Composition
One tablet contains:
Active ingredient: Â
Mifepristone — 0.01 g.
Auxiliary substances: Â
Microcrystalline cellulose — 0.0746 g,
Carboxymethyl Starch
Sodium — 0.0045 g,
Calcium stearate — 0.0009 g.
Characteristics flat-cylindrical tablets from light yellow to light yellow with a greenish tinge of color.
Pharmacological action
Ginepristone is a synthetic steroid anti-gestational drug (blocks the action of progesterone at the level of receptors), has no progestogenic activity.
Antagonism with glucocorticoids is noted (due to competition at the level of communication with receptors).
Increases the contractility of the myometrium, stimulating the release of interleukin-8 in choriodecidual cells and increasing the sensitivity of the myometrium to prostaglandins.
Depending on the phase of the menstrual cycle, it causes ovulation inhibition, changes in the endometrium and prevents the implantation of a fertilized egg.
Pharmacokinetics
Suction
After a single oral dose of 600 mg, the Cmax is reached in 1.3 hours and is 1.98 mg/l. Absolute bioavailability is 69%.
Distribution
Binding to plasma proteins (with albumin and acidic α1-glycoprotein) is 98%.
Elimination
T1 / 2-18 hours Elimination is carried out in two phases: first, slow elimination of the drug (the concentration of mifepristone in blood plasma decreases by 2 times between 12-72 hours), then the rapid elimination phase.
Active ingredients
Mifepristone
Indications
Emergency post-coital contraception (after unprotected sexual intercourse or if the method of contraception used cannot be considered reliable).
Contraindications
- adrenal insufficiency;
- long-term use of corticosteroids;
- acute or chronic renal failure;
- acute or chronic liver failure;
- the presence of severe extragenital pathology;
- hypersensitivity to mifepristone (in the anamnesis).
With caution, the drug should be prescribed for impaired hemostasis (including previous treatment with anticoagulants), chronic obstructive pulmonary diseases (including bronchial asthma), severe arterial hypertension, cardiac arrhythmias, and chronic heart failure.
Side effects
From the digestive system: Â nausea, vomiting.
From the central nervous system: Â dizziness, headache.
From the side of the reproductive system: Â spotting from the genital tract, menstrual disorders.
Allergic reactions: Â urticaria.
Other services: Â feeling of discomfort in the lower abdomen, weakness, hyperthermia.
Interaction
Nonsteroidal anti-inflammatory drugs should be avoided.
How to take, course of use and dosage
The drug is administered orally in a single dose of 10 mg (1 tablet) for 72 hours after unprotected sexual intercourse.
To maintain the contraceptive effect, you should refrain from eating 2 hours before using the drug and for 2 hours after taking it.
Ginepristone can be used at any stage of the menstrual cycle.
Overdose
Symptoms: Â possible adrenal insufficiency.
Treatment: Â conducting symptomatic therapy.
Description
Anti-gestational drugs
Description
Flat-cylindrical tablets from light yellow to light yellow with a greenish tinge of color.
Functional features
Absorption: After a single dose of 600 mg, the maximum serum concentration of 1.98 mg / l is reached in 1.30 hours. Absolute bioavailability is 69%. The binding to plasma proteins (albumin and acid alpha-1-glycoprotein) is 98%. After the distribution phase, elimination occurs slowly at first, the concentration decreases 2-fold between 12-72 hours, then more quickly. The elimination half-life is 18 hours.
Complete set
1 or 2 tablets in a contour cell package and 1 or 2 tablets in a polymer jar,1 contour cell package or jar together with the instructions for use are placed in a pack of cardboard.
Special instructions
Ginepristone® is not recommended for regular use as a planned, permanent contraception. Ginepristone® does not protect against sexually transmitted diseases and AIDS. Effects on the ability to drive a car and other mechanisms Currently, there is no evidence that the drug can affect the ability to drive a car and other mechanisms. Ginepristone® should not be used during pregnancy. Breast-feeding should be discontinued for 14 days after taking Ginepristone®.
Composition
Tablet Form of production
Storage conditions
Store in a dry place protected from light at a temperature not exceeding 30°C. Keep out of reach of children.
Shelf
life is 5 years. Do not use after the expiration date indicated on the package.
Active ingredient
Mifepristone
Conditions of release from pharmacies
By prescription
Dosage form
Tablets
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