5 years.

Active ingredient

Levonorgestrel

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Description

For women of childbearing age

Indications

Contraception