Convulzor

ER tab: Primary generalized seizures, absence & myoclonic seizures, partial seizures. Acute manic phase of bipolar disorder. Prophylaxis of migraine. Syr: Monotherapy & adjunctive therapy in patients w/ complex partial seizures that occur either in isolation or in association w/ other types of seizures. As sole & adjunctive therapy of simple & complex absence seizures, & adjunctively in patients w/ multiple seizure types that include absence seizures.

ER tab Mania Initially 25 mg/kg/day. Max: 60 mg/kg/day. Complex partial seizures Initially 10-15 mg/kg/day, increasing by 5-10 mg/kg/day at 1 wk interval. Max: 60 mg/kg/day. Absence seizures Initially 15 mg/kg/day, increasing by 5-10 mg/kg/day at 1 wk interval until seizure control or limiting side effects. Max: 60 mg/kg/day. Migraine Initially 500 mg/day for 1 wk, increasing to 1,000 mg/day thereafter. Syr Complex partial seizures Adult & childn ≥10 yr Monotherapy, conversion to monotherapy, or adjunctive therapy: Initially 10-15 mg/kg/day, increased by 5-10 mg/kg/wk. Max: 60 mg/kg/day. For adjunctive therapy, give in divided doses if total daily dose exceeds 250 mg. Simple & complex absence seizures Initially 15 mg/kg/day, increasing at 1 wk intervals by 5-10 mg/kg/day until seizures are controlled or side effects preclude further increases. Max: 60 mg/kg/day. Give in divided doses if total daily dose exceeds 250 mg.

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

Hypersensitivity. Patients w/ known urea cycle disorders; hepatic disease or significant hepatic dysfunction. Syr: Patients known to have mitochondrial disorders caused by mutations in mitochondrial DNA polymerase γ (POLG; eg, Alpers-Huttenlocher syndrome); w/ porphyria. Prophylaxis of migraine headaches in pregnant women. Childn <2 yr suspected to have POLG-related disorder.

Hepatic failure resulting in fatalities during the 1st 6 mth of treatment. Loss of seizure control in patients w/ epilepsy. History of hepatic disease. Patients on multiple anticonvulsants, & those w/ congenital metabolic disorders, severe seizure disorders accompanied by mental retardation, & organic brain disease. Discontinue immediately in the presence of significant hepatic dysfunction (suspected or apparent). Perform LFTs prior to therapy & at frequent intervals thereafter especially during the 1st 6 mth. Pregnancy. Childn <2 yr. Elderly. Syr: Discontinue if multiorgan hypersensitivity reaction is suspected. Induced acute liver failure & liver-related deaths in patients w/ hereditary neurometabolic syndromes caused by mutations in the gene for mitochondrial DNA POLG (eg, Alpers-Huttenlocher syndrome). Perfom POLG mutation testing in accordance w/ current clinical practice for diagnostic evaluation in patients w/ family history or suggestive symptoms of POLG-related disorders, including but not limited to unexplained encephalopathy, refractory epilepsy (focal, myoclonic), status epilepticus at presentation, developmental delays, psychomotor regression, axonal sensorimotor neuropathy, myopathy cerebellar ataxia, ophthalmoplegia, or complicated migraine w/ occipital aura. Discontinue if pancreatitis is diagnosed. Hyperammonemic encephalopathy following initiation of therapy in patients w/ urea cycle disorders. Monitor patients for the emergence or worsening of depression, suicidal thoughts or behavior, &/or any unusual changes in mood or behavior. Thrombocytopenia. Hyperammonemia in patients w/ hypothermia; w/ or w/o encephalopathy in patients w/ inborn errors of metabolism or reduced hepatic mitochondrial activity. Discontinue therapy if ammonia is increased. Reversible/irreversible cerebral & cerebellar atrophy. Platelet counts & coagulation tests before initiating therapy & at periodic intervals. False interpretation for urine ketone test & altered thyroid function tests. Concomitant use w/ carbapenems (ertapenem, imipenem, meropenem); topiramate; another CNS depressant (eg, alcohol). Do not engage in hazardous activities eg, driving an automobile or operating dangerous machinery. Use of effective contraception in women of childbearing potential. Lactation.

