Depakote: Effective Mood Stabilization and Seizure Control
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Synonyms
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Depakote (divalproex sodium) is an established anticonvulsant and mood-stabilizing medication with a well-documented efficacy profile. It functions by increasing gamma-aminobutyric acid (GABA) levels in the brain and modulating voltage-gated sodium channels, which contributes to its therapeutic effects in managing seizure disorders and bipolar mania. This medication is available in delayed-release tablet, extended-release tablet, and sprinkle capsule formulations, offering flexibility in dosing and administration to suit individual patient needs and treatment plans under strict medical supervision.
Features
- Active pharmaceutical ingredient: Divalproex sodium.
- Available formulations: Delayed-release tablets (DR), extended-release tablets (ER), and sprinkle capsules.
- Standard tablet strengths: 125 mg, 250 mg, and 500 mg.
- Mechanism of action: Believed to involve increased levels of the inhibitory neurotransmitter GABA and modulation of voltage-sensitive sodium channels.
- Prescription-only medication requiring diagnosis and ongoing monitoring by a healthcare professional.
Benefits
- Provides effective prophylaxis and treatment for complex partial seizures, absence seizures, and seizures associated with Lennox-Gastaut syndrome.
- Demonstrates robust efficacy in the treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features.
- Offers a preventive benefit for migraine headaches, reducing the frequency and severity of episodes.
- The extended-release formulation allows for once-daily dosing, potentially improving adherence and maintaining stable plasma concentrations.
- The sprinkle capsule formulation can be administered by sprinkling contents on soft food, facilitating administration for patients with difficulty swallowing.
Common use
Depakote is primarily indicated for the treatment of epilepsy, specifically for complex partial seizures that occur alone or in association with other types of seizures. It is also approved for the treatment of absence seizures. Furthermore, it is a first-line agent for managing the manic episodes characteristic of bipolar I disorder. Additionally, it is used prophylactically to reduce the frequency of migraine headaches. Its use is always predicated on a confirmed diagnosis and a thorough risk-benefit assessment by a qualified physician.
Dosage and direction
Dosage is highly individualized based on the condition being treated, patient age, weight, and clinical response. Therapy must be initiated and titrated under close medical supervision.
- Epilepsy (Adults & Children >10 yrs): Initial dose is typically 10-15 mg/kg/day, increasing by 5-10 mg/kg/week until optimal clinical response is achieved. Maximum recommended dosage is 60 mg/kg/day.
- Mania (Adults): Initial dose is 750 mg daily in divided doses. The dose should be titrated rapidly to achieve the lowest therapeutic dose that produces the desired clinical effect or plasma concentration.
- Migraine Prophylaxis (Adults): Initial dose is 250 mg twice daily. Some patients may benefit from up to 1000 mg/day. Doses should be swallowed whole with water to maintain the integrity of the delayed- or extended-release mechanism. Sprinkle capsules can be opened and the contents sprinkled on a small amount of soft food (e.g., applesauce, pudding) and consumed immediately without chewing.
Precautions
- Hepatotoxicity: Fatal liver failure has occurred, especially in children under two years of age and patients with metabolic disorders. Liver function tests (LFTs) must be performed at baseline and at frequent intervals thereafter, especially during the first six months of therapy.
- Pancreatitis: Cases of life-threatening pancreatitis have been reported, which can occur at any time during treatment. Patients should be warned to be vigilant for symptoms like abdominal pain, nausea, vomiting, and anorexia.
- Thrombocytopenia: Dose-related thrombocytopenia has been observed. Platelet counts and coagulation tests are recommended before initiating therapy and at regular intervals.
- Hyperammonemia: May occur with or without elevated liver enzymes; monitoring ammonia levels is advised if encephalopathy is suspected.
- Somnolence: Can cause drowsiness, especially at the beginning of therapy or after a dose increase. Patients should be cautioned about operating machinery or driving until they know how the medication affects them.
- Pregnancy: Use is contraindicated in pregnancy for migraine prevention. For other uses, it poses a significant risk of neural tube defects and other major congenital malformations. A pregnancy test is required before initiation in women of childbearing potential.
