Pantoloc潘妥洛克

Pantoloc

pantoprazole

Manufacturer:

Takeda

Distributor:

Zuellig
/
Firma Chun Cheong
Concise Prescribing Info
Contents
Pantoprazole Na
Indications/Uses
20-mg tab: Symptomatic GERD, & long-term management & prevention of relapse in reflux oesophagitis in adults & adolescents ≥12 yr. Prevention of gastroduodenal ulcers induced by nonselective NSAIDs in adults at risk w/ a need for continuous NSAID treatment. 40-mg tab: Reflux oesophagitis in adults & adolescents ≥12 yr. Eradication of H. pylori in combination w/ appropriate antibiotic therapy in adult patients w/ H. pylori-associated ulcers; gastric & duodenal ulcer, Zollinger-Ellison syndrome & other pathological hypersecretory conditions in adults. IV: Reflux oesophagitis. Gastric & duodenal ulcer. Zollinger-Ellison syndrome & other hypersecretory conditions.
Dosage/Direction for Use
20-mg tab Adult & adolescent ≥12 yr Symptomatic GERD One 20-mg tab daily. Long-term management & prevention of relapse in reflux oesophagitis One 20-mg tab daily, increased to 40 mg daily if a relapse occurs. Adult Prevention of gastroduodenal ulcers induced by nonselective NSAIDs in patients at risk w/ a need for continuous NSAID treatment One 20-mg tab daily. Patients w/ severe hepatic impairment Max: 20 mg daily. 40-mg tab Adult & adolescent ≥12 yr Reflux oesophagitis 1 tab (40 mg) daily for 4 wk, may be increased to 2 tab daily. Adult Eradication of H. pylori in combination w/ 2 appropriate antibiotics 1 tab (40 mg) bd w/ combination of amoxicillin 1,000 mg bd & clarithromycin 500 mg bd; or w/ combination of metronidazole 400-500 mg (or tinidazole 500 mg) bd & clarithromycin 250-500 mg bd; or w/ combination of amoxicillin 1,000 mg bd & metronidazole 400-500 mg (or tinidazole 500 mg) bd. Gastric ulcer 1 tab (40 mg) daily for 4 wk, may be increased to 2 tab daily. Duodenal ulcer 1 tab (40 mg) daily for 2 wk, may be increased to 2 tab daily. Zollinger-Ellison syndrome & other pathological hypersecretory conditions Initially 80 mg daily & should be adapted according to clinical needs. IV Gastric & duodenal ulcer, reflux oesophagitis 40 mg daily. Zollinger-Ellison syndrome & other pathological hypersecretory conditions Initially 80 mg daily for long-term management, titrated up or down as needed. For doses >80 mg daily, divide dose & give bd. For rapid acid control, starting dose of 2 x 80 mg w/in 1 hr. Patient w/ severe liver impairment Max: 20 mg daily.
Administration
Tab: Should be taken on an empty stomach: Take 1 hr before meals. Swallow whole, do not chew/crush.
Contraindications
Hypersensitivity to the active substance substituted benzimidazoles.
Special Precautions
May mask symptoms of gastric malignancy. Risk of GI infections; osteoporosis-related fractures of the hip, wrist, or spine (in long term & multiple daily dose); symptomatic or asymptomatic hypomagnesemia; subacute cutaneous lupus erythematosus. Increased Chromogranin A (CgA) level may interfere w/ investigations for neuroendocrine tumors. Not recommended to be co-administered w/ HIV PIs. Regularly monitor liver enzymes, particularly on long-term use, or in patients w/ severe liver impairment. Avoid use during pregnancy. Discontinue breast-feeding or discontinue/abstain from therapy taking into account the benefit of breast-feeding for the child & the benefit of therapy for the woman. 20- & 40-mg tab: In patients w/ Zollinger-Ellison-Syndrome & other pathological hypersecretory conditions requiring long-term treatment, pantoprazole may reduce vit B12 absorption due to hypo- or achlorhydria. Patients on long-term treatment should be kept under regular surveillance especially when exceeding a treatment period of 1 yr. Not recommended in childn <12 yr. 20-mg tab: Discontinue use if lesions occur, especially in sun exposed areas of the skin, & if accompanied by arthralgia; for at least 5 days before CgA measurements to avoid interference w/ lab tests. Exclude malignancy when gastric ulcer is suspected/present. Consider monitoring of Mg levels prior to treatment initiation & periodically. Adequate vit D & Ca intake in patients at risk of osteoporosis. Patients should use lowest dose & shortest duration of therapy appropriate to the condition being treated. Use w/ NSAIDs should be restricted to patients who require continued NSAID treatment & have an increased risk to develop GI complications. May affect ability to drive & use machines. 40-mg tab: Must not be used in combination treatment for eradication of H. pylori in patients w/ moderate to severe hepatic dysfunction or patients w/ impaired renal function. IV: Not recommended in childn <18 yr.
Adverse Reactions
Benign fundic gland polyps. 20- & 40-mg tab: Diarrhoea, headache. IV: Inj site thrombophlebitis.
Drug Interactions
May interfere w/ absorption of pH-dependent medicinal products eg, some azole antifungals (eg, ketoconazole, itraconazole, posaconazole) & other medicine (eg, erlotinib). Reduction in bioavailability of HIV PIs eg, atazanavir. Increased INR & prothrombin time w/ coumarin anticoagulants eg, warfarin or phenprocoumon. May elevate & prolong serum levels of MTX &/or its metabolite. May increase systemic exposure w/ CYP2C19 inhibitors eg, fluvoxamine. May reduce plasma conc w/ CYP2C19 & CYP3A4 inducers eg, rifampicin & St. John's wort.
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
Pantoloc inj 40 mg
Packing/Price
1's
Form
Pantoloc tab 20 mg
Packing/Price
14's
Form
Pantoloc tab 40 mg
Packing/Price
14's
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