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White, round, biconvex, film coated tablet with engraved 50 on one side and plain on the other.
Each film coated tablet contains Itopride hydrochloride 50 mg.
Pharmacology: Pharmacodynamics: Itopride is acetylcholinesterase inhibitor and dopamine D2 receptor antagonism. The effect of itopride is an increase in acetylcholine concentration, which increases the lower oesophageal sphincter (LOS) pressure, promotes gastric motility, accelerates gastric emptying, and improves gastroduodenal coordination.
Pharmacokinetics: Absorption: Itopride hydrochloride is rapidly and almost completely absorbed from the gastrointestinal tract. Relative bioavailability is calculated to be 60%. There is no effect of food on bioavailability.
The peak plasma concentration is achieved within 35 minutes of oral administration.
Distribution: Approximately 96% of itopride hydrochloride is bound to plasma proteins. Albumin accounts for most of the binding. itopride has extensive tissue distribution, except in the tissues of CNS. As itopride is highly polar molecule, it does not cross the blood brain barrier readily.
Metabolism: Itopride undergoes extensive hepatic metabolism in humans. It is metabolized in the liver by N-oxidation to inactive metabolites by a flavin-dependent monooxygenase (FMO3).
Biotransformation of itopride does not involve the cytochrome P450 enzyme.
Excretion: Itopride hydrochloride and its metabolites are primarily excreted in the urine. The urinary excretions of itopride and its N-oxide were 3.7% and 75.4%, respectively.
The plasma half-life of itopride is about 6 hours.
Itride 50 is indicated for the treatment of gastrointestinal symptoms caused by gastric dysmotility and delayed gastric emptying, like sensation of bloating, early satiety, postprandial fullness, upper abdominal pain or discomfort, anorexia, heartburn, nausea and vomiting in patients with functional (non-ulcer) dyspepsia or chronic gastritis.
The recommended dose of itopride hydrochloride for adult patients is 150 mg daily (one tablet (50 mg) taken orally three times a day before meals).
The dose may be reduced according to the patient's age and symptoms.
Duration of Treatment in clinical studies: itopride hydrochloride has been administered up to 8 weeks.
Overdose and Treatment: In case of excessive overdose the usual measures of gastric lavage and symptomatic therapy should be applied.
Itopride hydrochloride is contraindicated in patients with known hypersensitivity to itopride hydrochloride or any of the excipients as follows: lactose, silicified microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, hypromellose, talc, titanium dioxide, triethyl citrate.
Itopride hydrochloride should not be used in patients in whom an increase in gastrointestinal motility could be harmful, e.g. gastrointestinal hemorrhage, mechanical obstruction or perforation.
Itopride hydrochloride enhances the action of acetylcholine and may produce cholinergic side effects.
Data on long-term use are not available.
Pregnancy: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of itopride in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. As a precautionary measure, it is preferable to avoid the use of itopride during pregnancy.
Lactation: Itopride is excreted in breast milk of animals, but there is insufficient information on the excretion of itopride in human milk. A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from itopride therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
The following undesirable effects have been experienced with the following indicated frequencies in 998 itopride-treated patients in clinical trials with a standard daily itopride dose of 150 mg or lower. (See table.)
Click on icon to see table/diagram/image
Post-marketing Experience: The following adverse events have been reported spontaneously during post marketing use. A precise frequency cannot be estimated from the available data.
Blood and lymphatic system disorders: Leukopenia and thrombocytopenia.
Immune system disorders: Hypersensitivity, including anaphylactoid reaction.
Endocrine disorders: Blood prolactin increased.
Nervous system disorders: Dizziness, headache, and tremor.
Gastrointestinal disorders: Diarrhea, constipation, abdominal pain, salivary hypersecretion, and nausea.
Hepato-biliary disorders: Jaundice.
Skin and subcutaneous tissue disorders: Rash, erythema and pruritus.
Reproductive system and breast disorders: Gynecomastia.
Investigations: Aspartate aminotransferase increased, alanine aminotransferase increased, gamma-glutamyltransferase increased, blood alkaline phosphatase increased, and blood bilirubin increased.
Itopride is metabolized by the flavine monooxygenase not by the CYP450, therefore the drug is unlikely to interact with other drugs metabolized by CYP450.
No changes in protein binding have been seen with coadministration of warfarin, diazepam, diclofenac sodium, ticlopidine hydrochloride, nifedipine, and nicardipine hydrochloride.
Since itopride has gastrokinetic effects it could influence the absorption of concomitantly orally administered drugs. Particular caution should be taken with drugs with a narrow therapeutic index, sustained release or enteric-coated formulations.
Anti-ulcer drugs like cimetidine, ranitidine, teprenone and cetraxate do not affect the prokinetic action of itopride.
Anticholinergic drugs may reduce the action of itopride.
A03FA07 - itopride ; Belongs to the class of propulsives. Used in the treatment of functional gastrointestinal disorders.
Itride 50 FC tab 50 mg
1 × 10's;6 × 10's
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