Composition, form of production and packaging
Tablets 1 tab.
mifepristone 200 mg
Excipients: lactose, corn starch, microcrystalline cellulose, calcium stearate, aerosil.
3 pcs. - polymer cans (1) - packs of cardboard.
3 pcs. - banks of dark glass (1) - packs of cardboard.
3 pcs. - packings of cellular contour (1) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the print edition of 2007.
An antiprogestronic preparation. The action of Pencrofton is due to the blocking of progesterone activity at the receptor level.
After oral administration, it is rapidly absorbed from the gastrointestinal tract and reaches the C max values вЂ‹вЂ‹in the blood plasma. The degree of binding to plasma proteins is high. T 1/2 - about 18 hours.
- drug interruption of uterine pregnancy at early stages (up to 42 days of amenorrhea), confirmed by a pregnancy test.
The drug is administered orally 600 mg (3 tablets 200 mg) for 1 reception in the presence of a doctor.
After taking the drug, the patient should be under the supervision of medical personnel for at least 2 hours.
After 8-14 days, a clinical examination using ultrasound, determining the level of? -HCG in the blood. In the absence of the effect of the drug on the 14th day (incomplete abortion or developing pregnancy), the patient should be vacuumed, followed by a histological examination of the aspirate.
The drug can be used only in an institution that has highly qualified, certified, trained medical personnel and the necessary reanimation equipment.
Related to the procedure: may bleed profuse, which may require immediate surgical intervention (curettage); sometimes pain in the lower abdomen; inflammatory processes of the uterus and appendages.
Associated with reception of Pencrofton: rarely - a feeling of discomfort in the lower abdomen, weakness, headache, nausea, vomiting, diarrhea, dizziness, hyperthermia.
- suspicion of ectopic pregnancy;
- Pregnancy exceeding in duration 42 days of amenorrhea;
- chronic adrenal insufficiency;
- long-term therapy with corticosteroids;
- hemorrhagic disorders;
- treatment with anticoagulants;
- inflammatory diseases of the vagina;
- Pregnancy that has arisen against the background of intrauterine contraceptive use or after the abolition of hormonal contraception;
- presence of a scar on the uterus;
- myoma of the uterus;
- Smoking women over the age of 35;
- hypersensitivity to mifepristone.
PREGNANCY AND LACTATION
Patients should be informed that in case of ineffectiveness of this method (continuing pregnancy), pregnancy should be interrupted in another way, because the effect of the drug on the fetus is possible.
If you need Pencrofton during lactation, breastfeeding should be discontinued for 14 days after taking the drug.
The use of the drug requires compliance with all the preparation associated with abortion. It is necessary to take precautions when taking synthetic prostaglandins.
APPLICATION FOR FUNCTIONS OF THE LIVER
It is not recommended to appoint Pencroftone to patients with renal insufficiency.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
It is not recommended to appoint Pencroftone to patients with hepatic insufficiency.
With extreme caution, the drug should be used in patients of the following high-risk groups: with bronchial asthma, COPD, cardiovascular diseases or a predisposition to them.
It is not recommended to appoint Pencroftone to patients with renal and hepatic insufficiency.
In case of an overdose of Pencroftone, acute adrenal insufficiency may develop.
It is necessary to avoid the simultaneous use of Pencroftone with NSAIDs (including acetylsalicylic acid), because they can affect the effectiveness of the drug.
TERMS OF RELEASE FROM PHARMACY
The drug is supplied only to medical auxiliaries and gynecological institutions related to the public health system, municipal and private property agencies that have licenses for this type of activity.
TERMS AND CONDITIONS OF STORAGE
List A. The drug should be stored in a dry, protected from light and out of reach of children at a temperature of 18 В° to 22 В° C. Shelf life - 2 years.