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In: Hoffman RJ, Wang VJ, Scarfone RJ. Available data suggest that anti-epileptic polytherapy including valproate may be associated with a greater risk of congenital malformations than valproate monotherapy.Valproate was shown to cross the placental barrier in both animal species and humans (see section 5.2).Data derived from a meta-analysis (including registries and cohort studies) has shown that 10.73% of children of epileptic women exposed to valproate monotherapy during pregnancy suffer from congenital malformations (95% CI: 8.16 – 13.29). • Patients with known urea cycle disorders (see section 4.4). When Depakote is taken along with the following drugs, it may cause interactions within the body. The prothrombin time should be closely monitored.Valproic acid plasma levels may be increased (as a result of reduced hepatic metabolism) in case of concomitant use with cimetidine or erythromycinDecreases in blood levels of valproic acid have been reported when it is co-administered with carbapenem agents resulting in a 60 – 100% decrease in valproic acid levels within two days, sometimes associated with convulsions. 2-4 DEPAKOTE comes in different dosage forms. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.Many drugs can interact with divalproex sodium. Patients receiving daily doses higher than 45 mg/kg/day body weight should be carefully monitored.Continuation of treatment of manic episodes in bipolar disorder should be adapted individually using the lowest effective dose.Although the pharmacokinetics of Depakote are modified in the elderly, they have limited clinical significance and dosage should be determined on the basis of clinical response.The safety and efficacy of Depakote for the treatment of manic episodes in bipolar disorder have not been evaluated in patients aged less than 18 years.It may be necessary to decrease dosage. Increased liver enzymes are common, particularly early in treatment and may be transient (see section 4.4.1).The above adverse events frequently occur at the start of treatment, but they usually disappear after a few days without discontinuing treatment. Spontaneous bruising or bleeding is an indication for withdrawal of medication pending investigations (see section 4.6).Reporting suspected adverse reactions after authorisation of the medicinal product is important. Valproate should not be used in female children or women of childbearing potential unless other treatments are ineffective or not tolerated (see sections 4.3, 4.4 and 4.6).Valproate is prescribed and dispensed according to the Valproate Pregnancy Prevention Programme (see sections 4.3 and 4.4). Use of this site constitutes acceptance of eHealthMe.com's terms of service and privacy policy. In such cases further investigations should be considered.The blood picture returned to normal when the drug was discontinued.Isolated findings of a reduction in blood fibrinogen and/or an increase in prothrombin time have been reported, usually without associated clinical signs and particularly with high doses (Depakote has an inhibitory effect on the second phase of platelet aggregation). If treatment with these antibiotics cannot be avoided, close monitoring of valproic acid blood level should be performed.Rifampicin may decrease the valproic acid blood levels resulting in a lack of therapeutic effect. In particular, valproate-induced acute liver failure and liver-related deaths have been reported at a higher rate in patients with hereditary neurometabolic syndromes caused by mutations in the gene for the mitochondrial enzyme polymerase γ (POLG), e.g. After the age of 3 years, the incidence of occurrence is significantly reduced and progressively decreases with age. Cases of intracranial hypertension related to cerebral oedema have been reported.The presence of sodium content in the Depakote formulations may lead to hypernatraemia when taken in overdose. Depakote tablets are also used in adults to prevent Depakote can cause liver failure that may be fatal, especially in children under age 2 and in people with liver problems caused by certain genetic disorders.Do not stop using this medicine without your doctor's advice. • The patient has acknowledged that she has understood the hazards and necessary precautions associated with valproate use (Annual Risk Acknowledgement Form).These conditions also concern women who are not currently sexually active unless the prescriber considers that there are compelling reasons to indicate that there is no risk of pregnancy. • In women of childbearing potential unless the conditions of the pregnancy prevention programme are fulfilled (see sections 4.4 and 4.6). Additionally, salicylates should not be used in children under 16 years (see aspirin/salicylate product information on Reye's syndrome).In most cases, such liver damage occurred during the first 6 months of therapy, the period of maximum risk being 2 – 12 weeks.Clinical symptoms are essential for early diagnosis. Drug interactions are reported among people who take Depakote and Proventil together. Afibrinogenemia has also been reported and may be fatal. The nimodipine dose should therefore be decreased in case of hypotension.Co-administration of temozolomide and Depakote may cause a small decrease in the clearance of temozolomide that is not thought to be clinically relevant.Anti-epileptics with enzyme inducing effects (including phenytoin, phenobarbital, carbamazepine) decrease valproic acid plasma concentrations. Salicylates should not be used in children under 16 years (see aspirin/salicylate product information on Reye's syndrome). Encephalopathy and coma have very rarely been observed. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Depakote therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman. • Cases of hypoglycaemia have been reported in neonates whose mothers have taken valproate during the third trimester of their pregnancy. Even if she has amenorrhea, she must follow all the advice on effective contraception.Concomitant use with oestrogen-containing products, including oestrogen-containing hormonal contraceptives, may potentially result in decreased valproate efficacy (see section 4.5).