Pantoloc

Pantoprazole

20-mg tab: Prevention of gastroduodenal ulcers induced by NSAIDs in adults at risk w/ continuous NSAID treatment. Symptomatic improvement (eg, heartburn, acid regurgitation, pain in swallowing) & healing of mild reflux esophagitis; long term management & prevention of relapse in reflux esophagitis in adult & adolescent ≥12 yr. Symptomatic GERD, heartburn & other symptoms associated w/ GERD; reflux esophagitis in childn 5-11 yr. (Duration: Should not exceed 8 wk.) 40-mg tab: Moderate & severe reflux esophagitis; in combination w/ 2 appropriate antibiotics for the eradication of H. pylori in patients w/ peptic ulcers w/ the objective of reducing duodenal & gastric ulcers recurrence; duodenal & gastric ulcer; Zollinger-Ellison syndrome & other pathological hypersecretory conditions in adults. Reflux esophagitis in childn 5-17 yr. (Duration: Should not exceed 8 wk.) IV: Duodenal & gastric ulcer; moderate & severe reflux esophagitis; Zollinger-Ellison syndrome & other conditions associated w/ pathological overproduction of gastric acid; treatment of bleeding peptic ulcer & prevention of re-bleeding; prophylaxis of acute bleeding stress ulcer.

20-mg tab Adult Prevention of gastroduodenal ulcer induced by NSAIDs in patient w/ continuous NSAID treatment 20 mg/day. Adult & adolescent ≥12 yr For symptomatic improvement (eg, heartburn, acid regurgitation, pain in swallowing) & healing of mild reflux esophagitis 20 mg/day w/in 2-4 wk, & 4-wk treatment period is usually required for associated esophagitis. Long term management & prevention of relapse in reflux esophagitis Maintenance: 20 mg/day increasing to 40 mg/day if relapse occurs. After healing of relapse, can reduce again to 20 mg. Childn 5-11 yr Symptomatic GERD 20 mg/day for 4 wk. Treatment of reflux esophagitis in childn >35 kg 40 mg/day, 19-35 kg 20 mg/day. 4 wk treatment period is required for healing. Duration: Should not exceed 8 wk. Severe liver impairment Max: 20 mg daily. 40-mg tab Adult Moderate & severe reflux esophagitis 1 tab/day, may increase to 2 tab daily. Eradication of H. pylori in combination w/ 2 appropriate antibiotics 40 mg bid w/ amoxicillin 1,000 mg bid & clarithromycin 500 mg bid; or 40 mg bid w/ metronidazole 500 mg bid & clarithromycin 500 mg bid; or 40 mg bid w/ amoxicillin 1,000 mg bid & metronidazole 500 mg bid. Gastric & duodenal ulcer 1 tab/day, may increase to 2 tab daily. Zollinger-Ellison syndrome & other pathological hypersecretory conditions 80 mg daily, can be titrated up or down as needed. Temporary increase to >160 mg should not be longer than required. Reflux esophagitis in childn 5-17 yr w/ >35 kg 40 mg/day, 19-35 kg 20 mg/day. 4 wk treatment period is required for healing. May be increased up to 80 mg/day in adolescent ≥12 yr. Duration: Should not exceed 8 wk. Severe liver impairment 40 mg every other day. Elderly & patient w/ impaired renal function Max: 40 mg daily. IV Duodenal & gastric ulcer, moderate & severe reflux esophagitis 40 mg/day. Long-term management of Zollinger-Ellison syndrome & other pathological hypersecretory conditions Initially 80 mg divided & given bid. Dosage can be titrated up or down as needed. Temporary increase to >160 mg should not be longer than required. Rapid acid control Initially 80 mg twice w/in 1 hr until acid output is <10 mEq/hr. Upper digestive hemorrhage (complimentary to endoscopic therapy) & prevention of rebleeding 80 mg IV bolus followed by 8 mg/hr IV infusion during 72 hr. Prophylaxis of acute bleeding due to stress ulcer 40-80 mg once daily to bid.

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

Hypersensitivity to pantoprazole, substituted benzimidazoles. 40-mg tab: Not to be used in combination treatment for H. pylori eradication in patients w/ moderate to severe hepatic or renal dysfunction.

Regularly monitor liver enzymes during treatment particularly on long-term use. Discontinue treatment in case of a rise of liver enzymes. May mask symptoms of gastric malignancy & may delay diagnosis. Co-administration w/ HIV PIs is not recommended. Slightly increased risk of GI infections caused by Salmonella & Campylobacter or C. difficile. Severe hypomagnesemia. Measure Mg levels prior to & periodically during treatment for patients expected to be on prolonged treatment or who take PPI w/ digoxin or medicinal products that may cause hypomagnesaemia (eg, diuretics). May modestly increase risk of hip, wrist & spine fracture in older people or in presence of other risk factors especially if used in high doses & over long durations (>1 yr). Patients at risk of osteoporosis should have an adequate intake of vit D & Ca. May increase risk of subacute cutaneous lupus erythematosus w/ other PPI. May interfere w/ chromogranin A levels. Stop treatment for at least 5 days before chromogranin A measurements to avoid interference & should be repeated 14 days after cessation of treatment if chromogranin A & gastrin levels have not returned to reference range after initial measurement. Patients should not drive or operate machines when dizziness & visual disturbances occur. Severe liver impairment. Avoid use during pregnancy. Lactation. Not recommended in childn <5 yr. 20-mg tab: Patients who require continued NSAID treatment & have an increased risk to develop GI complications. Assess risk according to individual risk factors eg, age (>65 yr), history of gastric or duodenal ulcer or upper GI bleeding. Exclude possibility of malignancy of gastric ulcer or malignant disease of the esophagus prior to treatment & investigate patients who do not respond after 4 wk as treatment may alleviate symptoms of malignant ulcers. 20-mg tab & 40-mg: May reduce absorption of vit B₁₂ due to hypo- or achlorhydria. Reduced body stores or vit B₁₂ absorption on long-term therapy. Patients should be kept under regular surveillance in long-term treatment especially when exceeding 1 yr. 40-mg tab: Observe product characteristics of respective drugs in case of combination therapy. 40-mg tab & IV: Not indicated for mild GI complaints eg, nervous dyspepsia. IV: IV administration is recommended only if oral application is not appropriate. Not recommended in childn <18 yr. 40 mg daily dose should not be exceeded in elderly patients or w/ impaired renal function.

Benign fundic gland polyps. IV: Inj site thrombophlebitis.

May interfere w/ absorption of azole antifungals eg, ketoconazole, itraconazole, posaconazole & erlotinib. Significant reduction in bioavailability of HIV PIs eg, atazanavir. Increased INR & prothrombin time w/ warfarin or phenprocoumon. Increase MTX levels w/ high dose MTX (eg, 300 mg). Increased systemic exposure w/ fluvoxamine. May reduce plasma conc w/ rifampicin & St. John's wort.

Antacids, Antireflux Agents & Antiulcerants

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

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