Land: India
Taal: Engels
Bron: Central Drugs Standard Control Organization
ITOPRIDE
Abbott
150MG
OD CAP
10
PRODUCT NAME Itopride Hydrochloride in sustained release form BRAND NAME Ganaton OD DESCRIPTION Itopride hydrochloride is an orally active gastroprokinetic agent. Ganaton OD is a film-coated slow release tablet containing itopride hydrochloride 150 mg. INDICATIONS Ganaton OD is indicated for the treatment of gastrointestinal symptoms caused by reduced gastrointestinal motility, like feeling of fullness, upper abdominal pain, anorexia, heartburn, nausea and vomiting; non-ulcer dyspepsia or chronic gastritis. DOSAGE AND ADMINISTRATION ADULTS The usual dose of itopride hydrochloride for adult patients is 150 mg daily before meals. The dose may be reduced according to the patient’s age and symptoms (see PRECAUTIONS). DURATION OF TREATMENT In clinical studies, itopride hydrochloride has been administered up to 8 weeks. CONTRAINDICATIONS Itopride hydrochloride is contraindicated in patients with known hypersensitivity to itopride hydrochloride or any of the excipients. 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. WARNINGS AND PRECAUTIONS GENERAL Itopride hydrochloride enhances the action of acetylcholine and may produce cholinergic side effects. Data on long-term use are not available. PEDIATRIC USE Safety of itopride in children under the age of 16 has not been established. GERIATRIC USE In general, appropriate caution should be exercised in the administration and monitoring of itopride hydrochloride in elderly patients reflecting the greater frequency of decreased hepatic, renal function, and of concomitant disease or other drug therapy. DRUG INTERACTIONS Metabolic interactions are not expected since itopride is primarily metabolized by flavine monooxygenase and not 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 h Lees het volledige document