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DIVANEX ER-250/ER-500/ER-750/ER-1000 (DIVALPROEX SODIUM TABLETS)
DESCRIPTION
Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide. Chemically it is designated as sodium hydrogen bis(2-propylpentanoate). Divalproex sodium has the following structure:
DOSAGE
Initial Therapy: 10 to 15 mg/kg/day. Titration: Increase by 5 to 10 mg/kg/week to achieve optimal clinical response. Maintenance: Usually below 60 mg/kg/day. No recommendation regarding safety at doses above 60 mg/kg/day can be made.
CLINICAL PHARMACOLOGY
Divalproex sodium dissociates to the valproate ion in the gastrointestinal tract. The mechanisms by which valproate exerts its therapeutic effects have not been established. It has been suggested that its activity in epilepsy is related to increased brain concentrations of gamma-aminobutyric acid (GABA).
INDICATIONS
A manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritable mood. Typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas.
CONTRA INDICATIONS
Divalproex should not be administered to patients with hepatic disease or significant hepatic dysfunction. Divalproex is contraindicated in patients with known hypersensitivity to the drug. Divalproex is contraindicated in patients with known urea cycle disorders. Divalproex is contraindicated for use in prophylaxis of migraine headaches in pregnant women
SIDE EFFECTS
confusion, tiredness, cold feeling, vomiting, change in your mental state, easy bruising, unusual bleeding (nose, mouth, or gums), purple or red pinpoint spots under your skin, severe drowsiness, worsening seizures, mild nausea or vomiting, mild stomach pain, diarrhea, headache, mild dizziness, weakness, tremors, problems with balance or walking, blurred vision, double vision or changes in appetite, weight gain.
DRUG INTERACTIONS
Liver Disease, Mental Retardation, Metabolic Disorder – Congenital, Brain Anomalies – Congenital.
AVAILABILITY
Divalproex sodium is available in strips of ten capsules containing Divalproex sodium Capsules.