Encorate 200 Tab

ENCORATE 200 TAB

ENCORATE 200 TAB, manufactured by Sun Pharma, is an anticonvulsant medication primarily used for neurological and mood disorders.

• Name

  • Brand Name: ENCORATE 200 TAB, Encorate Chrono 200 Tablet.
  • Common Name: Sodium Valproate (the primary active ingredient). The "Chrono" formulation also includes Valproic Acid.

• Composition

  • Each enteric-coated tablet of ENCORATE 200 contains Sodium Valproate BP 200 mg.
  • ENCORATE Chrono 200 Tablet typically contains Sodium Valproate BP 133.2 mg and Valproic Acid USP 58 mg, which together correspond to 200 mg of Sodium Valproate.

• Uses ENCORATE 200 TAB is prescribed for a range of medical conditions:

  • Epilepsy: Effective in treating various seizure types including partial, absence (petit mal), generalized tonic-clonic (grand mal), myoclonic, atonic, and mixed seizures. It works by decreasing abnormal nerve activity in the brain. It is also used for the prophylaxis of febrile and post-traumatic epilepsy.
  • Bipolar Disorder: Used to stabilize mood and manage manic episodes associated with bipolar disorder.
  • Migraine Prophylaxis: Indicated for the prevention of migraine headaches.

• Dosage and Administration ENCORATE 200 TAB is taken orally, preferably with or after food, to minimize gastrointestinal upset. Dosage is individualized based on age, weight, and condition severity.

  • Adults (Epilepsy): Initial dose of 600 mg daily, divided into two doses. The dose may be increased by 200 mg/day every 3 days, up to a maximum of 2.5 gm daily. The usual maintenance dose is 1-2 gm daily (20-30 mg/kg daily).
  • Children (over 20 kg): Initial dose of 400 mg daily, divided into doses, with gradual increases to achieve control (usually 20-30 mg/kg daily; maximum 35 mg/kg daily).
  • Children (up to 20 kg): Initial dose of 20 mg/kg daily in divided doses, with careful monitoring.
  • Bipolar Disorder: Initially 600 mg daily in 2-3 divided doses, with a maintenance dose of 1000-2000 mg daily.
  • Migraine Prophylaxis: Typically 400-600 mg daily, though some may require 1000-1500 mg daily.
  • Important: Do not discontinue the medicine suddenly, as this can increase seizure frequency; gradual tapering under medical supervision is necessary.

• Side Effects

  • Common Side Effects: Nausea, vomiting, anorexia, sedation, ataxia, tremor, rash, alopecia (hair loss), increased appetite, headache, sleepiness/drowsiness, impaired coordination, apathy, irregular periods, weight gain, diarrhea, confusion, muscle pain, unusual tiredness/weakness, blurred vision, acid or sour stomach, forgetfulness, and ear pain. Enteric-coated tablets can help minimize gastrointestinal side effects.
  • Serious Side Effects:
    • Liver Injury: Elevation of liver enzymes can occur, and rarely, severe or fatal fulminant hepatitis, especially in children under 2 years.
    • Pancreatitis: Severe, life-threatening inflammation of the pancreas has been reported.
    • Bleeding Disorders: May cause thrombocytopenia or other bleeding issues.
    • Hyperammonemia: High levels of ammonia in the blood.
    • Suicidal Ideation: Increased risk of suicidal thoughts or behavior.
    • Birth Defects: If taken during pregnancy, it can lead to serious neural tube defects such as anencephaly and spina bifida.

• Precautions

  • Contraindications: Not recommended for patients with known hypersensitivity to valproate, active/severe liver disease, urea cycle disorders, or mitochondrial disorders. It is contraindicated in pregnancy and in women of childbearing potential unless effective contraception is used.
  • Monitoring: Liver function tests should be performed before and during the first six months of therapy, particularly in high-risk patients.
  • Pregnancy and Lactation: ENCORATE is unsafe during pregnancy (Pregnancy Category D) due to the risk of severe birth defects. While it may pass into breast milk, breastfeeding is generally considered safe if prescribed by a doctor.
  • Alcohol: Concurrent alcohol consumption is unsafe and should be avoided as it can increase drowsiness, dizziness, and the risk of seizures.
  • Driving and Machinery: Due to potential drowsiness, dizziness, or impaired alertness, caution is advised when driving or operating heavy machinery.
  • Kidney Impairment: Use with caution in patients with kidney problems, as dose adjustments may be necessary.
  • Drug Interactions: May interact with other anticonvulsants, certain antidepressants, cimetidine, and salicylates. Charcoal may reduce absorption. Valproate sodium oral solution should not be mixed with carbonated beverages.
  • Weight Management: Patients should monitor their weight and maintain a healthy lifestyle, as weight gain can be a side effect.
  • False Ketone Test: The medicine can lead to a false positive urine ketone test result.

