RiteMED Pantoprazole

RiteMED Pantoprazole

pantoprazole

Manufacturer:

Standard Chem

Distributor:

RiteMED
Concise Prescribing Info
Contents
Pantoprazole Na sesquihydrate
Indications/Uses
Gastric & duodenal ulcer, moderate & severe reflux esophagitis; Zollinger-Ellison syndrome & other pathological hypersecretory conditions; treatment of bleeding peptic ulcer & prevention of re-bleeding; prophylaxis of acute bleeding stress ulcer.
Dosage/Direction for Use
Gastric & duodenal ulcer, moderate & severe reflux esophagitis 40 mg/day. Management of reflux esophagitis Administer either by slow IV inj over 2-5 min or by IV infusion over 15 min. Zollinger-Ellison syndrome & other pathological hypersecretory conditions Initially 80 mg/day IV inj. Daily doses >80 mg should be administered in 2 divided doses. Rapid acid control Initially 160 mg to decrease acid output into the target range (<10 mEq/hr) w/in 1 hr. Treatment of bleeding peptic ulcer & prevention of re-bleeding 80 mg IV bolus followed by 8 mg/hr infusion for 3 days. Prophylaxis of acute bleeding stress ulcer 40-80 mg once daily or bid as bolus for at least 2 min or as infusion for 15 min. Elderly Max: 40 mg daily dose. Severe hepatic impairment Max: 20 mg daily dose. Renal impairment Max: 40 mg daily dose.
Contraindications
Hypersensitivity to pantoprazole or other PPI. In combination treatment for eradication of H. pylori in patients w/ moderate to severe renal & hepatic impairment. Patients receiving atazanavir.
Special Precautions
Not indicated for mild GI complaints eg, nervous dyspepsia. Do not administer concomitantly w/ other medications through the same IV line. Always flush w/ either 0.9% NaCl or 5% dextrose soln before & after administration. Discontinue IV administration as soon as oral treatment is possible. Monitor liver enzymes of patients w/ severe hepatic impairment, particularly on long-term use. Discontinue treatment if liver enzymes increased. Exclude malignancy when gastric ulcer is suspected or present. Discontinue if acute interstitial nephritis develops or subacute cutaneous lupus erythematosus occurs. Increased risk of GI infections eg, Salmonella & Campylobacter; C. difficile-associated diarrhea. High-dose & long-term therapy may increase risk for osteoporosis-related fractures of the hip, wrist or spine. Hypomagnesemia; consider monitoring Mg levels prior to initiation of treatment & periodically. May contribute to the development of cyanocobalamin deficiency in prolonged use (eg, >3 yr). Atrophic gastritis in long-term use particularly in patients w/ H. pylori. Increased risk of developing community-acquired pneumonia. Anaphylaxis & other serious reactions eg, erythema multiforme, SJS, & TEN. False +ve urine screening tests for tetrahydrocannabinol. Engaging in activities requiring alertness eg, operating machinery or driving a car. Hepatic & renal impairment. Pregnancy & lactation. Childn <1 yr.
Adverse Reactions
Headache, diarrhea, flatulence, abdominal pain, nausea, constipation, dyspepsia, insomnia, vomiting, & dizziness.
Drug Interactions
Decreased plasma conc of atazanavir, nelfinavir or rilpivirine. Increased conc of saquinavir or raltegravir. May decrease absorption of ketoconazole, ampicillin esters, atazanavir, Fe salts, erlotinib, & mycophenolate mofetil. Reduced mycophenolic acid exposure. May increase plasma conc w/ fluvoxamine. May decrease plasma conc w/ rifampicin & St. John's wort. Increased INR & prothrombin time w/ warfarin. May reduce exposure to the active metabolite & decrease platelet inhibitory effects of clopidogrel. Increased risk of hypomagnesemia w/ digoxin or drugs that may cause hypomagnesemia (eg, loop or thiazide diuretics). May elevate & prolong serum levels of MTX &/or its metabolite hydroxymethotrexate. Delayed absorption & decreased bioavailability w/ sucralfate.
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
RiteMED Pantoprazole powd for inj 40 mg
Packing/Price
10 × 1's (P7,300/box, P730/vial)
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