pantoprazole sodium

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pantoprazole sodium

Apo-Pantoprazole (CA), Co Pantoprazole (CA), Gen-Pantoprazole (CA), Novo-Pantoprazole (CA), Pantoloc (CA) PMS-Pantoprazole (CA), Protium (UK), Protonix, Protonix IV, Ran-Pantoprazole (CA), Ratio-Pantoprazole (CA), Sandoz Pantoprazole (CA)

Pharmacologic class: Proton pump inhibitor

Therapeutic class: GI agent

Pregnancy risk category B


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


Granules (delayed-release oral suspension): 40 mg

Powder for injection (freeze-dried): 40 mg/vial

Tablets (delayed-release): 20 mg, 40 mg

Indications and dosages

Erosive esophagitis caused by gastroesophageal reflux disease (GERD)

Adults: 40 mg I.V. daily for 7 to 10 days or 40 mg P.O. daily for 8 weeks. May repeat P.O. course for 8 additional weeks.

Children ages 5 and older weighing 40 kg (88 lb) or more: 40 mg P.O. daily for up to 8 weeks

Children ages 5 and older weighing 15 kg (33 lb) to less than 40 kg (88 lb): 20 mg P.O. daily for up to 8 weeks

Erosive esophagitis

Adults: 40 mg P.O. daily

Pathologic hypersecretory conditions

Adults: Initially, 40 mg P.O. b.i.d., increased as needed to maximum of 240 mg P.O. daily; some patients may need up to 2 years of therapy. Alternatively, 80 mg I.V. q 12 hours, to a maximum of 240 mg/day (80 mg q 8 hours).


• Hypersensitivity to drug or any substituted benzimidazole


Use cautiously in:
• severe hepatic disease
• atrophic gastritis with long-term use
• increased risk of osteoporosis-related hip, wrist, or spine fractures with long-term use or multiple daily doses
• concurrent use of atazanavir, nelfi-navir, or methotrexate
• pregnant or breastfeeding patients
• children.


• Be aware that oral granules may be mixed with applesauce or apple juice and given 30 minutes before a meal. Once mixed, give drug within 10 minutes.
• Know that oral granules may be mixed with 10 ml apple juice and administered into nasogastric tube using 60-ml catheter-tip syringe. Rinse syringe with additional apple juice so that no granules remain in syringe.
• For I.V. administration, use in-line filter provided. If Y-site is used, place filter below Y-site closest to patient.
• Dilute I.V. form with 10 ml of normal saline solution; further dilute in dextrose 5% in water, normal saline solution, or lactated Ringer's solution, as directed. Give over 15 minutes at a rate no faster than 3 mg/minute.
• Don't give I.V. form with other I.V. solutions.
• Know that I.V. form is indicated for short-term treatment of GERD in patients with history of erosive esophagitis as alternative to P.O. therapy.
• Be aware that symptomatic response doesn't rule out gastric cancer.

Adverse reactions

CNS: dizziness, headache

CV: chest pain

EENT: rhinitis

GI: vomiting, diarrhea, abdominal pain, dyspepsia

Metabolic: hyperglycemia

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

Skin: rash, pruritus

Other: injection site reaction


Drug-drug.Ampicillin, cyanocobalamin, digoxin, iron salts, ketoconazole: delayed absorption of these drugs Atazanavir, nelfinavir: substantially decreased atazanavir or nelfinavir plasma concentration with loss of therapeutic effect and development of drug resistance

Clarithromycin, diazepam, flurazepam, phenytoin, triazolam: increased panto-prazole blood level

Sucralfate: delayed pantoprazole absorption

Warfarin: increased bleeding

Drug-diagnostic tests.Aspartate aminotransferase, glucose: increased levels

Tetrahydrocannabinol test: false-positive result

Patient monitoring

• Assess for symptomatic improvement.
• Monitor blood glucose level in diabetic patient.

Patient teaching

• Tell patient to swallow delayed-release tablets whole without crushing, chewing, or splitting.
• Tell patient he may take tablets with or without food.
• Explain that antacids don't affect drug absorption.
• Instruct diabetic patients to monitor blood glucose level carefully and stay alert for signs and symptoms of hyperglycemia.
• As appropriate, review all other significant adverse reactions and interactions, especially those related to the drugs and tests mentioned above.

References in periodicals archive ?
According to IMS Health, Pantoprazole Sodium Delayed-Released tablets recorded total US sales of approximately USD1.
Reddy's Pantoprazole Sodium Delayed-Released tablets are available in 90 count bottles.
Nasdaq:TEVA) announced today that it has commercially launched Pantoprazole Sodium Delayed Release (DR) Tablets, 20 mg and 40 mg, which are AB-rated to Wyeth's erosive GERD treatment Protonix[R] DR Tablets.
Kremers Urban extended-release products that require complex drug development technology and manufacturing process include hydrocodone polistirex and chlorpheniramine polistirex pennkinetic extended-release suspension CIII (authorized generic for Tussionex Pennkinetic Extended-Release Suspension CIII), pantoprazole sodium delayed-release tablets, oxybutynin chloride extended-release tablets USE omeprazole delayed-release capsules, nifedipine extended-release tablets USE verapamil hydrochloride extendedrelease capsules, and several other extendedrelease and transdermal generic products.
District Court for the District of New Jersey has denied a motion filed by Wyeth and Altana for a preliminary injunction related to Teva's Pantoprazole Sodium Delayed Release (DR) Tablets, AB-rated to Wyeth's Protonix[R] DR Tablets.
Teva's Pantoprazole Sodium DR Tablets are the AB-rated equivalent of Protonix[R] DR Tablets, a product indicated for short term treatment of erosive esophagitis associated with GERD, maintenance of healing of erosive esophagitis and for treatment of hypersecretory conditions.
Upon final approval, Teva's Pantoprazole Sodium DR Tablets will be the AB-rated equivalent of Protonix(R) DR Tablets, a product indicated for short term treatment of erosive esophagitis associated with GERD, maintenance of healing of erosive esophagitis and for treatment of hypersecretory conditions.