Bupivacaine products: information for supporting intrathecal risk assessment

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

Bupivacaine 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.

Aspen (Marcain®)

Strength

5mg/mL (0.5%) in 4mL ampoule

Panpharma

Strength

5mg/mL in 4mL 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.

Accord

Strength

2.5mg/mL (0.25%) in 5mL ampoule
2.5mg/mL (0.25%) in 10mL ampoule
2.5mg/mL (0.25%) in 20mL ampoule

Excipients

Sodium chloride, sodium hydroxide, water for injection

Osmolarity

No information

pH

No information

Endotoxin content

≤ 0.23 EU/mL

Strength

5mg/mL (0.5%) in 2mL ampoule
5mg/mL (0.5%) in 4mL ampoule
5mg/mL (0.5%) in 5mL ampoule
5mg/mL (0.5%) in 10mL ampoule
5mg/mL (0.5%) in 20mL ampoule
5mg/mL (0.5%) in 20mL vial

Excipients

Sodium chloride, sodium hydroxide, water for injection

Osmolarity

No information

pH

No information

Endotoxin content

≤ 0.47 EU/mL

Aspen (Marcain Polyamp Steripack®)

Strength

2.5mg/mL (0.25%) in 10mL ampoule
2.5mg/mL (0.25%) in 20mL ampoule

Excipients

Sodium chloride (tonicity contributor), sodium hydroxide/hydrochloric acid (pH adjustment to 4.0-6.5), water for injection

Osmolarity

No information

pH

4.0 – 6.5 

Endotoxin content

≤ 0.23 EU/mL

Strength

5mg/mL (0.5%) in 10mL ampoule
5mg/mL (0.5%) in 20mL ampoule

Excipients

Sodium chloride (tonicity contributor), sodium hydroxide/hydrochloric acid (pH adjustment to 4.0-6.5)

Osmolarity

No information

pH

4.0 – 6.5 

Endotoxin content

≤ 0.46 EU/mL

Baxter

Strength

2.5mg/mL (0.25%) in 10mL vial
2.5mg/mL (0.25%) in 20mL vial
5mg/mL (0.5%) in 10mL vial
5mg/mL (0.5%) in 20mL vial

Excipients

Sodium chloride, 0.4% sodium hydroxide (for pH adjustment), 0.85% hydrochloric acid (for pH adjustment), water for injection

Osmolarity

290 mOsmol/L 

pH

4.0 – 6.5 

Endotoxin content

No information

Mercury Pharmaceuticals

Strength

1mg/mL (0.1%) in 100mL infusion bags
1mg/mL (0.1%) in 250mL infusion bags
1.25mg/mL (0.125%) in 100mL infusion bags
1.25mg/mL (0.125%) in 250mL infusion bags

Excipients

Sodium chloride, sodium hydroxide, water for injection

Osmolarity

No information

pH

4.0 – 6.5 

Endotoxin content

0.5 EU/mL

Strength

2.5mg/mL (0.25%) in 10mL ampoule
2.5mg/mL (0.25%) in 20mL ampoule
5mg/mL (0.5%) in 10mL ampoule (glass)
5mg/mL (0.5%) in 10mL ampoule (plastic)
5mg/mL (0.5%) in 20mL ampoule (glass)
5mg/mL (0.5%) in 20mL ampoule (plastic)

Excipients

Sodium chloride, sodium hydroxide, water for injection

Osmolarity

No information

pH

No information

Endotoxin content

≤ 2.5 EU/mL

MilPharm

Strength

2.5mg/mL (0.25%) in 10mL ampoule
5mg/mL (0.5%) in 10mL ampoule

Excipients

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

Osmolarity

270 – 330 mOsmol/kg

pH

4.0 – 6.5 

Endotoxin content

No information

Noriderm

Strength

2.5mg/mL (0.25%) in 5mL ampoule
2.5mg/mL (0.25%) in 10mL ampoule
2.5mg/mL (0.25%) in 20mL ampoule
5mg/mL (0.5%) in 5mL ampoule
5mg/mL (0.5%) in 10mL ampoule
5mg/mL (0.5%) in 20mL ampoule

Excipients

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

Osmolarity

270 – 320 mOsmol/kg

pH

4.0 – 6.5

Endotoxin content

No information

Pacira (Exparel®)

Bupivacaine liposomal (Exparel®) prolonged-release dispersion for injection

Strength

133mg in 10mL vial
266mg in 20mL vial

Excipients

Dierucoylphosphatidylcholine (DEPC), Dipalmitoylphosphatidylglycerol (DPPG), cholesterol for parenteral use, tricaprylin, sodium chloride, phosphoric acid, water for injection

Osmolarity

260 – 330 mOsmol/L 

pH

5.8 – 7.8

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.

St Mary’s Pharmaceutical Unit, Cardiff

Strength

Bupivacaine hydrochloride 3% in 10mL vials

Unlicensed ‘Special’, specified for epidural use

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

Plain

Huddersfield Royal Infirmary Pharmacy Manufacturing Unit

Strength

Bupivacaine 0.25% in 960mL bottles
Bupivacaine 0.5% in 500mL bottles

Adrenaline containing

Stepping Hill Hospital – Stockport Pharmaceuticals

Strength

Bupivacaine hydrochloride 0.5% and Adrenaline 1:200,000 in 10mL ampoules

Note that this product contains sodium metabisulphate

Torbay PMU

Strength

Bupivacaine hydrochloride 0.5% and Adrenaline 1:200,000 in 10mL ampoules

Note that this product contains sodium metabisulphate

Fentanyl containing

Queen Alexandra Hospital, Portsmouth

Strength

Bupivacaine 0.1% and Fentanyl 2 micrograms/mL in 50mL syringes

Torbay PMU

Strength

Bupivacaine 0.1% and Fentanyl 2 micrograms/mL in 10mL ampoules

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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