Available data suggest that anti-epileptic polytherapy including valproate may be associated with a greater risk of congenital malformations than valproate monotherapy.
• The patient understands the need to urgently consult her physician in case of pregnancy. Folate supplementation before the pregnancy may decrease the risk of neural tube defects which may occur in all pregnancies. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Epilim therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
• The parents/caregivers of female children understand the need to contact the specialist once the female child using valproate experiences menarche. • The Patient Card is provided with every valproate dispensation and that patients understand its content.
Hospital management of overdose should be symptomatic, including cardio-respiratory monitoring. The daily dose should be divided into at least two single doses (see section 4.6). Therefore, clinical monitoring is recommended; when phenytoin plasma levels are determined, the free form should be evaluated.Clinical toxicity has been reported when Epilim was administered with carbamazepine as Epilim may potentiate toxic effects of carbamazepine. The most common types of malformations include neural tube defects, facial dysmorphism, cleft lip and palate, craniostenosis, cardiac, renal and urogenital defects, limb defects (including bilateral aplasia of the radius), and multiple anomalies involving various body systems. These patients must be provided with comprehensive information on pregnancy prevention and should be referred for contraceptive advice if they are not using effective contraception. Valproate administration may also impair fertility in men (see section 4.8). Experience in epilepsy has indicated that patients most at risk, especially in cases of multiple anti-convulsant therapy, are infants and in particular young children under the age of 3 years and those with severe seizure disorders, organic brain disease, and (or) congenital metabolic or degenerative disease associated with mental retardation. Clinical monitoring is recommended especially at the beginning of combined therapy with dosage adjustment when appropriate.Epilim reduces the metabolism of lamotrigine and increases the lamotrigine mean half-life by nearly to fold.
plasma concentration 10 – 20 times maximum therapeutic levels, usually include CNS depression or coma with muscular hypotonia, hyporeflexia, miosis, impaired respiratory function, metabolic acidosis, hypotension and circulatory collapse/shock. Patients experiencing nausea, vomiting or acute abdominal pain should have a prompt medical evaluation (including measurement of serum amylase). Accordingly, the dosage of Epilim may need adjustment.In case of concomitant use of Epilim and highly protein bound agents (e.g.
The nimodipine dose should therefore be decreased in case of hypotension.Co-administration of temozolomide and Epilim may cause a small decrease in the clearance of temozolomide that is not thought to be clinically relevant.Anti-epileptics with enzyme inducing effect (including phenytoin, phenobarbital, carbamazepine) decrease valproic acid plasma concentrations. This will affect the clinical interpretation of plasma valproic acid levels.It may be necessary to decrease the dosage. • The patient is counselled regarding contraception, and that the patient is capable of complying with the need to use effective contraception (for further details please refer to subsection contraception of this boxed warning), without interruption during the entire duration of treatment with valproate. Severe seizures and severe neurological impairment with combination anti-convulsant therapy may be risk factors.
Thomas AL, Morgan B, Horsfield MA, et al. Epilim is hygroscopic. Investigations including clinical examination and biological assessment of liver function should be undertaken immediately.Liver function should be measured before therapy and then periodically monitored during the first 6 months of therapy, especially in those who seem most at risk, and those with a prior history of liver disease.Amongst usual investigations, tests which reflect protein synthesis, particularly prothrombin rate, are most relevant.
The most likely mode of action for Epilim is potentiation of the inhibitory action of gamma amino butyric acid (GABA) through an action on the further synthesis or further metabolism of GABA.The reported effective therapeutic range for plasma valproic acid levels is 40 – 100 mg/L (278 – 694 µmol/L).
Dosage should start at 600 mg daily increasing by 200 mg at three-day intervals until control is achieved. Hyperammonaemia associated with neurological symptoms has also been reported (see section 4.4.2). When starting Epilim in patients already on other anti-convulsants, these should be tapered slowly; initiation of Epilim therapy should then be gradual, with target dose being reached after about 2 weeks.
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