netFormulary

Lancashire and South Cumbria
Formulary

4 Central nervous system

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:

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

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.

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

MHRA: Antiepileptic drugs in pregnancy: updated advice following comprehensive safety review

MHRA: Antiepileptic drugs: updated advice on switching between different manufacturers� products

MHRA: Antiepileptics: risk of suicidal thoughts and behaviour

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

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.

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