• Storage Store ENCORATE 200 TAB below 30°C, in a cool and dry place, away from direct sunlight, and out of the reach of children.

What is Encorate 200 Tab used for?

Encorate 200 Tab, which contains Sodium Valproate (and sometimes Valproic Acid in controlled-release forms), is primarily used to treat various types of epilepsy, including partial, absence (petit mal), generalized tonic-clonic (grand mal), myoclonic, and atonic seizures. It is also indicated for the treatment of manic episodes associated with bipolar disorder and for the prophylaxis of migraine headaches.

How does Encorate 200 Tab work?

The exact mechanism of action of Encorate 200 Tab is not fully established, but it is believed to work by increasing the levels of gamma-aminobutyric acid (GABA) in the brain. GABA is a neurotransmitter that has an inhibitory effect, which helps to calm abnormal and excessive nerve activity in the brain, thereby controlling seizures and stabilizing mood.

What is the usual dosage for Encorate 200 Tab?

The dosage of Encorate 200 Tab varies depending on the condition being treated, age, and body weight. For adults with epilepsy, an initial dose of 600 mg per day, given in two divided doses, is common, preferably after food. This dose may be gradually increased by 200 mg per day at 3-day intervals up to a maximum of 2.5 grams daily until seizure control is achieved. For bipolar disorder, the initial dosage might be around 600 mg daily in 2-3 divided doses. For migraine prophylaxis, adults typically start with 400-600 mg daily. It's crucial to follow your doctor's specific instructions, as the dose may be adjusted slowly.

What are the possible side effects of Encorate 200 Tab?

Common side effects include nausea, vomiting, stomach pain, headache, drowsiness, dizziness, tremor, weight gain, and hair loss. More serious, though rare, side effects can include liver injury, pancreatitis, and an increased risk of suicidal thoughts or behavior. If any side effects persist or worsen, or if you experience severe abdominal pain, yellowing of the skin or eyes, or unusual changes in mood, contact your doctor immediately.

Is Encorate 200 Tab safe during pregnancy or breastfeeding?

Encorate 200 Tab is generally not recommended during pregnancy as it carries a definite risk of harm to the developing baby, including neural tube defects like anencephaly and spina bifida, particularly if exposed during the first trimester. Its use is restricted in pregnant women and those of childbearing potential unless other treatments are ineffective or not tolerated. Regarding breastfeeding, Encorate 200 Tab may excrete into breast milk. While some sources suggest it probably causes no risk, others advise discussing all risks and benefits with your doctor, who might recommend discontinuing breastfeeding or the medication based on your clinical condition.

Can Encorate 200 Tab be taken with other medications?

Encorate 200 Tab can interact with several medications. It may affect or be affected by other anti-epileptic drugs (e.g., phenytoin, carbamazepine, lamotrigine), certain antidepressants, antipsychotics, and blood thinners like warfarin. Carbapenem antibiotics (e.g., imipenem) can decrease the blood levels of sodium valproate. Oral contraceptives containing estrogen may have reduced effectiveness. It's essential to inform your doctor about all medications, supplements, and herbal products you are currently taking to avoid potential interactions.

What precautions should be taken while using Encorate 200 Tab?

Liver function should be monitored before starting therapy and regularly during the first six months, especially in at-risk patients like children under two years old or those on multiple anti-epileptic agents. Caution is advised in patients with kidney impairment, bleeding disorders, or systemic lupus erythematosus. There is a risk of suicidal thoughts, and patients (and caregivers) should monitor for any unusual changes in mood or behavior. Alcohol consumption should be avoided as it can worsen side effects and increase the risk of liver damage. Do not stop taking this medicine suddenly, as it can worsen your condition or trigger seizures.

What happens if a dose of Encorate 200 Tab is missed?

If you miss a dose of Encorate 200 Tab, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to compensate for the missed one. Missing doses can trigger seizures or worsen symptoms of bipolar disorder.

How should Encorate 200 Tab be stored?

Encorate 200 Tab should be stored below 30°C. Keep it away from light and out of the reach of children.