Administration

The usual adult dose for oral use is 50 mg of Itopride Hydrochloride administered orally three times daily. The dose may be reduced according to the patient’s age and symptoms. Itopride Hydrochloride should be taken before meals.

Interaction

Itopride Hydrochloride should be administered with care when co-administered with the following drugs: Anticholinergic Drugs, Tiquizium bromide, Scopolamine butyl bromide, Timepidium bromide, etc. Sign: There is a possibility of reducing the activity of Itopride Hydrochloride which activates gastrointestinal motility (cholinergic action). Mechanism & risc factor: Gastrointestinal motility inhibitory action of Anticholinergic pharmacologically decreases the activity of the drug.

Contraindications

Hypersensitivity to the active substance or to any of the excipients onthis preparation. This should not be used in patients in whom increased gastrointestinal motility could be harmful, e.g. in patients with gastrointestinal haemorrhage, mechanical obstruction or perforation.

Precautions & Warnings

Important Precautions: This drug should be used with caution since it enhances the action of acetylcholine. This drug should not be consumed continuously for an extended period when no improvement of gastrointestinal symptoms is observed. Precautions concerning Use: When granting agent: For drugs packaged in a press-through package (PTP), instruct the patient to remove the drug from the package prior to ingestion. (It has been reported that, by accidental ingestion of the PTP sheet, the hard and sharp corners may puncture the esophageal mucosa, or even lead to perforation resulting in serious complications such as mediastinal sinusitis.)

Overdose Effects

In case of excessive overdose, the usual measures of gastric lavage and symptomatic therapy should be applied.

Storage Conditions

Store below 30°C, in a cool and dry place. Keep away from light. Keep all the medicine out of the reach of children.

Safety Advice

CAUTION – Alcohol: Caution is advised when consuming alcohol with Itopride Hydrochloride. Please consult your doctor.
CONSULT YOUR DOCTOR – Pregnancy: Safety of itopride in pregnancy was not verified. Therefore itopride can be used in pregnant women or women in that pregnancy cannot be excluded only if therapeutic benefits outweigh possible risks considerably.
UNSAFE – Breastfeeding: Data about excretion in mother milk is known only in animals. Because of lack of experience with use of itopride during breast-feeding itopride it is not recommended for breast-feeding women.
CONSULT YOUR DOCTOR – Driving: It is not known whether Itopride Hydrochloride alters the ability to drive. Do not drive if you experience any symptoms that affect your ability to concentrate and react.
SAFE IF PRESCRIBED – Kidney: Itopride Hydrochloride is safe to use in patients with kidney disease. Dose adjustment of Itopride Hydrochloride is recommended.
CAUTION – Liver: Itopride Hydrochloride should be used with caution in patients with severe liver disease. Dose adjustment of Itopride Hydrochloride may be needed. If abnormalities occur, the drug should be discontinued and appropriate therapeutic measures implemented.