Lancashire and South Cumbria
Formulary
 
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4 Central nervous system

This chapter of the formulary is under continual development, please let the team know if you have any comments about the contents: mlcsu.lscformulary@nhs.net

For more information about the formulary development process, please see: https://www.lancsmmg.nhs.uk/lancashire-and-south-cumbria-icb-formulary-development/

04-08-01 Valproate

In November 2023, due to known significant risk of serious harm to a baby after exposure to valproate the MHRA has stipulated that new regulatory measures will be put in place in January 2024 for oral valproate medicines as follows:


Sodium Valproate Epilim®
Formulary

Crushable tablets 100mg
e/c tablets 200mg, 500mg
Liquid 200mg/5mL

 Category 2 - Doctors should use clinical judgement when deciding whether to switch between different manufacturer's products

Different preparations may vary in bioavailability and are therefore not interchangeable, prescriptions should include the brand name.

Counselling: hepatic & blood disorders - see BNF

In November 2023, due to known significant risk of serious harm to a baby after exposure to valproate the MHRA has stipulated that new regulatory measures will be put in place in January 2024 for oral valproate medicines as follows:

  • Valproate must not be initiated in patients male or female under the age of 55 years, unless two specialists independently consider and document that there is no other effective or tolerated treatment and any use of valproate in women of childbearing potential should be in accordance with the Pregnancy Prevention Programme.
  • At their next annual review females of childbearing potential will require the signature of a second specialist if valproate is to be continued

National Patient Safety Alert:  Valproate: organisations to prepare for new regulatory measures for oversight of prescribing to new patients and existing female patients https://assets.publishing.service.gov.uk/media/6565ddf162180b0012ce82fd/NatPSA-2023-013-MHRA.pdf

MHRA Drug Safety Update - Valproate medicines (Epilim▼, Depakote▼): contraindicated in women and girls of childbearing potential unless conditions of Pregnancy Prevention Programme are met https://www.gov.uk/drug-safety-update/valproate-medicines-epilim-depakote-contraindicated-in-women-and-girls-of-childbearing-potential-unless-conditions-of-pregnancy-prevention-programme-are-met?utm_source=eshot&utm_medium=email&utm_campaign=DSUApril2018Split2

**Under review**

Link  MHRA: Valproate use in men: as a precaution, men and their partners should use effective contraception

Amber 0 View adult BNF  View SPC online  View childrens BNF
Sodium Valproate Epilim® Chrono
Formulary

m/r tablets 200mg, 300mg, 500mg

 Category 2 - Doctors should use clinical judgement when deciding whether to switch between different manufacturer's products

Different preparations may vary in bioavailability and are therefore not interchangeable, prescriptions should include the brand name.

Counselling: hepatic & blood disorders - see BNF

In November 2023, due to known significant risk of serious harm to a baby after exposure to valproate the MHRA has stipulated that new regulatory measures will be put in place in January 2024 for oral valproate medicines as follows:

  • Valproate must not be initiated in patients male or female under the age of 55 years, unless two specialists independently consider and document that there is no other effective or tolerated treatment and any use of valproate in women of childbearing potential should be in accordance with the Pregnancy Prevention Programme.
  • At their next annual review females of childbearing potential will require the signature of a second specialist if valproate is to be continued

National Patient Safety Alert:  Valproate: organisations to prepare for new regulatory measures for oversight of prescribing to new patients and existing female patients https://assets.publishing.service.gov.uk/media/6565ddf162180b0012ce82fd/NatPSA-2023-013-MHRA.pdf

MHRA Drug Safety Update - Valproate medicines (Epilim▼, Depakote▼): contraindicated in women and girls of childbearing potential unless conditions of Pregnancy Prevention Programme are met https://www.gov.uk/drug-safety-update/valproate-medicines-epilim-depakote-contraindicated-in-women-and-girls-of-childbearing-potential-unless-conditions-of-pregnancy-prevention-programme-are-met?utm_source=eshot&utm_medium=email&utm_campaign=DSUApril2018Split2

**Under review**

Link  MHRA: Valproate use in men: as a precaution, men and their partners should use effective contraception

Amber 0 View adult BNF  View SPC online  View childrens BNF
Sodium Valproate Epilim® Intravenous
Formulary

Injection 400mg with 4mL water for injections

Different preparations may vary in bioavailability and are therefore not interchangeable, prescriptions should include the brand name.

Counselling: hepatic & blood disorders - see BNF

In November 2023, due to known significant risk of serious harm to a baby after exposure to valproate the MHRA has stipulated that new regulatory measures will be put in place in January 2024 for oral valproate medicines as follows:

  • Valproate must not be initiated in patients male or female under the age of 55 years, unless two specialists independently consider and document that there is no other effective or tolerated treatment and any use of valproate in women of childbearing potential should be in accordance with the Pregnancy Prevention Programme.
  • At their next annual review females of childbearing potential will require the signature of a second specialist if valproate is to be continued

National Patient Safety Alert:  Valproate: organisations to prepare for new regulatory measures for oversight of prescribing to new patients and existing female patients https://assets.publishing.service.gov.uk/media/6565ddf162180b0012ce82fd/NatPSA-2023-013-MHRA.pdf

MHRA Drug Safety Update - Valproate medicines (Epilim▼, Depakote▼): contraindicated in women and girls of childbearing potential unless conditions of Pregnancy Prevention Programme are met https://www.gov.uk/drug-safety-update/valproate-medicines-epilim-depakote-contraindicated-in-women-and-girls-of-childbearing-potential-unless-conditions-of-pregnancy-prevention-programme-are-met?utm_source=eshot&utm_medium=email&utm_campaign=DSUApril2018Split2

**Under review**

Link  MHRA: Valproate use in men: as a precaution, men and their partners should use effective contraception

Red View adult BNF  View SPC online  View childrens BNF
Sodium Valproate Episenta®
Formulary

m/r capsules 150mg, 300mg
m/r granules 50mg, 100mg, 250mg, 500mg,750mg,1g

 Category 2 - Doctors should use clinical judgement when deciding whether to switch between different manufacturer's products

Different preparations may vary in bioavailability and are therefore not interchangeable, prescriptions should include the brand name.

Counselling: hepatic & blood disorders - see BNF

In November 2023, due to known significant risk of serious harm to a baby after exposure to valproate the MHRA has stipulated that new regulatory measures will be put in place in January 2024 for oral valproate medicines as follows:

  • Valproate must not be initiated in patients male or female under the age of 55 years, unless two specialists independently consider and document that there is no other effective or tolerated treatment and any use of valproate in women of childbearing potential should be in accordance with the Pregnancy Prevention Programme.
  • At their next annual review females of childbearing potential will require the signature of a second specialist if valproate is to be continued

National Patient Safety Alert:  Valproate: organisations to prepare for new regulatory measures for oversight of prescribing to new patients and existing female patients https://assets.publishing.service.gov.uk/media/6565ddf162180b0012ce82fd/NatPSA-2023-013-MHRA.pdf

MHRA Drug Safety Update - Valproate medicines (Epilim▼, Depakote▼): contraindicated in women and girls of childbearing potential unless conditions of Pregnancy Prevention Programme are met https://www.gov.uk/drug-safety-update/valproate-medicines-epilim-depakote-contraindicated-in-women-and-girls-of-childbearing-potential-unless-conditions-of-pregnancy-prevention-programme-are-met?utm_source=eshot&utm_medium=email&utm_campaign=DSUApril2018Split2

**Under review**

Link  MHRA: Valproate use in men: as a precaution, men and their partners should use effective contraception

Amber 0 View adult BNF  View SPC online  View childrens BNF