Expiration date: 01/2025

Release form and composition: 

Tablets from pale yellow to light yellow with greenish hue color, Valium.

1 tablet contains mifepristone 10 mg

Excipients: lactose, starch, carboxymethyl starch, microcrystalline cellulose, polyvinylpyrrolidone, magnesium stearate.

Pharmachologic effect:

Antigestagens synthetic steroid drug (blocks the action of progesterone at the receptor level) progestogenic activity is not. There antagonism with GCS (due to competition on the level of communication with the receptors).

Increases contractility of the myometrium, stimulating the release of interleukin-8 in horiodetsidualnyh cells and increasing the sensitivity of the myometrium to prostaglandins. Depending on the phase of the menstrual cycle causes inhibition of ovulation, endometrial changes in and prevents implantation of a fertilized egg.

Pharmacokinetics:

Suction

After a single oral dose of 600 mg Cmax achieved after 1.3 hours and is 1.98 mg / l. The absolute bioavailability is 69%.

Distribution

Binding to plasma proteins (albumin and apha1-acidic glycoprotein) amounts to 98%.

breeding

. T1 / 2 - 18 hours Excretion performed in two phases: first, a slow elimination of the drug (mifepristone concentration in blood plasma decreases in 2 times between 12-72 hours), and then rapid elimination phase.

Testimony:

Emergency postcoital contraception (after unprotected intercourse or if the applied method of contraception can not be considered reliable).

Dosage and administration:

The drug is administered orally in a single dose of 10 mg (1 tab.) For 72 hours after unprotected intercourse.

To preserve the contraceptive effect it is necessary to refrain from eating for 2 hours before drug application and during the 2 hours after administration.

Gynepriston can be used in any phase of the menstrual cycle.

Side effects:

From the digestive system: nausea, vomiting.

CNS: dizziness, headache.

From the reproductive system: bleeding from the genital tract, menstrual irregularities.

Allergic reactions: urticaria.

Other: a sense of discomfort in the lower abdomen, fatigue, pyrexia.

Contraindications:

• Adrenal insufficiency
  
• Long-term use of GCS
  
• Acute or chronic renal failure
  
• Acute or chronic liver failure
  
• Presence of severe extragenital pathology
  
• Hypersensitivity to mifepristone (in history).
  

Precautions should be prescribed the drug in violation of hemostasis (including previous treatment with anticoagulants), chronic obstructive lung disease (including asthma), severe hypertension, cardiac arrhythmias, congestive heart failure.

Pregnancy and lactation:

The drug is contraindicated during pregnancy.

It should stop breast-feeding for 14 days after receiving Gynepriston.

Special instructions:

Gynepriston not recommended for regular use as a planned permanent contraception.

Application Gynepriston drug does not protect against sexually transmitted diseases and AIDS through.

Avoid simultaneous reception Gynepriston with NSAIDs.

Overdose:

Receiving Gynepriston at doses up to 2 g does not cause unwanted reactions. In cases of overdose adrenal insufficiency may occur.

Drug Interactions:

Drug Interactions Gynepriston preparation is not described.

Conditions and terms:

List A. The preparation should be stored in a dry, dark, place inaccessible to children at temperature not above 30 ° C. Shelf life - 3 years. Do not use after the expiration date printed on the package.