Precautions

Important Precautions Precaution on Special Populations Precaution Concerning Dosage & Administration (N/A) Precaution Concerning Use

Important 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 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 PPls 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 PPls 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.

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 PPls 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 (PPls). 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 PPls.

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.


Precautions on Special Populations

Renal and hepatic impairment:

No dosage adjustment is necessary for patients with renal or hepatic impairment.

Children:

Safety and effectiveness of Rabeprazole sodium (PARIET®) for the short-term (up to eight weeks) treatment of GERD in adolescents 12 years of age and above is supported by

  1. a) extrapolation of results from adequate and well-controlled studies that supported the effectiveness of Rabeprazole sodium (PARIET®) for adults.
  2. b) safety and pharmacokinetic studies performed in adolescent patients. The recommended oral dose for adolescents 12 years of age and above is 20 mg once daily for up to eight weeks.

 

Rabeprazole sodium (PARIET®) is not recommended for the treatment of GERD in children <12 years of age, as there is no experience of its use in this group. The safety and effectiveness of rabeprazole sodium for other uses have not been established in pediatric patients.


Precaution Concerning Use

For indications requiring once daily treatment, Rabeprazole sodium Rabeprazole sodium (PARIET®) tablets should be taken in the morning, before eating and although neither the time of day nor food intake was shown to have any effect on rabeprazole sodium activity, this regimen will facilitate treatment compliance.

Patients should be cautioned that the Rabeprazole sodium (PARIET®) tablets should not be chewed or crushed but should be swallowed whole.