Precautions

Important Precautions

• MOSAPRIDE CITRATE (GASMOTIN®) should not be used for more than 2 weeks in patients if no clinically therapeutic outcome is observed. When this drug is used for the treatment of gastrointestinal symptoms associated with chronic gastritis, after administration for a certain period of time (usually 2 weeks), the gastrointestinal symptoms should be assessed for improvement and the necessity of continuing administration should be evaluated.
• This drug should not be administered for a long period of time, without adequate evaluation, because fulminant hepatitis, severe hepatic function disorder, and jaundice may occur. During administration of this drug, the patients should be carefully monitored and if any abnormality is observed, this drug should be discontinued immediately and appropriate measures taken. Furthermore, the patients should be instructed to discontinue the drug and contact a physician or other healthcare professional should they observe any symptoms such as malaise, anorexia, thick urine, and conjunctive bulbi coloring yellow after administration of this drug.
• When this drug is used for the adjunctive treatment to the pre-treatment with oral gastrointestinal lavage solution for barium enema X-ray examination, be sure to confirm precautions such as “Warnings,” “Contraindications,” “Careful Administration,” “Important Precautions,” and “Clinically Significant Adverse Reactions” indicated in the package insert of the oral gastrointestinal lavage solution.

Precautions on Special Populations

USE IN THE ELDERLY

Since in the elderly patients their physiological function in the kidneys and the liver are reduced in general, this drug should be administered with care by monitoring patients’ condition. If any adverse reactions are found, appropriate measures such as reducing the dose (e.g. to 7.5 mg daily) should be given.

PEDIATRIC USE

Safety of this drug in children has not been established [no clinical experience].

Precaution Concerning Dosage & Administration

When 100 to 330 times the recommended clinical dose (30 to 100 mg/kg/day) of mosapride citrate was orally administered in rodents for a long period (104 weeks in rats, 92 weeks in mice), increased incidence of hepatocellular adenoma and thyroid follicular cell adenoma were observed.

Precaution Concerning Use

When dispensing the drug: For drugs that are dispensed in a press-through package (PTP), instruct the patient to remove the drug from the package prior to use. [It has been reported that, if the PTP sheet is swallowed, the sharp corners of the sheet may puncture the esophageal mucosa, resulting in severe complications such as mediastinitis.]