Lancashire and South Cumbria
Formulary
 
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4 Central nervous system
04-08-01 Valproate

 

Due to known significant risk of serious harm the MHRA has stipulated new regulatory measures for oral valproate medicines:

  • 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 specialist review, women and girls of childbearing potential receiving valproate should have their treatment reviewed using the revised Annual Risk Acknowledgement Form. At this review, if the patient has never been reviewed by two specialists either at initiation or annual review, a second specialist signature will be needed if the patient is to continue on valproate. Women do not need to be recalled for an additional review. Once a patient has received a treatment review by two specialists, subsequent annual reviews only require one specialist.

 


Sodium Valproate Epilim®
Formulary

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

Episenta® capsules (prolonged release sodium valproate) are also available for use, and are especially helpful for those patients with swallowing difficulties.
They are given once daily as capsules or sachets which can be opened and put on soft food if required, without chewing. Like other valproate preparations when used for epilepsy, they should be prescribed by brand name.

Due to known significant risk of serious harm the MHRA has stipulated new regulatory measures for oral valproate medicines:

  • 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 specialist review, women and girls of childbearing potential receiving valproate should have their treatment reviewed using the revised Annual Risk Acknowledgement Form. At this review, if the patient has never been reviewed by two specialists either at initiation or annual review, a second specialist signature will be needed if the patient is to continue on valproate. Women do not need to be recalled for an additional review. Once a patient has received a treatment review by two specialists, subsequent annual reviews only require one specialist.

 

MHRA Drug Safety Update - Valproate reproductive risks

https://www.gov.uk/guidance/valproate-reproductive-risks#materials-and-resources

 
Link  MHRA: Antiepileptics: risk of suicidal thoughts and behaviour
Link  MHRA: Full pack dispensing of valproate-containing medicines
Link  National Patient Safety Alert: Valproate: organisations to prepare for new regulatory measures for oversight of prescribing to new patients and existing female patients

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

Injection 400mg with 4mL water for injections

Injection 400mg/4ml solution ampoules

Epilepsy.

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

Due to known significant risk of serious harm the MHRA has stipulated new regulatory measures for oral valproate medicines:

  • 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 specialist review, women and girls of childbearing potential receiving valproate should have their treatment reviewed using the revised Annual Risk Acknowledgement Form. At this review, if the patient has never been reviewed by two specialists either at initiation or annual review, a second specialist signature will be needed if the patient is to continue on valproate. Women do not need to be recalled for an additional review. Once a patient has received a treatment review by two specialists, subsequent annual reviews only require one specialist.

 

MHRA Drug Safety Update - Valproate reproductive risks

https://www.gov.uk/guidance/valproate-reproductive-risks#materials-and-resources

 
Link  MHRA: Antiepileptics: risk of suicidal thoughts and behaviour
Link  MHRA: Full pack dispensing of valproate-containing medicines
Link  National Patient Safety Alert: Valproate: organisations to prepare for new regulatory measures for oversight of prescribing to new patients and existing female patients

Red View adult BNF  View SPC online  View childrens BNF