Proton-P

Proton-P

pantoprazole

Manufacturer:

Aristopharma

Distributor:

KTZ
Full Prescribing Info
Contents
Pantoprazole.
Description
Each vial contains lyophilized pantoprazole sodium sesquihydrate USP equivalent to pantoprazole 40 mg.
Action
Pharmacology: Pantoprazole is a specific inhibitor of the gastric proton pump (H+/K+-ATPase) in the parietal cell. It inhibits acid secretion by binding to the H+/K+-ATPase enzyme.
Indications/Uses
When oral therapy is not appropriate eg, duodenal ulcer, gastric ulcer, reflux esophagitis, gastrointestinal lesion refractory to H2-blockers, Zollinger-Ellison syndrome and maintenance of healed reflux esophagitis.
Dosage/Direction for Use
Duodenal Ulcer, Gastric Ulcer, Gastrointestinal Lesions Refractory to H2-blockers and Zollinger-Ellison syndrome: 40 mg daily.
Reflux Esophagitis: 20-40 mg daily.
Administration: Injection: Pantoprazole IV injection is obtained by adding 10 mL sodium chloride 0.9% injection to the vial containing powder. After reconstitution the injection should be given slowly over a period of at least 2 min. The injection should be used within 6 hrs of reconstitution when stored at room temperature. Besides the resulting injection should be used within 12 hrs when stored at 2°-8°C.
Infusion: Pantoprazole IV infusion should be reconstituted with 10 mL of sodium chloride 0.9% injection and further diluted with 100 mL sodium chloride 0.9% injection or 5% dextrose injection. The reconstituted infusion maybe stored for up to 24 hrs at room temperature after reconstitution. The reconstituted infusion should be administered intravenously over a period of 15 min.
Contraindications
Known hypersensitivity to pantoprazole sodium sesquihydrate or any excipients of Proton-P.
Special Precautions
Proton-pump inhibitors should be used with caution in patients with liver disease, in pregnancy and breastfeeding, before treatment the presence of gastric malignancy should be excluded. No problem with pantoprazole that has been encountered in clinical use with elderly patients. No dosage adjustment of pantoprazole is required in patients with renal impairment but prolongation of metabolism leading to a slight rise in peak plasma levels occurs in hepatic cirrhosis and it is recommended that the dosing is reduced to every other day.
Use in pregnancy: Pregnancy Category B: Proton-P should be used during pregnancy only if clearly needed.
Use in lactation: Pantoprazole is likely to be excreted in human milk, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of Proton-P to the mother.
Use in children: There are no data currently available on the use of pantoprazole in children.
Use In Pregnancy & Lactation
Use in pregnancy: Pregnancy Category B: Proton-P should be used during pregnancy only if clearly needed.
Use in lactation: Pantoprazole is likely to be excreted in human milk, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of Proton-P to the mother.
Adverse Reactions
Adverse effects of proton-pump inhibitors include gastrointestinal disturbances (including diarrhoea, nausea and vomiting, constipation, flatulence, abdominal pain), headache, hypersensitivity reactions (including rash, urticaria, angioedema, bronchospasm), pruritus, dizziness, peripheral edema, muscle and joint pain, malaise, blurred vision, depression and dry mouth.
Drug Interactions
Pantoprazole does not react with the cytochrome P-450 system. No drug interaction has been reported in a large series of studies examining reactions with contraceptives, diazepam, diclofenac, ethanol, caffeine, metoprolol, theophylline, digoxin, phenytoin, nifedipine and warfarin.
Storage
Store below 30°C. Protect from light.
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
Soln for inj (vial) 40 mg x 1's + amp 10 mL.
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