Levobupivacaine products: information for supporting intrathecal risk assessment

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

Levobupivacaine 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.

AbbVie Ltd (Chirocaine®)

Strength

2.5 mg/mL in 10mL ampoules
5 mg/mL in 10mL ampoules
7.5 mg in 10mL ampoules

Altan Pharma

Strength

2.5 mg/mL in 10mL ampoules
5 mg/mL in 10mL ampoules
7.5mg/mL in 10mL ampoules

Fresenius

Strength

2.5mg/mL in 10mL ampoule
5mg/mL in 10mL ampoule
7.5mg/mL in 10mL ampoule

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.

AbbVie Ltd (Chirocaine®)

Strength

1.25 mg/mL in 100mL/200mL bags

Excipients

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

Osmolarity

No information

pH

No information

Endotoxin content

No information

Altan Pharma

Strength

0.625 mg/mL in 100mL bags

Excipients

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

Osmolarity

270 – 330 mOsmol/kg

pH

4.0 – 6.5

Endotoxin content

No information

Strength

1.25 mg/mL in 100mL and 200mL bags

Excipients

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

Osmolarity

270 – 330 mOsmol/kg

pH

4.0 – 6.5

Endotoxin content

≤ 2.5 EU/mL

Fresenius

Strength

0.625 mg/mL solution for infusion in 100mL and 200mL bags

Excipients

Sodium Chloride, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), water for injection

Osmolarity

271 – 332 mOsmol/L

pH

4.0 – 6.0

Endotoxin content

≤ 0.525 EU/mL

Strength

1.25 mg/mL in 100mL and 200mL bags

Excipients

Sodium Chloride, sodium hydroxide (for pH adjustment), hydrochloric acid (for pH adjustment), water for injection

Osmolarity

271 – 332 mOsmol/L

pH

4.0 – 6.0

Endotoxin content

≤ 1.05 EU/mL

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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