Vancomycin products: information for supporting intrathecal risk assessment

John Minshull, Deputy Director, London Medicines Information Service, Specialist Pharmacy ServicePublished

Vancomycin products vary in their licensed status and other characteristics which affects their suitability for intrathecal administration

Licensed for intrathecal use

Products licensed for intrathecal use are the first line option and should be used wherever suitable.

There are currently no known vancomycin products licensed for intrathecal administration.

Not licensed for intrathecal use, limited information available

Products with partial information that are not licensed for intrathecal administration can still sometimes be used. Refer to the advice in our article and complete a risk assessment to enable you to interpret the details below and choose an appropriate product.

Bowmed

Strength

1000mg vial
500mg vial

Excipients

Sodium hydroxide and hydrochloric acid (for pH adjustment)

Osmolarity

275 – 276 mOsmol/kg

pH

2.5 – 4.5

Endotoxin content

≤ 0.25 EU/mg

Flynn Pharma (Vancocin®)

Strength

1000mg vial
500mg vial

Excipients

No information

Osmolarity

No information

pH

2.5 – 4.5

Endotoxin content

≤ 0.25 EU/mg

Generics/Mylan

Strength

500mg vial

Excipients

Sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment)

Osmolarity

No information

pH

2.5 – 4.5

Endotoxin content

No information

Strength

1000mg vial

Excipients

Sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment)

Osmolarity

No information

pH

2.5 – 4.5

Endotoxin content

≤ 0.25 EU/mg

Hikma Farmaceutica

Strength

500mg vial
1000mg vial

Excipients

None

Osmolarity

No information

pH

2.5 – 4.5

Endotoxin content

≤ 0.25 EU/mg

Laboratorios Azevedos

Strength

500mg vial

Excipients

Sodium hydroxide and hydrochloric acid (for pH adjustment)

Osmolarity

No information

pH

2.5 – 4.5

Endotoxin content

No Information

Strength

1000mg vial

Excipients

Sodium hydroxide and hydrochloric acid (for pH adjustment)

Osmolarity

No information

pH

2.5 – 4.5

Endotoxin content

≤ 0.25 EU/mg

MIP Pharma

Strength

1000mg vial
500mg vial

Excipients

None

Osmolarity

249 – 291 mOsmol/kg (5mg in 1mL concentration in glucose 5% or sodium chloride 0.9%)

pH

2.5 – 4.5

Endotoxin content

No information

Noriderm

Strength

500mg vial
1000mg vial

Excipients

Hydrochloric acid (for pH adjustment) 

Osmolarity

No information

pH

2.5 – 4.5

Endotoxin content

No information

Reig Jofre

Strength

500mg vial
1g vial

Excipients

None

Osmolarity

No information

pH

2.5 – 4.5

Endotoxin content

0.33 EU/mg

Wockhardt

Strength

500mg vial
1g vial

Excipients

None

Osmolarity

No information

pH

2.5 – 4.5

Endotoxin content

No information

Unlicensed ‘Special’, specified for intrathecal use

Unlicensed medicines that are manufactured in MHRA-licensed Specials Manufacturing Units, at the request of an authorised healthcare professional specifically for intrathecal use.

Barts and The London NHS Trust – specials manufacturing unit

Vancomycin Intrathecal Injection

Strength

20mg in 4mL PFS

Newcastle Specials Pharmacy Production Unit – Royal Victoria Infirmary

Vancomycin Intrathecal Injection

Strength

20mg in 4mL PFS

Royal Liverpool Hospitals Foundation Trust

Vancomycin Intrathecal Injection

Strength

20mg in 4mL PFS

All our intrathecal product resources

Understand what to consider when giving medicines via the intrathecal route and use our material to help inform your risk assessment

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Vancomycin products vary in their licensed status and other characteristics which affects their suitability for intrathecal administration
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