Rabeprazole Sandoz

Rabeprazole Sandoz

rabeprazole

Manufacturer:

Sandoz

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Rabeprazole Na
Indications/Uses
Active duodenal & benign gastric ulcer, & anastomotic ulcer. Erosive or ulcerative GERD; long-term management of GERD (maintenance). Symptomatic treatment of moderate to very severe GERD. Zollinger-Ellison syndrome. In combination w/ antibacterial therapeutic regimens for H. pylori eradication in patients w/ PUD. Prevention of gastric & duodenal ulcer recurrence associated w/ low-dose aspirin therapy.
Dosage/Direction for Use
Elderly & adult Active duodenal & benign gastric ulcer, & anastomotic ulcer 10 or 20 mg once daily in the morning. Erosive or ulcerative GERD 10 or 20 mg once daily for 4-8 wk. Long-term management of GERD Maintenance dose: 10 or 20 mg once daily. Symptomatic treatment of moderate to very severe GERD Patient w/o oesophagitis 10 mg once daily. Zollinger-Ellison syndrome Individualized dose. Initially 60 mg once daily. May use doses up to 100 mg daily or 60 mg bid. H. pylori eradication 20 mg bid + clarithromycin 500 mg bid & amoxicillin 1 g bid for 7 days. Adolescent ≥12 yr 20 mg once daily up to 8 wk.
Administration
May be taken with or without food: Swallow whole, do not chew/crush.
Contraindications
Special Precautions
Stop treatment for at least 5 days before chromogranin A measurements. Blood dyscrasias (thrombocytopaenia & neutropaenia). Hepatic enzyme abnormalities. Severe hypomagnesaemia. Sub-acute cutaneous lupus erythematosus. Patients on long-term treatment particularly those treated for >1 yr; at risk of osteoporosis; w/ reduced body stores or risk factors for reduced vit B12 absorption on long-term therapy. Increased risk of GI infections eg, Salmonella, Campylobacter & Clostridium difficile. May reduce vit B12 absorption. Exclude gastric or esophageal malignancy prior to commencing treatment. Consider measuring Mg levels prior to & periodically during treatment in patients expected to be on prolonged treatment or taking digoxin or medicinal products causing hypomagnesaemia (eg, diuretics); temporary w/drawal in high-dose MTX administration; stopping treatment if lesions occur, especially in sun-exposed areas of skin, & if accompanied by arthralgia. Risk of cross-hypersensitivity reactions w/ other PPIs or substituted benzimidazoles. Not recommended to be co-administered w/ atazanavir. May impair ability to drive or operate machinery. Severe hepatic dysfunction. Not recommended in childn.
Adverse Reactions
Infection; insomnia; headache, dizziness; cough, pharyngitis, rhinitis; diarrhoea, vomiting, nausea, abdominal pain, constipation, flatulence, benign fundic gland polyps; non-specific & back pain; asthenia, flu-like illness. Erythema multiforme, TEN, SJS.
Drug Interactions
Decreased antifungal plasma levels w/ ketoconazole or itraconazole. Concomitant use w/ atazanavir. Elevated & prolonged serum levels of MTX &/or its metabolite hydroxymethotrexate.
MIMS Class
Antacids, Antireflux Agents & Antiulcerants
ATC Classification
A02BC04 - rabeprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
Presentation/Packing
Form
Rabeprazole Sandoz gastro-resistant tab 10 mg
Packing/Price
2 × 7's
Form
Rabeprazole Sandoz gastro-resistant tab 20 mg
Packing/Price
2 × 7's
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