Pantoloc

Gastro-resistant tab 20 mg: Symptomatic GERD in adults & adolescents ≥12 yr. Long-term management & prevention of relapse in reflux oesophagitis in adults & adolescents ≥12 yr. Prevention of gastroduodenal ulcers induced by non-selective NSAIDs in adults at risk w/ need for continuous NSAID treatment. Gastro-resistant tab 40 mg: Reflux oesophagitis in adults & adolescents ≥12 yr. Eradication of H. pylori in combination w/ appropriate antibiotic therapy in adults w/ H. pylori-associated ulcers. Gastric & duodenal ulcer in adults. Zollinger-Ellison syndrome & other pathological hypersecretory conditions in adults. Powd for soln for inj: Reflux oesophagitis in adults. Gastric & duodenal ulcer in adults. Zollinger-Ellison syndrome & other pathological hypersecretory conditions in adults.

PO Adult & adolescent ≥12 yr Symptomatic GERD One 20-mg tab daily. Long-term management & prevention of relapse in reflux oesophagitis One 20-mg tab daily, increased to 40 mg daily if relapse occurs. Reflux oesophagitis One 40-mg tab daily, may be increased to 2 tab daily when there has been no response to other treatment. Adult Prevention of gastroduodenal ulcers induced by non-selective NSAIDs w/ need for continuous NSAID treatment One 20-mg tab daily. Eradication of H. pylori in combination w/ 2 appropriate antibiotics Pantoloc 40 mg bd combined w/ amoxicillin 1,000 mg bd & clarithromycin 500 mg bd; or combined w/ metronidazole 400-500 mg (or tinidazole 500 mg) bd & clarithromycin 250-500 mg bd; or combined w/ amoxicillin 1,000 mg bd & metronidazole 400-500 mg (or tinidazole 500 mg) bd. Gastric & duodenal ulcer One 40-mg tab daily, may be increased to 2 tab daily when there has been no response to other treatment. Zollinger-Ellison syndrome & other pathological hypersecretory conditions Start treatment w/ 80 mg daily, then titrate up or down as needed using measurements of gastric acid secretion thereafter. Doses >80 mg daily should be divided & given bd. Temporary increase >160 mg is possible but should not be applied longer than required for adequate acid control. Patient w/ severe hepatic impairment Max dose: 20 mg daily. IV Administer over 2-15 min. Adult Gastric & duodenal ulcer; reflux oesophagitis 40 mg daily. Zollinger-Ellison syndrome & other pathological hypersecretory conditions Start treatment w/ 80 mg daily, then titrate up or down as needed using measurements of gastric acid secretion thereafter. Doses >80 mg daily should be divided & given bd. Temporary increase >160 mg is possible but should not be applied longer than required for adequate acid control. In case rapid acid control is required, starting dose of 2 x 80 mg is sufficient to manage decrease of acid output into target range w/in 1 hr. Patient w/ severe hepatic impairment Max dose: 20 mg daily (½ vial).

Gastro-resistant tab: Should be taken on an empty stomach: Do not chew/crush. Swallow whole w/ water 1 hr before meals.

Hypersensitivity to pantoprazole or substituted benzimidazoles.

Symptomatic response may mask symptoms of gastric malignancy & may delay diagnosis. Treatment may lead to slightly increased risk of GI infections eg, Salmonella, Campylobacter, & possibly Clostridium difficile. Consider monitoring of Mg levels prior to treatment initiation & periodically during treatment. Long-term therapy (≥1 yr) & multiple daily doses may be associated w/ increased risk for osteoporosis-related fractures of the hip, wrist or spine. Subacute cutaneous lupus erythematosus (SCLE) after previous PPI treatment may increase risk of SCLE w/ other PPIs. Co-administration is not recommended w/ HIV PIs for which absorption is dependent on acidic intragastric pH. Increased chromogranin A level may interfere w/ investigations for neuroendocrine tumours. Patients should not drive or operate machines if dizziness & visual disturbances occur. Regularly monitor liver enzymes during treatment in patients w/ severe hepatic impairment, particularly on long-term use. Discontinue treatment in case of raised liver enzymes. Preferable to avoid use during pregnancy. Discontinue breast-feeding or discontinue/abstain from Pantoloc therapy. Gastro-resistant tab: Patients on long-term treatment (especially >1 yr) should be kept under regular surveillance. May reduce absorption of vit B₁₂ (cyanocobalamin) due to hypo/achlorhydria. Not recommended in childn <12 yr. Use of Pantoloc 20 mg as preventive of gastroduodenal ulcers induced by non-selective NSAIDs should be restricted to patients who require continued NSAID treatment & have increased risk to develop GI complications. Pantoloc 40 mg must not be used in combination treatment for eradication of H. pylori in patients w/ moderate to severe hepatic impairment or patients w/ renal impairment. Powd for soln for inj: IV administration is recommended only if oral application is not appropriate. Not recommended in childn <18 yr.

Benign fundic gland polyps. Powd for soln for inj: Inj site thrombophlebitis.

Interference w/ absorption of medicinal products where gastric pH is an important determinant of oral bioavailability (eg, ketoconazole, itraconazole, posaconazole, erlotinib). Significant reduction in bioavailability of HIV PIs for which absorption is dependent on acidic intragastric pH (eg, atazanavir). Reports of increased INR & prothrombin time if concomitantly used w/ warfarin or phenprocoumon. Elevated & prolonged serum levels of MTX &/or its metabolite hydroxymethotrexate. Increased systemic exposure w/ CYP2C19 inhibitors (eg, fluvoxamine). Reduced plasma conc w/ CYP2C19 & CYP3A4 inducers (eg, 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).

P₁S₁S₃