Morphine products: information for supporting intrathecal risk assessment

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

Morphine sulfate 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 currently no known morphine 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.

AS KALCEKS (Latvia)

Strength

10 mg/mL in 1mL ampoules
15 mg/mL in 1mL ampoules
30 mg/mL in 1mL ampoules

Excipients

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

Osmolarity

No information

pH

No information

Endotoxin content

No information

Aurum

Strength

1mg/mL 50mL or 100mL vials
2mg/mL 50mL or 100mL vials

Excipients

Sodium chloride, water for injections

Osmolarity

No information

pH

No information

Endotoxin content

No information

Strength

10 mg/mL in 1mL pre-filled syringes

Excipients

Sodium chloride, sodium metabisulphite, water for injection, sulphuric acid, nitrogen

Osmolarity

No information

pH

No information

Endotoxin content

No information

Hameln

Strength

1 mg/mL in 10mL ampoules

Excipients

Sodium chloride, hydrochloric acid, water for injections

Osmolarity

270 – 310 mOsmol/kg

pH

3.2 – 3.8

Endotoxin content

< 12 EU/mg

Strength

10 mg/mL in 1mL ampoules

Excipients

Sodium chloride, hydrochloric acid, water for injection, nitrogen

Osmolarity

270 – 310 mOsmol/kg

pH

3.4 – 3.8

Endotoxin content

< 12 EU/mg

Macarthys t/a Martindale Pharm

Strength

10 mg/mL in 1mL ampoules
15 mg/mL in 1mL ampoules
20 mg/mL in 1mL ampoule
30 mg/mL in 1mL ampoule

Excipients

Sodium chloride, sodium metabisulfite (E223), water for injection
The pH may be adjusted with sodium hydroxide or sulfuric acid solution

Osmolarity

No information

pH

2.5 – 4.5

Endotoxin content

No information

Torbay & South Devon NHS Foundation Trust

Strength

1 mg/mL in 1mL, 5mL or 10mL ampoules, or 50mL vials

Excipients

Sodium Chloride, water for injection

Osmolarity

288 mOsmol/L

pH

4.0 – 6.5

Endotoxin content

≤ 17 EU/mL

Strength

2 mg/mL in 50mL vials

Excipients

Sodium chloride, water for injection

Osmolarity

291 mOsmol/L

pH

4.0 – 6.5

Endotoxin content

≤ 34 IU/mL

Wockhardt

Strength

10 mg/mL in 1mL ampoules
15 mg/mL in 1mL ampoules
30 mg/mL in 1mL or 2mL ampoules

Excipients

Water for injection, sodium metabisulfite, sodium hydroxide, hydrochloric acid

Osmolarity

No information

pH

3.0 – 5.0

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.

Torbay PMU

Morphine Sulfate Intrathecal Injection

Strength

300mg in 10mL

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