GANATON Itopride Hydrochloride 50mg Film-Coated Tablet 1's
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Features
- Itopride
Description
Indications/Uses
Dosage/Direction for Use
Overdosage
Administration
Contraindications
Patients in whom an increase in gastrointestinal motility could be harmful eg, gastrointestinal hemorrhage, mechanical obstruction or perforation.
Special Precautions
Adverse Reactions
Abnormal laboratory findings observed in the trials include decreased white blood cells (leukocytopenia) in 4 cases (0.7%), increased prolactin in 2 cases (0.3%).
Post Marketing Experience: The following adverse events have been reported in patients receiving itopride hydrchloride.
Blood and Lymphatic System Disorders: Leukopenia and thrombocytopenia.
Immune System Disorders: Anaphylactoid reaction.
Endocrine Disorders: Increased prolactin level and gynecomastia.
Nervous System Disorders: Dizziness, headache and tremor.
Gastrointestinal Disorders: Diarrhea, constipation, abdominal pain, increased saliva and nausea.
Hepatobiliary Disorders: Jaundice.
Skin and Subcutaneous Tissue Disorders: Rash, redness and itching.
Investigations: Increased aspartate aminotransferase (AST) [serum glutamic oxaloacetic transaminase (SGOT)], alanine aminotransferase (ALT) [serum glutamic pyruvic transaminase (SGPT)], γ-glutamyl transpeptidase (γ-GTP), alkaline phosphatase and bilirubin.
Drug Interactions
Storage
Action
Distribution: Approximately 96% of itopride HCl is bound to plasma proteins. Albumin accounts for most of the binding. Alpha1-acid glycoprotein accounts for <15% of binding.
In rats, itopride is distributed extensively (Vdβ=6.1 L/kg) with high concentrations in the kidneys, small intestines, liver, adrenal glands and stomach. Protein-binding in the rat was lower than that seen in humans (78% vs 96%). The transfer into the central nervous system (CNS), including brain and spinal cord, was minimal. Itopride distributes into the breast milk of rats.
Metabolism: Itopride undergoes extensive hepatic metabolism in humans. Three (3) metabolites have been identified, of which only 1 exerts minor activity without pharmacological relevance (approximately 2-3% of that of itopride). The primary metabolite in humans is the N-oxide, generated by oxidation of the tertiary amine N-dimethyl group.
Itopride is metabolized by a flavin-dependent monooxygenase (FMO3). The abundance and efficiency of the human FMO-isozymes can be subject to genetic polymorphisms, which can lead to a rare autosomal recessive condition known as trimethylaminuria (fish odor syndrome). The half-life (t½) of itopride may therefore, be longer in trimethylaminuria patients.
In vivo pharmacokinetic studies on CYP-mediated reactions revealed that itopride showed neither inhibitory nor inductory effect on CYP2C19 and CYP2E1. CYP content and uridine diphosphate glucuronosyl transferase activity were not altered with the administration of itopride.
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, in healthy subjects after oral administration of a single therapeutic dose.
The terminal phase t½ of itopride hydrochloride was approximately 6 hrs.