RABEPRAZOLE SODIUM

Manufacturer: Advagen Pharma Limited

Score: 141.0

Quick Summary

Rabeprazole Sodium is a proton pump inhibitor used for the treatment of various conditions such as gastroesophageal reflux disease (GERD), duodenal ulcers, and pathological hypersecretory conditions. It works by reducing the amount of acid produced in the stomach. The medication is available in delayed-release tablets and should be swallowed whole, without chewing, crushing, or splitting. The recommended dosage varies depending on the condition being treated, and patients should follow the prescribed dosage regimen. Rabeprazole Sodium has been shown to be effective in healing and preventing the recurrence of duodenal ulcers, as well as in treating GERD and other conditions. However, it is essential to be aware of the potential risks and contraindications, including hypersensitivity reactions and interactions with other medications.

Key Clinical Findings and Indications

Healing of erosive or ulcerative gastroesophageal reflux disease (GERD)
Maintenance of healing of erosive or ulcerative GERD
Treatment of symptomatic GERD
Healing of duodenal ulcers
Helicobacter pylori eradication to reduce the risk of duodenal ulcer recurrence
Treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome

Important Safety Information

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

Dosing Recommendations

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.

Healing of erosive or ulcerative GERD

Adult Dose

20 mg once daily for 4-8 weeks

Pediatric Dose

20 mg once daily for up to 8 weeks (adolescents 12 years and older)

Maintenance of healing of erosive or ulcerative GERD

Adult Dose

20 mg once daily

Pediatric Dose

Not recommended for pediatric patients

Treatment of symptomatic GERD

Adult Dose

20 mg once daily for 4 weeks

Pediatric Dose

20 mg once daily for up to 8 weeks (adolescents 12 years and older)

Healing of duodenal ulcers

Adult Dose

20 mg once daily after morning meal for up to 4 weeks

Pediatric Dose

Not recommended for pediatric patients

Helicobacter pylori eradication

Adult Dose

20 mg twice daily for 7 days, in combination with amoxicillin and clarithromycin

Pediatric Dose

Not recommended for pediatric patients

Special Population Considerations

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

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