Question

A medication label contains the following information:

Cytarabine, USP
500 mg
When reconsituted with 10 mL Bacteriostatic Water for Injection, USP with benzyl alcohol, each mL contains 50 mg cytarabine. Do not use a diluent containing benzyl alcohol for intrathecal and high dose investigational use.

Store both powder and reconstituted solution at controlled room temperature (20
to 25
C).
Use reconstituted solution within 48 hours.

If reconstituted with bacteriostatic water for injection with benzyl alcohol, can this be used for intrathecal injection?

Answer 1

Cytarabin is an antineoplastic drug( chemotherapy drug) and it causes bone marrow suppression. When it is needed to use intrathecaly, it should not be reconstituted with its given diluent( bacteriostatic water for injection with benzyl alcohol)due to increased risk for adverse neurological effect. When a drug to be given intrathecal, it should not contain any presevatives( such as benzyl alcohol and paraben containing compounds). For intrathecal administration, it should be reconstituted with preservative free 0.9% sodium chloride USP or autologus spinal fluid.