Valpros/Valpros Pedia/Valpros i-IV

Valpros/Valpros Pedia/Valpros i-IV

valproic acid

Manufacturer:

Medichem

Distributor:

United Lab
Concise Prescribing Info
Contents
Valpros Na valproate 500 mg (equiv to Na valproate 333 mg, valproic acid 145 mg). Valpros Pedia/Valpros i-IV Na valproate
Indications/Uses
Valpros Generalized, partial or other epilepsy. Treatment & prevention of mania associated w/ bipolar disorders. Valpros Pedia Monotherapy or adjunctive therapy of complex partial seizures &/or simple or complex absence seizures, including petit mal & is useful in primary generalized seizures w/ tonic-clonic manifestations. Adjunctive therapy of multiple seizure types including absence seizures or tonic-clonic seizures. Manic episodes, maintenance & prophylactic treatment of bipolar disorder. 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.
Dosage/Direction for Use
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 Pedia Epilepsy: Monotherapy Adult Initially 600 mg/day increasing by 200/day at 3-day intervals until control is achieved. Dose range: 1,000-2,000 mg/day (ie, 20-30 mg/kg/day). When adequate control is not achieved, may be further increased to max of 2,500 mg/day (in divided doses). Childn >20 kg Initially 400 mg/day (irrespective of wt) w/ spaced increases until control is achieved (dose range: 20-30 mg/kg/day), if adequate control of seizure is not achieved, may be increased to 35 mg/kg/day, <20 kg 20 mg/kg/day, may be increased in severe cases, but only in patient w/ monitored plasma valproate levels. Combined 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. Bipolar disorder Adult ≥18 yr Initially 600 mg/day in 2-3 divided doses. Day 2: Increase dose as rapidly as possible to achieve the lowest therapeutic dose. Dose range: 1,000-2,000 mg/day (ie, 20-30 mg/kg/day). If adequate control is not achieved, may increase dose to max of 2,500 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.
Administration
CR tab: Should be taken with food: Swallow whole, do not chew/crush.
Contraindications
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.
Special Precautions
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.
Adverse Reactions
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, Stevens-Johnson syndrome, 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 erythematosis, 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.
Drug Interactions
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.
MIMS Class
ATC Classification
N03AG01 - valproic acid ; Belongs to the class of fatty acid derivatives antiepileptic.
Presentation/Packing
Form
Valpros i-IV 400 mg lyophilized powd for inj
Packing/Price
(+ amp (4 mL) ) 1's (P1,894/box)
Form
Valpros Pedia 200 mg/5 mL syr
Packing/Price
100 mL x 1's (P277.3/box)
Form
Valpros 500 mg CR tab
Packing/Price
30's (P25.72/CR tab, P660/box)
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