rabeprazole sodium

rabeprazole sodium

AcipHex, Novo-Rabeprazole (CA), Pariet (UK), PMS-Rabeprazole (CA), Ran-Rabeprazole (CA)

Pharmacologic class: Proton pump inhibitor

Therapeutic class: Gastric antisecretory agent

Pregnancy risk category B

Action

Reduces gastric acid secretion and increases gastric mucus and bicarbonate production, creating a protective coating on gastric mucosa

Availability

Tablets (delayed-release): 20 mg

Indications and dosages

Erosive or ulcerative gastroesophageal reflux disease (GERD)

Adults: 20 mg P.O. daily for 4 to 8 weeks. If healing doesn't occur within 8 weeks, another 8 weeks of therapy may be considered. Maintenance dosage is 20 mg P.O. daily.

GERD

Adults: 20 mg P.O. daily for 4 weeks. If symptoms don't resolve after 4 weeks, another course of therapy may be considered.

Short-term treatment of symptomatic GERD

Adolescents ages 12 and older: 20 mg P.O. daily for up to 8 weeks

Hypersecretory conditions, including Zollinger-Ellison syndrome

Adults: Initially, 60 mg P.O. daily; adjust dosage as needed up to 100 mg P.O. daily as a single dose or 60 mg P.O. b.i.d. Maximum daily dosage is 120 mg.

Duodenal ulcer

Adults: 20 mg P.O. daily for up to 4 weeks

Helicobacter pylori eradication

Adults: 20 mg P.O. b.i.d. for 7 days (given with amoxicillin and clarithromycin)

Off-label uses

• Dyspepsia
• Benign gastric ulcer

Contraindications

• Hypersensitivity to drug, its components, or benzimidazoles

Precautions

Use cautiously in:
• severe hepatic impairment
• concurrent use of atazanavir (not recommended)
• pregnant patients
• breastfeeding patients (not recommended)
• children (safety not established).

Administration

• Don't crush or split tablets.
• Give without regard to food.

Adverse reactions

CNS: headache

Metabolic: hypomagnesemia

Musculoskeletal: fractures of hip, wrist, spine (with long-term daily use)

Interactions

Drug-drug.Atazanavir: substantially decreased atazanavir plasma concentration and reduced therapeutic effect Combined administration of rabeprazole, amoxicillin, and clarithromycin: increased rabeprazole and 14-hydroxyclarithromycin plasma concentrations

Gastric pH-dependent drugs (such as digoxin, ketoconazole): increased or decreased absorption

Methotrexate: possibly elevated and prolonged methotrexate serum level

Warfarin: increased risk of bleeding

Drug-diagnostic tests.Magnesium: decreased level

Patient monitoring

• Stay alert for symptomatic response, but know that a positive response doesn't rule out gastric cancer.
• Monitor magnesium level before starting therapy and periodically thereafter in patients expected to be on prolonged therapy or who take proton pump inhibitors with drugs such as digoxin or drugs that may cause hypomagnesemia (such as diuretics).

Patient teaching

• Tell patient he may take with or without food. Instruct him not to crush, chew, or split tablets.
• Caution female patient not to breastfeed during therapy.
• As appropriate, review all significant adverse reactions and interactions, especially those related to the drugs mentioned above.

rabeprazole sodium

(rə-bĕp′rə-zōl′)
n.
A proton pump inhibitor drug used to treat erosive or ulcerative gastroesophageal reflux disease, duodenal ulcers, and hypersecretory conditions such as Zollinger-Ellison syndrome.
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References in periodicals archive ?
announced today that Eisai has obtained the approval of additional dosage and administration in Japan of the proton pump inhibitor Pariet 5 mg Tablets and 10 mg Tablets (generic name: rabeprazole sodium) to administer 10 mg of rabeprazole sodium per dose twice-daily for the maintenance therapy of proton pump inhibitor-resistant reflux esophagitis (reflux esophagitis in which it is difficult to achieve satisfactory therapeutic effects by existing treatment with once-daily dosing of proton pump inhibitors).
The Company increased 9 clinical trial approvals for five kinds of medicines, namely recombinant anti-CD20 humanized monoclonal antibody injection, Lacosamide API and Tablet, Ferric carboxymaltose API and Injection, sugammadex API and Injection, rabeprazole sodium, 1 approval for production of thyoidin as well as 2 clinical trial approvals for injectable recombinant anti-HER2 humanized monoclonal antibody composition and beclometasone dipropionate aerosol.
Breckenridge also received clearance for rabeprazole sodium delayed-release tablets.
Tenders are invited for Tab Rabeprazole Sodium 20 Mg
Pharmaceutical company Mylan Inc (NasdaqGS:MYL) said on Monday that its US subsidiary Mylan Pharmaceuticals Inc has launched Rabeprazole Sodium Delayed-release Tablets, 20 mg.
announced today that the company has decided to discontinue global development of rabeprazole sodium extended-release capsules, 50 mg.
Contract awarded for 2588 order code 10580 rabeprazole sodium enteric coated tablet with 20 mg
pylori eradication by concomitant therapy with four proton pump inhibitors―lansoprazole, omeprazole, rabeprazole sodium and esomeprazole magnesium hydrate-manufactured and marketed by the four companies in Japan under five brand names.
3 June 2010 - Eisai Inc, a US subsidiary of Japanese Eisai Co Ltd (TYO: 4523), said yesterday that the US Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for rabeprazole sodium extended-release 50 mg for the healing and maintenance of healing of erosive gastroesophageal reflux disease (GERD), and for the treatment of symptomatic GERD.
Eisai announced today that the company received a Complete Response Letter from the United States Food and Drug Administration (FDA) regarding the New Drug Application (NDA) of rabeprazole sodium extended-release capsules, 50 mg, an investigational proton pump inhibitor (PPI) under review for the healing and long-term maintenance of healing and symptom resolution of erosive gastroesophageal reflux disease (GERD), and for the treatment of daytime and nighttime heartburn and other symptoms of non-erosive GERD.