Valpex CR Tablet

Sodium Valproate (valproic acid)

500mg

Alkem Laboratories Ltd.

Pack size	1
Dispensing mode
Source
Agent
Retail Price	12.63 NPR

Available as:

200mg - Tablet 300mg - Tablet

Indications

Valpex CR Tablet is used for: Epilepsy, e.g. Partial seizures, Absence seizures (petit mal), Generalized tonic-clonic seizures (grand mal), Myoclonic seizures, Atonic seizures, Mixed seizures, Anxiety disorder, Posttraumatic stress disorder, Febrile convulsion, Anorexia nervosa, Panic attack, Migraine and bipolar disorder.

Adult Dose

Oral Complex Partial Seizures Indicated as monotherapy and adjunctive therapy for complex partial seizures that occur either in isolation or in association with other types of seizures PO: 10-15 mg/kg/day initially; increase by 5-10 mg/kg/day at weekly intervals; may increase dose up to 60 mg/kg/day Simple & Complex Absence Seizures Also indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types that include absence seizures PO: 15 mg/kg/day initially, divided q6-12hr; increase by 5-10 mg/kg/day at weekly intervals; may increase dose up to 60 mg/kg/day Migraine Indicated for prophylaxis of migraine headaches; there is no evidence of use for acute treatment 250 mg PO q12hr; adjust dose based on clinical response, not to exceed 1000 mg/day Bipolar Mania Indicated for treatment of manic episodes associated with bipolar disorder 750 mg/day PO in divided doses; adjust dose as rapidly as possible to desired therapeutic effect; not to exceed 60 mg/kg/day Hepatic impairment Administer lower doses Contraindicated in severe impairment

Child Dose

<10 years: Safety and efficacy not established Complex Partial Seizures Indicated as monotherapy and adjunctive therapy for complex partial seizures that occur either in isolation or in association with other types of seizures PO: 10-15 mg/kg/day initially; increase by 5-10 mg/kg/day at weekly intervals; may increase dose up to 60 mg/kg/day Simple & Complex Absence Seizures Indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types that include absence seizures >10 years 250 mg PO q12hr; adjust dose based on clinical response up to 1000 mg/day

Renal Dose

Renal impairment No adjustment necessary

Administration

Contra Indications

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

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.

Pregnancy-Lactation

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.

Adverse Effects

Side effects of Sodium Valproate (valproic acid) : >10% Nausea (31%),Headache (<31%),Increased bleeding time (26-30%),Thrombocytopenia (26-30%),Tremor (25%),Alopecia (<24%),Asthenia (16-20%),Infection (16-20%),Somnolence (16-20%),Amblyopia (11-15%),Diarrhea (11-15%),Diplopia (11-15%),Dizziness (11-15%),Dyspepsia (11-15%),Nystagmus (11-15%),Tinnitus (11-15%),Vomiting (11-15%) 1-10% Ataxia (<8%),Increased appetite (<6%),Rash (<6%),Abdominal pain (<5%),Tremor (<5%),Back pain (<5%),Mood changes (<5%),Anxiety (<5%),Confusion (<5%),Abnormal gait (<5%),Paresthesia (<5%),Hallucinations (<5%),Catatonia (<5%),Dysarthria (<5%),Tardive dyskinesia (<5%),Vertigo (<5%),Irregular menses (<5%),Weight gain (4%) Frequency Not Defined Anorexia,Acute pancreatitis (may be life-threatening),Hepatic toxicity,Hyperammonemia,Weight loss,Fractures,Osteoporosis,Osteopenia,Decreased bone mineral density,Cerebral pseudoatrophy

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 ?-aminobutyric acid (GABA).

Note

Valpex CR 500mg Tablet manufactured by Alkem Laboratories Ltd.. Its generic name is Sodium Valproate (valproic acid). Valpex CR is availble in Nepal. Farmaco Nepal drug index information on Valpex CR Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.

Some other brands of Sodium Valproate (valproic acid) :

Tablet

Proate 200 ^{133.5mg + 58mg}

Nepal Pharmaceuticals Pvt. Ltd.

Tablet

Proate 300 ^{200mg + 87mg}

Nepal Pharmaceuticals Pvt. Ltd.

Tablet

Encorate ^333mg

Sun Pharmaceutical Industries Ltd.

Tablet

Encorate ^{200 mg}

Sun Pharmaceutical Industries Ltd.

Tablet

Encorate ^133.5mg

Sun Pharmaceutical Industries Ltd.