Pantocid I.V.

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Pantoprazole sodium sesquihydrate 45.12mg equivalent to pantroprazole 40.0 mg (2% manufacturing overage not included)

Available from:

PSM Healthcare Ltd trading as API Consumer Brands

INN (International Name):

Pantoprazole sodium sesquihydrate 45.12 mg (equivalent to pantroprazole 40.0 mg (2% manufacturing overage not included))

Dosage:

40 mg

Pharmaceutical form:

Powder for injection

Composition:

Active: Pantoprazole sodium sesquihydrate 45.12mg equivalent to pantroprazole 40.0 mg (2% manufacturing overage not included)

Units in package:

Vial, glass, Type I 10 mL with bromobutyl stopper and flip off cap. carton of 1 vial, 1 dose unit

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Sun Pharmaceutical Industries Ltd

Product summary:

Package - Contents - Shelf Life: Vial, glass, Type I 10 mL with bromobutyl stopper and flip off cap. carton of 1 vial - 1 dose units - 24 months from date of manufacture stored at or below 25°C protect from light 3 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Authorization date:

2007-06-06

Summary of Product characteristics

DATA SHEET 
PANTOCID I.V.
®

_PANTOPRAZOLE POWDER FOR INJECTION _
PRESENTATION 
Pantocid  I.V.  is  available  as  single  vials  of  Pantoprazole  for  Injection  40  mg.  Each 
vial  of  Pantocid  I.V.  contains  45.12  mg  pantoprazole  sodium  sesquihydrate 
(equivalent to pantoprazole 40mg) as lyophilized powder.  
The molecular weight of pantoprazole sodium is 405.5. Pantoprazole is a substituted 
benzimidazole  which  inhibits  basal  and  stimulated  gastric  secretion.  Pantoprazole 
sodium  is  a  white  to  off-white  amorphous  hygroscopic  powder.  Solubility  is  low  at 
neutral pH and increases with increasing pH. 
PHARMACOLOGY 
_PHARMACODYNAMICS _
Pantoprazole  is  a  proton  pump  inhibitor  (PPI).  It  inhibits  specifically  and  dose-
proportionately  H+/K+-ATPase,  the  enzyme  which  is  responsible  for  gastric  acid 
secretion in the parietal cells of the stomach. 
The  substance  is  a  substituted  benzimidazole  which  accumulates  in  the  acidic 
environment  of  the  parietal  cells  after  absorption.  There,  it  is  converted  into  the 
active form, a cyclic sulphenamide which binds to the H+/K+-ATPase, thus inhibiting 
the  proton  pump  and  causing  potent  and  long-lasting  suppression  of  basal  and 
stimulated gastric acid secretion. As pantoprazole acts distal to the receptor level, it 
can  influence  gastric  acid  secretion  irrespective  of  the  nature  of  the  stimulus 
(acetylcholine, histamine, gastrin). Oral and intravenous pantoprazole 40 mg/day for 
5 days had equivalent effect on intra-gastric pH in 20 healthy adult male volunteers 
in  a  randomised,  open,  2-period  crossover  trial  with  14-day  wash-out.  The  pre-
defined