Epilex Syrup

Uses of Epilex Syrup

Valproate or valproic acid is an anti-epileptic medicine. It is used in the treatment of epilepsy and bipolar disorders. Some times it is used in the treatment of migraine headaches .Valproate is helpful in the prevention of seizures in those with absence seizures, partial seizures, and generalized seizures.

Side Effects of Epilex Syrup

Headache, nausea, vomiting, diarrhoea, anorexia, increased appetite, wt gain, nystagmus, somnolence, dizziness, fatigue, hyperammonaemic encephalopathy, hypothermia, hallucinations. Thrombocytopenia (dose related), tremors, LFT elevation. Chronic use may lead to carnitine deficiency. Potentially Fatal: Fatal hepatotoxicity esp in childn <2 yr, multi-organ and dermatologic hypersensitivty reactions (e.g. Stevens-Johnson syndrome, erythema multiforme), pancreatitis, blood dyscrasias.

Drug Interactions

Increased risk of toxicity w/ bupropion. Increased risk of convulsions w/ mefloquine. Increased risk of carnitine deficiency w/ pivmecillinam and pivampicillin. Increased risk of hepatotoxicity and carbamazepine toxicity w/ a decrease in valproic acid levels w/ concurrent carbamazepine. Decreased valproic acid and increased ethosuximide serum levels w/ ethosuximide. Decreased valproic acid levels w/ carbapenems, rifampicin, phenytoin, phenobarbital (or primidone) and antineoplastic drug regimens. Increased valproic acid levels w/ felbamate and aspirin. Increased risk of hepatotoxicity w/ olanzepine. Concurrent use increased phenobarbital, nimodipine, nifedipine, lamotrigine, zidovudine, amitriptyline, nortriptyline and benzodiazepines levels. Concurrent use decreased tigabine and clozapine levels. Increased risk of absence status w/ clonazepam. Increased risk of hyperammonaemia w/ topiramate. Increased free valproic acid concentrations w/ highly protein bound drugs. Potentially Fatal: Concomitant carbapenem is not recommended as this may decrease valproate levels. Avoid concurrent salicylates in childn <3 yr due too risk of hepatotoxicity. Increased risk of hepatotoxicity w/ cosyntropin. Avoid ethanol as this may increase CNS depression.

Contraindications

Preexisting or family history of hepatic dysfunction, active liver disease, porphyria; mitochondrial and urea cycle disorders. Hepatic impairment. Pregnancy.

Mechanism of Action

Valproate is a generic term used to describe valproic acid, its salts and derivatives. It is available in various forms including the sodium salts (valproate semisodium and sodium valproate), the amide derivative (valpromide), or as valproic acid. Valproate is a carboxylic acid anticonvulsant. It has been suggested that its antiepileptic activity is related to increased brain levels of γ-aminobutyric acid (GABA). Absorption: Valproic acid is rapidly and completely absorbed from the GI tract while valpromide is absorbed slower than valproic acid. Time to peak plasma concentration: Oral: Approx 4 hr; extended release: 4-17 hr. Bioavailability: Extended release: Approx 90%. Distribution: Plasma protein binding (concentration dependent): 80-90%; free fraction: Increases from approx 10% at 40 mcg/mL to approx 18.5% at 130 mcg/mL; decreases in the elderly and patients w/ hepatic or renal impairment. Crosses the placenta; enters breast milk. Metabolism: Valpromide is almost completely and rapidly metabolised in the liver to valproic acid. Valproic acid is extensively metabolised by liver, via glucuronidation and mitochondrial β-oxidation. Excretion: Excreted in urine (30-50% as glucuronide conjugate; <3% as unchanged drug), small amounts in faeces and expired air. Elimination half-life: Adult: 5-20 hr; >2 mth: 7-13 hr.

Special Precautions

Increased risk of hepatotoxicity in childn <2 yr, congenital metabolic disorders, organic brain disease or severe seizure disorders. HIV or cytomegalovirus (CMV) infection; SLE. Decrease dose or discontinue in patients w/ excessive somnolence, decreased food or fluid intake. Gradual withdrawal or transition to and from another type of antiepileptic therapy. Suspect hyperammonemic encephalopathy and measure ammonia levels in patients who develop unexplained lethargy, vomiting or changes in mental status. Immobilised patients or those who have insufficient sun exposure or calcium intake should consider vitamin supplementation. Decrease GI side effects by taking w/ meals, starting w/ low dose or taking the enteric coated formulations. Lactation. Patient Counselling Seek medical advice during first signs of pancreatitis (e.g. abdominal pain, nausea, vomiting and anorexia), blood and liver toxicity. Monitoring Parameters Monitor LFT before and during the 1st 6 mth of therapy. Monitor blood cell count (including platelet count), bleeding time and coagulation tests before the start of therapy or before surgery, and in cases of spontaneous bruising or bleeding. Monitor for atypical behaviour (e.g. suicidal ideation and behaviour) during and after therapy.

How to Use

Take orally with food and water, as directed by your physician.

How to Store

Keep in a cool, dry place away from sunlight and moisture.

Safety Concerns

• Alcohol: Avoid during treatment.
• Breastfeeding: Not recommended.
• Pregnancy: Contraindicated.
• Liver/Kidney: Use with caution.

Content Disclaimer

This content is for educational purposes only. Please consult your doctor before use.