Panvell

Panvell

pantoprazole

Manufacturer:

PT Novell

Distributor:

Prosweal Healthcare
Concise Prescribing Info
Contents
Pantoprazole (as Na sesquihydrate)
Indications/Uses
Reflux esophagitis, gastric & duodenal ulcer, Zollinger-Ellison syndrome & other pathological hypersecretory conditions. Tab: Reflux esophagitis for adults & adolescents ≥12 yr; eradication of H. pylori in combination w/ appropriate antibiotic therapy in adult patients w/ H. pylori associated ulcers.
Dosage/Direction for Use
Tab Adult & adolescents ≥12 yr Reflux oesophagitis 1 tab once daily may be increased to 2 tabs daily. Adult Eradication of H. pylori in combination w/ two appropriate antibiotics Depending upon the resistance pattern, the following combinations may be given a) 1 tab bid + 1000 mg amoxicillin bid + 500 mg clarithromycin bid; b) one tab bid + 400-500 mg metronidazole (or 500 mg tinidazole) bid + 250-500 mg clarithromycin bid; c) one tab bid+ 1000 mg amoxicillin bid + 400-500 mg metronidazole (or 500 mg tinidazole) bid. Combination therapy is implemented for 7 days may be prolonged for up to total of 2 wk. Gastric & duodenal ulcer 1 tab daily, may be increase up to 2 tab daily. Zollinger-Ellison-syndrome & other pathological hypersecretory conditions Initially 80 mg daily, may be titrated as needed up to 160 mg. Patients w/ hepatic impairment 20 mg daily. IV Reflux esophagitis, gastric & duodenal ulcer 40 mg/day. Zollinger-Ellison syndrome & other pathological hypersecretory conditions Initially, 80 mg/day, can be titrated as needed. Severe liver impairment Max: 20 mg/day.
Administration
Should be taken on an empty stomach: Take 1 hr before meals. Swallow whole, do not chew/crush.
Contraindications
Hypersensitivity to pantoprazole or substituted benzimidazoles.
Special Precautions
Monitor liver enzymes in long-term use. Concomitant use w/ vit B12. Increased risk of GI infections caused by Salmonella & Campylobacter or C. difficile. Risk of severe hypomagnesaemia; measure Mg levels before starting PPI treatment & periodically during treatment; hip, wrist & spine fractures in older people w/ long term use (>1 yr). May effect the ability to drive & use machine. Pregnancy & lactation. Childn ≤18 yr. Tab: May mask gastric malignancy. Co-administration w/ HIV PIs. Discontinue if sub-acute cutaneous lupus erythematosus occurs. Stop for at least 5 days before CgA measurements; if CgA & gastrin levels have not returned to reference range after initial measurement, repeat test 14 days after cessation. IV: Concomitant use w/ atazanavir. Monitor prothrombin time in concomitant use w/ phenprocoumon or warfarin.
Adverse Reactions
Benign fundic gland polyps. IV: Increased liver enzymes (transaminases, γ-GT).
Drug Interactions
May reduce absorption of drugs w/ a gastric pH-dependent bioavailability eg, azole antifungals (ketoconazole, itraconazole, posaconazole) & erlotinib. Substantial reduction in the bioavailability of HIV medications eg, atazanavir. Increased levels of MTX (at high dose eg, 300 mg). May reduce absorption of vit B12. Monitor prothrombin time/INR in patients treated w/ coumarin anticoagulants eg, phenprocoumon, warfarin. Tab: Increase systemic exposure w/ CYP2C19 inhibitors (eg, fluvoxamine). Reduced plasma conc w/ CYP2C19 & CYP3A4 inducers (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
Panvell EC tab 40 mg
Packing/Price
10's
Form
Panvell powd for inj 40 mg
Packing/Price
1's
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