Depakote 500 Tablets (15 Tab)

DEPAKOTE 500 TABLETS (15 TAB) by SANOFI INDIA LIMITED

Name

• Common Name: Divalproex Sodium
• Brand Name: Depakote 500 Tablets

Composition

Each tablet contains 538.20 mg of valproate semisodium, which is equivalent to 500 mg of valproic acid. Valproate semisodium is also known as divalproex sodium (USAN).

Uses

Depakote 500 Tablets are primarily used for:

• Epilepsy/Seizures: Monotherapy and adjunctive therapy for complex partial seizures, simple and complex absence seizures, and adjunctive therapy for patients with multiple seizure types including absence seizures. It works by decreasing excessive and abnormal nerve activity in the brain and increasing levels of gamma-aminobutyric acid (GABA), a chemical that helps control brain activity.
• Bipolar Disorder: Treatment of manic episodes associated with bipolar disorder, with or without psychotic features. It helps stabilize mood and prevent extreme mood changes.
• Migraine Prophylaxis: Prevention of migraine headaches in adults.

Dosage and Administration

Depakote 500 Tablets are for oral administration and should be swallowed whole without crushing or chewing. They can be taken with or after food. The daily dosage is established and controlled individually by a treating physician based on age, body weight, and clinical response.

• Mania: The initial recommended daily dose can be 750 mg in 2-3 divided doses or 25 mg/kg/day, increased rapidly to achieve the desired clinical effect. The maximum recommended dosage is 60 mg/kg/day.
• Epilepsy/Seizures: Starting dosage is typically 10 to 15 mg/kg/day, increasing by 5 to 10 mg/kg/week until optimal clinical response. The maximum dosage is 60 mg/kg/day.
• Migraine Prophylaxis: The recommended starting dose is 250 mg twice daily. Some patients may benefit from doses up to 1,000 mg/day.

Side Effects

Common Side Effects:

• Nausea, vomiting, abdominal pain, diarrhea
• Headache, dizziness, drowsiness, weakness, tiredness
• Tremors (uncontrolled shaking)
• Hair loss (alopecia)
• Weight gain or weight loss, increased or decreased appetite
• Vision problems (e.g., blurred vision, double vision)
• Infection

Serious Side Effects:

• Liver Damage (Hepatotoxicity): Can be severe and potentially fatal, especially in children younger than 2 years old and patients with mitochondrial disorders. Symptoms include persistent nausea, vomiting, abdominal pain, anorexia, diarrhea, weakness, and/or jaundice. Liver function tests should be performed before and during treatment.
• Pancreatitis: Inflammation of the pancreas, which can be life-threatening. Symptoms include severe abdominal pain, nausea, vomiting, and loss of appetite.
• Fetal Harm: Depakote can cause serious birth defects, particularly neural tube defects (e.g., spina bifida), and other major malformations if taken during pregnancy.
• Suicidal Thoughts or Behavior: Like other antiepileptic drugs, Depakote may increase the risk of suicidal thoughts or actions.
• High Blood Ammonia Levels (Hyperammonemia): Can lead to confusion, tiredness, vomiting, and changes in mental state.
• Bleeding Problems: May include easy bruising, unusual bleeding (nose, mouth, gums), or blood in stools.

Precautions

• Contraindications: Do not take Depakote if you have liver problems, a history of liver problems (especially if drug-induced), a known metabolic disorder (e.g., urea cycle disorder, porphyria), a genetic problem caused by a mitochondrial disorder (e.g., Alpers-Huttenlocher syndrome), untreated carnitine deficiency, or known hypersensitivity to valproate semisodium or any other ingredients.
• Pregnancy: Depakote is contraindicated in pregnancy due to the risk of serious birth defects. Women of childbearing potential must use effective contraception.
• Abrupt Discontinuation: Do not stop taking Depakote suddenly without consulting a doctor, as it can cause serious problems, including status epilepticus (seizures that will not stop) in patients with epilepsy.
• Drug Interactions: Depakote can interact with various medications, including other antiepileptics (e.g., phenobarbital, phenytoin, carbamazepine, lamotrigine, topiramate), anticoagulants (e.g., warfarin), antipsychotics, antidepressants, MAO inhibitors, benzodiazepines, and certain anti-infectives. Alcohol intake is not recommended during treatment.
• Monitoring: Regular monitoring of liver function, blood cell counts, and ammonia levels may be necessary.
• Alertness: Depakote can cause drowsiness and affect thinking and motor skills. Patients should avoid driving or operating dangerous machinery until they know how the medicine affects them.

Storage

Store tablets below 30°C (86°F) in a cool and dry place. Keep the container tightly closed and protect it from light and moisture. Do not store in a damp place like a bathroom medicine cabinet. Keep out of sight and reach of children.

DEPAKOTE 500 TABLETS (15 TAB) by SANOFI INDIA LIMITED, containing Divalproex sodium, is a medication primarily used for neurological and psychiatric conditions. It works by stabilizing brain activity.

What is DEPAKOTE 500 TABLETS used for?

DEPAKOTE is used to treat various conditions, including epilepsy and seizures (focal impaired awareness seizures, simple and complex absence seizures), manic episodes associated with bipolar disorder, and to prevent migraine headaches in adults. It can also be used to treat trigeminal neuralgia.

How does DEPAKOTE 500 TABLETS work?

