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Daily dosage requirements vary according to age and body weight.
In patients where adequate control has been achieved, Epilim Chrono formulations are interchangeable with other conventional or prolonged-release formulations on an equivalent daily dosage basis.
Dosage: Usual requirements are as follows: Epilim EC tab, Syr and Chrono: Adults: Dosage should start at 600 mg daily, increasing by 200 mg at 3-day intervals until control is achieved. This is generally within the dosage range of 1000-2000 mg/day ie, 20-30 mg/kg body weight. Where adequate control is not achieved within this range, the dose may be further increased to 2500 mg/day.
Children over 20 kg: Where adequate control is not achieved within this range, the dose may be increased to 35 mg/kg body weight/day.
Epilim EC Tab & Syr: Initial dosage should be 400 mg/day (irrespective of weight) with spaced increases until control is achieved; this is usually within the range of 20-30 mg/kg body weight/day.
Epilim Chrono: Initial dosage should be 500 mg/day (irrespective of weight) with spaced increases until control is achieved; this is usually within the range of 20-30 mg/kg body weight/day.
Children under 20 kg: 20 mg/kg of body weight/day; in severe cases, this may be increased but only in patients in whom plasma valproic acid levels can be monitored. Above 40 mg/kg/day, clinical chemistry and haematological parameters should be monitored.
Epilim EC tab and Chrono: An alternate formulation of Epilim should be used in this group of patients, due to the tablet size and need for dose titration. Epilim syrup is an alternative.
Use in the elderly: Although the pharmacokinetics of Epilim is modified in the elderly, they have limited clinical significance and dosage should be determined by seizure control.
The volume of distribution is increased in the elderly and because of decreased binding to serum albumin, the proportion for free drug is increased. This will affect the clinical interpretation of plasma valproic acid levels.
In patients with renal insufficiency: It may be necessary to decrease dosage. Dosage should be adjusted according to clinical monitoring since monitoring of plasma concentration may be misleading (see Pharmacology: Pharmacokinetics under Actions).
In patients with hepatic insufficiency: Salicylates should not be used concomitantly with Epilim since they employ the same metabolic pathway (see Precautions and Adverse Reactions).
Liver dysfunction, including hepatic failure resulting in fatalities, has occurred in patients whose treatment included valproic acid (see Contraindications and Precautions).
Salicylates should not be used in children under 16 years (see aspirin/salicylate product information on Reye's syndrome). In addition in conjunction with Epilim, concomitant use in children under 3 years can increase the risk of liver toxicity (see Warnings).
Female children and women of childbearing potential: Valproate must be initiated and supervised by a specialist experienced in the management of epilepsy. Valproate should not be used in female children and women of childbearing potential unless other treatments are ineffective or not tolerated (see Precautions and Use in Pregnancy & Lactation). The benefit and risk should be carefully reconsidered at regular treatment reviews. Valproate should preferably be prescribed as monotherapy and at the lowest effective dose, if possible as a prolonged release formulation. The daily dose should be divided into at least two single doses.
Combined Therapy: When starting Epilim in patients already on other anticonvulsants, these should be tapered slowly: initiation of Epilim therapy should then be gradual, with target dose being reached after about 2 weeks. In certain cases, it may be necessary to raise the dose by 5-10 mg/kg/day when used in combination with anticonvulsants which induce the liver enzyme activity eg, phenytoin, phenobarbital and carbamazepine. Once known enzyme inducers have been withdrawn, it may be possible to control seizure on a reduced dose of Epilim. When barbiturates are being administered concomitantly and particularly if sedation is observed (particularly in children), the dosage of barbiturates should be reduced.
Note: In children requiring doses higher than 40 mg/kg/day, clinical chemistry and haematological parameters should be monitored.
Optimum dosage is mainly determined by seizure control and routine measurement of plasma levels is unnecessary. However, a method for measurement of plasma levels is available and may be helpful where there is poor control or side effects are suspected (see Pharmacology: Pharmacokinetics under Actions).
Epilim EC tab, Syr and Chrono: In treatment and prevention of mania associated with bipolar disorders: Adults: The recommended initial dose is 1000 mg/day. The dose should be increased as rapidly as possible to achieve the lowest therapeutic dose, which produces the desired clinical effects.
The recommended maintenance dosage for treatment of bipolar disorder is 1000-2000 mg daily. In exceptional cases, the dose may be increased to not more than 3000 mg daily. Doses should be adjusted according to individual clinical response.
Prophylactic treatment should be established individually with the lowest effective dose.
Epilim IV: Dosage: To reconstitute, inject the solvent provided (4 ml) into the vial, allow to dissolve and extract the appropriate dose. Due to displacement of solvent by sodium valproate the concentration of reconstituted sodium valproate is 95 mg/ml.
Each vial of Epilim Intravenous is for single dose injection only. It should be reconstituted immediately prior to use and infusion solutions containing it used within 24 hours. Any unused portion should be discarded (see Instructions for Use/ Handling under Cautions for Usage).
Epilim Intravenous should not be administered via the same IV line as other IV additives. The intravenous solution is suitable for infusion by PVC, polyethylene or glass containers.
Patients already satisfactorily treated with Epilim may be continued at their current dosage using continuous or repeated infusion. Other patients may be given a slow intravenous injection over 3-5 minutes, usually 400-800 mg depending on body weight (up to 10 mg/kg) followed by continuous or repeated infusion up to a maximum of 2500 mg/day.
Epilim Intravenous should be replaced by oral Epilim therapy as soon as practicable.
Use with children: Daily requirement for children is usually in the range 20-30 mg/kg/day and method of administration is as follows. Where adequate control is not achieved within this range the dose may be increased up to 40 mg/kg/day but only in patients in whom plasma valproic acid levels can be monitored. Above 40 mg/kg/day clinical chemistry and haematological parameters should be monitored.
Female children and women of childbearing potential: Valproate is prescribed and dispensed according to the Valproate Pregnancy Prevention Programme (see Contraindications, Warnings and Precautions).
Method of Administration: Epilim EC Tab, Syr and Chrono: Epilim 200 Enteric Coated Tablets, Syrup and Epilim Chrono Controlled Release Tablets are for oral administration.
Epilim EC and Chrono tab: Epilim tablets may be given once or twice daily. Tablets should be swallowed whole and not crushed or chewed.
Epilim Syr: Epilim Syrup may be given twice daily. If it is necessary to dilute Epilim Syrup, the recommended diluent is Syrup BP, but syrup containing SO2 as a preservative should not be used. The diluted product will have a 14-day shelf life.
Epilim Chrono: Epilim Chrono is a prolonged release formulation of Epilim which reduces peak concentration and ensures more even plasma concentrations throughout the day.
Epilim IV: Epilim Intravenous may be given by direct slow intravenous injection or by infusion using a separate intravenous line in normal saline, dextrose 5%, or dextrose saline.
