Epifri

Epifri

valproic acid

Manufacturer:

Darya-Varia
Concise Prescribing Info
Contents
Na valproate
Indications/Uses
Monotherapy or adjunctive therapy in partial seizures (elementary & complex) & absence seizures (petit mal seizures).
Dosage/Direction for Use
Initially 15 mg/kg daily, increasing at 1-wk intervals by 5-10 mg/kg daily until seizures are controlled or side effects preclude further increases. Total daily dose by wt: Patient 75-89.9 kg 1,250 mg, 60-74.9 kg 1,000 mg, 40-59.9 kg 750 mg, 25-39.9 kg 500 mg, 10-24.9 kg 250 mg. Total daily doses >250 mg should be given in a divided regimen. Max: 60 mg/kg daily.
Administration
Should be taken with food.
Contraindications
Hypersensitivity. Known urea cycle disorders. Hepatic disease or significant dysfunction.
Special Precautions
Monitor patients for symptoms of serious or fatal hepatotoxicity eg, malaise, weakness, lethargy, facial edema, anorexia, vomiting & loss of seizure control in patients w/ epilepsy; emergence or worsening of depression, suicidal thoughts or behavior &/or unusual changes in mood or behavior; serum valproic acid conc after initiating carbapenem therapy. Perform LFT prior to therapy & at frequent intervals thereafter, especially during 1st 6 mth; platelet counts & coagulation tests prior to therapy & at periodic intervals. Patients w/ prior history of hepatic disease; on multiple anticonvulsants; congenital metabolic disorders; severe seizure disorders accompanied by mental retardation; organic brain disease; Urea Cycle Disorders (UCD). Discontinue treatment in the presence of significant hepatic dysfunction; if pancreatitis is diagnosed. Hyperammonemic encephalopathy; thrombocytopenia. Patients w/ inborn errors of metabolism or reduced hepatic mitochondrial activity may be at increased risk for hyperammonemia w/ or w/o encephalopathy. Consider discontinuation in patients who develop hypothermia; hemorrhage, bruising or hemostasis/coagulation disorders; multi-organ hypersensitivity reaction; or dose reduction in patients w/ decreased food or fluid intake & in patients w/ excessive somnolence. False interpretation of urine ketone test; altered thyroid function tests. May impair ability to drive & use machines. Pregnancy & lactation. Childn especially <2 yr. Elderly patients w/ dementia.
Adverse Reactions
Headache, asthenia, fever, back pain, chest pain, malaise; nausea, vomiting, abdominal pain, diarrhea, anorexia, dyspepsia, constipation, increased appetite, flatulence, hematemesis, eructation, pancreatitis, periodontal abscess; somnolence, tremor, dizziness, diplopia, amblyopia/blurred vision, ataxia, nystagmus, emotional lability, abnormal thinking, amnesia, insomnia, nervousness, depression, anxiety, confusion, abnormal gait, paresthesia, hypertonia, incoordination, abnormal dreams, personality disorder; flu syndrome, infection, bronchitis, rhinitis, pharyngitis, dyspnea, sinusitis, increased cough, pneumonia, epistaxis; thrombocytopenia, ecchymosis, petechia; wt gain or loss, alopecia, peripheral edema, increased SGOT & SGPT; tinnitus, taste perversion, abnormal vision, deafness, otitis media; tachycardia, HTN, palpitation; myalgia, twitching, arthralgia, leg cramps, myasthenia; urinary incontinence, vaginitis, dysmenorrhea, amenorrhea, urinary frequency; rash, pruritis, dry skin.
Drug Interactions
Increased clearance w/ phenytoin, carbamazepine, phenobarb or primidone. Aspirin. Reduced serum conc w/ carbapenem antibiotics eg, ertapenem, imipenem, meropenem. Dose adjustment may be necessary w/ felbamate & rifampin. Increased trough plasma levels w/ chlorpromazine. Increased levels of amitriptyline. Decreased levels of carbamazepine. Induction of absence status w/ clonazepam in patients w/ history of absence type seizures. Inhibition of metabolism of diazepam, ethosuximide, phenobarb or primidone, phenytoin. Serious skin reactions w/ lamotrigine. Hyperammonemia & hypothermia w/ topiramate.
MIMS Class
Anticonvulsants
ATC Classification
N03AG01 - valproic acid ; Belongs to the class of fatty acid derivatives antiepileptic.
Presentation/Packing
Form
Epifri syr 250 mg/5 mL
Packing/Price
120 mL x 1's
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