Pariet Special Precautions

Symptomatic response to therapy with sodium rabeprazole does not preclude the presence of gastric or esophageal malignancy, therefore, the possibility of malignancy should be excluded prior to commencing treatment with Pariet.
Patients on long-term treatment (particularly those treated for >1 year) should be kept under regular surveillance. Patients should be carefully observed during administration and the cumulative dose should be kept to a minimum in accordance with the disease condition.
No evidence of significant drug-related safety problems was seen in a study of patients with mild to moderate hepatic impairment versus normal age and sex matched controls. However, because there are no clinical data on the use of Pariet in the treatment of patients with severe hepatic dysfunction, the prescriber is advised to exercise caution when treatment with Pariet is first initiated in such patients.
Increases in thyroid weight and blood thyroxine levels have been reported in animal experiments (rats ≥25 mg/kg/day orally), therefore thyroid function should be carefully monitored during administration of Pariet.
Carcinogenicity: It has been reported that in a carcinogenicity study in which ≥5 mg/kg/day of sodium rabeprazole was given to rats by oral administration for 2 years, carcinoids in the stomach were observed in female rats.
Effects on the Ability to Drive or Operate Machinery: Based on the pharmacodynamic properties and the adverse events profile, it is unlikely that Pariet would cause an impairment of driving performance or compromise the ability to use machinery. If however, alertness is impaired due to somnolence, it is recommended that driving and operating complex machinery be avoided.
Use in children: Pariet is not recommended for use in children, as there is no experience of its use in this group.
Use in the elderly: Pariet is metabolized mainly in the liver. Since the elderly often have a physiologic hepatic hypofunction, they are liable to experience adverse drug reactions. Therefore, it is advisable to take such measures as having a drug-free interval under careful supervision if adverse reactions eg, gastrointestinal symptoms (see Adverse Reactions) occur.