Controloc

Controloc

pantoprazole

Manufacturer:

Takeda

Distributor:

DKSH
Concise Prescribing Info
Contents
Pantoprazole Na
Indications/Uses
20 mg: Mild GERD & associated symptoms eg, heartburn, acid regurgitation, pain on swallowing. Long-term management & prevention of reflux oesophagitis relapse. Prevention of nonselective NSAID-induced gastroduodenal ulcers in patients at risk w/ need for continuous NSAID treatment. 40 mg: H pylori eradication in patients w/ peptic ulcers. 40 mg, inj: Duodenal & gastric ulcer. Moderate & severe reflux esophagitis. Zollinger-Ellison syndrome & other pathological hypersecretory conditions.
Dosage/Direction for Use
Tab Adult & adolescent ≥12 yr Mild reflux disease & associated symptoms 20 mg daily for 2-4 wk. Long-term management & prevention of reflux oesophagitis relapse 20 mg daily, may be increased to 40 mg daily. Reduce to 20 mg daily once relapse is controlled. Moderate & severe reflux oesophagitis 40 mg daily, may be increased to 2-tab 40 mg daily. Adult Duodenal & gastric ulcer 40 mg daily, may be increased to 2-tab 40 mg daily. Prevention of NSAID-induced gastroduodenal ulcers in patient at risk 20 mg daily. H pylori eradication in gastric or duodenal ulcers 40 mg bd w/ combination of amoxicillin 1,000 mg bd & clarithromycin 500 mg bd or metronidazole 500 mg bd & clarithromycin 500 mg bd or amoxicillin 1,000 mg bd & metronidazole 500 mg bd. Gastric & duodenal ulcer 40 mg daily, may be increased to 40 mg bd. Zollinger-Ellison syndrome & other pathological hypersecretory conditions Initially 80 mg daily, may be titrated up or down as needed. Duration of treatment: H pylori eradication 1-2 wk. Duodenal ulcer 2 wk. Gastric ulcer & reflux esophagitis 4-8 wk. Inj Gastric & duodenal ulcer, moderate & severe reflux oesophagitis 40 mg IV daily if oral therapy is inappropriate. Zollinger-Ellison syndrome & other pathological hypersecretory conditions Initially 80 mg IV daily, may be titrated up or down as needed.
Administration
Should be taken on an empty stomach: Take 30 min before breakfast. Swallow whole, do not chew/crush.
Contraindications
Hypersensitivity. 40 mg: Not to be used in combination therapy for H pylori eradication in patients w/ moderate to severe hepatic or renal impairment.
Special Precautions
Discontinue use if subacute cutaneous lupus erythematosus occurs. Gastric malignancy. Increased risk of Clostridium difficile-associated diarrhea; osteoporosis-related hip, wrist or spine fractures. Hypomagnesemia, hypomagnesemia-associated hypocalcemia &/or hypokalemia. Long-term use. Discontinue use 14 days prior to chromogranin A measurements. Vit B12 malabsorption due to long-term therapy (>3 yr). Not recommended w/ HIV PIs eg, atazanavir, nelfinavir. Concomitant use w/ high-dose methotrexate. May affect ability to drive & use machines. Severe hepatic impairment. Not to be used during pregnancy. Lactation. Not recommended in childn <12 yr.
Adverse Reactions
Benign fundic gland polyps. Inj: Inj site thrombophlebitis.
Drug Interactions
Interfered absorption of pH-dependent drugs. Reduced bioavailability of HIV PIs eg, atazanavir, nelfinavir. Elevated & prolonged serum levels of methotrexate &/or its metabolite. Increased whole blood levels of tacrolimus. Increased systemic exposure by fluvoxamine. Increased INR & prothrombin time w/ coumarin anticoagulants eg, phenprocoumon or warfarin.
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 (enteric-coated) tab 20 mg
Packing/Price
14's;7's
Form
Controloc gastro-resistant (enteric-coated) tab 40 mg
Packing/Price
14's;7's
Form
Controloc powd for inj (vial) 40 mg
Packing/Price
1's
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in