Amikacin products: information for supporting intrathecal risk assessment

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

Amikacin 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 no amikacin 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.

Hospira

Strength

250 mg/mL in 2mL vials

Excipients

Sodium citrate, sodium metabisulfite (E223), water for injection

Osmolarity

No information

pH

3.5 – 5.5

Endotoxin content

No information

Neon Healthcare

Strength

250 mg/mL in 2mL vials

Excipients

Sodium metabisulfite (E223), sodium citrate, sulfuric acid, water for injection

Osmolarity

No information

pH

3.5 – 5.5

Endotoxin content

No information

Tillomed Laboratories

Strength

250 mg/mL in 2mL vials

Excipients

Sodium metabisulfite (E223), sodium citrate dihydrate, sulfuric acid, water for injection

Osmolarity

No information

pH

3.5 – 5.5

Endotoxin content

No information

Vianex

Strength

50 mg/mL in 2mL vials

Excipients

Sodium metabisulfite (E223), sodium citrate, sulfuric acid, water for injection

Osmolarity

365 mOsmol/L

pH

3.5 – 5.5

Endotoxin content

≤ 0.33 EU/mg

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.

Royal Liverpool Hospitals NHS Foundation Trust

Amikacin Intrathecal Injection in sodium chloride 0.9%

Strength

25mg / 5mL

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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