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Chronic hepatitis; personal or family history of severe liver disease, especially drug-induced; Hypersensitivity to components or other closely related substances in terms of chemical porphyria, bleeding, Breastfeeding, generally contraindicated in infants and children under three years of age.

Adverse reactions:

Rare cases of hepatitis. Teratogenic risk. Confusion, or seizure: a case of stupor has been described during therapy with valproic acid, were isolated or associated with an increased incidence of seizures during therapy and regressed upon discontinuation of treatment or the decrease in dose. These cases have been reported, particularly during combination therapy (especially with phenobarbital) or after a sharp increase in doses of valproate. Digestive disorders (nausea, stomach pain) occur frequently in some patients early in treatment but usually disappear after a few days without interrupting the treatment. Frequently reported side effects were transient and / or dose-related: hair loss, fine postural tremor. Have been isolated reports of reduction of fibrinogen or lengthening of bleeding time, usually without associated clinical signs and particularly with high doses (valproate has an inhibitory effect on the second phase of platelet aggregation). Frequent occurrence of: thrombocytopenia, rare cases of anemia, leucopenia or pancytopenia. There have been occasional reports of pancreatitis, sometimes lethal. It ’was reported the appearance of vasculitis. May occur frequently isolated moderate hyperammonemia without alteration of liver function tests and this should not cause treatment discontinuation. However, in the course of monotherapy or polytherapy (phenobarbital, carbamazepine, phenytoin, topiramate) may have a syndrome of acute hyperammonemic encephalopathy with normal liver function and absence of cytolysis. Syndrome encephalopathy hyperammonemia induced by valproate is manifested in an acute form and is characterized by loss of consciousness, and focal neurological signs and with the general increase in the frequency of epileptic seizures. May appear after several days or several weeks of therapy and regresses after discontinuation of valproate. The encephalopathy is not dose-related, and changes are characterized by the appearance of EEG slow waves and increase in epileptic discharges. There may be weight gain, have also been reported amenorrhea and irregular menstruation. It has been rare reports of hearing loss, both reversible irreversible, however, is not an established cause-effect relationship. Rash, irritability (occasionally aggression, behavioral problems and hyperactivity), hypoplastic glubuli red reduction of fibrinogen. Also been reported cases of Stevens-Johnson syndrome and toxic epidermal necrolysis.


Neuroleptics, antidepressants and anti-MAO. Valproate may potentiate the effect of other psychotropics such as neuroleptics, anti-MAO and antidepressants, so it is recommended to perform clinical monitoring and, when necessary, dose adjustment. Phenobarbital Since valproate increases plasma concentrations of phenobarbital (by inhibition of hepatic catabolism) sedation may occur, especially in children. It is therefore recommended clinical monitoring for the first fifteen days of treatment combined with instant reduction of phenobarbital doses if sedation and possible control of plasma levels of phenobarbital. Primidone. Valproate increases primidone plasma levels and increasing its side effects (sedation), this interaction ceases with the long-term treatment. Clinical monitoring is recommended, especially at the beginning of combined therapy with dosage adjustment of primidone when necessary. Phenytoin. Initially valproate decreases the total plasma concentration of phenytoin, increasing the free fraction, however, with possible symptoms of overdose (phenytoin, valproic acid moves from its sites of protein binding and slows its hepatic catabolism). It is recommended, therefore, clinical monitoring and in case of plasmatic dosage of phenytoin should be taken into account especially the free fraction. Later, after chronic treatment, concentrations of phenytoin returned to baseline Pre-Valproate. Lamotrigine Valproate may reduce lamotrigine metabolism, so when necessary and appropriate to decrease the dose of the latter. Ethosuximide. Valproate can cause increased plasma concentrations of ethosuximide. Effects of other drugs on valproate. The antiepileptic effect of enzyme induction (particularly phenytoin, phenobarbital and carbamazepine) decrease serum concentrations of valproate. In the case of combination therapy doses are adjusted according to blood levels. The mefloquine increases the metabolism of valproic acid and has more effect on convulsant, and in cases of combined therapy may experience epileptic seizures. When using comcomitante of valproate and substances that bind to proteins highly (aspirin), serum free valproate may increase. Serum levels of valproate may increase (due to a reduced hepatic metabolism) in case of use of cimetidine or erythromycin. Other interactions Valproate usually has no enzyme-inducing and therefore does not reduce the effectiveness of estrogen in the case of hormonal contraception. If concomitant use of oral anticoagulants must be careful monitoring of prothrombin time.


It ’was reported exceptionally severe liver damage which sometimes proved fatal. Patients most at risk, especially if multiple anticonvulsant therapy, are infants and children under three years with severe forms of epilepsy, particularly those with brain damage, mental retardation and / or metabolic disease, congenital or degenerative.After the completion of three years and significantly reduces the incidence decreases with age. In most cases the liver damage occurs during the first six months of therapy. Clinical symptoms are essential for early diagnosis. In particular, especially in patients at risk must be taken into account two types of events that may precede jaundice: recurrence of seizures, non-specific symptoms, usually with rapid onset, such as anorexia, lethargy, drowsiness, sometimes associated with repeated vomiting and abdominal pain. Patients (or their parents if they are children) should be advised to inform your doctor immediately if you experience any of the signs above.In addition to clinical examinations, blood chemistry monitoring will be undertaken immediate liver function.Hepatic function should be checked periodically during the first six months of therapy.Among the usual analysis the most relevant are those which reflect protein synthesis, particularly prothrombin time. The confirmation of a very low percentage of prothrombin activity, especially if associated with other abnormal biological findings (significant decrease in fibrinogen and coagulation factors, increased levels of bilirubin and increased transaminases) requires cessation of therapy with valproate. As a precaution, and if they are undertaken simultaneously, including salicylates should be stopped because metabolized by the same route. Before initiation of therapy should be performed liver function tests that periodically be repeated during the first six months, especially in patients at risk. As with most anti-epileptic drugs, you may notice increased liver enzymes particularly during initiation of therapy, they are transitory and isolated, with no associated clinical signs. In these patients, laboratory tests are recommended more extensive (including prothrombin time), you may also consider an adjustment of dosage and, if necessary, you must repeat the analysis. The prescription of monotherapy is recommended for children under three years, but the potential benefit must be assessed before initiating therapy in comparison to the high risk of liver damage in these patients. Concomitant use of salicylates should be avoided in children under three years for the risk of hepatotoxicity. It is recommended to perform blood tests (complete with emacromo platelet count, bleeding time and coagulation tests) before initiation of therapy or before surgery and in the case of spontaneous bruising or bleeding. In patients with renal insufficiency is necessary to take into account the increase in serum valproic acid free and therefore decrease the dosage. Although there has been only rarely encountered during the use of immune disorders valproate, it should consider the potential benefits against the potential risk of valproate in patients with systemic lupus erythematosus. Because of the exceptional cases were reported of pancreatitis, which is recommended in patients with acute abdominal pain is dosed the amylase. If you suspect an impaired urea cycle before treatment to assess the hyperammonemia, because valproate can deteriorate. During the treatment should be monitored periodically Mg. THE MEDICINAL KEEP OUT OF REACH OF CHILDREN.



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