Epilim/Epilim Chrono

Na valproate

Epilim Oral Treatment of generalized, partial or other epilepsy. Inj Treatment of epileptic patients who would normally be maintained on oral Na valproate, & for whom oral therapy is temporarily not possible. Epilim Chrono Treatment of generalised, partial or other epilepsy. Treatment of manic episode in bipolar disorder when lithium is contraindicated or not tolerated. The continuation of treatment after manic episode could be considered in patients who have responded to Epilim Chrono for acute mania.

Epilim oral Adult Initially 600 mg daily then increased by 200 mg at 3-day intervals until control is achieved. Dose range: 1,000-2,000 mg daily (20-30 mg/kg), may be further increased to 2,500 mg daily. Childn >20 kg Initially 400 mg daily w/ spaced increases until control is achieved. Dose range: 20-30 mg/kg daily, may be increased to 35 mg/kg daily Childn <20 kg 20 mg/kg daily. Syr If dilution is necessary, dilute only w/ Syrup BP. Do not use any diluents containing SO₂ as a preservative. Inj Adult 400-800 mg depending on body wt (up to 10 mg/kg) given by slow IV inj over 3-5 min, followed by continuous or repeated infusion up to a max of 2,500 mg daily. Childn 20-30 mg/kg daily, may be increased up to 40 mg/kg daily. Epilim Chrono Epilepsy Adult Initially 600 mg daily then increase by 200 mg at 3-day intervals until control is achieved. Dose range: 1,000-2,000 mg daily (20-30 mg/kg), may be increased to 2,500 mg daily. Childn >20 kg Initially 400 mg daily w/ spaced increases until control is achieved. Dose range: 20-30 mg/kg daily, may be increased to 35 mg/kg daily. Manic episodes in bipolar disorder Adult Initially 750 mg daily, given once daily or bd. Dose range: 1,000-2,000 mg daily.

Should be taken with food: Epilim EC tab/Epilim Chrono PR-FC tab: Swallow whole, do not chew/crush.

Hypersensitivity. Personal or family history of severe hepatic dysfunction, especially drug-related. Patients w/ known urea cycle disorders; mitochondrial disorders caused by mutations in nuclear gene encoding the mitochondrial enzyme polymerase γ (POLG) eg, Alpers-Huttenlocher Syndrome. Porphyria. Active liver disease (acute or chronic hepatitis). Women of childbearing potential who failed to meet pregnancy prevention programme. Pregnancy unless there is no suitable alternative treatment (treatment of epilepsy). Childn <2 yr w/ suspected POLG-related disorder. Epilim Chrono Pregnancy (treatment of bipolar disorder).

Reports of severe liver damage; higher risk, especially in cases of multiple anticonvulsant therapy, in infants & young childn <3 yr & those w/ severe seizure disorders, organic brain disease, &/or congenital metabolic or degenerative disease associated w/ mental retardation. Measure liver function before therapy & periodically monitor during the 1st 6 mth of therapy, especially in patients at risk, & those w/ prior history of liver disease. Discontinue therapy in case of pancreatitis. Monitor patients for signs of suicidal ideation & behaviour. Perform blood tests prior to initiation of therapy or before surgery, & in case of spontaneous bruising or bleeding. Caution in patients w/ SLE. Valproate may trigger or worsen clinical signs of underlying mitochondrial diseases. Risk of hyperammonaemia; wt gain; reversible worsening of convulsion frequency & severity, or onset of new types of convulsions. Greater risk of rhabdomyolysis in patients w/ underlying carnitine palmitoyltransferase (CPT) type II deficiency. May give false +ve result for ketone bodies in the urine testing of possible diabetics. Slowly taper other anticonvulsants when starting Epilim/Epilim Chrono. Monitor clinical response (seizure or mood control) when initiating or discontinuing oestrogen-containing products. Not recommended w/ carbapenem or alcohol. Should not be used concomitantly w/ salicylates. May affect ability to drive or operate machinery. Dose adjustment may be necessary in patients w/ renal insufficiency. High teratogenic potential. Pregnancy must be excluded before starting treatment w/ valproate. Reports of amenorrhoea, polycystic ovaries & increased testosterone levels in women using valproate. May impair fertility in men. Women of childbearing potential must use effective contraception w/o interruption during the entire treatment. Discontinue breast-feeding or discontinue/abstain from Epilim therapy. Monotherapy is recommended in childn <3 yr when prescribing Epilim. Epilim Chrono Epilim Chrono 200, 300 & 500 contain 18.43 mg, 27.65 mg & 46.08 mg Na per tab, respectively.

Nausea; tremor. Liver injury; vomiting, gingival disorder (mainly gingival hyperplasia), stomatitis, gastralgia, diarrhoea; extrapyramidal disorder, stupor, somnolence, convulsion, memory impairment, headache, nystagmus; confusional state, hallucinations, aggression, agitation, disturbance in attention; hyponatraemia, increased wt; anaemia, thrombocytopenia; hypersensitivity, transient &/or dose-related alopecia, nail & nail bed disorders; dysmenorrhea; haemorrhage; deafness; urinary incontinence. Epilim inj Dizziness.

May potentiate the effect of psychotropics eg, antipsychotics, MAOIs, antidepressants & benzodiazepines. Increased plasma conc of phenobarb; primidone; rufinamide; zidovudine. Decreased total plasma conc of phenytoin. May potentiate toxic effects of carbamazepine. Reduced metabolism & increased mean t_½ of lamotrigine. Decreased mean clearance of felbamate. Decreased plasma conc of olanzapine. Increased blood level of propofol. Increased exposure of nimodipine. Decreased plasma conc of valproic acid w/ anti-epileptics w/ enzyme-inducing effect (eg, phenytoin, phenobarb, carbamazepine). Increased metabolism & lowered seizure threshold w/ mefloquine & chloroquine. Increased valproic acid free serum levels w/ highly protein-bound agents (eg, aspirin). Increased valproic acid plasma levels w/ felbamate; cimetidine or erythromycin. Increased anticoagulant effect of warfarin & other coumarin anticoagulants. Decreased valproic acid blood levels w/ carbapenem antibiotics (eg, imipenem, panipenem & meropenem). Decreased valproate blood levels w/ rifampicin. Decreased valproate plasma levels w/ PIs (eg, lopinavir, ritonavir); cholestyramine. Increased clearance w/ oestrogens. Risk of encephalopathy &/or hyperammonaemia w/ topiramate or acetazolamide. Increased risk of neutropenia/leucopenia w/ quetiapine. Risk of liver damage w/ salicylates, or other anticonvulsants. Epilim Chrono Decreased valproate serum levels w/ metamizole.

Anticonvulsants

N03AG01 - valproic acid ; Belongs to the class of fatty acid derivatives antiepileptic.

P₁S₁S₃