NIKP-Rabeprazole Special Precautions





Full Prescribing Info
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 NIKP-Rabeprazole enteric coated tablet. Patients on long-term treatment (particularly those treated for more than a year) should be kept under regular surveillance.
Patients should be cautioned that NIKP-Rabeprazole enteric coated tablet should not be chewed or crushed, but should be swallowed whole.
NIKP-Rabeprazole enteric coated tablet in the treatment of patients with hepatic dysfunction: The prescriber is advised to exercise caution when treatment with NIKP-Rabeprazole enteric coated tablet is first initiated in such patients.
Subacute cutaneous lupus erythematosus (SCLE): Proton pump inhibitors are associated with very infrequent cases of SCLE. 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 NIKP-Rabeprazole enteric coated tablet. SCLE after previous treatment with a proton pump inhibitor may increase the risk of SCLE with other proton pump inhibitors.
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.
Decreased gastric acidity due to any means, including proton pump inhibitors such as rabeprazole, increases gastric counts of bacteria normally present in the gastrointestinal tract. Treatment with proton pump inhibitors may lead to slightly increased risk of gastrointestinal infections such as Salmonella and Campylobacter and possibly Clostridium difficile.
Long-term (a year or longer) and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine.
Patients should 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 the pharmacodynamics properties and the adverse events profile, it is unlikely that NIKP-Rabeprazole enteric coated tablet 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: NIKP-Rabeprazole enteric coated tablet is not recommended for use in children, as there is no experience of its use in this group.
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