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Composition:


active ingredient: rebamipid,


1 tablet contains rebamipid 100 mg;


excipients: microcrystalline cellulose, low-substituted hydroxypropylcellulose, hydroxypropylcellulose, magnesium stearate;


coating mixture: hypromellose, titanium dioxide (e 171), polyethylene glycol (macrogol).


Dosage form. Film-coated tablets.


Basic physical and chemical properties: white round, smooth biconvex film-coated tablets on both sides.


Pharmacotherapeutic group. Means for the treatment of acid-dependent diseases.


The ATX code is A02X.


Pharmacological properties.


Pharmacodynamics.


Rebamipid increases the endogenous content of prostaglandins E2 and i2 (PGE2 and PGI2), which are contained in gastric juice, and also increases the level of prostaglandin E2 (PGE2) in the gastric mucosa, which helps protect it from damaging factors. Rebamipid has a cytoprotective effect, proven in in vitro studies, improves blood circulation in the gastric mucosa and stimulates cell proliferation. By increasing the activity of enzymes that stimulate the biosynthesis of high-molecular glycoproteins, rebamipid increases the amount of superficial gastric mucus. Rebamipid does not affect basal and stimulated gastric secretion.


Pharmacokinetics.


After a single oral administration of 100 mg of rebamipid, the maximum plasma concentration (216 ± 79 ng/mL) was observed after 2.4 ± 1.2 hours. In vitro experiments, approximately 90% of the drug bound to plasma proteins, but numerous studies have shown that the drug does not accumulate in the body. The drug undergoes little metabolism in the human body, but for the most part it is released unchanged. The plasma half-life is approximately 1.9 ± 0.7 hours. When using rebamipid at a dose of 100 mg in patients with renal insufficiency, an increase in the concentration of the drug in blood plasma was observed and the Half-Life was longer compared to healthy patients.


Clinical characteristics.


Indications.


Stomach ulcer, acute gastritis, period of exacerbation of chronic gastritis, pathological changes in the gastric mucosa (erosion, bleeding, hyperemia, edema).


Contraindications.


Hypersensitivity to rebamipid or to any other components of the drug. Malignant diseases of the stomach.


Interactions with other drugs and other types of interactions.


When using rebamipid as part of traditional antichelicobacter regimens, the effectiveness of traditional therapy is likely to increase. Interaction with other drugs has not been studied.


Application features.


Sometimes there may be a decrease in the number of white blood cells and platelets. If a deviation from the norm is detected, it is necessary to stop taking the drug and take appropriate measures to improve the patient's condition.


Sometimes there may be an increase in the level of ASAT, alt, y-GGTP, ALP (alkaline phosphatase) and other liver function disorders, jaundice. In case of such reactions, it is necessary to conduct an appropriate examination, if deviations from the norm are detected, stop taking the drug and take the necessary measures to improve the patient's condition.


Use during pregnancy or lactation.


Since the safety of using rebamipid during pregnancy or lactation has not been proven, the drug is contraindicated for use.


Since rebamipid passes into breast milk, breast-feeding should be discontinued during the use of the drug.


Ability to influence the reaction rate when driving vehicles or other mechanisms.


When taking rebamipid, dizziness and drowsiness may occur. In such cases, you should stop driving vehicles, working with mechanisms, as well as engaging in other activities that require increased attention and quick reaction.


Dosage and administration.


For oral administration.


Stomach ulcer


Adults-3 times a day for 100 mg (1 tablet) in the morning, afternoon and evening.


To improve the condition of acute gastritis, during the period of exacerbation of chronic gastritis, with pathological changes in the gastric mucosa (erosion, bleeding, hyperemia, edema)


Adults-3 times a day for 100 mg (1 tablet).


Elderly patients.


Caution should be exercised when prescribing the drug to elderly patients to reduce the risk of developing disorders of the digestive tract, since this category of patients is more sensitive to the action of the drug.


Children.


The drug should not be prescribed to children, since studies on the use in this age category have not been conducted.


Overdose.


Cases of overdose have not been described. Possible nausea, vomiting, abdominal pain, diarrhea or constipation, headache, increased manifestations of adverse reactions.


In case of overdose, flush the stomach and prescribe symptomatic therapy. There is no specific antidote.


Adverse reactions.


Adverse reactions were classified by organ and system and frequency of occurrence. According to the frequency of occurrence, they are divided into the following categories: very often (>1/10), often (>1/100 and 1/1000 and 1/10000 and


From the blood and lymphatic system: infrequently-leukopenia, granulocytopenia; frequency unknown-thrombocytopenia.


From the hepatobiliary system: infrequently-increased levels of liver enzymes ASAT, alt, gammaglutamyltransferase, ALP and other liver function disorders; frequency unknown – jaundice.


From the immune system: infrequently – skin rashes, pruritus, drug – type eczema, other allergic symptoms; frequency unknown-urticaria.


From the central and peripheral nervous systems: frequency unknown – numbness, dizziness, drowsiness.


From the gastrointestinal tract: infrequently-constipation, a feeling of fullness and filling in the abdomen, diarrhea, nausea, vomiting, heartburn, abdominal pain, belching of air, impaired taste sensations; frequency unknown – thirst.


From the respiratory system: frequency unknown – cough, difficulty breathing.


From the genitourinary system: infrequently – menstrual disorders in women; frequency unknown – swelling and pain in the mammary glands, development of "female breasts" in men (gynecomastia), induction of milk release.


Laboratory tests: frequency unknown-increased urea levels.


General reactions: infrequently-hypersensitivity reactions, swelling, sensation of a foreign object in the nasopharynx; frequency unknown – fever, anxiety, hot flashes (sudden redness of the face), numbness of the tongue, palpitations.


If you experience allergy symptoms, you should stop taking the drug.


In case of a significant increase in the level of transaminases or in case of simultaneous fever, rashes and other symptoms, it is necessary to stop taking the drug and take measures to improve the condition.

Tags: Rebamipide