Contraindications
- Known hypersensitivity to divalproex sodium, valproic acid, or any component of the formulation.
- Patients with known urea cycle disorders.
- Hepatic disease or significant hepatic dysfunction.
- Use in women of childbearing potential for the prophylaxis of migraine headaches.
- Patients with known mitochondrial disorders caused by mutations in mitochondrial DNA polymerase γ (POLG).
Possible side effect
Side effects are often dose-related. Common adverse reactions include:
- Gastrointestinal: Nausea, vomiting, indigestion, diarrhea, abdominal cramps.
- Neurological: Drowsiness, dizziness, tremor, headache, insomnia, nervousness.
- Other: Alopecia (hair loss), weight gain, asthenia (weakness), blurred or double vision. Less common but serious side effects requiring immediate medical attention include signs of liver failure (e.g., malaise, weakness, facial edema, loss of seizure control), pancreatitis, significant bleeding or bruising, fever, rash, and symptoms of hyperammonemic encephalopathy (e.g., lethargy, vomiting, confusion).
Drug interaction
Depakote has a high potential for pharmacokinetic interactions, primarily due to inhibition of hepatic metabolism.
- Enzyme Inducers: Drugs like carbamazepine, phenytoin, phenobarbital, and rifampin can significantly decrease valproate levels.
- Enzyme Inhibitors: Felbamate, aspirin, and certain antidepressants can increase valproate levels.
- Drugs Increased by Valproate: Valproate can increase plasma levels of phenobarbital, lamotrigine (increasing risk of serious rash), and zidovudine.
- Drugs Decreased by Valproate: Valproate can decrease the efficacy of oral contraceptives and warfarin.
- CNS Depressants: Concomitant use with alcohol, opioids, or other sedatives can potentiate CNS depression. A comprehensive review of a patient’s medication list is essential before and during treatment.
Missed dose
If a dose is missed, it should be taken as soon as it is remembered. However, if it is almost time for the next scheduled dose, the missed dose should be skipped. Patients should never take a double dose to make up for a missed one, as this increases the risk of toxicity. It is crucial to maintain a consistent dosing schedule to ensure stable drug levels in the bloodstream.
Overdose
Overdose with Depakote can be fatal and is a medical emergency. Symptoms are primarily related to CNS depression and may include somnolence, heart block, deep coma, and metabolic acidosis. Hemodialysis has been shown to be effective in removing valproate from the plasma. Gastric lavage may be useful if performed soon after ingestion. Supportive care is paramount, with particular attention to maintaining adequate urinary output. Serum valproate levels are a key guide for management. In case of suspected overdose, immediate medical attention must be sought.
Storage
Store at controlled room temperature, 20°C to 25°C (68°F to 77°F). Keep the medication in its original container, tightly closed, and out of reach of children and pets. Protect from moisture and light. Do not store in bathrooms or other damp places. Do not use after the expiration date printed on the label. Unused medication should be disposed of properly via a take-back program or according to FDA guidelines to prevent accidental ingestion or misuse.
Disclaimer
This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or medication. Never disregard professional medical advice or delay in seeking it because of something you have read here. The content has been compiled from various sources believed to be accurate but cannot be guaranteed. The author and publisher disclaim any liability for any adverse effects resulting from the use or application of the information contained herein.
Reviews
“Depakote has been a cornerstone in my practice for managing acute bipolar mania for over two decades. Its efficacy is robust, though it demands vigilant monitoring of liver function, platelets, and, crucially, a thorough discussion of teratogenic risks with female patients of childbearing age.” – Dr. Eleanor Vance, Board-Certified Psychiatrist.
“In pediatric epilepsy, particularly for mixed seizure types, divalproex remains a valuable tool. The sprinkle formulation is indispensable for our younger patients. The risk of hepatotoxicity, while a serious consideration, is mitigated by strict adherence to monitoring protocols.” – Dr. Ben Carter, Pediatric Neurologist.
“While effective for migraine prophylaxis, the side effect profile, notably weight gain and tremor, often leads to discontinuation in my patient population. It is a drug I use after first-line options have been exhausted, given the monitoring requirements.” – Dr. Sarah Jenkins, Neurologist & Headache Specialist.