DIVAREX
DIVALPROEX SODIUM (SODIUM VALPROATE) · by MEDERA
Composition
Susp 250 mg/500 mg: Per 5 ml: Sodium valproate equiv to valproic acid 250 mg/500 mg. Susp 200 mg: Per 5 ml: Sodium valproate 200 mg. Tab 250 mg/500 mg: Divalproex sodium 250 mg/500 mg. Tab 125 mg/200 mg: Sodium valproate 125 mg/200 mg. Inj 500 mg: Sodium valproate 500 mg; powder in vials and amp (5 ml).Inj 400 mg: Sodium valproate 400 mg: vial (with 4 ml amp solvent); powder for reconstitution.
Indications & Dosage
All form of Epilepsy, Complex Partial Seizures, Absence Seizures: ORAL: Adult: Initial: 10-15 mg/kg/day, increase by 5-10 mg/kg/wk. Max: 60 mg/kg/day. Children: Neonate: initially 20 mg/kg once daily; usual maintenance dose 10 mg/kg twice daily; 1 month-12 yrs: initially 10-15 mg/kg (max 600 mg) daily in 1-2 divided doses; usual maintenance dose 25-30 mg/kg daily in 2 divided doses (up to 60 mg/kg daily in 2 divided doses); 12-18 yrs: initially 600 mg daily in 1-2 divided doses increased gradually (in steps of 150-300 mg) every 3 days; usual maintenance dose 1-2 gm/day in 2 divided doses, max 2.5 gm/day in 2 divided doses. BY IV INJ: Adult: Initially 10 mg/kg (usually 400-800 mg) by IV injection (over 3-5 mins) followed by IV INF or IV injection (over 3-5 mins) in 2-4 divided doses or by continuous IV INF up to max 2.5 gm daily; usual range 1-2 gm dally(20-30 mg/kg daily). Children: Neonate: 10 mg/kg twice daily; 1 month-12 yr: initially 10 mg/ kg by IV injection, followed by continuous IV INF, or by intermittent IV INF or IV injection in 2-4 divided doses up to usual range 20-40 mg/kg daily; 12-18 yr: Initially 10 mg/ kg by IV injection, followed by continuous IV INF, or by intermittent IV INF or IV injection in 2-4 divided doses up to max 2.5 gm daily; usual range 1-2 gm daily (20-30 mg/kg/ day). Bipolar Disorder, Manic Episodes: ORAL: Adult: Initial: 750 mg in divided doses, increase rapidly to clinical effect. Max: 60 mg/kg/day. Migraine prophylaxis: ORAL: Adult: Starting dose 250 mg twice daily, some patients may benefit from upto 1000 mg/day.
Administration
Administer over 60 min at a rate of <20 mg/min after dilution to final concentration,alternatively, single doses upto 15 mg/kg have been administered as a rapid infusion over 5-10 min (1.5-3 mg/kg/min).Injection should be diluted in 50 ml of a compatible diluent.
Compatibility
Physically compatible and chemically stable in D5W, NS, and LR for at least 24 hours when stored in glass or PVC. See manufacturer direction.
Stability
Store vial at room temperature 15C-30C.
Contraindications
Active liver disease, history of hepatic disease, acute porphyria.
Precautions
Women of child bearing age, false positive test in urine testing for diabetes.Infants; in infantile spasms; monitor clinical chemistry and haematological parameters
Interactions
Barbiturates, MAOls, anticonvulsants and thy-moleptics e.g. imipramine.
Pregnancy
Avoid unless the potential benefit outweighs the risk.
Lactation
Contraindicated
Side Effects
Aggression, anxiety, amnesia, bronchial and salivary hyper-secretion in infants and small children, coordination disturbances, confusion, dizziness, drowsiness, GI disturbance, hair loss, angioedema, thrombocytopenia, agranulocytosis, bone-marrow failure, rash, pancreatitis.