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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).
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).
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.
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).
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.
Method of administration
Oral use.
The syrup should only be administered using the oral syringe (white plunger) supplied in the box. The dose per administration is shown on the plunger of the oral syringe. The dose can be read directly from the scale marked on the syringe with graduations every 20 mg from 10 mg to 260 mg and intermediate graduations of 10 mg. For intermediate doses, the dose administered in mg should be calculated and then rounded down to the nearest corresponding graduation mark on the oral syringe, taking into account the half graduation marks.
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
Valproate has a high teratogenic potential and children exposed in utero to valproate have a high risk for congenital malformations and neuro-developmental disorders. Valproate should not be used in female children and women of childbearing potential unless other treatments are ineffective or not tolerated. If no other treatment is possible, the Pregnancy Prevention Programme below must be complied with.
Depakine is contraindicated in the following situations:
• In pregnancy unless there is no suitable alternative treatment.
• In women of childbearing potential, unless the conditions of the Pregnancy Prevention
Conditions of the Pregnancy Prevention Programme
The prescriber must ensure that:
• individual circumstances are evaluated in each case, involving the patient in the discussion, to guarantee her engagement, discuss therapeutic options and ensure her understanding of the risks and the measures needed to minimise these risks.
• the potential for pregnancy is assessed in all female patients.
• the patient has understood and acknowledged the risks of congenital malformations and neurodevelopmental disorders, including the magnitude of these risks for children exposed to valproate in utero.
• the patient understands the need to undergo pregnancy testing prior to initiation of treatment and during treatment, as needed.
• the patient is advised on contraception and is capable of complying with the need to use effective contraception (for further details please refer to the subsection on "Contraception" of this boxed warning), without interruption throughout the entire duration of treatment with valproate.
• the patient understands the need for regular (at least annual) review of treatment by a specialist experienced in the management of epilepsy.
• the patient understands the need to consult her physician as soon as she is planning to become pregnant to ensure timely discussion and switching to alternative treatment options prior to conception and before contraception is discontinued.
• the patient understands the need to consult her physician urgently in case of pregnancy.
• the patient has received the Patient Guide.
• the patient has acknowledged that she has understood the hazards and necessary precautions associated with valproate use (Annual Risk Acknowledgment Form).
These conditions also concern women who are not currently sexually active, unless the prescriber considers that there are compelling reasons to indicate that there is no risk of pregnancy.
Please refer to the full Summary of Product Characteristics for the complete information on this section.
References:
• Depakine SmPC
• Depakine Risk minimization documents for HCP
Valproate is excreted in human milk with a concentration ranging from 1% to 10% of maternal serum levels. Haematological disorders have been shown in breast-fed newborns/infants of treated women (see section 4.8). A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Depakine therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
References:
• Depakine SmPC
• Depakine Risk minimization documents for HCP
Valproate as treatment for epilepsy is contraindicated in pregnancy unless there is no suitable alternative treatment (see sections 4.3 and 4.4).
If a woman using valproate becomes pregnant, she must be immediately referred to a specialist to consider alternative treatment options. During pregnancy, maternal tonic-clonic seizures and status epilepticus with hypoxia may carry a particular risk of death for mother and the unborn child
If, despite the known risks of valproate in pregnancy and after careful consideration of alternative treatment, in exceptional circumstances a pregnant woman must receive valproate for epilepsy:
• the lowest effective dose must be used
• the daily dose of valproate should be divided into several small doses to be taken throughout the day. The use of a prolonged-release formulation may be preferable to other treatment formulations in order to avoid high peak plasma concentrations (see section 4.2).
All patients with a valproate-exposed pregnancy and their partners should be referred to a specialist experienced in teratology for evaluation and counselling regarding the exposed pregnancy.
• Specialised prenatal monitoring should take place to detect the possible occurrence of neural tube defects or other malformations.
Before delivery
Coagulation tests should be performed in the mother before delivery, including in particular a platelet count, fibrinogen levels and coagulation time (activated partial thromboplastin time: aPTT).
Risk in the neonate
• Cases of haemorrhagic syndrome have been reported very rarely in neonates whose mothers have taken valproate during pregnancy. This haemorrhagic syndrome is related to thrombocytopenia, hypofibrinogenemia and/or to a decrease in other coagulation factors. Afibrinogenemia has also been reported and may be fatal. However, this syndrome must be distinguished from the decrease of the vitamin-K factors induced by phenobarbital and enzymatic inducers. Normal haemostasis test results in the mother do not make it possible to rule out haemostasis abnormalities in the neonate. Therefore, platelet count, fibrinogen plasma level, coagulation tests and coagulation factors should be investigated in neonates at birth.
• Cases of hypoglycaemia have been reported in neonates whose mothers have taken valproate during the third trimester of their pregnancy.
• Cases of hypothyroidism have been reported in neonates whose mothers have taken valproate during pregnancy.
• Withdrawal syndrome (in particular, agitation, irritability, hyper-excitability, jitteriness, hyperkinesia, tonicity disorders, tremor, convulsions and feeding disorders) may occur in neonates whose mothers have taken valproate during the last trimester of their pregnancy.
Post-natal monitoring/monitoring of children
Close monitoring of the neuro-developmental behaviour must be implemented in children exposed to valproate during pregnancy and suitable treatment initiated as early as possible if necessary.
References:
• Depakine SmPC
• Depakine Risk minimization documents for HCP
Depakine treatment must be started and supervised by a doctor who specialises in the treatment of epilepsy. This treatment must not be prescribed for female children, female adolescents or women capable of becoming pregnant unless other treatments do not work or are not tolerated. If no other treatment is possible, valproate will be prescribed for you and dispensed under very strict conditions (Given in the Pregnancy Prevention Programme). A specialist will have to re-evaluate the need for treatment at least once per year.
How much of this medicine to take
References:
• Depakine SmPC
• Depakine Risk minimization documents for HCP