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Depakote Divalproex: The Complete Medical Guide

Depakote contains an active substance called Divalproex sodium. This drug affects the chemicals in your brain, which is why it is used in the treatment of mania, epilepsy, and migraine.

It is assumed that the mechanism of action of this drug is based on increasing the concentration of gamma-aminobutyric acid (GABA) in the brain. GABA is the major inhibitor neurotransmitter and plays a significant role in the development of epilepsy.

Depakote is completely metabolized via the liver, whereas 30-50% of its metabolite is excreted in the form of glucuronide via urine.

Efficiency

The efficacy of Depakote Divalproex in the treatment of mania was demonstrated in two placebo-controlled studies lasting 3 weeks. In both studies, the drug proved to be superior compared to placebo.

The efficacy of Depakote Divalproex in the treatment of migraine was also demonstrated in two double-blind, randomized and placebo-controlled clinical studies including a total of 283 patients. The study included patients who had at least two migraine attacks per month for at least 6 months. The studies lasted for 12 weeks and confirmed that patients taking Depakote have significantly less headaches compared to placebo.

The efficacy of Depakote Divalproex in the treatment of epilepsy was confirmed in two multicentre, placebo-controlled clinical studies including a total of 406 patients. These studies have shown that as many as 45% of patients taking this drug have a 50% decrease in seizures compared to only 23% of patients taking placebo.

Warnings and Precautions

Liver failure, including fatal cases, has been reported due to the use of this medicine. Studies have shown that the risk of liver damage is higher in children less than 2 years of age, especially if they use more than one anti-epileptic drug or are suffering from metabolic disorders.

Contact your doctor immediately if symptoms or signs of liver damage occur, such as: nausea, lethargy, facial swelling, decreased appetite, nausea, vomiting, 

jaundice, and abdominal pain. Liver damage most commonly occurs at the beginning of the therapy, and monitoring liver function is recommended during the first six months of therapy.

Clinical studies have shown that Depakote has a teratogenic potential and it has been proven that the use of this drug during pregnancy can lead to a neural tube defect (condition known as spina bifida). Therefore, defect should not be used during pregnancy.

Cases of pancreatitis that may have serious consequences have also been reported following the administration of Depakote Divalproex. Symptoms of acute pancreatitis include severe pain in the upper part of the abdomen that spreads to the back (this pain is more intense in the lying position, and after meals), nausea, vomiting, abdominal tenderness, abdominal distension, increased sweating, and general weakness. If you notice these symptoms, you should contact your doctor immediately.

Depakote Divalproex is contraindicated in patients with urea cycle disorder. Encephalopathy followed by elevated ammonium levels was reported in patients who used this medicine. Since encephalopathy can have a fatal outcome, it is very important to contact your doctor if you notice impaired consciousness, vomiting, drowsiness, slow thinking, lethargy, and focal neurological deficits.

Data from 199 clinical studies indicate that the use of Depakote Divalproex double the risk of suicidal thoughts and behavior as compared to the placebo group. Suicidal ideas usually appear in the first week of therapy and can last throughout the entire course of treatment. The risk of suicidal ideas does not depend on age. Immediately tell your doctor if you notice suicidal thoughts, but you should not abruptly discontinue Depakote.

Dosage

The usual starting dose in the treatment of mania in adult patients is 750mg daily (divided into two or three equal doses). The dosage may be increased until an appropriate therapeutic effect is achieved. The maximum daily dose is 60mg/kg of body weight.

The usual dose in the treatment of complex partial seizures in children older than 10 years is 10-15mg/kg per day, divided into two or three doses. If the dosage is increased to 60mg/kg of body weight and it still does not achieve the appropriate therapeutic effect, then it is necessary to determine the concentration of Depakote in the blood. The recommended concentration of Depakote Divalproex in the blood is 50-100 µ / mL. If the concentration of the drug in men is greater than 135 µ / mL or 110 µ / mL in women, then the risk of thrombocytopenia (low blood platelet count) is significantly increased.

The recommended starting dose for the treatment of migraine is 250mg twice a day. The dosage may be increased to a maximum of 1000mg per day.

In the treatment of epilepsy, Depakote Divalproex can be used as a monotherapy or in combination with other antiepileptic drugs, and the dosage should be adjusted accordingly.

The dose should also be reduced in patients over 65 years of age.

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Side Effects

Depakote Divalproex may cause the following side effects:

  • Suicidal ideas
  • Pancreatitis
  • Somnolence
  • Eosinophilia
  • Thrombocytopenia
  • Vomiting
  • Dizziness
  • Dyspepsia
  • Asthenia
  • Edema
  • High blood pressure
  • Low blood pressure
  • Palpitations
  • Rapid heart rate
  • Difficulty breathing
  • Eye pain
  • Urinary incontinence
  • Hair loss
  • Dysmenorrhea
  • Allergic reactions

Tell your doctor if you notice any side effects.

Drug Interactions

Depakote Divalproex should not be used concomitantly with the following medicines:

  • Narcotic analgesics, such as Propoxyphene and Buprenorphine. The concomitant use with these medicines increases the risk of side effects, such as confusion, drowsiness, dizziness, impaired concentration, respiratory depression, and coma.
  • Teriflunomide and Leflunomide (medicines used in the treatment of rheumatoid arthritis). These drugs have certain hepatotoxic potential, just like Depakote, and the concomitant application must therefore be avoided.
  • Bexarotene – a drug used in the treatment of T-cell lymphoma. The continuous administration with this medicine increases the risk of pancreatitis.
  • Imipenem, Ertapenem, and Doripenem (antibiotics). These drugs can significantly reduce the concentration of Depakote in the blood, thereby reducing its effectiveness.
  • Lomitapide and Mipomersen – drugs used to treat high levels of cholesterol. The concomitant administration with these medicines increases the risk of liver damage.
  • Lamotrigine – a drug that is also used in the treatment of epilepsy. The concomitant administration increases the risk of side effects, such as muscle weakness, seizures, and anxiety.

Tell your doctor about all medicines and herbal remedies you are taking.