1. Depakine 500 mg Gastro-resistant tablets
This dosage form is not appropriate for children under the age of 6 (risk of choking).Among the oral pharmaceutical forms, the syrup, oral solution and prolonged-release granules are more appropriate for administration to children less than 11 years. Posology Mean daily dose:
•Infants and children: 30 mg/kg (syrup, oral solution or prolonged-release granules should preferably be used).
•Adolescents and adults: 20 to 30 mg/kg (tablets, prolonged-release tablets or prolonged-release granules should preferably be used).
2. Depakine CHRONO® 500 mg prolonged-release scored film-coated tablets
Depakine Chrono is a prolonged-release formulation of Depakine, which reduces peak plasma concentrations and ensures more regular plasma concentrations over a 24-hour period.
In view of the dosage strength, this medicinal product is for use in adults and children weighing over 17 kg only.
This dosage form is not appropriate for children under the age of 6 (risk of choking).
Among the oral pharmaceutical forms, the syrup, oral solution and prolonged-release granules are more appropriate for administration to children less than 11 years.
The initial daily dose is usually 10 to 15 mg/kg, after which doses are increased up to the optimal dose (see Initiation of treatment).
The mean dose is 20 to 30 mg/kg per day. However, if seizures are not brought under control at this dose, the dose may be increased, and patients must be closely monitored.
In children, the usual dose is 30 mg/kg per day.
In adults, the usual dose is 20 to 30 mg/kg per day.
In elderly patients, the dose should be determined based on the control of seizures.
The daily dose should be determined based on age and bodyweight; however, the significant variations in inter-individual sensitivity to valproate must be taken into account.
No clear correlation between daily dose, serum levels and therapeutic effect has been established: the dosage should be determined mainly on the basis of clinical response.
Determination of plasma valproic acid levels should be considered along with clinical monitoring when control of seizures is not achieved or when adverse effects are suspected. The effective therapeutic range is usually between 40 and 100 mg/L (300 to 700 micromole/L).
3.Depakine® 400 mg/4 mL injection for IV administration
As simple replacement treatment (for example, in preparation for surgery): between 4 and 6 hours after the last oral dose, intravenous administration of sodium valproate in a 0.9% sodium chloride solution for injection:
• either as a continuous infusion over 24 hours,
• or divided into 4 one-hour infusions per day, at the previous dose (usual mean dose: 20 to 30 mg/kg/day).
When effective plasma concentrations must be reached rapidly and maintained: intravenous injection of a 15 mg/kg bolus over 5 minutes, followed by a continuous infusion at a flow rate of 1 mg/kg/hour to be gradually adjusted in order to reach blood valproic acid levels of approximately 75 mg/L. The flow rate is to be adjusted based on the clinical course.
When the infusion is stopped, re-initiation of treatment with the oral form will immediately compensate for the amount of drug eliminated. This should be carried out either at the previous dosage or after dose adjustment.
4. Depakine 200 Gastro-resistant tablets
This dosage form is not appropriate for children under the age of 6 (risk of choking). Among the oral pharmaceutical forms, the syrup, oral solution and prolonged-release granules are more appropriate for administration to children less than 11 years.
Infants and children: 30 mg/kg (syrup, oral solution or prolonged-release granules should preferably be used).
• Adolescents and adults: 20 to 30 mg/kg (tablets, prolonged-release tablets or prolonged-release granules should preferably be used).
The medicinal product should be administered daily as 2 or 3 divided doses, preferably during meals.
Initiation of treatment:
• If the patient is already being treated and is taking other antiepileptics, treatment with sodium valproate should be initiated gradually, to reach the optimal dose in approximately 2 weeks, then the concomitant treatments reduced, if necessary, on the basis of treatment efficacy.
• If the patient is not taking any other antiepileptics, the dosage should preferably be increased stepwise every 2 or 3 days, in order to reach the optimal dose in approximately 1 week.
• If necessary, combination treatment with other antiepileptics should be instituted gradually.
5. Depakine® 200 mg/mL oral solution
Mean daily dose
•Infants and children: 30 mg/kg (syrup, oral solution or prolonged-release granules should preferably be used).
•Adolescents and adults: 20 to 30 mg/kg (tablets, prolonged-release tablets or prolonged-release granules should preferably be used).
The medicinal product should be prescribed only in milligrams. The bottle of oral solution is supplied with an oral syringe. The graduation marks indicate doses in milligrams (mg) (1 graduation mark every 25 mg, from 50 mg to 400 mg). Method of administration Oral route. The oral solution should only be administered using the oral syringe (mauve plunger) supplied in the box.
The daily dose should preferably be administered during meals:
•as 2 divided doses in patients under 1 year of age,
•as 3 divided doses in patients over 1 year of age.
The solution should be drunk after diluting in a small amount of non-carbonated drink.
Initiation of treatment
•If the patient is already being treated and is taking other antiepileptics, treatment with sodium valproate should be initiated gradually, to reach the optimal dose in approximately 2 weeks, then the concomitant treatments reduced, if necessary, based on treatment efficacy.
•If the patient is not taking any other antiepileptics, the dosage should preferably be increased stepwise every 2 or 3 days, to reach the optimal dose in approximately 1 week.
•If necessary, combination treatment with other antiepileptics should be instituted gradually (see section 4.5).
References:
• Depakine SmPC
• Depakine Risk minimization documents for HCP
