Controloc

Controloc

pantoprazole

Manufacturer:

Takeda

Distributor:

DKSH
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/ a need for continuous NSAIDs treatment. 40-mg tab: Reflux esophagitis. In combination w/ 2 appropriate antibiotics for the 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 a 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 + amoxycillin 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. A temporary increase of the 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/day. Long-term management of Zollinger-Ellison syndrome & other pathological hypersecretory conditions Initially 80 mg/day. 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: Tab: 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, methotrexate. 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 methotrexate &/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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