Valex CR 500mg Tablet (Box)

✔️ Side Effects

• GI disturbances (anorexia, nausea, vomiting) — minimized with enteric-coated tablets
• CNS effects: sedation, tremor, ataxia — dose-dependent
  Occasional:
• Rash, hair thinning, increased appetite
• Elevated liver enzymes in ~40% of patients (often transient)
  Serious (rare):
• Fulminant hepatitis, especially in young children or those on multiple AEDs
• Acute pancreatitis
• Hyperammonemia

✔️ Dosage & Administration

Epilepsy

• Adults: Start with 600 mg/day in 2 doses, increasing by 200 mg/day every 3 days up to 2.5 g/day as needed. Usual maintenance: 1–2 g/day (20–30 mg/kg/day).
• Children >20 kg: Begin at 400 mg/day in divided doses; adjust up to 35 mg/kg/day.
• Children <20 kg: Initiate at 20 mg/kg/day in divided doses.

Febrile Seizures: 20–30 mg/kg/day in 3 doses.

Bipolar Disorder: Begin with 600 mg/day (20–30 mg/kg/day) in 2–3 doses; maintenance: 1000–2000 mg/day.

Migraine Prophylaxis: Usually 400–600 mg/day; some may need 1000–1500 mg/day.

✔️ Drug Interactions

Sodium Valproate can inhibit hepatic drug metabolism, notably interacting with:

• Phenobarbital
• Phenytoin
• Warfarin
• Aspirin

✔️ Contraindications

• Known hypersensitivity to sodium valproate
• Liver dysfunction
• Use is restricted during pregnancy and in women of childbearing potential

✔️ Use in Pregnancy & Lactation

• Crosses pthe lacenta; first trimester exposure linked to neural tube defects (e.g., spina bifida)
• Monitor maternal serum alpha-fetoprotein during pregnancy
• Excreted in breast milk, though considered relatively safe for breastfeeding infants

✔️ Precautions & Warnings

• Monitor liver function before initiation and regularly during the first 6 months, particularly in high-risk patients
• Ensure no bleeding risk before initiating or performing major surgery
• Caution in renal impairment, pregnancy, lactation, and lupus
• May cause false-positive urine ketone tests
• Do not abruptly discontinue therapy
• Contraindicated during pregnancy and in women with reproductive potential

✔️ Storage

Store below 30°C. Protect from light and keep out of reach of children.