Encorate Chrono contains Valproate. Valproic acid (VPA) is a chemical compound that has found clinical use as an anticonvulsant and mood-stabilizing drug, primarily in the treatment of epilepsy, bipolar disorder, and less commonly major depression. It is also used to treat migraine headaches and schizophrenia.
Encorate Chrono is product of Sun Pharmaceutical Industries Limited. Sunpharma is an Indian multinational pharmaceutical company headquartered in Mumbai, Maharashtra, that manufactures and sells pharmaceutical formulations and active pharmaceutical ingredients (APIs) primarily in India and the United States. The company offers formulations in various therapeutic areas, such as cardiology, psychiatry, neurology, gastroenterology and diabetology. It also provides APIs such as warfarin, carbamazepine, etodolac, and clorazepate, as well as anti-cancers, steroids, peptides, sex hormones, and controlled substances.
Epilepsy is a chronic disorder that causes unprovoked, recurrent seizures. A seizure is a sudden rush of electrical activity in the brain.
There are two main types of seizures. Generalized seizures affect the whole brain. Focal, or partial seizures, affect just one part of the brain. A mild seizure may be difficult to recognize. It can last a few seconds during which you lack awareness.
Stronger seizures can cause spasms and uncontrollable muscle twitches, and can last a few seconds to several minutes. During a stronger seizure, some people become confused or lose consciousness. Afterward you may have no memory of it happening.
As directed by physician
As directed by physician
Adverse Reactions/ Side Effects
Headache, nausea, vomiting, diarrhoea, anorexia, increased appetite, weight gain, nystagmus, somnolence, dizziness, fatigue, hyperammonaemic encephalopathy, hypothermia, hallucinations. Thrombocytopenia (dose related), tremors, LFT elevation. Chronic use may lead to carnitine deficiency.
Potentially Fatal: Fatal hepatotoxicity especially in children <2 years, multi-organ and dermatologic hypersensitivty reactions (e.g. Stevens-Johnson syndrome, erythema multiforme), pancreatitis, blood dyscrasias.
Warnings and Precautions
Patients with HIV, cytomegalovirus (CMV) infection, SLE. Renal impairment. Children (<2 years on anticonvulsant polytherapy, with congenital metabolic disorders, severe seizure disorders, mental retardation, organic brain disease). Use in children ≥2 years of age who are suspected of having POLG-related disorder only after other anticonvulsants have failed.
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 month 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.
Pre-existing or family history of hepatic dysfunction, porphyria, urea cycle disorders, known mitochondrial disorders caused by POLG mutation and in children (<2 years) who are suspected of having a mitochondrial disorder. Hepatic impairment. Pregnancy (prophylaxis of migraine).
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.
Symptoms: Somnolence, CNS depression, heart block, deep coma, respiratory insufficiency, multiple organ failure, death. Management: Activated charcoal may be given orally to adults and children who present within 1 hr of ingesting >100 mg/kg; alternatively gastric lavage or emesis may be useful in reducing drug absorption but effectiveness may vary with time since ingestion. Due to saturable protein binding, haemodialysis may be useful in removing unbound drug. Treatment is supportive and it is important to maintain adequate urinary output. Naloxone may be useful in reversing the CNS depressant effects of valproate overdosage but it should be used with caution in patients with epilepsy as it may reverse the antiepileptic effects of valproate.
Intravenous: Store between 15-30°C. Oral: Store between 15-30°C.
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 γ-aminobutyric acid (GABA).