DEPAKOTE (divalproex sodium) is thought to work by increasing the level of gamma-aminobutyric acid (GABA) in the brain, an inhibitory neurotransmitter that has a calming effect on brain activity. This helps to decrease excessive electrical activity in the brain, which is believed to cause seizures, mood imbalances in bipolar disorder, and migraines.

What is the usual dosage for DEPAKOTE 500 TABLETS?

The dosage of DEPAKOTE varies depending on the condition being treated and is often based on body weight.

• For seizures: The starting dosage for both complex partial and absence seizures is typically 10-15 mg/kg of body weight per day, divided into 1-3 doses. Your doctor may increase this dose weekly by 5-10 mg/kg/day up to a maximum of 60 mg/kg/day.
• For manic episodes associated with bipolar disorder: A typical starting dosage for Depakote tablets is 750 mg per day, divided into smaller doses. The dose may be increased up to a maximum of 60 mg/kg daily.
• For migraine prevention: The starting dose for Depakote tablets is 250 mg twice daily, which can be increased up to a maximum daily dose of 1,000 mg.

It is crucial to follow your doctor's instructions for dosage and not to stop taking the medication suddenly.

What are the possible side effects of DEPAKOTE 500 TABLETS?

DEPAKOTE can cause a range of side effects, from mild to serious.

• Common mild side effects include nausea, vomiting, stomach pain, diarrhea, headache, dizziness, weakness, sleepiness, tremors, hair loss, and changes in appetite or weight.
• Serious side effects can include liver damage (which can be fatal, especially in children younger than 2 years old), pancreatitis (inflammation of the pancreas, which can also be fatal), bleeding problems, high blood ammonia levels, low body temperature (hypothermia), and suicidal thoughts or behaviors. It's important to contact your healthcare provider if you experience severe side effects or any new or worsening symptoms.

Is DEPAKOTE 500 TABLETS safe during pregnancy or breastfeeding?

Pregnancy: DEPAKOTE carries significant risks if taken during pregnancy. It has a boxed warning from the FDA due to the risk of serious birth defects, particularly neural tube defects (like spina bifida), and other major malformations affecting the heart, head, arms, and legs. There is also an increased risk of lower cognitive test scores and autism spectrum disorders in children exposed to valproate products during pregnancy. For migraine prevention, DEPAKOTE is contraindicated in women who are pregnant or of childbearing potential and not using effective contraception. For epilepsy or bipolar disorder, it should only be used during pregnancy if other medications are ineffective or unsuitable, and effective birth control is advised for women of childbearing potential. Breastfeeding: Divalproex sodium passes into breast milk. The amount is generally low, but there is a theoretical concern for liver toxicity in breastfed infants, so infants should be monitored. Discuss with your doctor the best way to feed your baby if you are taking this medication.

Can DEPAKOTE 500 TABLETS be taken with other medications?

DEPAKOTE can interact with many other medications, potentially making it less effective or increasing the risk of side effects.

• Other seizure medications: Carbamazepine, phenytoin, phenobarbital, primidone, lamotrigine, felbamate, topiramate, ethosuximide, and rufinamide can interact with Depakote, affecting their levels or increasing side effects.
• Antidepressants: Certain antidepressants like amitriptyline and nortriptyline can have increased levels when taken with Depakote.
• Blood thinners: Aspirin and warfarin can increase the level of Depakote in your system, raising the risk of side effects, including bleeding.
• Hormonal birth control: Estrogen-containing birth control pills may decrease Depakote levels, making it less effective.
• Antibiotics: Certain antibiotics, especially carbapenem antibiotics (like meropenem and imipenem/cilastatin), can significantly decrease Depakote levels and should generally be avoided due to the risk of seizures. Always inform your healthcare provider about all medications, supplements, and herbal products you are taking before starting Depakote.

What precautions should be taken with DEPAKOTE 500 TABLETS?

• Liver and Pancreas: DEPAKOTE can cause serious liver damage and pancreatitis. Your doctor will monitor your liver function with blood tests before and during treatment, especially in the first six months. Be aware of symptoms like persistent nausea, vomiting, abdominal pain, loss of appetite, and jaundice, and seek medical attention immediately if they occur.
• Suicidal Thoughts: Like other antiepileptic drugs, DEPAKOTE may cause suicidal thoughts or actions in a small number of people. Report any new or worsening depression, anxiety, agitation, panic attacks, irritability, aggressive behavior, or thoughts of self-harm to your doctor immediately.
• Mitochondrial Disorders: Patients with known or suspected mitochondrial disorders caused by POLG mutations are at an increased risk of fatal hepatotoxicity and should use Depakote with extreme caution or avoid it.
• Driving and operating machinery: DEPAKOTE can cause dizziness, sleepiness, and affect vision, impairing your ability to drive or operate dangerous machinery. Avoid these activities until you know how the medication affects you.
• Alcohol: Do not drink alcohol while taking Depakote, as both can cause liver damage and increase side effects like dizziness and sleepiness.

What happens if a dose is missed?

If you miss a dose of DEPAKOTE, 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 make up for a missed one. If you are unsure, contact your doctor or pharmacist.

How should DEPAKOTE 500 TABLETS be stored?

DEPAKOTE tablets should be stored at room temperature, typically between 68°F to 77°F (20°C to 25°C), with excursions permitted to 59-86°F (15-30°C). Keep the medication in a closed container, away from heat, moisture, and direct light, and out of the reach of children. Do not store it in the refrigerator.