Restizol-DSR

Drug Information of RESTIZOL

Indication & Dosage


Oral
GERD
Adult: For erosive oesophagitis: 20 mg once daily in the morning for 4-8 wk. Maintenance: 10-20 mg once daily according to response. For non-erosive oesophagitis: 10 mg once daily for 4 wk, upon symptom resolution, may continue with 10 mg once daily when necessary.

Oral
Pathological hypersecretory conditions e.g. Zollinger-Ellison syndrome
Adult: Initially, 60 mg daily adjusted according to response. Max dose: 120 mg daily.

Oral
Active peptic ulcer disease
Adult: 20 mg daily given for 4-8 wk for duodenal ulcer and 6-12 wk for gastric ulcer.

Oral
Eradication of H. pylori infection
Adult: As a combination with two antibacterials: 20 mg bid combined with clarithromycin 500 mg bid and either amoxicillin 1 g bid or metronidazole 400 mg bid. To be taken for a wk.

Administration


Delayed-release: May be taken with or without food.

Overdosage


May result in drowsiness, headache and tachycardia.

Contraindications


Hypersensitivity.

Special Precautions


Severe hepatic impairment, gastric malignancy. May increase the risk of GI infections due to acid suppressive effects. Pregnancy.

Adverse Drug Reactions


Headache, diarrhoea, rash, infection and flu-like syndrome. Dizziness, fatigue, constipation, nausea and vomiting.
Potentially Fatal: Anaphylaxis, agranulocytosis.

Drug Interactions


May reduce absorption of ketoconazole and itraconazole. May prolong the elimination of diazepam, phenytoin and warfarin.

Food Interaction


Delayed absorption with high-fat meals.

Pregnancy Category (US FDA)


Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).

Storage


Oral: Store at 15-30°C.

Mechanism of Action


Rabeprazole is a PPI that suppresses gastric acid secretion by inhibiting the gastric H+/K+ ATPase at the secretory surface of the gastric parietal cell.
Onset: 1 hr.
Duration: 24 hr.
Absorption: Oral bioavailability: about 52% and peak plasma concentrations are reached about 3.5 hr after oral admin.
Distribution: Protein-binding: 97%.
Metabolism: Extensively metabolised in the liver by cytochrome P450 isoenzymes.
Excretion: Metabolites are mainly excreted in the urine (90%). Half-life: about 1 hr.

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).



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