Beprazole – 20 tablets (rabeprazole)
BEPRAZOLE-20 NAFDAC NO: A4 – 5500
(RABEPRAZOLE TABLETS 20MG)
Each enteric coated TABLET contains:
Equivalent to Rabeprazole………….20mg
THERAPEUTIC CATEGORY: Proton Pump Inhibitor, Gastric acid secretion inhibitor.
INDICATIONS: Beraprazole tablets are indicated for the treatment of active duodenal ulcer. Active benign gastric ulcer. Symptomatic erosive or ulcerative gastro-esophageal reflux disease (GERD).H.Pylori- positive duodenal ulcers, as part of the eradication programme with appropriate antibiotics, maintenance treatment of healed erosive or ulcerative GERD.
DOSAGE AND ADMINISTRATION: Route: Oral
Adults / elderly: Active duodenal ulcer and active benign gastric ulcer: 20mg to be taken once daily in the morning. Some patients with active duodenal ulcer may respond to one 10 mg tablets to be taken once daily in the morning.
Erosive or ulcerative gastro-esophageal reflux disease (GERD): 20mg to be taken once daily for four to eight weeks.
Gastro-esophageal reflux diseases long-term management (GERD Maintenance): For long term management up to 12month,a maintenance dose of rabepazole 10 mg or 20 mg once daily can be used.
Eradication of H.pylori:it is indicated for H.pylori-positive duodenal ulcers, as a part of the eradication programme with appropriate antibiotics. No dosage adjustment is necessary for patients with renal or hepatic impairment.
CONTRAINDICATIONS: Rabeprazole tablets are contraindicated in patients with known hypersensitivity to rabeprazole, substituted benzimidazoles or to any component of the formulation.
SIDE EFFECTS: This medication is generally well tolerated. The most common side effect are diarrhea,nausea,vomiting,constipation,rash and headaches,dizziness,nervousness,abnormal heartbeat,muscle pain, weakness,leg cramps and water retention rarely occur although uncommon, headache may occur.
DRUGS INTERACTIONS: Co-administration of rabeprazole sodium with ketoconazole or itraconazole may result in a significant decrease in antifungal plasma level. This may lead to reduced effectiveness of ketoconazole.
PPIs, including rabeprazole, should not be co-administered with atazanavir.
Co- administration of rabeprazole with digoxin will lead to Increase in the absorption and concentration of digoxin (Lanoxin) in the blood. This may lead to increased digoxin toxicity.
PRECAUTIONS: Special warning and precautions
Patients should be cautioned that rabeprazole tablets should not be chewed or crushed, but should be swallowed whole.
Rabeprazole is not recommended for use in children.
OVERDOSAGE: Rabeprazole sodium is extensively protein bound and is therefore, not dialyzable. As usually case of overdose, treatment should be symptomatic and general supportive measures should be utilized.
STORAGE: Store in a cool place and protect from light. Keep out of reach of children.
PRESENTATION: Alu/Alu Blister pack of 14 tablets