PANTOPRAZOLE SODIUM FOR INJECTION 40 MG

DESCRIPTION:

The active ingredient in PROTONIX® I.V. (pantoprazole sodium) for Injection is a substituted benzimidazole, sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl] sulfinyl]-1Hbenzimidazole, a compound that inhibits gastric acid secretion. 

PANOTOX for Injection is supplied as a freeze-dried powder in a clear glass vial fitted with a rubber stopper and crimp seal containing Pantoprazole sodium, equivalent to 40 mg of pantoprazole.

MECHANISM OF ACTION:

Pantoprazole is a Proton Pump Inhibitor (PPI) that suppresses the final step in gastric acid production by covalently binding to the (H+, K+)-ATPase enzyme system at the secretory surface of the gastric parietal cell. This effect leads to inhibition of both basal and stimulated gastric acid secretion irrespective of the stimulus. The binding to the (H+, K+)-ATPase results in a duration of antisecretory effect that persists longer than 24 hours for all doses tested. 



INDICATIONS:

PANOTOX is indicated for the treatment of gastric ulcer, duodenal ulcer, moderate and severe reflux oesophagitis. 

DOSAGE AND ADMINISTRATION: 

Route of Administration: For IV use only 

Dosage: 

PANOTOX is recommended only in cases where the oral administration is not indicated. The recommended dose is intravenous administration of the content of one vial ( 40 mg Pantoprazole ) once daily for 7 days. 

Duodenal Ulcer:

Duodenal Ulcers generally heal within 2 weeks. If a 2-week period of treatment is not sufficient, healing will be achieved in almost all cases within a further 2 weeks. 

Gastric Ulcer & Gastro-oesophageal reflux: A 4 week period is usually required for the treatment of gastric ulcers & gastro-oesophageal reflux. If this is not sufficient, healing will usually be achieved within a further 4 weeks. 

Elderly: No dose adjustment is necessary in the elders.

Patients with Impaired Renal Function: No dose adjustment is necessary in patients with impaired renal function. 

Patients with Impaired Hepatic Function: In patients with severe liver impairments, the daily dose should be reduced to 20 mg Pantoprazole. Also, in these patients the liver enzymes should be monitored during PANOTOX therapy. In case of liver enzymes, it should be discontinued. 

DIRECTION FOR RECONSTITUTION: 

The content of the vial needs to be reconstituted with 10 ml of Sodium Chloride Injection BP 0.9% w/v before injection.

This freshly prepared solution should be administered intravenously over 2 to 15 minutes, either as a slow injection or it may be further diluted with 100 ml of Sodium Chloride Injection BP 0.9 % w/v or 5% Glucose Injection and administered as a short term infusion.

The duration of administration should be 2 to 15 minutes. The reconstituted solution must be used within 12 hours of preparation. 

Adverse Effects:

Treatments with Pantoprazole can occasionally lead to headache or diarrhea. Rarely nausea/vomiting, abdominal pain, flatulence, constipation, allergic reactions such as skin rash and pruritus may occur. Individual cases of oedema, blurred vision, fever, dizziness, thrombophlebitis, depression or myalgia subsiding after termination of therapy have been reported. 


Contraindications: PANOTOX is contra indicated in patients with known hypersensitivity to the formulation.

Presentation: PANOTOX is available as Box of one 10 ml vial with 10 ml Sodium Chloride Injection BP as diluent.