Value-added services:
1) Packaging design by our team
2) Registration service by our team
3) Registration dossier available by our team
-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Sodium Valproate Concentrated Solution for Injection 500mg/5ml
Composition:
Each 5mL ampoule contains:
Description:
Sodium Valproate is an antiepileptic drug (AED) used for the treatment of epilepsy, seizures, and bipolar disorder. It works by increasing the availability of gamma-aminobutyric acid (GABA), a neurotransmitter that stabilizes nerve activity.
Indications:
Sodium Valproate Injection is indicated for:
- Epilepsy (generalized & focal seizures)
- Acute manic episodes in bipolar disorder
- Prophylaxis of migraine (in certain cases, if oral therapy is not feasible)
Dosage & Administration:
Intravenous (IV) Use Only
- Can be given as a slow IV injection (over 3-5 minutes) or IV infusion (over 30-60 minutes).
- Transition to oral therapy as soon as feasible.
Adult Dosage:
- Epilepsy: 400-800mg IV per day (max 30mg/kg/day)
- Acute seizures (status epilepticus): Initial 15-20mg/kg IV bolus, followed by infusion 1-3mg/kg/hr
Pediatric Dosage:
- Children >20kg: 10-15mg/kg/day, max 30mg/kg/day
- Children <20kg: 20mg/kg/day, divided into 2-3 doses
Reconstitution & Administration:
- Dilution (for infusion): Dilute with normal saline (0.9% NaCl) or 5% dextrose
- Administer slowly to avoid CNS depression & cardiovascular effects
Contraindications:
- Hypersensitivity to Sodium Valproate
- Severe liver dysfunction
- Urea cycle disorders
Precautions:
- Monitor liver function (risk of hepatotoxicity, especially in children <2 years)
- Use with caution in renal impairment
- Risk of teratogenicity (avoid in pregnancy unless necessary)
Adverse Reactions:
- Common: Nausea, dizziness, tremors, drowsiness
- Serious: Hepatotoxicity, pancreatitis, thrombocytopenia, hyperammonemia
Drug Interactions:
- Increased effect with phenytoin, carbamazepine
- Increased sedation with benzodiazepines
- Avoid alcohol & CNS depressants
Overdose & Management:
- Symptoms: Respiratory depression, hypotension, metabolic acidosis
- Treatment: Supportive care, hemodialysis if needed
Storage Conditions:
- Store below 25°C, protect from light
- Use reconstituted solution within 24 hours (if refrigerated at 2-8°C)

