Pantoloc

Pantoloc

pantoprazole

Manufacturer:

Takeda

Distributor:

Zuellig
Concise Prescribing Info
Contents
Pantoprazole
Indications/Uses
20 mg: Prevention of gastroduodenal ulcers induced by NSAIDs in adult patients at risk w/ continuous NSAID treatment. Symptomatic improvement (eg, heartburn, acid regurgitation, pain in swallowing) & healing of mild reflux esophagitis; long term management & prevention of relapse in reflux esophagitis in adult & adolescent ≥12 yr. Symptomatic GERD, heartburn & other symptoms associated w/ GERD in childn 5-11 yr. (Duration: Should not exceed 8 wk.) 40 mg: Moderate & severe reflux esophagitis in combination w/ 2 appropriate antibiotics for the eradication of H. pylori in patients w/ peptic, duodenal & gastric ulcer; Zollinger-Ellison syndrome & other pathological hypersecretory conditions. Reflux esophagitis in childn 5-17 yr. (Duration: Should not exceed 8 wk.) IV: Duodenal & gastric ulcer, moderate & severe reflux esophagitis; Zollinger-Ellison-syndrome & other conditions associated w/ pathological overproduction of gastric acid; treatment of bleeding peptic ulcer & prevention of re-bleeding; prophylaxis of acute bleeding stress ulcer.
Dosage/Direction for Use
20 mg Adult Prevention of gastroduodenal ulcer induced by NSAIDs in patients w/ continuous NSAID treatment 20 mg/day. Adult & adolescent ≥12 yr For symptomatic improvement eg, heartburn, acid regurgitation, pain in swallowing, & healing of mild reflux esophagitis 20 mg/day w/in 2-4 wk, & 4 wk treatment period is required. Long term management & prevention of relapse in reflux esophagitis Maintenance: 20 mg/day increasing to 40 mg/day if relapse occurs. After healing of relapse, can reduce again to 20 mg. Childn 5-11 yr Symptomatic GERD 20 mg/day. Treatment of reflux esophagitis in childn 19-35 kg 20 mg, >35 kg 40 mg. 4 wk treatment period is required for healing. Duration: Should not exceed 8 wk. Patients w/ severe liver impairment 20 mg daily dose should not be exceeded. 40 mg Adult Treatment of moderate & severe reflux esophagitis 1 tab/day, may increase to 2 tab daily. Eradication of H. pylori in combination w/ 2 appropriate antibiotic 40 mg bid w/ 1,000 mg amoxicillin & 500 mg clarithromycin bid or 40 mg bid w/ 500 mg metronidazole & 500 mg clarithromycin bid or 40 mg bid w/ 1,000 mg amoxicillin & 500 mg metronidazole bid. Gastric & duodenal ulcer 1 tab/day, may increase to 2 tab daily. Zollinger-Ellison syndrome & other pathological hypersecretory conditions 80 mg daily, can be titrated up or down as needed. Temporary increase to 160 mg should not be longer than required. Reflux esophagitis in childn 5-17 yr w/ 19-35 kg 20 mg, >35 kg 40 mg. 4 wk treatment period is required for healing. Duration: Should not exceed 8 wk. Severe liver impairment 40 mg every other day. IV Duodenal & gastric ulcer, moderate & severe reflux esophagitis 40 mg/day. Long-term management of Zollinger-Ellison syndrome & other pathological hypersecretory conditions Initially 80 mg divided & given bid. Dosage can be titrated up or down as needed. Temporary increase to 160 mg should not be longer than required. Rapid acid control Initially 80 mg bid w/in 1 hr until acid output is <10 mEq/hr. Upper digestive hemorrhage (complimentary to endoscopic therapy) & prevention of rebleeding 80 mg IV bolus followed by 8 mg/hr IV infusion during 72 hr. Prophylaxis of acute bleeding due to stress ulcer 40-80 mg once daily to bid.
Administration
Should be taken on an empty stomach: Take 1 hr before meals. Swallow whole, do not chew/crush.
Contraindications
Hypersensitivity to pantoprazole, substituted benzimidazoles. 40 mg: Not be used in combination treatment for H. pylori eradication in patients w/ moderate to severe hepatic or renal dysfunction.
Special Precautions
Reduced body stores or vit B12 absorption on long-term therapy. Regularly monitor liver enzymes particularly on long-term use. Discontinue treatment if liver enzymes increased. May mask symptoms of gastric malignancy & may delay diagnosis. Co-administration w/ HIV PIs is not recommended. Slightly increased risk of GI infections caused by Salmonella & Campylobacter or C. difficile. Severe hypomagnesemia. Measure Mg levels prior & periodically during treatment. May modestly increase risk of hip, wrist & spine fracture in older people or in presence of other risk factors. Patients at risk of osteoporosis should have an adequate intake of vit D & Ca. May increase risk of subacute cutaneous lupus erythematosus w/ other proton pump inhibitors. May interfere w/ chromogranin A levels. Treatment should be stopped for at least 5 days before chromogranin A measurements & should be repeated 14 days after cessation, if chromogranin A & gastrin levels have not returned to reference range after initial measurement. Patients who require continued NSAID treatment & have an increased risk to develop GI complications. Assess risk according to individual risk factors eg, age (>65 yr), history of gastric or duodenal ulcer or upper GI bleeding. May reduce absorption of vit B12 due to hypo- or achlorydria. Patients should be kept under regular surveillance in long-term treatment especially when exceeding 1 yr. Investigate patients who do not respond after 4 wk. Not indicated for mild GI complaints eg, nervous dyspepsia. IV administration is recommended only if oral application is not appropriate. Patients should not drive or operate machines when dizziness & visual disturbances occur. Severe liver impairment. Avoid use during pregnancy. Lactation. Not recommended for childn <5 yr. 40 mg daily dose should not be exceeded in elderly patients or w/ impaired renal function.
Adverse Reactions
Benign fundic gland polyps; inj site thrombophlebitis.
Drug Interactions
May interfere w/ absorption of azole antifungals eg, ketoconazole, itraconazole, posaconazole & erlotinib. Significant reduction in bioavailability w/ atazanavir. Increased INR & prothrombin time w/ warfarin or phenprocoumon. Increase methotrexate levels. Increased systemic exposure w/ fluvoxamine. May reduce plasma conc w/ rifampicin & St. John's wort.
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
Pantoloc EC tab 40 mg
Packing/Price
14's (P1,388.6/pack)
Form
Pantoloc EC tab 20 mg
Packing/Price
14's (P956.26/pack)
Form
Pantoloc powd for inj 40 mg
Packing/Price
1's (P955.24/vial)
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