Rebagit, 100 mg 90 pcs.

Pharmacotherapeutic group

Gastroprotective agent

ATCode

A02BX

Pharmacodynamics:

Rebampide increases prostaglandin E2 (PGE2) in gastric mucosa and increases PGE2 and GI2 in the contents of gastric juice.

It has a cytoprotective effect on the gastric mucosa in the damaging effects of ethanol acids and acetylsalicylic acid alkalis.

Promotes activation of enzymes accelerating the biosynthesis of high molecular weight glycoproteins and increases the content of mucus on the surface of the gastric wall.

. Helps improve the blood supply to the gastric mucosa Activates its barrier function Activates alkaline gastric secretion Enhances the proliferation and metabolism of gastric epithelial cells Cleanses the mucosa of hydroxyl radicals and suppresses superoxides produced by polymorphonuclear leukocytes and neutrophils in the presence of Helicobacter pylori protects the gastric mucosa from the damage by bacteria has a gastroprotective effect when the mucosa is exposed to nonsteroidal anti-inflammatory drugs (NSAIDs).

Pharmacokinetics:

Absorption when taken orally is high. After administration at a dose of 100 mg, the peak plasma concentration (Cmaõ) is reached after approximately 2 h and is 340 ng/ml. The elimination half-life (T1/2) is approximately 10 hours. Repeated administration of the drug does not lead to its cumulation in the body. Approximately 10% of the drug is excreted by the kidneys mainly unchanged. When taken in a dose of 600 mg, traces of the hydroxylated metabolite can be excreted.

In in vitro experiments it was shown that from 984% to 986% of the drug is bound to plasma proteins.

Indications

stomach ulcer;
chronic gastritis with increased acid-forming function of the stomach in the acute phase, erosive gastritis;
preventing the occurrence of damage to the mucous membrane while taking NSAIDs.

Can be used as part of combination therapy.

Pharmacological effect

Pharmacotherapeutic group

Gastroprotective agent

ATX code

A02BX

Pharmacodynamics:

Rebamipide increases the content of prostaglandin E2 (PGE2) in the gastric mucosa and increases the content of PGE2 and GI2 in the gastric juice.

It has a cytoprotective effect against the gastric mucosa under the damaging effects of ethanol, acids and alkalis, acetylsalicylic acid.

Promotes the activation of enzymes that accelerate the biosynthesis of high molecular weight glycoproteins and increases the mucus content on the surface of the stomach wall.

Helps improve blood supply to the gastric mucosa, activates its barrier function, activates alkaline secretion of the stomach, enhances the proliferation and metabolism of gastric epithelial cells, cleanses the mucosa from hydroxyl radicals and suppresses superoxides produced by polymorphonuclear leukocytes and neutrophils in the presence of Helicobacter pylori, protects the gastric mucosa from bacterial damage, has a gastroprotective effect when exposed to non-steroidal anti-inflammatory drugs on the mucosa (NSAIDs).

Pharmacokinetics:

Absorption when taken orally is high. After taking a dose of 100 mg, the peak plasma concentration (Cmax) is reached after approximately 2 hours and is 340 ng/ml. The half-life (T1/2) is approximately 10 hours. Repeated doses of the drug do not lead to its accumulation in the body. Approximately 10% of the drug is excreted by the kidneys, predominantly unchanged. When taken at a dose of 600 mg, traces of the hydroxylated metabolite can be isolated.

In vitro experiments have shown that from 984% to 986% of the drug is bound by plasma proteins.

Special instructions

Impact on the ability to drive vehicles and machinery

The effect of the drug on the speed of psychomotor reactions and/or the ability to drive vehicles or operate machinery has not been studied. If you are taking the drug, you should be careful when driving a car and other activities that require increased concentration.

Active ingredient

Rebamipide

Composition

1 tab. contains:

Active substances:

rebamipide – 100 mg;

Excipients:

mannitol – 35.7 mg,

croscarmellose sodium – 14 mg,

pregelatinized starch – 80.7 mg,

sodium lauryl sulfate – 2 mg,

citric acid – 2.3 mg,

purified talc – 3.1 mg,

magnesium stearate – 2.2 mg.

Film shell composition:

hypromellose – 2.77 mg,

purified talc – 0.57 mg,

titanium dioxide – 1.11 mg,

propylene glycol – 0.55 mg.

Contraindications

individual intolerance to ribamipide or other components of the drug;
pregnancy;
lactation period;
age up to 18 years.

Side Effects

From the gastrointestinal tract: constipation flatulence diarrhea nausea vomiting pain in the abdomen disturbance of taste heartburn.

From the liver: signs of liver dysfunction, increased serum glutamine alanine aminotransferase (ALT) and serum glutamine aspartate aminotransferase (AST).

From the hematopoietic system: leukopenia, granulocytopenia.

Allergic reactions: itching, skin rash, eczematous rash.

Other: menstrual irregularities.

Interaction

When rebamipide is used as part of traditional treatment regimens for patients with Helicobacter pylori infection, the effectiveness of eradication therapy significantly increases.

Interaction reactions with other drugs have not been studied.

Overdose

Symptoms of overdose with rebamipide have not been described, and to date there have been no reports of cases of intentional overdose. Nausea, vomiting, abdominal pain, diarrhea or constipation, and headache are possible.

Treatment: specific antidote is unknown. In case of overdose, the stomach should be rinsed and symptomatic therapy should be carried out.

Functional features

Suction and distribution

After taking a dose of 100 mg, Cmax is reached after approximately 2 hours and is 340 ng/ml. Repeated doses of the drug do not lead to its accumulation in the body.

In vitro experiments have shown that from 98.4% to 98.6% of the drug is bound by plasma proteins.

Metabolism and excretion

T1/2 is approximately 1.0 hours. Approximately 10% of the drug is excreted by the kidneys, mainly unchanged. When taken at a dose of 600 mg, traces of the hydroxylated metabolite can be isolated.

Storage conditions

The drug should be stored out of the reach of children, in a dry place, protected from light, at a temperature not exceeding 25°C.

Shelf life

2 years.

Manufacturer

PRO.MED.CS Prague, Czech Republic