Introduction
Valporin CR 300 is a combination of two medicines used to treat epilepsy, a neurological disorder in which there are recurrent episodes of seizures or fits. It controls the abnormal activity of the brain, relaxes the nerves and hence, prevents seizures or fits.
Valporin CR 300 should be taken with food. Your doctor will decide the correct dose for you. This may increase gradually until your condition is stable. This medicine may take several weeks to work but it is important to take it regularly to get the benefit. Do not stop taking it, even if you feel fine unless your doctor advises you to. You may have more seizures, or your bipolar disorder may get worse.
The most common side effects of this medicine include nausea, vomiting, loss of appetite, swelling of gums, headache, sleepiness, tremor, hair loss and liver injury. Most side effects wear off, but if they bother you or do not go away, tell your doctor. There may be ways of preventing or reducing these effects.
Before taking this medicine, tell your doctor if you have kidney or liver problems, meningitis or depression or suicidal thoughts. Also let your doctor know about all other medications you are using as some may affect, or be affected by, this medicine, including contraceptive pills. If you are pregnant or breastfeeding, Valporin CR 300 can be taken if it is clearly needed but the dose may be adjusted. You should avoid driving or riding a bicycle if this medicine makes you drowsy or dizzy. You may need frequent blood tests to check how you are responding to this medicine.
You should avoid alcohol while taking Valporin CR 300, as it may worsen certain side effects. This medicine can also lead to weight gain, eat a healthy balanced diet, avoid snacking with high-calorie food, and exercise regularly. Inform your doctor if you develop any unusual changes in mood or behavior, new or worsening depression, or suicidal thoughts or behavior.
Side effects of Valporin CR 300
Common
- Nausea
- Vomiting
- Weight gain
- Loss of appetite
- Gum swelling
- Headache
- Sleepiness
- Tremor
- Hair loss
- Liver injury
How to use Valporin CR 300
Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Valporin CR 300 is to be taken with food.
How Valporin CR 300 works
Valporin CR 300 is a combination of two antiepileptic medicines: Sodium Valproate and Valproic Acid. They work together to control seizures or fits by decreasing the abnormal and excessive activity of the nerve cells in the brain.
Indication
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, 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
Contraindication
Preexisting or family history of hepatic dysfunction, active liver disease, porphyria; mitochondrial and urea cycle disorders. Hepatic impairment. Pregnancy.
Mode 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).
Precaution
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.
Side Effect
>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
Interaction
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.