Valporic acid

Valproic acid 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. it is indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types which include absence seizures. Simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. Complex absence is the term used when other signs are also present

Fatty acid derivative and anticonvulsant

Sodium Valproate, the active ingredient of this preparation is endowed with anti-epileptic activity against a variety of seizures. The mechanism by which Sodium Valproate exerts its anti-epileptic effects has not been established. However, it has been suggested that its activity is related to increase brain levels of gamma-aminobutyric acid (GABA).

2.1 Epilepsy Depakene is intended for oral administration. Depakene capsules should be swallowed whole without chewing to avoid local irritation of the mouth and throat. Patients should be informed to take Depakene every day as prescribed. If a dose is missed it should be taken as soon as possible, unless it is almost time for the next dose. If a dose is skipped, the patient should not double the next dose. Depakene is indicated as monotherapy and adjunctive therapy in complex partial seizures in adults and pediatric patients down to the age of 10 years, and in simple and complex absence seizures. As the Depakene dosage is titrated upward, concentrations of clonazepam, diazepam, ethosuximide, lamotrigine, tolbutamide, phenobarbital, carbamazepine, and/or phenytoin may be affected . Complex Partial Seizures For adults and children 10 years of age or older. Monotherapy (Initial Therapy) Depakene has not been systematically studied as initial therapy. Patients should initiate therapy at 10 to 15 mg/kg/day. The dosage should be increased by 5 to 10 mg/kg/week to achieve optimal clinical response. Ordinarily, optimal clinical response is achieved at daily doses below 60 mg/kg/day. If satisfactory clinical response has not been achieved, plasma levels should be measured to determine whether or not they are in the usually accepted therapeutic range (50 to 100 mcg/mL). No recommendation regarding the safety of valproate for use at doses above 60 mg/kg/day can be made. The probability of thrombocytopenia increases significantly at total trough valproate plasma concentrations above 110 mcg/mL in females and 135 mcg/mL in males. The benefit of improved seizure control with higher doses should be weighed against the possibility of a greater incidence of adverse reactions. Conversion to Monotherapy Patients should initiate therapy at 10 to 15 mg/kg/day. The dosage should be increased by 5 to 10 mg/kg/week to achieve optimal clinical response. Ordinarily, optimal clinical response is achieved at daily doses below 60 mg/kg/day. If satisfactory clinical response has not been achieved, plasma levels should be measured to determine whether or not they are in the usually accepted therapeutic range (50-100 mcg/mL). No recommendation regarding the safety of valproate for use at doses above 60 mg/kg/day can be made. Concomitant antiepilepsy drug (AED) dosage can ordinarily be reduced by approximately 25% every 2 weeks. This reduction may be started at initiation of Depakene therapy, or delayed by 1 to 2 weeks if there is a concern that seizures are likely to occur with a reduction. The speed and duration of withdrawal of the concomitant AED can be highly variable, and patients should be monitored closely during this period for increased seizure frequency. Adjunctive Therapy Depakene may be added to the patient's regimen at a dosage of 10 to 15 mg/kg/day. The dosage may be increased by 5 to 10 mg/kg/week to achieve optimal clinical response. Ordinarily, optimal clinical response is achieved at daily doses below 60 mg/kg/day. If satisfactory clinical response has not been achieved, plasma levels should be measured to determine whether or not they are in the usually accepted therapeutic range (50 to 100 mcg/mL). No recommendation regarding the safety of valproate for use at doses above 60 mg/kg/day can be made. If the total daily dose exceeds 250 mg, it should be given in divided doses.

Sodium Vaiproate appears to act as a non specific inhibitor of drug metabolism. Drugs to which it interacts most significantly are Phenobarbital, Phenytoin, Warfarin, Aspirin etc.

It hould not be administered to patients with hepatic disease or significant hepatic dysfunction. It is contraindicated in patients with known hypersensitivity to the drug. It is contraindicated in patients with known urea cycle disorders

Nausea, vomiting, stomach pain, diarrhea; dizziness, drowsiness, weakness; headache; tremors, problems with walking or coordination; blurred vision, double vision; hair loss; or. changes in appetite, weight gain

All pregnancies have a background risk of birth defects (about 3%), pregnancy loss (about 15%), or other adverse outcomes regardless of drug exposure. Maternal valproate use during pregnancy for any indication increases the risk of congenital malformations, particularly neural tube defects, but also malformations involving other body systems (e.g., craniofacial defects, cardiovascular malformations). The risk of major structural abnormalities is greatest during the first trimester; however, other serious developmental effects can occur with valproate use throughout pregnancy.It is excreted in human milk. Caution should be exercised when valproate is administered to a nursing woman.

Cases of accidental and suicidal overdosage have been reported. Fatalities are rare. Symptoms At plasma concentrations of up to 5 or 6 times the maximum therapeutic levels, there are unlikely to be any symptoms other than nausea, vomiting and dizziness. Symptoms of overdosage may include serious CNS depression and impairment of respiration. In cases of overdose, long half-lives up to 30 hours have been reported. Signs of an acute massive overdose usually include coma, with muscular hypotonia, hyporeflexia and miosis, impaired respiratory functions and metabolic acidosis, hypotension and circulatory collapse/shock. Symptoms may however be variable and seizures have been reported in the presence of very high plasma levels. Cases of intracranial hypertension related to cerebral oedema have been reported. Deaths have occurred following massive overdose. Hospital management of overdose including assisted ventilation and other supportive measures are recommended. The presence of sodium content in the valproate formulations may lead to hypernatraemia when taken in overdose.

Do not store above 30°C. Keep away from light and out of the reach of children.

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Sodium Valproate tablet: Each enteric-coated tablet contains Sodium Valproate BP 200 mg. Sodium Valproate syrup: Each 5 ml syrup contains Sodium Valproate BP 200 mg. Sodium Valproate controlled release 200 tablet: Each enteric-coated controlled release tablet contains Sodium Valproate 200 mg as Sodium Valproate BP 133.2 mg & Valproic acid BP 58 mg. Sodium Valproate controlled release 300 tablet: Each enteric-coated controlled release tablet contains Sodium Valproate 300 mg as Sodium Valproate BP 199.8 mg & Valproic acid BP 87 mg. Sodium Valproate controlled release 500 tablet: Each enteric-coated controlled release tablet contains Sodium Valproate 500 mg as Sodium Valproate BP 333 mg & Valproic acid BP 145 mg. Sodium Valproate injection: Each 5 ml injectable solution contains Sodium Valproate BP eqv. to Valproic Acid 500 mg.