Gentamicin products: information for supporting intrathecal risk assessment

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

Gentamicin 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.

Zentiva

Gentamicin Intrathecal

Strength

5 mg/mL in 1mL ampoules

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.

Advanz (Genticin®)

Strength

40 mg/mL in 2mL ampoules

Excipients

Water for injection, sulfuric acid

Osmolarity

No information

pH

3.0 – 5.5

Endotoxin content

≤ 28.4 EU/mg

B.Braun

Strength

1 mg/mL in 80mL bottles

Excipients

Sodium chloride, water for injection

Osmolarity

No information

pH

3.0 – 5.5

Endotoxin content

No information

Strength

3 mg/mL in 80mL bottles
3 mg/mL in 120mL bottles

Excipients

Disodium edetate, sodium chloride, water for injection

Osmolarity

No information

pH

3.0 – 5.5

Endotoxin content

No information

Ennogen

Gentamicin Paediatric

Strength

10 mg/mL in 2mL ampoules

Excipients

Sodium metabisulphite, sodium edetate, sodium citrate, citric acid, water for injection

Osmolarity

No information

pH

3.0 – 5.5

Endotoxin content

No information

Hospira

Strength

40 mg/mL in 2mL vials

Excipients

Sodium metabisulphite, disodium edetate, methyl hydroxybenzoate, propyl hydroxybenzoate, water for injection, sulphuric acid (2.5N), sodium hydroxide (2.5N)

Osmolarity

No information

pH

3.0 – 5.5

Endotoxin content

No information

Noriderm

Strength

20 mg/mL in 2mL ampoules
40 mg/mL in 2mL ampoules
80 mg/mL in 2mL ampoules

Excipients

Disodium edetate, Sodium metabisulfite (E223), sodium hydroxide 1 N (for pH adjustment), sulfuric acid 0.5 M (for pH adjustment), water for injection

Osmolarity

80 – 90 mOsmol/kg

pH

3.0 – 5.5

Endotoxin content

No information

Panpharma

Strength

40 mg/mL in 2mL ampoules

Excipients

Disodium edetate, sodium chloride, sulfuric acid (for pH adjustment), water for injection

Osmolarity

No information

pH

3.0 – 5.5

Endotoxin content

No information

Sanofi (Cidomycin®)

Strength

40 mg/mL in 2mL ampoules or vials

Excipients

Sodium chloride, water for injection, 2N sodium hydroxide (for pH adjustment), 2N sulphuric acid (for pH adjustment)

Osmolarity

No information

pH

3.0 – 5.5

Endotoxin content

No information

Wockhardt

Strength

10 mg/mL in 2mL ampoules
40 mg/mL in 2mL ampoules

Excipients

Sodium metabisulfite (E223), sulfuric acid (10%) or sodium hydroxide (for pH adjustment), water for injection

Osmolarity

No information

pH

3.0 – 5.5

Endotoxin content

No information

Zentiva

Gentamicin Paediatric

Strength

10 mg/mL in 2mL vials

Excipients

Sodium chloride, 2M sodium hydroxide, 1M sulphuric acid, water for injection

Osmolarity

No information

pH

3.0 – 5.5

Endotoxin content

< 0.71 EU/mg

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