Eskapel

Active material: Levonorgestrel
When ATH: G03AC03
CCF: Postkoital′nyj oral contraceptive
ICD-10 codes (testimony): Z30.0
When CSF: 15.11.03
Manufacturer: GEDEON RICHTER Ltd. (Hungary)

PHARMACEUTICAL FORM, COMPOSITION AND PACKAGING

Pills white or nearly white, flat, round, bevelled and engraved “GOO” on one side.

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

1 PC. – blisters (1) packs cardboard.

Pharmacological action

Postkoital′nyj contraceptive device with a pronounced gestagennym and antièstrogennym action. Causes inhibition of ovulation, If the sexual act takes place in the preovulâtornoj phase of menstrual cycle, ie. during the period of the greatest probability of fertilization. Besides, drug called regression endometrial proliferation prevents implantation of a fertilized egg. When held implantation drug ineffective.

Contraceptive effectiveness decreases as you increase the time, elapsed between sexual intercourse and the admission of the drug. While respecting the recommended dosage of levonorgestrel has no significant effect on coagulation factors, fat and carbohydrate metabolism.

The risk of pregnancy averages 1.1%.

Pharmacokinetics

Absorption

After intake of levonorgestrel is rapidly and completely absorbed from the digestive tract. C_max of active substance in plasma achieved through 2 h and is 18.5 ng / ml.

Distribution

Levonorgestrel binds to albumin and globulin, sex hormone binding (SHBG). 1.5% the total number of plasma is in the form of free steroid, 65% specifically linked to SHBG. Upon receiving 1 tab. Èskapela average concentration of SHBG in blood approximately 40 nmoli /. During 24 h concentration of SHBG in the blood remains unchanged or increases slightly, then starts to decline and after 190 h is approximately 30 nmoli /. The absolute bioavailability of 100% of the dose.

Provided with breast milk; when breastfeeding around 0.1% the dose along with breast milk enters the body of a child.

Metabolism

Levonorgestrel is metabolized in the liver by gidrauxilirovania. Pharmacologically active metabolites of levonorgestrel are unknown.

Deduction

Reduced concentrations of levonorgestrel in plasma is two-phase nature. T_1/2 is 2-7 no. 60% return with urine in the form of metabolites and 40% – with feces.

Pharmacokinetics in special clinical situations

Diseases of the digestive tract, proceeding in violation of suction, lower absorption of the drug, that can affect its effectiveness.

Testimony

-emergency (postcoital) contraception.

Dosage regimen

The drug is prescribed in a dose 1.5 mg (1 tab.) during the first 96 hours after intercourse.

Side effect

On the part of the endocrine system: rarely – the feeling of tension of the mammary glands, menstrual disorders (may temporarily change the nature of the menstrual cycle in the form of delayed menstruation, usually not exceeding 5-7 days).

From the digestive system: rarely – nausea, vomiting, diarrhea.

CNS: rarely – fatigue, headache, dizziness.

Other: seldom-pain in lower abdomen.

Contraindications

-diseases of the liver or bile ducts;

- Jaundice (incl. history);

-puberty;

- Pregnancy;

- Hypersensitivity to the drug.

Pregnancy and lactation

Èskapel is contraindicated for use in pregnancy.

If necessary, the use of the drug during lactation after receiving Èskapela should stop breastfeeding 36 no.

Cautions

This product is intended for emergency contraception and does not replace regular contraception. It is recommended that regular contraception after use of the drug Èskapel: either you should use barrier contraceptives, eg, condom, until the next menstruation, either continue accepting oral hormonal contraceptive drug, If it started earlier.

Èskapela shall not be used as a means of constant and continuous contraception, tk. This leads to a decrease in efficacy and frequent adverse reactions. With regular sex life should apply permanent methods of contraception.

Levonorgestrel is not in all cases prevents fertilization. When, When intercourse is not precisely known, or when since sexual intercourse without contraception more than 96 no, the probability of fertilization is high. When delay menstruation for more than 7 days, and in the case, When the timely onset of menstruation is unusual flows, or suspected pregnancy occurs for any other reason, should conduct gynecological examination to exclude pregnancy.

In cases, When the drug was used Èskapel due to an error in regular hormonal contraception, and in the subsequent seven-day break menstruation is absent, pregnancy should be deleted.

If during the 3 hours after taking the pill originated vomiting, Èskapela efficiency is reduced.

Diseases of the digestive tract, leaking intake process violations, lower absorption of the drug, that may also affect its effectiveness.

Èskapela tablet can be taken any day of the menstrual cycle, subject, that the previous menstruation proceeded normally.

Use of the drug, usually, does not violate normal regularity and nature of menstruation. Sometimes maybe more early or late (about 2 day) the appearance of menstruation.

You should avoid reapplying Èskapel pills during the same menstrual cycle in order to avoid violations of.

Patients, in history which has a ectopic pregnancy, surgical operations on fallopian tubes, pelvic inflammatory disease application of levonorgestrel may serve as an additional risk factor for the occurrence of ectopic pregnancy. If there is pain in the lower abdomen, occurrence of syncope, a history of ectopic pregnancy, operations on the pelvic organs or their inflammation should exclude ectopic pregnancy.

Postkoital′nyj Èskapel reception drug does not protect against disease, sexually transmitted.

Overdose

Symptoms: nausea, menstrual irregularities.

Treatment: if necessary, symptomatic therapy, No specific antidote.

Drug Interactions

If you are applying to Èskapela with inducers of enzymes mikrosomalnogo oxidation in the liver levonogestrela metabolism amplifies.

When the joint application of rifampicin, ampicillin, tetracycline, barbiturates (incl. prymydon), phenytoin, Carbamazepine, St. John's wort preparations, ritonavir, rifabutin, griseofulvin reduce the contraceptive effect of Èskapela.

Together with the use of Èskapelom increases the toxicity of Cyclosporine because his inhibiting metabolism.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

List B. The drug should be stored out of reach of children at temperature from 15 ° to 25 ° C. Shelf life – 2 year.