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Controloc

Controloc

pantoprazole

Manufacturer:

Takeda

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Pantoprazole (equiv to pantoprazole Na sesquihydrate 22.6 mg)
Indications/Uses
20-mg tab: Symptomatic treatment of GERD. Long-term management & prevention of relapse in reflux esophagitis. Prevention of gastroduodenal ulcers induced by nonselective NSAIDs in patients at risk w/ need for continuous NSAIDs treatment. 40-mg tab: Reflux esophagitis. In combination w/ 2 appropriate antibiotics for eradication of H. pylori in patients w/ PUD w/ objective of reducing recurrence of duodenal & gastric ulcers caused by this microorganism. Zollinger-Ellison-syndrome & other pathological hypersecretory conditions. Inj: Moderate & severe reflux esophagitis. Duodenal & gastric ulcers. Zollinger-Ellison-syndrome & other pathological hypersecretory conditions.
Dosage/Direction for Use
Gastro-resistant tab Adult & adolescent ≥12 yr Symptomatic treatment of GERD 20 mg once daily for 2-4 wk for symptom relief or for 4 wk for healing of associated esophagitis. Long-term management & prevention of relapse in reflux oesophagitis 20 mg once daily, increased to 40 mg daily if relapse occurs, then reduced again to 20 mg after healing of relapse. Reflux esophagitis 40 mg once daily (1 tab) for 4 wk. May be increased to 80 mg daily. Adult Prevention of gastroduodenal ulcer induced by non-selective NSAIDs 20 mg once daily. Eradication of H. pylori Combination therapy: Controloc 40-80 daily mg + amoxicillin 1,000 mg bid + clarithromycin 250-500 mg bid for 7 days & may be prolonged for further 7 days. Gastric & duodenal ulcer 40 mg daily. May be increased to 80 mg daily. Zollinger-Ellison syndrome & other pathological hypersecretory conditions Initially 80 mg daily. Thereafter, dosage can be titrated up or down as needed using measurements of gastric acid secretion to guide. Doses >80 mg daily should be given in 2 divided doses daily. Temporary increase of dosage >160 mg pantoprazole is possible but should not be applied longer than required for adequate acid control. Childn 5-11 yr Symptomatic GERD 20 mg once daily. Reflux esophagitis ≥35 kg 40 mg once daily, ≥19 to <35 kg 20 mg once daily. Treatment period: 4 wk. Severe impaired hepatic function Max: 20 mg daily. IV inj Administer IV over 2-15 min. Duodenal & gastric ulcer, moderate & severe reflux esophagitis 1 vial daily. Long-term management of Zollinger-Ellison syndrome & other pathological hypersecretory conditions Initially 80 mg daily. Thereafter, dosage can be titrated up or down as needed using measurements of gastric acid secretion as guide. Doses >80 mg daily should be given in 2 divided doses daily. A temporary increase of the dosage >160 mg pantoprazole is possible but should not be applied longer than required for adequate acid control. Rapid acid control Initially 2 x 80 mg IV to manage a decrease in acid output (<10 meq/hr) w/in 1 hr. Transition from IV to oral should be performed as soon as it is clinically justified. Severe impaired hepatic function Max: 20 mg daily.
Administration
Should be taken on an empty stomach: Take at least 30 min before breakfast. Swallow whole, do not chew/crush.
Contraindications
Special Precautions
Increased risk for osteoporosis-related fractures of the hip, wrist, or spine in patients who received high doses, multiple daily doses & long-term use. Clostridium difficile infection. Hypomagnesemia. Monitor liver enzymes regularly in patients w/ severe liver impairment, particularly on long-term use. Concomitant use w/ HIV PIs eg, atazanavir, nelfinavir, MTX. Gastric malignancy. Consider cyanocobalamin deficiency in patients w/ Zollinger-Ellison syndrome & other pathological hypersecretory conditions requiring long-term treatment, individuals w/ reduced body stores or risk factors for reduced vit B12 absorption (eg, elderly) on long term therapy. May affect ability to drive or operate machines. Pregnancy & lactation. Childn <5 yr. Tab: Discontinue PPI treatment 14 days before chromogranin A (CgA) measurements. Subacute cutaneous lupus erythematosus (SCLE).
Adverse Reactions
Sleep disorder; headache, dizziness; diarrhea, nausea & vomiting, abdominal distention & bloating, constipation, dry mouth, abdominal pain & discomfort; increased liver enzymes; rash/exanthema/eruption, pruritus; asthenia, fatigue & malaise. IV inj: Inj site thrombophlebitis.
Drug Interactions
Reduced bioavailability of HIV PIs for which absorption is pH-dependent eg, ketoconazole, atazanavir, nelfinavir. May elevate & prolong serum level of MTX &/or its metabolite. Increased INR & prothrombin time w/ warfarin or phenoprocoumon. Increased systemic exposure w/ CYP2C19 inhibitors eg, fluvoxamine. Decreased systemic exposure w/ CYP2C19 inducers. Inj: Increase whole blood levels of tacrolimus.
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
Controloc gastro-resistant tab 20 mg
Packing/Price
14's
Form
Controloc gastro-resistant tab 40 mg
Packing/Price
14's
Form
Controloc powd for inj 40 mg
Packing/Price
1's
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