Instruction for use: Escapellele

Active substance Levonorgestrel

ATX code G03AC03 Levonorgestrel

Pharmacological group

Estrogens, gestagens; Their homologues and antagonists

Nosological classification (ICD-10)

Z30 Monitoring contraceptive use

Local Contraception, Contraception oral, Local contraception, Episodic prevention of pregnancy, Hormonal Contraception, Contraception, Prevention of Pregnancy, Prevention of unwanted pregnancy, Contraceptive intrauterine, Contraception in women with androgenization phenomena, Installation and removal of the intrauterine device, Prevention of pregnancy (contraception)

Z30.0 General advice and advice on contraception

Safe sex, Intrauterine device contraception, Contraception, Contraceptive intrauterine, Oral contraception, Oral contraception during lactation and with estrogen contraindications, Postcoital contraception, Prevention of Pregnancy, Prevention of unwanted pregnancy, Emergency Contraception, Episodic prevention of pregnancy, Contraception in adolescents, Prevention of pregnancy (contraception)

Composition

Tablets 1 table.

active substance:

Levonorgestrel 1.5 mg

Auxiliary substances: potato starch - 1 mg; Silicon dioxide colloidal - 1 mg; Magnesium stearate - 2 mg; Talc - 5 mg; Corn starch - 47 mg; Lactose monohydrate 142.5 mg

Description of dosage form

Flat round tablets of white or almost white color, with a facet and engraving "G00" on one side.

pharmachologic effect

Pharmacological action - contraceptive, progestational, anti-estrogenic.

Pharmacodynamics

Levonorgestrel is a synthetic gestagen with a contraceptive effect, expressed by gestagenic and antiestrogenic properties. With the recommended dosing regimen, levonorgestrel suppresses ovulation and fertilization if sexual contact occurs in the pre-vascular phase, when the possibility of fertilization is greatest. It can also cause changes in the endometrium, which prevent implantation. The drug is ineffective if the implantation has already occurred.

Efficiency. Reception of Escapelle® is recommended to begin as soon as possible (but not later than 72 hours) after sexual intercourse, if no protective measures have been applied. The more time passed between intercourse and taking the drug, the lower its effectiveness (95% within the first 24 hours, 85% from 24 to 48 hours and 58% from 48 to 72 hours). In the recommended dose, levonorgestrel does not significantly affect the factors of blood coagulability, the exchange of fats and carbohydrates.

Pharmacokinetics

When taken orally, levonorgestrel is quickly and almost completely absorbed. After taking one tablet, the Escapellele® Cmax preparation in serum, equal to 18.5 ng / ml, is reached after 2 hours. After reaching Cmax, the levonorgestrel content decreases and T1 / 2 is about 26 hours.

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

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

Indications

Emergency (postcoital) contraception (after unprotected sexual intercourse or if the method of contraception used is unreliable).

Contraindications

Hypersensitivity to any component of the drug;

Severe hepatic impairment;

Patients with rare hereditary diseases, such as lactose intolerance, lactase deficiency or glucose-galactose malabsorption;

pregnancy;

Adolescence (up to 16 years).

With caution: liver or bile duct disease; Jaundice (including in the anamnesis); Crohn's disease; lactation.

pregnancy and lactation

Escapelle ® can not be used during pregnancy. If pregnancy occurred when using an emergency method of contraception, it should be borne in mind that, based on the available data, the adverse effect of the drug on the fetus was not revealed.

Levonorgestrel penetrates into the mother's milk. After taking the drug, breast-feeding should be stopped for 24 hours.

Side effects

Allergic reactions are possible: hives, rashes, itching, swelling of the face.

Transient side effects that occur at different frequencies (often ≥1 / 100, <1/10, very often ≥1 / 10) and do not require medication.

Often - vomiting, diarrhea, dizziness, headache, breast tenderness, delay in menstruation (no more than 5-7 days), if menstruation is delayed for a longer period, pregnancy should be excluded; Very often - nausea, fatigue, pain in the lower abdomen, acyclic spotting (bleeding).

Interaction

At simultaneous reception of preparations-inducers of enzymes of a liver there is an acceleration of a metabolism of levonorgestrel.

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

Reduces the effectiveness of hypoglycemic and anticoagulant (coumarin derivatives, phenyldione) drugs. Increases plasma concentrations of GCS. Women who take these drugs should consult a doctor.

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

Dosing and Administration

Inside. 1 tab. Should be taken as soon as possible, but no later than 72 hours after unprotected intercourse. If within 3 hours after taking the tablet Escapelle ® there was vomiting, you should take another 1 table. Eskapel® can be used at any time of the menstrual cycle. In case of an irregular menstrual cycle, pregnancy should be excluded.

After taking an emergency contraceptive before the next menstrual period, local barrier contraceptive methods (eg a condom) should be used. The use of the drug with repeated unprotected intercourse during one menstrual cycle is not recommended because of the increased frequency of acyclic bleeding / bleeding.

Overdose

Symptoms: increased severity of side effects.

Treatment: symptomatic therapy. There is no specific antidote.

special instructions

Escapelle ® should be used exclusively for emergency contraception. Repeated use of the drug Escapelle® during one menstrual cycle is not recommended. Escapelle ® should be taken as soon as possible, but no later than 72 hours after unprotected 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, Escapelle® does not affect the character of the menstrual cycle. However, acyclic bleeding may occur and menstruation may be delayed for several days. If you delay menstruation for more than 5-7 days and change its nature (meager or abundant discharge) it is necessary to exclude pregnancy. The appearance of pain in the lower abdomen, fainting can indicate ectopic (ectopic) pregnancy.

Adolescents under 16 years in exceptional cases (including rape) need a consultation with a gynecologist to confirm pregnancy. After emergency contraception, a gynecologist's consultation is recommended to select the most acceptable method for permanent contraception.

Emergency contraception does not protect against sexually transmitted diseases.

For violations of the function of the gastrointestinal tract (eg Crohn's disease), the effectiveness of the drug may decrease.

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

Form of issue

Tablets, 1.5 mg. 1 tab. In an aluminum / PVC blister. 1 blister is placed in a cardboard box.

Terms of leave from pharmacies

On prescription.

storage Conditions

At a temperature of 15-25 ° C.

Keep out of the reach of children.

Shelf life

5 years.

Do not use after the expiry date printed on the package.