Divalprid- OD Tablets (Divalproex Sodium extended release)

• Composition :
  Each tablet contains Divalproex Sodium extended release 250/500/750 mg.
• Indications :
  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.
• Pharmacodynamics :
  Divalproex sodium dissociates to the valproate ion in the gastrointestinal tract. It has been suggested that its activity in epilepsy is related to increased brain concentrations of gamma-aminobutyric acid(GABA).
• Dosage and administration :
  Complex partial seizures- Adult: Initially 10-15 mg/kg/day in 2-4 divided doses, if necessary increaseat 5-10 mg/kg/week. Max: 60 mg/kg/day. Children: ≥10 yr: Initially 10-15 mg/kg/day in 2-4 divided doses, if necessary, increase at 5-10 mg/kg/wk. Max: 60 mg/kg/day. Manic episodes of bipolar disorder- Adults: Initially 25/kg mg daily,increaseas rapidly as possible to achieve therapeutic response or desired plasma levelMax: 60 mg/kg/day. Migraine prophylaxis: Adult: 500mg once daily for 1week, may increase to 1000 mg once daily.
• Contraindications :
  Hepatic disease or significant hepatic dysfunction, urea cycle disorder, known hypersensitivity to drug.
• Precautions and warnings :
  Hepatotoxicity- monitor liver function; Divalproex Sodium extended release should be discontinued in pancreatitis; increase the risk of suicidal thoughts or behavior; thrombocytopenia; monitor platelet counts and coagulation tests, hypothermia with or without associated hyperammonemia, multi-organ hypersensitivity reaction; discontinue Divalproex Sodium extended release , Somnolence in the elderly, so Divalproex Sodium extended release should be increased slowly and with regular monitoring for fluid and nutritional intake.
• Use in pregnancy, lactation & pediatrics :
  Pregnancy category D. Divalproex Sodium extended releasecan cause congenital malformations. Excreted in human milk and caution should be exercised when administered to a nursing woman.Children under the age of two years are at considerably higher risk of fatal hepatotoxicity.
• Drug interactions :
  Aspirin, carbapenem antibiotics: Monitoring of valproate concentrations are recommended, co-administration of valproate can affect the pharmacokinetics of other drugs (e.g. diazepam, ethosuximide, lamotrigine, phenytoin) by inhibiting their metabolism or protein binding displacement. Dosage adjustment of amitriptyline/nortriptyline, warfarin, and zidovudine may be necessary if used concomitantly.
• Adverse reactions :
  Most common adverse reactions (reported >5%) reported in patients are abdominal pain, accidental injury, alopecia, ambylopia/blurred vision, amnesia, anorexia, asthenia, ataxia, back pain, bronchitis, constipation, depression, diarrhea, diplopia, dizziness, dyspepsia, dyspnea, ecchymosis, emotional lability, fever, flu syndrome, headache, increased appetite, infection, insomnia, nausea, nervousness, nystagmus, peripheral edema, pharyngitis, rash, rhinitis, somnolence, thinking abnormal, thrombocytopenia, tinnitus, tremor, vomiting, weight gain, weight loss .
• Therapy Area :
  Anti-Eplileptics