Valpros/Valpros i-IV

Valpros Na valproate 500 mg (equiv to Na valproate 333 mg, valproic acid 145 mg). Valpros i-IV Na valproate

Valpros Generalized, partial or other epilepsy. Treatment & prevention of mania associated w/ bipolar disorders. Valpros i-IV Alternative in patients for whom oral administration is temporarily not feasible in: Monotherapy & adjunctive therapy for patients w/ complex partial seizures that occur either in isolation or association w/ other types of seizures & w/ simple & complex absence seizures, & adjunctively in patients w/ multiple seizure types that include absence seizures.

Valpros Epilepsy 1,000-2,000 mg/day, may be further increased to 2,500 mg/day. Combined therapy w/ anticonvulsants which induce liver enzyme activity (eg, phenytoin, phenobarb & carbamazepine) Increase dose by 5-10 mg/kg/day, target dose reached after about 2 wk. Bipolar disorder Initially 20 mg/kg/day. Max: 3,000 mg/day. Maintenance: 1,000-2,000 mg/day. Valpros i-IV Administer by slow IV inj (3-5 min) or slow IV infusion. Adult Monotherapy: 400-800 mg depending on body wt (up to 10 mg/kg) by slow IV inj over 3-5 min, followed by continuous infusion of 1-2 mg/kg/hr to a max of 2,500 mg/day. Adjunctive therapy: Patient already on other anticonvulsants Taper dose slowly. Used in combination w/ anticonvulsants which induce liver enzyme activity (eg, phenytoin, phenobarb & carbamazepine) Initiate gradually w/ target dose being reached after about 2 wk. May increase dose by 5-10 mg/kg/day if necessary when used in combination w/ anticonvulsants. Childn 20-30 mg/kg/day. May be increased up to 40 mg/kg/day in patient w/ monitored plasma levels. Elderly Starting dose should be reduced due to decreased inbound valproate clearance & possibly a greater sensitivity to somnolence. Subsequent dose should be increased more slowly. Dosage reduction or discontinuance of valproate should be considered w/ decreased food or fluid intake & those w/ excessive somnolence. Patient w/ impaired renal function Lower doses may be required. Dosage should be adjusted according to clinical monitoring as monitoring of plasma conc may be misleading.

CR tab: Should be taken with food: Swallow whole, do not chew/crush.

Hypersensitivity. Patients w/ preexisting, acute or chronic hepatic dysfunction or history of severe hepatic dysfunction, especially drug-related. Patients known to have mitochondrial disorders caused by mutations in mitochondrial DNA polymerase-γ gene & childn <2 yr suspected of having a POLG-related disorder; urea cycle disorders. Porphyria. Pregnancy & lactation.

May cause major congenital malformations eg, neural tube defects. Cases of life-threatening pancreatitis. Hepatotoxicity may occur; increased risk of developing fatal hepatotoxicity in childn <2 yr. Patients w/ hereditary neurometabolic syndromes. Risk of transient drowsiness. Women of childbearing potential. Pregnancy & lactation.

Pain, peripheral edema; chest pain, vasodilation, vasculitis, wt gain, hyperammonemia, hyponatremia; headache, dizziness, nervousness, sedation, ataxia, paresthesia, hypesthesia, Parkinsonism, tremor, reversible dementia, somnolence, hallucinations, encephalopathy, coma, lethargy, confusion, abnormal gait, aggression, increased alertness, hyperactivity, behavioral deterioration; abdominal pain, diarrhea, nausea, vomiting, pancreatitis; thrombocytopenia, anemia, leukopenia, pancytopenia, bone marrow suppression, red cell hypoplasia, agranulocytosis; hepatic dysfunction & failure, increased liver enzymes; pharyngitis, pneumonia; hearing loss, taste perversion; amenorrhea, irregular menses, breast enlargement; toxic epidermal necrolysis, SJS, erythema multiforme. Valpros Fever, flu syndrome, infection, fungal infection, malaise, chills, neck pain, neck rigidity, bone pain, back pain, hypothermia, face edema, accidental injury, increased drug level; HTN, tachycardia, bradycardia, palpitation, hypotension, postural hypotension, arrhythmia; depression, anxiety, excitement, aggression, stupor, asthenia, fatigue, hypertonia, insomnia, vertigo, abnormal dreams, thinking abnormalities, emotional lability, amnesia, incoordination, personality disorder, speech disorder, agitation, catatonic reaction, dysarthria, hypokinesia, psychosis, increased reflexes, tardive dyskinesia, asterixis, emotional upset, hostility, behavioral deterioration, tremor, incoordination, reversible cerebral atrophy, sleep disorder; anorexia, increased appetite, constipation, dyspepsia, stomatitis, hematemesis, eructation, periodontal abscess, fecal incontinence, gastroenteritis, glossitis, flatulence, dry mouth, indigestion, tooth disorder; bruising, ecchymosis, petechia, hematoma formation, epistaxis, frank hemorrhage, lymphocytosis, macrocytosis, hypofibrinogenemia, eosinophilia, aplastic anemia, acute intermittent porphyria, systemic lupus erythematosus; myalgia, leg cramps, arthralgia, twitching, myasthenia, arthrosis, weakness; galactorrhea, wt loss, parotid gland swelling, inappropriate antidiuretic hormone secretion, Fanconi's syndrome, hyperglycinemia; pharyngitis, rhinitis, dyspnea, sinusitis, bronchitis, increased cough, hiccup; increased ALT & AST, increased serum bilirubin; transient hair loss, pruritus, rash, alopecia, dry skin, furunculosis, maculopapular rash, seborrhea, anaphylaxis, photosensitivity, discoid lupus erythematosus, erythema nodosum, vesiculobullous rash; secondary amenorrhea, breast enlargement, UTI, vaginitis, metrorrhagia, urinary incontinence, dysmenorrhea, urinary frequency, dysuria, cystitis, polycystic ovary disease, enuresis, vag hemorrhage; tinnitus, otic pain, deafness, otitis media, conjunctivitis, dry eyes, eye pain, nystagmus, diplopia, amblyopia/blurred vision, abnormal vision. Valpros i-IV Euphoria; gastralgia; reduced blood fibrinogen; increased prothrombin time; Fanconi's syndrome; inj site inflammation, pain & reaction; sweating, transient hair loss, hirsutism, acne, angioedema, drug rash w/ eosinophilia systemic symptoms syndrome.

May potentiate CNS depressant activity of alcohol. May increase free-valproate conc & inhibit metabolism of valproate w/ aspirin. May enhance effects of vit K-dependent factor anticoagulants (eg, coumarin, warfarin). Decreased blood levels when co-administered w/ carbapenems (eg, ertapenem, imipinem, meropenem) & rifampicin. Inhibited metabolism by fluoxetine & chlorpromazine & increased metabolism w/ mefloquine & chloroquine. Increased risk of adverse events associated w/ olanzapine. May inhibit metabolism of carbamazepine & diazepam; ethosuximide. Increased plasma levels w/ cimetidine or erythromycin. Increased serum conc w/ felbamate. May increase toxicity of lamotigrine. Increased plasma levels w/ cimetidine or erythromycin. May increase phenobarb plasma conc & primidone plasma levels. May be associated w/ hyperammonemia w/ or w/o encephalopathy w/ topiramate; induce absence status in patients w/ history of absence type seizure in concomitant use w/ clonazepam. May decrease plasma clearance of lorazepam, zidovudine & temozolomide. Decreased absorption w/ cholestyramine.

Anticonvulsants

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

Rx