Composition, form of production and packaging
Tablets, film-coated 1 tab.
rebamipide 100 mg
10 pieces. - blisters (3) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2013.
PHARMACHOLOGIC EFFECT
Rebambid increases the content of prostaglandin E2 (PGE2) in the gastric mucosa and increases the content of PGE2 and GI2 in the contents of gastric juice. Has a cytoprotective effect against the gastric mucosa with the damaging effects of ethanol, acids and alkalis, acetylsalicylic acid. Promotes the activation of enzymes that accelerate the biosynthesis of high-molecular glycoproteins, and increases the mucus content on the surface of the stomach wall. It promotes blood circulation to the gastric mucosa, activates its barrier function, activates the gastric acid secretion, strengthens the proliferation and metabolism of gastric epithelial cells, cleans mucosa from hydroxyl radicals and suppresses superoxides produced by polymorphonuclear leukocytes and neutrophils in the presence of Helicobacter pylori, protects the gastric mucosa from infection by bacteria, has a gastroprotective effect when exposed to mucous non-steroidal anti-inflammatory drugs (NSAIDs).
PHARMACOKINETICS
Absorption when ingested - high. After taking a dose of 100 mg C max is achieved after approximately 2 hours and is 340 ng / ml. T 1/2 is approximately 1.0 h. Repeated drug administration does not lead to its cumulation in the body. Approximately 10% of the drug is excreted by the kidneys, mostly unchanged. When administered at a dose of 600 mg, it is possible to isolate traces of a hydroxylated metabolite.
In vitro experiments it was shown that from 98.4% to 98.6% of the drug is bound by plasma proteins.
INDICATIONS
- stomach ulcer;
- chronic gastritis with increased acid-forming function of the stomach in the stage of exacerbation, erosive gastritis;
- prevention of damage to the mucous membrane against the background of non-steroidal anti-inflammatory drugs;
- as part of combination therapy.
DOSING MODE
Inside, 1 tablet 3 times a day, squeezed a small amount of liquid. The course of treatment is 2-4 weeks, if necessary, can be extended to 8 weeks. The drug does not have the features of the action at the first reception or upon its cancellation. If you miss a dose, you need to take the next dose of the drug at the set time, do not take twice the dose of the drug.
SIDE EFFECT
From the gastrointestinal tract: constipation, flatulence, diarrhea, nausea, vomiting, pain in the abdomen, a violation of taste sensations, heartburn.
From the liver: signs of liver dysfunction, increased serum glutamine alanine aminotransferase (ALT) and serum glutamine aspartate aminotransferase (ACT).
On the part of the hematopoiesis system: leukopenia, granulocytopenia.
Allergic reactions: itching, skin rash, eczematous rashes.
Other: violation of the menstrual cycle.
CONTRAINDICATIONS
- individual intolerance to ribabipid or other components of the drug;
- pregnancy, lactation period;
- children under the age of 18 years.
With caution: with the first appointment of rebamipid to patients with the elderly due to the possibility of hypersensitivity to the drug.
PREGNANCY AND LACTATION
The safety of the use of rebamipide during pregnancy is not proven. Do not use during pregnancy. As rebamipide penetrates into breast milk, breastfeeding should be discontinued or the issue of infant feeding should be resolved if it is necessary to prescribe a rebamipide mother during breastfeeding.
APPLICATION FOR CHILDREN
Contraindicated for children under 18 years.
APPLICATION IN ELDERLY PATIENTS
At the first appointment of rebamipid patients from the elderly in connection with the possibility of the emergence of hypersensitivity to the drug.
SPECIAL INSTRUCTIONS
Impact on the ability to drive vehicles and manage mechanisms
The effect of the drug on the rate of psychomotor reactions and / or the ability to control vehicles or mechanisms has not been studied. In case of taking the drug should be cautious about driving the car and other activities that require increased concentration of attention.
OVERDOSE
Symptoms of an overdose with rebamipide are not described, until today information about cases of deliberate overdose has not been reported. There may be nausea, vomiting, abdominal pain, diarrhea or constipation, headache.
Measures to assist: a specific antidote is unknown. In case of an overdose, you should wash your stomach and perform symptomatic therapy.
DRUG INTERACTION
With the use of rebamipide in the traditional therapy regimens of patients with Helicobacter pylori infection, the effectiveness of eradication therapy is significantly increased.
Reactions with other drugs have not been studied.
TERMS OF RELEASE FROM PHARMACY
On prescription.
TERMS AND CONDITIONS OF STORAGE
In a dry, the dark place at a temperature of no higher than 25 В° C. Keep out of the reach of children. Shelf life - 2 years.
