Composition, form of production and packaging
Tablets are white or beige in color, round, flat on both sides, with bevelled edge, with a risk on one side and a marked symbol "61C" on both sides of the risk; on the other side of the tablet is engraved the sign of the firm.
1 tab.
pyrhenzepine dihydrochloride (in the form of monohydrate) 25 mg
Excipients: lactose, corn starch, silicon dioxide colloid (aerosil 200), magnesium stearate.
10 pieces. - blisters (2) - packs of cardboard.
10 pieces. - blisters (5) - packs of cardboard.
10 pieces. - blisters (10) - packs of cardboard.
Tablets from white to beige, round, convex on one side, with a bevelled edge, on the convex side - the sign of the firm, on the other side of the concave risk, on both sides of which the "50D" is printed.
1 tab.
pirenzepine dihydrochloride monohydrate 50 mg
Excipients: lactose, corn starch, silicon dioxide colloid, magnesium stearate.
10 pieces. - blisters (2) - packs of cardboard.
10 pieces. - blisters (5) - packs of cardboard.
10 pieces. - blisters (10) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2008.
PHARMACHOLOGIC EFFECT
Pirenzepine selectively blocks muscarinic receptors, reduces the formation of gastric juice and increases pH in the stomach. In therapeutic doses, the drug does not penetrate the BBB.
PHARMACOKINETICS
Pyrenzepine is not completely absorbed from the digestive tract. C max in plasma is noted 2-3 hours after taking the drug. The average absolute bioavailability with oral administration is only 10-20%.
Taking pirenzepine concomitantly with food results in AUC decrease by 30%.
Pyrenzepine only binds to a small extent with plasma proteins (about 12%). Pyrenzepine almost does not penetrate the BBB and placental barriers. In the milk of a nursing woman, only a minimal amount of the drug is found. When administered orally, pirenzepine is excreted, mainly with feces, mostly unchanged. The total plasma clearance is about 250 ml / min. Kidney clearance is approximately half this value, which corresponds to the level of glomerular filtration. Pyrenzepine is excreted from the body with an average T 1/2 of 10-12 hours. The pharmacokinetics of pyrenzepine are not significantly affected by either hepatic or renal insufficiency. V d of the main substance is about 14 liters, which roughly corresponds to the volume of the extracellular space of man.
INDICATIONS
acute ulcer of the stomach and duodenum;
- Stomach ulcer and duodenal ulcer.
DOSING MODE
Tablets should be taken about half an hour before meals, washed down with a small amount of liquid. If the doctor is not prescribed otherwise, you should take the drug 50-150 mg / day, divided into several receptions. The usual dosing regimen is 50 mg 2 times / day, morning and evening.
Sometimes the first 2-3 days of treatment may require the appointment of an additional dose of the drug in the middle of the day. Despite the rapid subjective improvement of the condition, the patient should not reduce the dose of the drug or refuse to take the drug, if it is not recommended by the doctor.
Treatment should be continued for 4-6 weeks.
SIDE EFFECT
After using the drug, the following side effects were observed: dry mouth, accommodation disorders, tachycardia, constipation, diarrhea, urinary retention, headache.Reported cases of the development of allergic reactions and anaphylactic shock.
CONTRAINDICATIONS
- hypersensitivity to any of the components of the drug;
paralytic ileus in the patient.
Patients with an existing intolerance to galactose (galactoseemia, lactase deficiency, or impaired absorption of glucose-galactose in the intestine) should not use this drug. The maximum recommended daily dose contains 833.64 mg of lactose.
Gastrotsepin should be used with caution in patients with glaucoma, benign prostatic hyperplasia, tachycardia.
PREGNANCY AND LACTATION
The drug should be administered to pregnant and lactating women only if the expected benefit exceeds any possible risk to the fetus or newborn.
SPECIAL INSTRUCTIONS
Patients with glaucoma are advised to periodically measure intraocular pressure.
Impact on the ability to drive vehicles and manage mechanisms
Due to visual impairment and accommodation, there may be a disruption in the ability to drive and machine equipment.
OVERDOSE
Symptoms: up to now there is no data on cases of overdose in humans. However, when ingested large doses of pyrenzepine may develop the following anticholinergic effects: hot flashes, dryness and skin hyperemia; dry mouth; mydriasis; rave; tachycardia; intestinal obstruction; retention of urine; convulsive twitching of muscles;chorea, athetosis.
Treatment: experience with the treatment of an overdose of pirenzepine is limited. In cases of poisoning with large doses of the drug taken internally, treatment begins with general measures (for example, the appointment of activated charcoal, gastric lavage). Hemodialysis, blood transfusion, peritoneal dialysis and re-administration of activated charcoal do not contribute to the removal of pirenzepine from the body. In cases of severe intoxication (with fever, delirium or severe tachycardia), physostigmine can be prescribed in a small dose of IV. In case of development of an acute attack of glaucoma, drugs that have m-cholinomimetic effect (pilocarpine in the form of eye drops) should be used and immediately consult a specialist.
DRUG INTERACTION
Simultaneous use of gastrotsepin and blockers of H 2 -gistamine receptors is accompanied by a more pronounced decrease in the secretion of hydrochloric acid in the stomach.
Gastrotsepin, used in combination with anti-inflammatory drugs, does not reduce their anti-inflammatory effect and improves their tolerability.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
Store in a dry place at a temperature of no higher than 25 В° C. Keep out of the reach of children.
Shelf life - 5 years. Do not use after the expiration date stated on the package.
