Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Aventis Pharma Limited, One Onslow Street, Guildford, Surrey, GU1 4YS, United Kingdom Or trading as: Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, United Kingdom
Pharmacotherapeutic group: Anti-epileptics; Fatty acid derivatives
ATC code: N03AG01
Sodium valproate is an anti-convulsant.
In certain in-vitro studies it was reported that Epilim could stimulate HIV replication but studies on peripheral blood mononuclear cells from HIV-infected subjects show that Epilim does not have a mitogen-like effect on inducing HIV replication. Indeed the effect of Epilim on HIV replication ex-vivo is highly variable, modest in quantity, appears to be unrelated to the dose and has not been documented in man.
In patients with severe renal insufficiency it may be necessary to alter dosage in accordance with free plasma valproic acid levels.
The reported effective therapeutic range for plasma valproic acid levels is 40–100 mg/litre (278–694 micromol/litre). This reported range may depend on time of sampling and presence of co-medication. The percentage of free (unbound) drug is usually between 6% and 15% of the total plasma levels. An increased incidence of adverse effects may occur with plasma levels above the effective therapeutic range.
The pharmacological (or therapeutic) effects of Epilim may not be clearly correlated with the total or free (unbound) plasma valproic acid levels.
The major pathway of valproate biotransformation is glucuronidation (~40%), mainly via UGT1A6, UGT1A9 and UGT2B7.
The half-life of Epilim is usually reported to be within the range 8–20 hours. It is usually shorter in children.
Inter-individual variability has been noted. There are insufficient data to establish a robust PK-PD relationship resulting from this PK interaction.
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
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