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Monday, June 15, 2015

Dilution Protocols For PPIs

Esomeprazole
Product
Reconstitution
Compatible Diluents
Esomeprazole 40 mg (Nexium)
Powder form
Reconstitution:
Add 5 ml of NaCl 0.9% into vial
NaCl 0.9%
Dextrose 5%

Dilution & Administration Method
Stability
Remarks
IV BOLUS:
Reconstituted (5 ml) Esomeprazole powder.
To be infused: > 3 mins 

IV INFUSION (INTERMITTENT):
Further dilute in 50-100 ml of compatible diluents
To be infused:
20-40 mg: 10-30 mins
80 mg: 30 mins

*40mg infusion – 1 vial in 100ml of diluents
80mg infusion– 2 vials of 40mg  in 100ml of diluents

Stability of reconstituted solution
Room: 12 hrs

Stability of diluted solution
NaCl 0.9%
Room: 12 hrs

Dextrose 5%
Room: 6 hrs

Physicochemical stability
Prepared solution can be exposed to normal lighting at a maximum of 30°C
Refrigeration is not required following reconstitution

Do not mix or co-administer in the same infusion set with any other drug

Only reconstitute the powder with the specified volume of NaCl 0.9%

Flush IV line with NaCl 0.9% or Dextrose 5% before and after esomeprazole sodium

The reconstituted solution for injection is clear & colourless to very slightly yellow. Only clear solution should be used

Pantoprazole
Product
Reconstitution
Compatible Diluents
Pantoprazole sodium
40 mg
(Pantocid i.v.)
Powder form
Reconstitution:
Add 10ml of NaCI 0.9% into vial
NaCl 0.9%
5% glucose

Dilution & Administration Method
Stability
Remarks
IV BOLUS
May be infused undiluted.
To be infused: 2 mins.
Max concentration:
4 mg/ml

IV INFUSION (INTERMITTENT)
Further dilute in 100 ml of compatible diluents.
To be infused: 15 mins
Max administration rate:
7 ml/min (3 mg/min)
Max concentration:
0.8 mg/ml.

IV CONTINUOUS INFUSION 24 Hr:
Further dilute (80 mg) in 50 ml of compatible diluent.
To be infused:
8 mg/hr
Max concentration:
0.4 mg/ml (to be confirmed)
Stability of reconstituted solution
Room: 6 hrs

Stability of diluted solutions 
Room: 12 hrs 

Physiochemical stability
The solution must have a pH of 9
Flush I.V. line before and after administration with either NaCl or lactated Ringer’s solution.

Not compatible with Midazolam and products containing zinc.

Omeprazole
Product
Reconstitution
Compatible Diluents
Omeprazole 40mg
(Omezol Lyo)
Powder form
Reconstitution :
Add 10 ml of solvent provided
*No other infusion solution should be used
Provided together in the box

Dilution & Administration Method
Stability
Remarks
IV BOLUS:
Inject over a period of not less than 2.5 minutes
Rate – not greater than 4ml/min
*Based on product leaflet, there are no recommendation for infusion
*However based on other guidelines, infusion omeprazole can be made by :

Initially 80mg IV; given as 40mg omeprazole in 100ml sodium chloride 0.9% infused over 20 – 30 minutes, then repeat.
Followed by IV continuous infusion of 8mg/hr for 72 hours.Given as 40mg omeprazole in100ml sodium chloride 0.9% or 5% dextrose ; infuse at 20ml (8mg) per hour over 5 hours for a total
of 72 hours.
Stability of reconstituted solution
Below 25°C and use within 4 hours

Stability of infusion is 5 hours
____
  
IV Omeprazole may ONLY be used for the following:
  • Patients who are haemodynamically unstable with major haematemesis and/or brisk melaena awaiting urgent endoscopy. 
  • Patients, who at endoscopy, are found to have a peptic ulcer deemed to be at high risk of rebleeding and have had endoscopic therapy. 
  • These are actively bleeding ulcers or non-bleeding ulcers with a visible vessel.

IV PPIs SHOULD NOT be used for:
  • Patients who can eat or drink or take other oral medicationsPatients who are nil by mouth/awaiting surgery 
  • Prescribe Ranitidine 50mg tds IV or if these patients are deemed to require a PPI they should be prescribed Lansoprazole FasTab 30mg daily. 
  • These tablets can be dissolved on the tongue and are swallowed with the patient’s own saliva.
Patients with NG or PEG tubes  
  • Lansoprazole FasTabs (may be dispersed in water) or Ranitidine Liquid may be given via these routes. Dose should be according to indication. 
REFERENCE:
HQE Dilution Protocol
Product Leaflet
http://www.gwh.nhs.uk/media/150907/1-policy_for_use_of_iv_ppis-reviewed-aug2009.pdf 

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