Symptomatic response to therapy with rabeprazole sodium 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 more than 1 year) should be kept under regular surveillance.
Patients should be cautioned that PARIET tablets should not be chewed or crushed, but should be swallowed whole.
PARIET is not recommended for use in children <12 years of age, as there is no experience of its use in this group.
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.
Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, in most cases after a year of therapy. Serious adverse events include tetany, arrhythmias, and seizures. In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of the PPI.
For patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), health care professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically.
Observational studies suggest that proton pump inhibitor (PPI) therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. The risk of fracture was increased in patients who received high-dose, and long-term PPI therapy (a year or longer).
Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. In high-dose methotrexate administration, a temporary withdrawal of the PPI may be considered in some patients.
Treatment with proton pump inhibitors may possibly increase the risk of gastrointestinal infections such as Clostridium difficile.
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.