sodium valproate 200mg alphagan

In order to assist healthcare professionals and patients in avoiding exposure to valproate during pregnancy, the Marketing Authorisation Holder has provided educational materials to reinforce the warnings and provide guidance regarding use of valproate in women of childbearing potential and the details of the pregnancy prevention programme.

In addition in conjunction with sodium valproate concomitant use in children under 3 years can increase the risk of liver toxicity (see section 4.4.1). Naloxone has been successfully used in a few isolated cases, sometimes in association with activated charcoal given orally. • non-specific symptoms, usually of sudden onset, such as asthenia, malaise, anorexia, lethargy, oedema and drowsiness which are sometimes associated with repeated vomiting and abdominal pain. 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.Confirmation of an abnormally low prothrombin rate, particularly in association with other biological abnormalities (significant decrease in fibrinogen and coagulation factors; increased bilirubin level and raised transaminases) requires cessation of sodium valproate therapy.As a matter of precaution and in case they are taken concomitantly salicylates should also be discontinued since they employ the same metabolic pathway.As with most anti-epileptic drugs, increased liver enzymes are common, particularly at the beginning of therapy; they are also transient.More extensive biological investigations (including prothrombin rate) are recommended in these patients; a reduction in dosage may be considered when appropriate and tests should be repeated as necessary.Pancreatitis, which may be severe and result in fatalities, has been very rarely reported. Alpers-Huttenlocher Syndrome and in children under two years of age who are suspected of having a POLG-related disorder (see section 4.4).Although there is no specific evidence of sudden recurrence of underlying symptoms following withdrawal of valproate, discontinuation should normally only be done under the supervision of a specialist in a gradual manner. Nagpur, Maharashtra Always consult your healthcare provider to ensure the information displayed on this page applies to … The risk seems to be dose-dependent but a threshold dose below which no risk exists, cannot be established based on available data. I This is a greater risk of major malformations than for the general population, for whom the risk is about 2-3%. Nagpur, Maharashtra plasma concentration 10 to 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. Young children are at particular risk; this risk decreases with increasing age. They have usually been reversible on withdrawal of treatment or reduction of dosage.An increase in alertness may occur; this is generally beneficial but occasionally aggression, hyperactivity and behavioural deterioration have been reported.Common: confusional state, aggression*, agitation*, disturbance in attention*, hallucinations.Rare: abnormal behaviour*, psychomotor hyperactivity*, learning disorder**These ADRs are principally observed in the paediatric population.Rare: obesity, hyperammonaemia* (see section 4.4.2)*Cases of isolated and moderate hyperammonaemia without change in liver function tests may occur are usually transient and should not cause treatment discontinuation.However, they may present clinically as vomiting, ataxia, and increasing clouding of consciousness.
Every effort should be made to switch to appropriate alternative treatment prior to conception, and before contraception is discontinued (see section 4.6). Depakene (valproic acid)."

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