Epilim/Epilim Chrono

Epilim/Epilim Chrono

valproic acid

Manufacturer:

sanofi-aventis

Distributor:

DKSH
Concise Prescribing Info
Contents
Per Epilim Na valproate. Per Epilim Chrono Na valproate, valproic acid
Indications/Uses
Generalised & partial epilepsy. Treatment & prevention of mania associated w/ bipolar disorders. Inj: Treatment of epileptic patients who would normally be maintained on oral Na valproate & for whom oral therapy is temporarily not possible.
Dosage/Direction for Use
Epilepsy Adult 600 mg daily, may be increased by 200 mg at 3-day intervals. Dose range: 1,000-2,000 mg daily (20-30 mg/kg daily). May be further increased to 2,500 mg daily. Childn <20 kg 20 mg/kg daily. In severe cases, dose may be increased in patient whose plasma valproic acid levels can be monitored. Mania associated w/ bipolar disorder Adult Initially 1,000 mg daily. Maintenance dose: 1,000-2,000 mg daily, may be increased not >3,000 mg daily. Epilim inj Monotherapy Adult 400-800 mg slow IV depending on body wt (up to 10 mg/kg) over 3-5 min then continuous or repeated infusion up to max: 2,500 mg daily. Childn 20-30 mg/kg daily, may be increased up to 40 mg/kg daily in patient whose valproic acid levels can be monitored. Combination therapy May be necessary to raise the dose by 5-10 mg/kg daily when used w/ anticonvulsants. Reduce dosage of barbiturates if sedation is observed. Childn >20 kg Epilim EC tab/syr Initially 400 mg daily w/ spaced increases until control is achieved. Usual dosage range: 20-30 mg/kg daily, may be increased to 35 mg/kg daily. Epilim Chrono Initially 500 mg daily w/ spaced increased until control is achieved. Usual dosage range: 20-30 mg/kg daily, may be increased to 35 mg/kg daily.
Administration
Should be taken with food: Tab: Swallow whole, do not chew/crush.
Contraindications
Hypersensitivity to Na valproate. Patients w/ known urea cycle disorders; mitochondrial disorders. Active liver disease, history of severe hepatic dysfunction, porphyria. Women of childbearing potential. Pregnancy.
Special Precautions
Discontinue use in case of pancreatitis. Monitor for signs of suicidal ideation & behaviours. Aggravated convulsions; SLE, hyperammonaemia, wt gain, diabetic patients. Patients w/ known or suspected mitochondrial disease; underlying carnitine palmitolyltransferase type II deficiency. Monitor liver function before & during 1st 6 mth of therapy. Perform blood tests prior to therapy or surgery & in case of spontaneous bruising or bleeding. Avoid abrupt w/drawal. Not recommended to be used w/ carbapenems, alcohol; salicylates. May affect ability to drive & use machines. Renal insufficiency. May impair male fertility. Not to be initiated in women of childbearing potential. Pregnancy & lactation. Not to be used in female childn. Avoid use of salicylates in childn <16 yr.
Adverse Reactions
Nausea; tremor. Liver injury; vomiting, gingival disorder, stomatitis, gastralgia, diarrhoea; extrapyramidal disorder, stupor, somnolence, convulsion, memory impairment, headache, nystagmus; confusional state, hallucinations, aggression, agitation, disturbance in attention; hyponatremia, increased wt; anaemia, thrombocytopenia; hypersensitivity, transient &/or dose-related alopecia; dysmenorrhea; haemorrhage; deafness; urinary incontinence.
Drug Interactions
Potentiated effects of antipsychotics, MAOIs, antidepressants, benzodiazepines. Decreased olanzapine plasma conc. Increased phenobarb plasma conc. Increased plasma levels w/ exacerbated adverse effects of primidone. Decreased phenytoin total conc. Potentiated toxic effects of carbamazepine. Reduced metabolism & increased mean t½ of lamotrigine. Decreased felbamate mean clearance. Increased plasma levels of rufinamide. Increased blood levels of propofol. Raised zidovudine plasma conc. Increased exposure of nimodipine. Decreased plasma conc w/ antiepileptics w/ enzyme-inducing effects. Increased metabolism & lowered seizure threshold by antimalarial agents eg, mefloquine, chloroquine. Increased plasma levels w/ highly protein bound agents eg, aspirin; cimetidine, erythromycin. Increased anticoagulant effect of warfarin, other coumarin anticoagulants. Decreased blood levels w/ carbapenems eg, panipenem, imipenem, meropenem. Decreased blood levels by rifampicin. Decreased plasma level w/ PIs eg, lopinavir, ritonavir; cholestyramine. Decreased serum conc & efficacy by UGT isoforms. Increased risk of neutropenia/leucopenia w/ quetiapine. Encephalopathy &/or hyperammonaemia w/ topiramate or acetazolamide.
MIMS Class
Anticonvulsants
ATC Classification
N03AG01 - valproic acid ; Belongs to the class of fatty acid derivatives antiepileptic.
Presentation/Packing
Form
Epilim EC tab 200 mg
Packing/Price
100's
Form
Epilim powd for inj (vial) 400 mg
Packing/Price
1's
Form
Epilim Chrono slow-release tab 500 mg
Packing/Price
30's
Form
Epilim syr 200 mg/5 mL
Packing/Price
300 mL x 1's
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