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Rabeprazole Sodium

Last updated on October 6, 2021

(British Approved Name Modified, US Adopted Name, rINNM)

Drug Nomenclature

INNs in main languages (French, Latin, Russian, and Spanish):

Rabeprazole SodiumSynonyms: E-3810; LY-307640; Rabeprazol sódico; Sodium Pariprazole
BAN: Rabeprazole Sodium [BANM]
USAN: Rabeprazole Sodium
INN: Rabeprazole Sodium [rINNM (en)]
INN: Rabeprazol sódico [rINNM (es)]
INN: Rabéprazole Sodique [rINNM (fr)]
INN: Natrii Rabeprazolum [rINNM (la)]
INN: Натрий Рабепразол [rINNM (ru)]
Chemical name: 2-({[4-(3-Methoxypropoxy)-3-methyl-2-pyridyl]methyl}sulfinyl)-1H-benzimidazole sodium
Molecular formula: C18H20N3NaO3S =381.4
CAS: 117976-89-3 (rabeprazole); 117976-90-6 (rabeprazole sodium)
ATC code: A02BC04

Adverse Effects and Precautions

As for Omeprazole.

Effects on the endocrine system

For cases of gynaecomastia associated with rabeprazole.

Effects on the kidneys

For reports of interstitial nephritis associated with rabeprazole.

Effects on the nervous system

For a report of neuropsychiatric symptoms associated with rabeprazole, see under Omeprazole.

Interactions

As for Omeprazole but clinically significant interactions with diazepam, phenytoin, theophylline, or warfarin have not been found in healthy subjects.

Rabeprazole SodiumPharmacokinetics

Rabeprazole is rapidly absorbed and peak plasma concentrations are reached about 3.5 hours after an oral dose. The oral bioavailability is about 52% with the enteric-coated tablet formulation, because of first-pass metabolism, and does not appear to vary after single or repeated doses. Rabeprazole is about 97% bound to plasma proteins. It is extensively metabolised in the liver by cytochrome P450 isoenzymes CYP2C19 and CYP3A4 to the thioether, thioether carboxylic acid, sulfone, and desmethylthioether. Metabolites are excreted principally in the urine (about 90%) with the remainder in the faeces. The plasma half-life is about 1 hour, increased two to threefold in hepatic impairment, 1.6 times in CYP2C19 slow metabolisers (see also Metabolism under Omeprazole), and by 30% in the elderly.

Uses and Administration

Rabeprazole is a proton pump inhibitor with actions and uses similar to those of omeprazole. It is given orally as rabeprazole sodium in the form of enteric-coated tablets. It is normally taken in the morning. In the treatment of severe (erosive or ulcerative) gastro-oesophageal reflux, the usual dose of rabeprazole sodium is 20 mg once daily for 4 to 8 weeks in the USA, a further 8-week course is permitted for healing of erosive oesophagitis. Thereafter, maintenance therapy can be continued with 10 or 20 mg daily depending on the response.

For symptomatic disease without erosive or ulcerative oesophagitis a dose of 10 or 20 mg may be given once daily for 4 weeks in the USA, a further 4-week course is permitted. Once symptoms have resolved, a dose of 10 mg once daily may be given as necessary. For the treatment of active peptic ulcer disease, 20 mg daily is given for 4 to 8 weeks for duodenal ulcer and 6 to 12 weeks for gastric ulcer. For the eradication of Helicobacter pylori:’rabeprazole sodium may be combined with two antibacterials in a 1-week triple therapy regimen.

Effective regimens include 20 mg twice daily combined with clarithromycin 500 mg twice daily and amoxicillin 1 g twice daily, or combined with clarithromycin 250 mg twice daily and metronidazole 400 mg twice daily. For Zollinger-Ellison syndrome, the starting dose is 60 mg once daily, adjusted according to response. Doses up to 120 mg daily have been given when the daily dose is more than 100 mg it should be given in 2 divided doses.

Proprietary Preparations

 

Argentina: Pariet Rabec

Australia: Pariet

Austria: Pariet

Belgium: Pariet

Brazil: Pariet

Canada: Pariet

Chile: Gastrodine

Denmark: Pariet

Finland: Pariet

France: Pariet

Germany: Pariet

Greece: Pariet

Hong Kong: Pariet

Hungary: Pariet

India: Odirab Rabeloc Rabicip

Indonesia: Pariet

Ireland: Pariet

Italy: Pariet

Japan: Pariet

Malaysia: Pariet

Mexico: Pariet

The Netherlands: Pariet

Philippines: Pariet

Poland: Pariet

Portugal: Pariet

Russia: Pariet

South Africa: Pariet

Singapore: Pariet

Spain: Aciphex Pariet

Sweden: Pariet

Switzerland: Pariet

Thailand: Pariet

Turkey: Pariet

United Kingdom: Pariet

USA: Aciphex

Venezuela: Pariet

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