ER tab: GI disturbances, increased appetite, wt gain. Oedema, headache, reversible prolongation of bleeding time, & thrombocytopenia. Leucopenia, bone marrow depression; ataxia, tremor, sedation, lethargy, confusion; increased alertness; rashes; transient hair loss (sometimes w/ regrowth of curly hair); liver dysfunction including hepatic failure (usually in the 1st 6 mth); elevation of liver enzyme values; hyperammonemia associated w/ neurological symptoms; hyperglycemia. Congenital malformations in infants born to women who had received antiepileptics during pregnancy. Syr: Nausea, vomiting, indigestion, diarrhea, abdominal cramps, constipation, anorexia, increased appetite; sedative effects, tremor (may be dose-related), hallucinations, ataxia, headache, nystagmus, diplopia, asterixis, spots before eyes, dysarthria, dizziness, confusion, hyperesthesia, vertigo, incoordination, memory impairment, cognitive disorder, Parkinsonism, reversible/irreversible cerebral & cerebellar atrophy, permanent sequelae, developmental delays & psychomotor impairment in childn; transient hair loss, skin rash, photosensitivity, generalized pruritus, erythema multiforme, SJS; emotional upset, depression, psychosis, aggression, psychomotor hyperactivity, hostility, agitation, disturbance in attention, abnormal behavior, learning disorder, behavioral deterioration; weakness, decreased bone mass (potentially leading to osteoporosis & osteopenia); thrombocytopenia & inhibition of the secondary phase of platelet aggregation, lymphocytosis, macrocytosis, hypofibrinogenemia, leukopenia, eosinophilia, anemia including macrocytic w/ or w/o folate deficiency, bone marrow suppression, pancytopenia, aplastic anemia, agranulocytosis, acute intermittent porphyria; minor elevations of transaminases (eg, SGOT & SGPT) & LDH, increases in serum bilirubin & abnormal changes in other LFTs; irregular menses, secondary amenorrhea, breast enlargement, galactorrhea, parotid gland swelling, abnormal thyroid function tests including hypothyroidism; acute pancreatitis; hyperammonemia, hyponatremia, inappropriate ADH secretion, hyperglycinemia; enuresis, UTI; hearing loss (reversible/irreversible), ear pain; myelodysplastic syndrome; pleural effusion; allergic reaction, anaphylaxis, edema of the extremities, lupus erythematosus, bone pain, increased cough, pneumonia, otitis media, bradycardia, cutaneous, vasculitis, fever, hypothermia. Complex partial seizures: Headache, asthenia, fever, back pain, chest pain, malaise; tachycardia, HTN, palpitation; nausea, vomiting, abdominal pain, diarrhea, anorexia, dyspepsia, constipation, increased appetite, flatulence, hematemesis, eructation, pancreatitis, periodontal abscess; thrombocytopenia, ecchymosis, petechiae; wt gain/loss, peripheral edema, increased SGOT & SGPT; myalgia, twitching, arthralgia, leg cramps, myasthenia; somnolence, tremor, dizziness, diplopia, amblyopia/blurred vision, ataxia, nystagmus, emotional lability, abnormal thinking, amnesia, 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; rash, pruritus, dry skin, alopecia; tinnitus, taste perversion, abnormal vision, deafness, otitis media; urinary incontinence, vaginitis, dysmenorrhea, amenorrhea, urinary frequency.

ER tab: Raised blood conc & toxicity w/ erythromycin. May antagonize the antiepileptic activity w/ antidepressant. Increased bioavailability w/ antacid (Al & Mg hydroxides). May increase free valproate plasma conc w/ highly protein bound drugs. Syr: May increase clearance w/ drugs that elevate levels of glucuronosyltransferases (eg, ritonavir); phenytoin, carbamazepine, & phenobarb (or primidone). May decrease protein binding & inhibition of metabolism w/ aspirin at antipyretic dose. Reduced serum conc w/ carbapenems (ertapenem, imipenem, meropenem). May increase mean peak conc w/ felbamate. May increase oral clearance w/ rifampin. May increase trough plasma levels w/ chlorpromazine. Decreased plasma clearance of amitriptyline & net clearance of nortriptyline. Decreased serum levels of carbamazepine & increased serum levels of carbamazepine-10,11-epoxide. May induce absence status w/ clonazepam in patients w/ history of absence type seizures. Reduced plasma clearance & vol of distribution of free diazepam. Increased elimination t_1/2 & decreased total clearance of ethosuximide. Increased elimination t_1/2 of lamotrigine. Serious skin reactions (eg, SJS & TEN) w/ lamotrigine. Increased t_1/2 & decreased plasma clearance of phenobarb/primidone. Increased free fraction, total plasma clearance & apparent vol of distribution of phenytoin. Breakthrough seizures w/ phenytoin in patients w/ epilepsy. Increased unbound fraction of tolbutamide & warfarin. Hyperammonemia w/ & w/o encephalopathy & hypothermia w/ topiramate. Decreased clearance of zidovudine in patients who were seropositive for HIV. Decreased plasma clearance of lorazepam.

Anticonvulsants

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

Rx