Pantoprazole Beximco 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 Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Pantoprazole

Indications/Uses

20 mg Mild reflux disease & associated symptoms eg, heartburn, acid regurgitation, pain on swallowing. Long-term management & prevention of relapse in reflux oesophagitis. Prevention of nonselective NSAID-induced gastroduodenal ulcer in patients at risk w/ need for continuous NSAID treatment. 40 mg Combination therapy for H pylori eradication in patients w/ peptic ulcer to reduce recurrence of duodenal & gastric ulcer. Moderate & severe reflux esophagitis. Zollinger-Ellison syndrome & other pathological hypersecretory conditions.

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Dosage/Direction for Use

20 mg Adult & adolescent ≥12 yr Mild reflux disease & associated symptoms 20 mg daily for 2-4 wk. Healing of associated esophagitis 20 mg daily for 4 wk. Long-term management & prevention of relapse in reflux oesophagitis Maintenance dose: 20 mg daily, may be increased to 40 mg daily if relapse occurs & reduced back to 20 mg after healing. Prevention of NSAID-induced gastroduodenal ulcer in patient at risk 20 mg daily. 40 mg Adult & adolescent ≥12 yr Moderate & severe reflux esophagitis 40 mg daily, may be increased to 80 mg daily. H pylori eradication Adult 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 ulcers 40 mg daily, may be increased to 80 mg daily. Duration of treatment: Duodenal ulcer 2-4 wk. Gastric ulcer & reflux oesophagitis 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. Co-administration w/ atazanavir. Not to be used in combination treatment for H pylori eradication in patients w/ moderate to severe hepatic or renal dysfunction.

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Special Precautions

Not to be used for mild GI complaints eg, nervous stomach. Exclude gastric malignancy prior to therapy. Increased risk of subacute cutaneous lupus erythematosus, osteoporosis-related hip, wrist & spine fractures, Clostridium difficile-associated diarrhea. Presence of any alarm symptom eg, significant unintentional wt loss, recurrent vomiting, dysphagia, haematemesis, anaemia or melaena. Vit B₁₂ malabsorption due to hypo- or achlorhydria; hypomagnesaemia. Discontinue use at least 5 day prior to CgA level measurement. Avoid sun exposure. Prolonged use. Ensure adequate intake of vit D & Ca. Concomitant use w/ digoxin or drugs causing hypomagnesemia eg, diuretics. Pregnancy & lactation. Not recommended in childn <12 yr. Elderly.

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Use In Pregnancy & Lactation

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Adverse Reactions

Upper abdominal pain, diarrhea, constipation, flatulence, benign fundic gland polyps; headache.

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Drug Interactions

Changed absorption of pH-dependent drugs eg, ketoconazole. Reduced bioavailability of atazanavir. Monitor prothrombin time/INR w/ coumarin anticoagulants eg, phenprocoumon or warfarin.

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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 Beximco gastro-resistant tab 20 mg

Packing/Price

3 × 10's

Form

Pantoprazole Beximco gastro-resistant tab 40 mg

Packing/Price

3 × 10's

Pantoprazole Beximco

pantoprazole

Manufacturer:

Beximco

Distributor:

Medispec