Divakote 250 mg 30 tablets

Divakote 250 mg 30 tablets

Composition:

Active ingredient:

Divalproex sodium 269.07 mg (equivalent to 250 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.