RABEPRAZOLE SODIUM

Warning

Rabeprazole Sodium is contraindicated in patients with known hypersensitivity to rabeprazole, substituted benzimidazoles, or any component of the formulation.

Contraindications

• History of hypersensitivity to rabeprazole
• Hypersensitivity to substituted benzimidazoles

Adverse Reactions

• Pain
• Pharyngitis
• Flatulence
• Infection
• Constipation
• Headache
• Diarrhea
• Nausea
• Vomiting
• Abdominal pain

General Guidance

No dosage adjustment is necessary in elderly patients, in patients with renal disease, or in patients with mild to moderate hepatic impairment. However, caution should be exercised in patients with severe hepatic impairment.

Pregnancy

• Category B: no adequate and well-controlled studies in pregnant women
• Use during pregnancy only if clearly needed

Nursing Mothers

• It is not known if Rabeprazole Sodium is excreted in human milk
• Caution should be exercised when Rabeprazole Sodium is administered to a nursing woman

Pediatric Use

• Rabeprazole Sodium is indicated for the treatment of symptomatic GERD in adolescents 12 years and older
• The safety and effectiveness of Rabeprazole Sodium have not been established in pediatric patients less than 12 years of age

Geriatric Use

• No overall differences in safety or effectiveness were observed between geriatric patients and younger patients
• Greater sensitivity of some older individuals cannot be ruled out