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Indications:

This medicine is indicated as an intravenous alternative in patients for whom oral administration of valproate products is temporarily not feasible in the following conditions: This medicine is indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. This medicine is also indicated for use as sole and adjunctive therapy in the treatment of patients with simple and complex absence seizures, and adjunctively in patients with multiple seizure types that include absence seizures.

Contraindications:

Valproate sodium is contraindicated in patients with known hypersensitivity to the drug. Valproate sodium is contraindicated in patients with known urea cycle disorders.

Adverse reactions:

The most frequently reported adverse effects associated with valproate therapy are gastrointestinal disturbances, particularly at the start of therapy; enteric-coated formulations, taking doses with meals, and starting with low doses may minimise symptoms. There may be increased appetite, and weight gain is common. Less common adverse effects include oedema, headache, reversible prolongation of bleeding time, and thrombocytopenia. Leucopenia and bone marrow depression have been reported. Neurological adverse effects including ataxia, tremor, sedation, lethargy, confusion, and more rarely encephalopathy and coma, have occasionally been reported, although these are often associated with too high a starting dose, increasing doses too rapidly, or use with other antiepileptics. Very rare cases of extrapyramidal symptoms or reversible dementia associated with cerebral atrophy have been reported. Increased alertness may occur, which is generally considered beneficial, but occasionally aggression, hyperactivity, and behavioural disturbances have been reported. Hearing loss has been noted. There may occasionally be rashes, and, rarely, hirsutism, acne, toxic epidermal necrolysis and Stevens-Johnson syndrome or erythema multiforme. Transient hair loss, sometimes with regrowth of curly hair, has occurred. Irregular periods, amenorrhoea, and gynaecomastia have been reported rarely. Liver dysfunction including hepatic failure has occasionally been reported, usually in the first few months of treatment, and requires valproate withdrawal; there have been fatalities. Elevation of liver enzyme values is common but normally transient and dose-related. Hyperammonaemia has occurred, even in the absence of overt hepatic failure, and is sometimes associated with neurological symptoms; hyperglycinaemia has also been reported. Pancreatitis has also been reported rarely; plasma amylase should be measured if there is acute abdominal pain. In a few patients there have been reports of reversible defects in renal tubular function (Fanconi’s syndrome). Congenital malformations have been reported in infants born to women who had received antiepileptics including valproate during pregnancy. Congenital malformations have been reported in infants born to women who had received antiepileptics including valproate during pregnancy.

Interactions:

There are complex interactions between antiepileptics and toxicity may be enhanced without a corresponding increase in antiepileptic activity. Such interactions are very variable and unpredictable and plasma monitoring is often advisable with combination therapy. Caution is recommended when giving valproate with other drugs liable to interfere with blood coagulation, such as aspirin or warfarin. Use with other hepatotoxic drugs should be avoided. Use of highly protein bound drugs with valproate may increase free valproate plasma concentrations.

Warnings:

Valproate is contra-indicated in patients with pre-existing liver disease or a family history of severe hepatic dysfunction. Children under 3 years of age and those with congenital metabolic or degenerative disorders, organic brain disease, or severe seizure disorders associated with mental retardation may be at particular risk of hepatotoxicity and the drug should be used with particular caution in these groups. Use with other antiepileptics, which may also increase the risks of liver damage, should be avoided if possible. Liver function tests should be carried out, particularly in those most at risk, before and during the first 6 months of therapy. Raised liver enzymes are not uncommon during treatment and are usually transient or respond to reduction in dosage, but patients should be reassessed clinically and liver function, including prothrombin time, monitored until they return to normal. Patients or their carers should be told how to recognise signs of blood and liver toxicity or pancreatitis, and they should be advised to seek immediate medical attention if symptoms develop. Patients should be monitored for potential bleeding complications before major elective surgery; some licensed product information suggests regular monitoring before and during therapy. Valproate should be used with caution if systemic lupus erythematosus is suspected. Patients should be warned of the risk of weight gain and appropriate strategies adopted to minimise the effect. Care is required when withdrawing valproate therapy. The protein binding of valproate is saturable and thus shows concentration dependency; significant increases in free drug occur at high total plasma concentrations. Because valproate is partly excreted in the form of ketone bodies, it may cause false positives in urine tests for diabetes mellitus. Dosage adjustments may be necessary in severe renal impairment in accordance with free serum valproate levels.

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