Treatment (in adult patients) of gastrointestinal symptoms of functional indigestion, not associated with peptic ulcer disease, such as feeling abdominal bloating, feeling of fullness in the stomach, epigastric pain, discomfort, lack of appetite, heartburn, nausea and vomiting.
Itoprid stimulates peristalsis of the gastrointestinal tract and accelerates gastric emptying through Dopamine D antagonism2 and inhibition of acetylcholinesterase activity. It stimulates the release of acetylcholine and inhibits its decomposition. It also acts anti-emetically through the D-receptors2 located in the triggering zone of the chemoreceptor. The effect of itopride is highly specific in relation to the upper gastrointestinal tract. It does not affect the concentration of gastrin in the blood. After oral administration, it is absorbed quickly and almost completely (food does not affect the absorption), reaching Cmax after 30-45 min. Bioavailability is about 60%, which is the result of first-pass metabolism in the liver. About 96% is bound to plasma proteins. It is extensively metabolised in the liver by flavin-dependent monooxygenase (FMO3). Three metabolites have been identified, of which only one shows little activity, without significant pharmacological significance. Itopride and its metabolites are mainly excreted in the urine.
Contraindications:
Hypersensitivity to itoprid or to any of the excipients. Gastrointestinal bleeding, mechanical obstruction or perforation.
Precautions:
Itoprid enhances the effects of acetylcholine and may cause side effects of cholinergic origin. If you have a mycotoxin or gynecomastia, stop or stop treatment. During the treatment, hematological parameters should be monitored; in case of any abnormalities, the treatment should be discontinued. There are no data on the long-term use of itopride. Patients with impaired liver or kidney function should be closely monitored and if adverse reactions occur, the dose should be reduced or treatment discontinued. Exercise caution in elderly patients. The safety and efficacy of itropride in children has not been established.Due to the lactose content, the drug should not be used in patients with galactose intolerance, lactase deficiency (Lapp type) or malabsorption of glucose-galactose.
Pregnancy and lactation:
During pregnancy, apply only if the benefits of treatment outweigh the potential risk. Use during breastfeeding is not recommended.
Side effects:
Not so often: leukopenia, headache, sleep disturbances, dizziness, diarrhea, constipation, abdominal pain, excessive salivation, chest pain, back pain, hyperprolactinemia, fatigue, dizziness,rażliwość. Rarely: rash, erythema, pruritus. Not known: increases in AST, ALAT, GGT and alkaline phosphatase, increase in bilirubin, thrombocytopenia, tremor, nausea, increase in urea nitrogen (BUN) and creatinine, gynaecomastia, anaphylactoid reactions, jaundice.
Dosage:
Orally. Adults: 1 tabl. 3 times a day. The dose may be reduced depending on the course of the disease. In clinical trials, the duration of treatment was up to 8 weeks. The tablets should be swallowed whole with a sufficient amount of liquid and taken before meals.
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