Cloxabiotic (Cloxacillin Sodium BP) 500 mg Injection [ MAL08021485AZ ] and Appropriate Diluent

 Based on the latest product leaflet for Cloxabiotic (Cloxacillin Sodium BP) Injection - strength 500 mg, MAL08021485AZ [revised 12 Feb 2018], the stability data found in the leaflet is as follow:

 1. Stability of the reconstituted solution cloxacillin injection is unstable in concentrated solution and, when prepared for intramuscular or direct intravenous injection, should be used within 30 minutes of preparation. Cloxacillin is compatible with most commonly-used intravenous fluids.

 Based on the in-use stability studies performed by the manufacturer, the following solutions were used:

* Water for injection * Dextrose 5% in water for injection * Fructose 10% in water for injection * M/6 sodium lactate solution * 0.9% NaCl solution

 

2. Cloxacillin for Injection is compatible at concentrations of 1 and 2 mg/mL :

 

Diluent	Controlled Room Temperature   (Not Exceeding 25°C)	Refrigerated  Conditions 2°C to 8°C	Reference
·       Dextrose 5% in water ·       Fructose 10% in water ·       M/6 sodium lactate	12 hrs after reconstitution	48 hrs after reconstitution	Product leaflet for Cloxabiotic (Cloxacillin Sodium BP) 500 mg Injection - MAL08021485AZ [Revised 12 Feb 2018]
Sodium Chloride 0.9%	24 hrs after reconstitution	48 hrs after reconstitution	In-used Stability Data from Manufacturer, Averroes Pharmaceuticals [E-mail reply, received on 22/02/2021]