Active Substance: Sodium valproate, Valproic acid.
Overview
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This medicine contains an important and useful components, as it consists of
Sodium valproate, Valproic acidis available in the market in concentration
Sodium Valproate (valproic acid)
Increased risk of hepatotoxicity in childn <2 yr, congenital metabolic disorders, organic brain disease or severe seizure disorders. HIV or cytomegalovirus (CMV) infection; SLE. Decrease dose or discontinue in patients w/ excessive somnolence, decreased food or fluid intake. Gradual withdrawal or transition to and from another type of antiepileptic therapy. Suspect hyperammonemic encephalopathy and measure ammonia levels in patients who develop unexplained lethargy, vomiting or changes in mental status. Immobilised patients or those who have insufficient sun exposure or calcium intake should consider vitamin supplementation. Decrease GI side effects by taking w/ meals, starting w/ low dose or taking the enteric coated formulations. Lactation. Patient Counselling Seek medical advice during first signs of pancreatitis (e.g. abdominal pain, nausea, vomiting and anorexia), blood and liver toxicity. Monitoring Parameters Monitor LFT before and during the 1st 6 mth of therapy. Monitor blood cell count (including platelet count), bleeding time and coagulation tests before the start of therapy or before surgery, and in cases of spontaneous bruising or bleeding. Monitor for atypical behaviour (e.g. suicidal ideation and behaviour) during and after therapy.
Epilepsy, e.g. Partial seizures, Absence seizures (petit mal), Generalized tonic-clonic seizures (grand mal), Myoclonic seizures, Atonic seizures, Mixed seizures, Anxiety disorder, Posttraumatic stress disorder, Febrile convulsion, Anorexia nervosa, Panic attack, Migraine and bipolar disorder.
Preexisting or family history of hepatic dysfunction, active liver disease, porphyria; mitochondrial and urea cycle disorders. Hepatic impairment. Pregnancy.
>10% Nausea (31%),Headache (<31%),Increased bleeding time (26-30%),Thrombocytopenia (26-30%),Tremor (25%),Alopecia (<24%),Asthenia (16-20%),Infection (16-20%),Somnolence (16-20%),Amblyopia (11-15%),Diarrhea (11-15%),Diplopia (11-15%),Dizziness (11-15%),Dyspepsia (11-15%),Nystagmus (11-15%),Tinnitus (11-15%),Vomiting (11-15%) 1-10% Ataxia (<8%),Increased appetite (<6%),Rash (<6%),Abdominal pain (<5%),Tremor (<5%),Back pain (<5%),Mood changes (<5%),Anxiety (<5%),Confusion (<5%),Abnormal gait (<5%),Paresthesia (<5%),Hallucinations (<5%),Catatonia (<5%),Dysarthria (<5%),Tardive dyskinesia (<5%),Vertigo (<5%),Irregular menses (<5%),Weight gain (4%) Frequency Not Defined Anorexia,Acute pancreatitis (may be life-threatening),Hepatic toxicity,Hyperammonemia,Weight loss,Fractures,Osteoporosis,Osteopenia,Decreased bone mineral density,Cerebral pseudoatrophy
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Valproate is a generic term used to describe valproic acid, its salts and derivatives. It is available in various forms including the sodium salts (valproate semisodium and sodium valproate), the amide derivative (valpromide), or as valproic acid. Valproate is a carboxylic acid anticonvulsant. It has been suggested that its antiepileptic activity is related to increased brain levels of ?-aminobutyric acid (GABA).
Increased risk of toxicity w/ bupropion. Increased risk of convulsions w/ mefloquine. Increased risk of carnitine deficiency w/ pivmecillinam and pivampicillin. Increased risk of hepatotoxicity and carbamazepine toxicity w/ a decrease in valproic acid levels w/ concurrent carbamazepine. Decreased valproic acid and increased ethosuximide serum levels w/ ethosuximide. Decreased valproic acid levels w/ carbapenems, rifampicin, phenytoin, phenobarbital (or primidone) and antineoplastic drug regimens. Increased valproic acid levels w/ felbamate and aspirin. Increased risk of hepatotoxicity w/ olanzepine. Concurrent use increased phenobarbital, nimodipine, nifedipine, lamotrigine, zidovudine, amitriptyline, nortriptyline and benzodiazepines levels. Concurrent use decreased tigabine and clozapine levels. Increased risk of absence status w/ clonazepam. Increased risk of hyperammonaemia w/ topiramate. Increased free valproic acid concentrations w/ highly protein bound drugs. Potentially Fatal: Concomitant carbapenem is not recommended as this may decrease valproate levels. Avoid concurrent salicylates in childn <3 yr due too risk of hepatotoxicity. Increased risk of hepatotoxicity w/ cosyntropin. Avoid ethanol as this may increase CNS depression.
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