Controloc 40 mg ( Pantoprazole ) 14 tablets

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Controloc 40 mg ( Pantoprazole ) 14 tablets

Contents

Pantoprazole Na

Indications / Uses

20 mg Mild GERD & associated symptoms (eg, heartburn, acid regurgitation, pain on swallowing). Long-term management & prevention of reflux oesophagitis relapse. Prevention of gastroduodenal ulcers in patients at risk w/ need for continuous NSAID treatment. 40 mg H pylori eradication in patients w/ peptic ulcers. 40 mg, inj Duodenal & gastric ulcer. Moderate & severe reflux esophagitis. Zollinger-Ellison syndrome & other pathological hypersecretory conditions.

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Dosage / Direction for Use

Tab Adult & adolescent ≥12 yr Mild reflux disease & associated symptoms 20 mg daily for 2-4 wk. Long-term management & prevention of reflux oesophagitis relapse 20 mg daily, may be increased to 40 mg daily. Reduce to 20 mg daily once relapse is controlled. Moderate & severe reflux oesophagitis 40 mg daily, may be increased to 2-tab 40 mg daily. Adult Duodenal & gastric ulcer 40 mg daily, may be increased to 2-tab 40 mg daily. Prevention of gastroduodenal ulcers induced by NSAIDs in patient at risk 20 mg daily. H pylori eradication in gastric or duodenal ulcers 40 mg bd w/ combination of amoxicillin 1,000 mg bd & clarithromycin 500 mg bd or metronidazole 500 mg bd & clarithromycin 500 mg bd or amoxicillin 1,000 mg bd & metronidazole 500 mg bd. Zollinger-Ellison syndrome & other pathological hypersecretory conditions Initially 80 mg daily, dose can be titrated up or down as needed. Duration of treatment: H pylori eradication 1-2 wk. Duodenal ulcer 2 wk. Gastric ulcer & reflux esophagitis 4-8 wk. Inj Gastric & duodenal ulcer, moderate & severe reflux oesophagitis 40 mg IV daily if oral therapy is inappropriate. Zollinger-Ellison syndrome & other pathological hypersecretory conditions 80 mg IV daily, may be titrated up or down 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. 40 mg Not to be used in combination therapy for eradication of H pylori in patients w/ moderate to severe hepatic or renal impairment.

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Special Precautions

Gastric malignancy. Increased risk of Clostridium difficile-associated diarrhea; osteoporosis-related fractures of hip, wrist or spine. Hypomagnesemia; subacute cutaneous erythematosus (SCLE). Vit B12 malabsorption due to long-term therapy (>3 yr); monitor regularly in long-term treatment. Concomitant w/ high-dose methotrexate. Not recommended w/ HIV PIs (eg, atazanavir, nelfinavir). Discontinue use 14 days before chemogranin A measurements. May affect ability to drive & use machines. Severe hepatic impairment. Not to be used during pregnancy. Lactation. Not recommended in childn <12 yr.

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Use In Pregnancy & Lactation

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Side Effects / Adverse Reactions

Benign fundic gland polyps. Inj Inj site thrombophlebitis.

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Interactions

Interfered absorption of pH-dependent drugs. Reduced bioavailability of atazanavir, nelfinavir. Elevated & prolonged serum levels of methotrexate &/or its metabolite. Increased whole blood levels of tacrolimus. Increased systemic exposure by fluvoxamine. Increased INR & prothrombin time w/ coumarin anticoagulants (eg, phenprocoumon or warfarin).

Preg Safety (US)

Category C: Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

Caution For Usage

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Storage

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Description

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Mechanism of Action

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Class

Antacids, Antireflux Agents & Antiulcerants