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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 / osmolality

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 / osmolality

No information

pH

5.0

Endotoxin content

≤0.33 IU/mg

Tillomed Laboratories

Strength

250 mg/mL in 2mL, 4mL vials

Excipients

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

Osmolarity / osmolality

No information

pH

No information

Endotoxin content

No information

Vianex

Strength

50 mg/mL in 2mL vials

Excipients

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

Osmolarity / osmolality

No information

pH

Release: 4.2-4.8
Shelf life: 3.5-5.5

Endotoxin content

≤0.33IU/mg

Hameln

Strength

250 mg/mL in 2mL vials

Excipients

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

Osmolarity / osmolality

No information

pH

3.5 – 5.5

Endotoxin content

≤0.25 EU/mg

Kent Pharmaceuticals

Strength

250 mg/mL in 2mL ampoules

Excipients

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

Osmolarity / osmolality

No information

pH

No information

Endotoxin content

No information

Galvany Pharma

Strength

250 mg/mL in 2mL ampoule

Excipients

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

Osmolarity / osmolality

800 – 1100 mOsmol/kg

pH

3.5 – 5.5

Endotoxin content

≤3.3 IU/mL

Fresenius Kabi

Strength

5mg/mL in 50mL, 100mL or 200mL bottle

Excipients

Sodium chloride, hydrochloric acid, sodium hydroxide, water for injections

Osmolarity / osmolality

270 – 330 mOsmol/kg

pH

3.5 – 5.5

Endotoxin content

<0.83 EU/mL

Mercury

Strength

250 mg/mL in 2mL ampoule

Excipients

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

Osmolarity / osmolality

No information

pH

3.5 – 5.5

Endotoxin content

No information

Demo Pharmaceutical

Strength

125mg/mL in 2mL ampoule

250mg/mL in 2mL, 4mL ampoule

Excipients

Sodium citrate dihydrate, sodium metabisulfite, sulfuric acid (2N), water for injections

Osmolarity / osmolality

No information

pH

3.5 – 5.5

Endotoxin content

≤3.3 EU/mL

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

Update history

  1. Republished
  2. Full update to monograph
  1. Title and URL shortened.
  1. Published