Divakote 500 mg 30 tablets
Available at Pharmaegy Pharmacy. Use as directed by your doctor.
Divakote 500 mg E.R. 20 Tablets
Composition:
Active ingredient:
Divalproex sodium 538.14 mg (equivalent to 500 mg of valproic acid)
Description:
Divakote ER is a prolonged-release formulation of divalproex sodium used for the treatment of epilepsy, bipolar disorder (manic or mixed episodes), and prophylaxis of migraine headaches. The active component, divalproex sodium, dissociates to valproate in the gastrointestinal tract. Each tablet delivers consistent plasma concentrations with once-daily dosing.
Indications for Use:
Treatment of acute manic or mixed episodes associated with bipolar disorder
Monotherapy or adjunctive therapy for complex partial seizures and absence seizures in patients ≥10 years
Prophylaxis of migraine headaches in adults (not for acute treatment)
Dosage and Method of Administration:
Tablets must be swallowed whole and not crushed or chewed.
Mania: Start with 25 mg/kg/day once daily; adjust to clinical response and plasma levels (85–125 mcg/mL). Max: 60 mg/kg/day
Epilepsy: Initial 10–15 mg/kg/day, increase 5–10 mg/kg/week; therapeutic range 50–100 mcg/mL
Migraine: Start with 500 mg/day for 1 week, increase to 1000 mg/day
Elderly: Start with reduced doses (<250 mg), titrate slowly
Take with food if GI irritation occurs
Avoid double dosing if a dose is missed
Contraindications:
Hepatic disease or significant hepatic dysfunction
Known POLG mutation-related mitochondrial disorders (e.g., Alpers-Huttenlocher Syndrome)
Known hypersensitivity to valproate or excipients
Urea cycle disorders
Use for migraine prophylaxis in pregnant women
Precautions:
Hepatotoxicity: Monitor liver function before and during treatment, especially in first 6 months
Pancreatitis: Discontinue if suspected; monitor for abdominal pain, nausea, vomiting
Teratogenicity:
Avoid in pregnancy unless essential; neural tube defects and decreased IQ risk
Urea Cycle Disorders: Evaluate for UCD in high-risk patients prior to therapy
Suicidal behavior: Monitor for depression and mood changes
Hematologic effects: Monitor blood counts and coagulation parameters
Hypothermia: Assess for drop in body temperature and manage clinically
Use caution in elderly due to risk of somnolence
Side Effects:
Common (>5%):
Somnolence, nausea, vomiting, dyspepsia, diarrhea, dizziness, abdominal pain, pharyngitis, asthenia
Serious (see Warnings):
Hepatic failure, pancreatitis, fetal harm, suicidal ideation, hematologic disorders, hypothermia, hypersensitivity reactions (DRESS)
Pregnancy and Breastfeeding:
Contraindicated for migraine prophylaxis during pregnancy
Use only if no alternatives in epilepsy/bipolar disorder
May reduce IQ and cause birth defects (e.g., spina bifida)
Women of childbearing potential should use effective contraception
Excreted in breast milk; caution advised
Storage Conditions:
Store below 30°C. Protect from moisture. Keep out of reach of children.
Packaging:
Carton box containing 2 strips, each with 10 tablets, and an insert leaflet.