Pantoprazole Sandoz Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Pantoprazole Na sesquihydrate

Indications/Uses

Reflux esophagitis. Combination therapy for H pylori eradication in patients w/ peptic ulcer. Gastric & duodenal ulcer. Zollinger-Ellison syndrome & other pathological hypersecretory conditions.

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Dosage/Direction for Use

Adult & adolescent ≥12 yr Reflux esophagitis 40 mg daily, may be increased to 80 mg daily. Duration of treatment: 4-8 wk. Adult H pylori eradication in duodenal or gastric ulcers 40 mg bd + amoxicillin 1,000 mg bd + clarithromycin 500 mg bd or 40 mg bd + metronidazole 500 mg bd + clarithromycin 500 mg bd or 40 mg bd + amoxicillin 1,000 mg bd + metronidazole 500 mg bd. Duration of treatment: 7 days up to max 2 wk. Duodenal & gastric ulcer 40 mg daily, may be increased to 80 mg daily. Duration of treatment: Duodenal ulcer 2-4 wk. Gastric ulcer 4-8 wk. Long-term management of Zollinger-Ellison syndrome & other pathological hypersecretory conditions Initially 80 mg daily, titrate dose as needed.

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Overdosage

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Administration

Should be taken on an empty stomach: Take 1 hr before meals. Swallow whole, do not chew/crush.

Contraindications

Hypersensitivity to pantoprazole or substituted benzimidazoles. Not to be used in combination therapy for H pylori eradication in patients w/ moderate to severe hepatic or renal dysfunction.

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Special Precautions

Exclude gastric malignancy in presence of alarming symptom eg, significant unintentional wt loss, recurrent vomiting, dysphagia, haematemesis, anaemia or melaena. Increased risk of GI infections caused by bacteria; osteoporosis-related hip, wrist or spine fractures; Clostridium difficile-associated diarrhea. Severe hypomagnesaemia; subacute cutaneous lupus erythematosus. Vit B₁₂ malabsorption due to hypo- or achlorhydria. Ensure adequate intake of vit D & Ca. Long-term & high-dose use. Discontinue use at least 5 days prior to chromogranin A measurements. May cause allergic reaction due to colouring agent. Not recommended w/ HIV PIs eg, atazanavir. Concomitant use w/ digoxin or substances causing hypomagnesemia eg, diuretics. May affect ability to drive & use machines. Severe hepatic impairment. Avoid use during pregnancy. Lactation. Not recommended in childn <12 yr.

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Use In Pregnancy & Lactation

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Adverse Reactions

Benign fundic gland polyps.

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Drug Interactions

Interfered absorption of gastric pH dependent medicinal products eg, some azole antifungals (eg, ketoconazole, itraconazole, posaconazole), erlotinib. Reduced bioavailability of atazanavir. Increased INR & prothrombin time w/ coumarin anticoagulants eg, phenprocoumon or warfarin. Increased systemic exposure w/ fluvoxamine. Reduced plasma conc w/ CYP2C19 & CYP3A4 inducers eg, rifampicin, St. John's wort (Hypericum perforatum). Increased MTX levels.

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Caution For Usage

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Storage

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Description

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Action

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MIMS Class

Antacids, Antireflux Agents & Antiulcerants

ATC Classification

A02BC02 - pantoprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).

Regulatory Classification

Presentation/Packing

Form

Pantoprazole Sandoz gastro-resistant tab 40 mg

Packing/Price

14's

Pantoprazole Sandoz

pantoprazole

Manufacturer:

Sandoz

Distributor:

DKSH