Pariet Special Precautions

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 Rabeprazole sodium (PARIET).
Patients on long-term treatment (particularly those treated for more than a year) should be kept under regular surveillance.
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 Rabeprazole sodium (PARIET) in the treatment of patients with severe hepatic dysfunction the prescriber is advised to exercise caution when treatment with Rabeprazole sodium (PARIET) is first initiated in such patients. The exposure to rabeprazole sodium (AUC) in patients with significant hepatic dysfunction is approximately two-fold that of healthy 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. See Adverse Reactions.
Fractures: 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).
Concomitant use of Rabeprazole with Methotrexate: 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.
Clostridium difficile: Treatment with proton pump inhibitors may possibly increase the risk of gastrointestinal infections such as Clostridium difficile.
Subacute cutaneous lupus erythematosus: Subacute cutaneous lupus erythematosus (SCLE) has been reported with the use of Proton Pump Inhibitors (PPIs). If lesions occur, especially in sun-exposed areas of the skin, and if accompanied by arthralgia, the patient should seek medical help promptly and the health care professional should consider stopping rabeprazole. The occurrence of SCLE with previous PPI treatment may increase the risk of SCLE with other PPIs.
Fundic Gland Polyps: Long term PPI use, including rabeprazole, appears to be associated with an increased risk of fundic gland polyps. Most fundic gland polyps are asymptomatic. Patients with large or ulcerated polyps may be at risk of gastrointestinal bleeding or small intestinal blockage. Use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.
Effects on ability to Drive and use Machines: Based on pharmacodynamic properties and the adverse events profile, it is unlikely that Rabeprazole sodium (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.