Sodium valproate (with childbearing potential) - Mania

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Status 1

Amber

Formulations :

Crushable tablets
Enteric coated tablets
Granules (slow release)
Modified release capsules
Modified release tablets
Oral solution

Formulary Status :

Primary Care

ASPH

RSFT

SASH

SABP

Associated Icons :

Off Label

SPC

Restrictions / Comments :

Important

Principles for shared care found here: https://surrey.res.services/PAD/Profile/NonClinicalProfile/9136

Documentation

Guidelines (Local)

Safer prescribing aide memoire for Sodium valproate in women (with childbearing potential) - Sep 2024

Shared Care

Valproate - Shared Care agreement - August 24

Safety Information

Valproate Reproductive Risks in Men and Women - MHRA guidance

Webpage

Valproate easy-read and multi-language patient information leaflets

Webpage

Pregnancy testing and contraception for pregnancy prevention in patients taking medicines of teratogenic potential - MHRA guidance 2024

Webpage

Link to MHRA Pregnancy Prevention programme

Webpage

Link to MHRA advice on switching

PAD Profile

ChemicalSubstance :

Sodium valproate (with childbearing potential)

Indication :

Mania

Group Name :

Keywords :

manic episodes, bipolar disorder, psychotic disorders, mood disorders

Brand Names Include :

Epilim, Epilim Chrono, Dyzantil, Epival CR, Episenta, Epilim Chronosphere

Important Information :

Off-label use. Licesned product is valproic acid (valproate semisodium).

Initiation and stabilisation by the mental health specialist team for at least 1 month before any request for transfer of prescribing responsbility to primary care.

Pregnancy prevention requirement - refer to additional information on the PAD (click on drug name to access)

Latest Additions Date From :

Latest Additions Date To :

Guidelines :

Supporting Documents :

Committee Recommendations (5)

12 Mar 25 - Surrey Heartlands Medicines Safety Committee (MSC)

An easy read leaflet has been produced in 30 different languages and is aimed at women and people who could become pregnant who are taking valproate. It is downloadable and printable. Valproate - Welcome

12 Mar 25 - Surrey Heartlands Medicines Safety Committee (MSC)

Three infographics have been produced to clarify in which situations review by two specialists may be required for patients who are prescribed valproate:
•   for female patients under 55 years old
•   for male patients under 55 years old
•   for male and female patients 55 years and older

11 Sep 24 - Surrey Heartlands Medicines Safety Committee (MSC)

The Medicine Safety Committee has updated the "Safer Prescribing aide-memoire" for primary care which provides guidance on safe prescribing of sodium valproate (for women of child bearing age) in line with the Medicines and Healthcare products Regulatory Agency (MHRA) recomendations.
It includes a summary of how to manage these patients within primary care, links to clinical resources and searches/ templates available on clinical systems (EMIS Web and SystmOne)

14 Aug 24 - Surrey Heartlands Medicines Safety Committee (MSC)

The Medicines Safety Committee recommend the MHRA 'Guidance on contraceptive methods and frequency of pregnancy testing to reduce inadvertent exposures during pregnancy in a woman taking a medicine of teratogenic potential' which can be found in the link below.

aide-memoire_table-2024.pdf (publishing.service.gov.uk)

07 Aug 24 - Surrey Heartlands Integrated Care System Area Prescribing Committee (APC)

The Surrey Heartlands Integrated Care System Area Prescribing Committee have agreed an updated AMBER shared care document for valproate for people of childbearing potential aged under 55 with:

Licensed uses:

Epilepsy
Treatment of mania in bipolar disorder
Continuation of treatment after a manic episode

Off label uses (refer to primary care responsibilities in shared care document for advice)

Mood stabiliser in mood disorders and primary psychotic disorders, under the direction of a consultant psychiatrist
Prevention of atypical antipsychotic-induced seizures
Management of compulsive and aggressive behaviour

Other Indications

Below are listed other indications that Sodium valproate (with childbearing potential) is used to treat.

Other Drugs

Below are listed other drugs that are used to treat Mania.