Concise Prescribing Info
20-mg tab: Mild reflux disease & associated symptoms (eg, heartburn, acid regurgitation, pain on swallowing). Long-term management & prevention of relapse in reflux oesophagitis. Prevention of gastroduodenal ulcers induced by non-selective NSAIDs in patients at risk w/ a need for continuous NSAID treatment. 40-mg tab: In combination w/ 2 appropriate antibiotics for the eradication of H. pylori in patients w/ peptic ulcers w/ the objective of reducing the recurrence of duodenal & gastric ulcers caused by this microorganisms. Duodenal & gastric ulcer. Moderate & severe reflux esophagitis. Inj: Short-term use for symptomatic improvement & healing of GI diseases which require a reduction in acid secretion: Duodenal & gastric ulcer, moderate & severe reflux esophagitis.
Dosage/Direction for Use
20-mg tab Mild reflux disease & associated symptoms (eg, heartburn, acid regurgitation, pain on swallowing) 20 mg daily for 2-4 wk. 4-wk treatment is required for healing of associated oesophagitis. Long-term management & prevention of reflux oesophagitis relapse Maintenance: 20 mg daily, increasing to 40 mg daily if relapse occurs. Reduce to 20 mg daily after healing of relapse. Prevention of gastroduodenal ulcers induced by non-selective NSAIDs in patients at risk w/ a need for continuous NSAID treatment 20 mg daily. 40-mg tab Eradication of H. pylori Treatment duration: 7 days-2 wk. Controloc 40 mg bd + amoxycillin 1,000 mg bd + clarithromycin 500 mg bd; or Controloc 40 mg bd + metronidazole 500 mg bd + clarithromycin 500 mg bd; or Controloc 40 mg bd + amoxycillin 1,000 mg bd + metronidazole 500 mg bd. Gastric & duodenal ulcer; reflux oesophagitis 40 mg daily, may be doubled (increase to 2 tab daily) especially when there has been no response to other treatment. Inj Administer only if oral therapy is inappropriate. Duodenal & gastric ulcer; moderate & severe reflux oesophagitis 40 mg to be administered as IV for 2-15 min, daily. Severe liver impairment Max: 20 mg daily. Elderly Gastric or duodenal ulcer Max: 40 mg daily.
May be taken with or without food: Swallow whole, do not chew/crush.
Hypersensitivity. 40-mg tab: Not to be used in combination treatment for H. pylori eradication in patients w/ moderate to severe liver or kidney function disturbances.
Special Precautions
Exclude malignancy in the presence of any alarm symptoms (eg, significant wt loss, recurrent vomiting, dysphagia, haematemesis, anaemia or melaena). Regularly monitor liver enzymes in patients w/ severe liver impairment. Discontinue treatment if liver enzymes rise. Increased risk of Clostridium difficile-associated diarrhoea (CDAD) especially in hospitalised patients. Slightly increased risk of GI infections caused by bacteria eg, Salmonella & Campylobacter. Hypomagnesemia which may lead to hypocalcemia &/or hypokalemia. Consider monitoring Mg levels prior to initiation of PPI treatment & periodically after, in patients expected to be on prolonged treatment or are taking PPIs w/ drugs that may cause hypomagnesemia. Increased risk for osteoporosis-related fractures of the hip, wrist or spine especially in patients receiving high-dose or long-term therapy. Concomitant use w/ methotrexate. Not recommended in co-administration w/ HIV protease inhibitors eg, atazanavir, nelfinavir. Consider cyanocobalamin deficiency in patients w/ Zollinger-Ellison syndrome & other pathological hypersecretory conditions requiring long-term treatment. Discontinue PPI treatment for 14 days prior to chromogranin A measurements. Avoid long-term treatment. Discontinue treatment if signs or symptoms consistent w/ cutaneous lupus erythematosus or SLE occur & evaluate patient. 20-mg tab: Concomitant use w/ NSAID. 40-mg tab: Do not use in combination treatment (eg, amoxicillin, clarithromycin) for eradication of H. pylori in patients w/ moderate to severe hepatic dysfunction or impaired renal function. Regularly monitor patients when exceeding a treatment period of 1 yr. Dizziness & visual disturbances may affect ability to drive or operate machinery. Do not use during pregnancy. Lactation. Not recommended for use in childn <12 yr (tab) & <18 yr (inj).
Adverse Reactions
Diarrhoea & headache. Inj: Inj site thrombophlebitis.
Drug Interactions
May affect absorption of drugs whose bioavailability are pH-dependent (eg, ketoconazole). Reduced bioavailability of HIV protease inhibitors (eg, atazanavir, nelfinavir). Concomitant use w/ coumarin anticoagulants eg, phenprocoumon or warfarin. May elevate & prolong serum levels of methotrexate &/or its metabolite hydroxymethotrexate. Increased systemic exposure w/ CYP2C19 inhibitors eg, fluvoxamine. Decreased systemic exposure w/ CYP2C19 inducers.
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).
Additional Information
Exemptions granted for limited sale and supply without prescription (with effect from 1 Jan 2014):
As an oral solid preparation containing not more than 20 mg
Indication: For the relief of heartburn symptoms associated with acid reflux
Maximum daily dose: 20 mg
Maximum supply: 14 days
Minimum age: 18 years
Controloc gastro-resistant tab 20 mg
Controloc inj 40 mg
(vial) 1's
Controloc gastro-resistant tab 40 mg
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