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Pantovex Tablet

Pantovex Tablet

pantoprazole

Manufacturer:

Antila Lifesciences

Distributor:

Sannovex
Concise Prescribing Info
Contents
Pantoprazole
Indications/Uses
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; Zollinger-Ellison syndrome & other pathological hypersecretory conditions in adults.
Dosage/Direction for Use
Adult & adolescent ≥12 yr Reflux oesophagitis 1 tab daily for 4 wk, continued further for 4 wk if not fully healed. May be increased to 2 tab daily especially when there has been no response to other treatment. Adult Eradication of H. pylori in combination w/ 2 appropriate antibiotics Pantoprazole 1 tab bid + amoxicillin 1,000 mg bid + clarithromycin 500 mg bid, or pantoprazole 1 tab bid + metronidazole 400-500 mg (or tinidazole 500 mg) bid + clarithromycin 250-500 mg bid, or pantoprazole 1 tab bid + amoxicillin 1,000 mg bid + metronidazole 400-500 mg (or tinidazole 500 mg) bid for 7 days, can be prolonged for further 7 days. Gastric ulcer 1 tab daily for 4 wk, continued further for 4 wk if not fully healed. May be increased to 2 tab daily especially when there has been no response to other treatment. Duodenal ulcer 1 tab daily for 2 wk, continued further for 2 wk if not fully healed. May be increased to 2 tab daily especially when there has been no response to other treatment. Zollinger-Ellison syndrome & other pathological hypersecretory conditions Initially 80 mg daily. Titrate dose up or down as needed using measurements of gastric acid secretion to guide. Doses >80 mg daily should be divided & given bid. Patient w/ severe hepatic impairment Should not exceed 20 mg daily.
Administration
Should be taken on an empty stomach: Take 1 hr before a meal w/ some water. Swallow whole, do not chew/crush.
Contraindications
Hypersensitivity to pantoprazole, or substituted benzimidazoles.
Special Precautions
May mask symptoms of gastric malignancy & delay diagnosis. Exclude malignancy in the presence of any alarm symptom (eg, significant unintentional wt loss, recurrent vomiting, dysphagia, haematemesis, anaemia or melaena) & when gastric ulcer is suspected or present. Not recommended w/ HIV PIs for which absorption is dependent on acidic intragastric pH (eg, atazanavir) due to significant reduction in bioavailability. May reduce vit B12 (cyanocobalamin) absorption due to hypo- or achlorhydria in patients w/ Zollinger-Ellison syndrome & other pathological hypersecretory conditions requiring long-term treatment. Slightly increased risk of GI infections caused by bacteria (eg, Salmonella, Campylobacter or Clostridium difficile). Severe hypomagnesaemia has been reported in patients treated w/ PPIs for at least 3 mth, & in most cases for 1 yr. Consider measuring Mg levels before starting PPI treatment & periodically during treatment for patients expected to be on prolonged treatment or who take PPIs w/ digoxin or medicinal products that may cause hypomagnesaemia (eg, diuretics). May modestly increase risk of hip, wrist & spine fracture, predominantly in elderly or in the presence of other recognised risk factors, especially if used in high doses & over long durations (>1 yr). Patients at risk of osteoporosis should receive care according to current clinical guidelines & should have an adequate intake of vit D & Ca. Very infrequent cases of subacute cutaneous lupus erythematosus associated w/ PPIs. Consider stopping treatment if lesions occur, especially in sun exposed areas of the skin, & if accompanied by arthralgia. Increased chromogranin A (CgA) level may interfere w/ investigations for neuroendocrine tumors. Stop treatment for at least 5 days before CgA measurements. Not to be used in combination treatment for eradication of H. pylori in patients w/ moderate to severe hepatic dysfunction or impaired renal function. Regularly monitor liver enzymes during treatment, particularly on long-term use, in patients w/ severe liver impairment. Discontinue treatment in case of liver enzyme elevation. Keep patients under regular surveillance in long-term treatment (especially >1 yr). Avoid use during pregnancy. Discontinue breastfeeding or discontinue/abstain from treatment. Not recommended in childn <12 yr.
Adverse Reactions
Diarrhoea & headache. Fundic gland polyps (benign).
Drug Interactions
May interfere w/ the absorption of medicinal products w/ pH-dependent absorption pharmacokinetics eg, some azole antifungals (eg, ketoconazole, itraconazole, posaconazole) & erlotinib. Significant reduction in bioavailability of HIV PIs eg, atazanavir. Increased INR & prothrombin time w/ coumarin anticoagulants (phenprocoumon or warfarin). Increased MTX levels w/ high-dose MTX. Increased systemic exposure w/ CYP2C19 inhibitors eg, fluvoxamine. Reduced plasma conc w/ CYP2C19 & CYP3A4 inducers eg, rifampicin & St. John's wort (Hypericum perforatum).
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).
Presentation/Packing
Form
Pantovex Tablet DR tab 40 mg
Packing/Price
30's
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