TOPRIDE HYDROCHLORIDE

Indications & Dose:

Functional Dyspepsia, Non-Ulcer Dyspepsia (chronic gastritis) i.e Sensation of bloating, Upper abdominal pain or discomfort, Anorexia, Heartburn, Nausea and Vomiting

GERIATRIC USE: In general, appropriate caution should be exercised in the administration and monitoring of  drug (Itopride hydrochloride) in elderly patients reflecting the greater frequency of decreased hepatic, renal function, and of concomitant disease or other drug therapy.

BY MOUTH

Adults:150 mg daily [one tablet (50 gm) taken orally three times a day before meals]. The dose may be reduced according to the patient’s age and symptoms  

Children: Safely of this product in children under the age of 16 has not been established.

Contraindications:

Patients with known hypersensitivity to Itopride hydrochloride or any of the excipients. Patients in whom an increase in gastrointestinal motility could be harmful, e.g. gastrointestinal hemorrhage, mechanical obstruction or perforation.

Side Effects:

Blood and lymphatic system disorders; Leukopenia and thrombocytopenia. 

Immune system disorders: Anaphylactoid reaction.

Endocrine disorders: Increased prolactin level and gynecomastia.

GIT: 

Diarrhea, constipation, abdominal pain, increased saliva, and nausea.

Hepatobiliary disorders: 

Jaundice, Increased AST (SGOT), increased ALT (SGPT), Increased gamma-GTP, increased alkaline phosphatase, and increased bilirubin.

Skin and subcutaneous tissue disorders: Rash, redness, and itching.

Investigation

Cautions:

Precautions:

General: Itopride hydrochloride) enhances the action of acetylcholine and may produce cholinergic side effects.

PREGNANCY & LACTATION: 

Should not be used during pregnancy unless the benefits outweigh the potential risks. Known effects on labor or delivery. Excreted in milk, and because of the potential for adverse reaction in nursing infants.

Interaction:

Metabolic interaction are not expected since Itopride hydrochloride 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 Ganaton 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 formulation. Antiulcer drugs like cimetidine, ranitidine, teprenone  and cetraxate do not affect the prokinetic action of itopride Anticholinergic drugs may reduce the action.

Warnings:

Adverse Effects:

Lactations:

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

Patient And Carer Advice: