Depakote: Comprehensive Mood Stabilizer and Anticonvulsant Therapy
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Synonyms
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Depakote (divalproex sodium) is a prescription medication primarily indicated for the management of seizure disorders, bipolar disorder, and the prevention of migraine headaches. As an established anticonvulsant and mood stabilizer, it functions by increasing gamma-aminobutyric acid (GABA) levels in the brain and modulating voltage-gated sodium channels. This dual mechanism provides robust neurological and psychiatric symptom control, making it a cornerstone in treatment protocols for various conditions. Healthcare providers rely on its proven efficacy and well-documented pharmacokinetic profile when designing long-term therapeutic regimens for appropriate patient populations.
Features
- Available in delayed-release tablets, extended-release tablets, and sprinkle capsule formulations
- Contains divalproex sodium, a stable coordination compound that dissociates to valproate in the gastrointestinal tract
- Multiple strength options: 125 mg, 250 mg, and 500 mg delayed-release tablets; 250 mg and 500 mg extended-release tablets
- FDA-approved for epilepsy, bipolar disorder, and migraine prophylaxis
- Demonstrated therapeutic serum concentration range: 50-125 μg/mL
- Protein binding approximately 90%, primarily to albumin
- Hepatic metabolism via glucuronidation and beta-oxidation
- Elimination half-life ranges from 9-16 hours in adults
Benefits
- Provides effective seizure control in multiple epilepsy syndromes including complex partial seizures and absence seizures
- Stabilizes mood episodes in bipolar disorder, reducing both manic and depressive symptom severity
- Decreases migraine frequency and intensity through neurological modulation
- Offers flexible dosing formulations to accommodate individual patient needs and preferences
- Established long-term safety profile with decades of clinical use and research
- May be used as monotherapy or in combination with other appropriate medications
Common use
Depakote is commonly prescribed for the treatment of complex partial seizures that occur either in isolation or in association with other seizure types in adults and children down to 10 years of age. In psychiatric practice, it is widely utilized for the acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features, and for maintenance therapy to prevent recurrence. For neurological applications beyond epilepsy, it serves as a prophylactic treatment for migraine headaches in adults, significantly reducing attack frequency. Off-label uses may include management of neuropathic pain, agitation in dementia, and impulse control disorders, though these applications require careful risk-benefit assessment by treating physicians.
Dosage and direction
Dosage must be individualized based on therapeutic response and serum concentration monitoring. For epilepsy in adults and children over 10 years: initial dose of 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. For bipolar disorder: initial dose of 750 mg daily in divided doses, with rapid titration to achieve clinical response. Target dose typically ranges from 1000-2500 mg daily. For migraine prophylaxis: start with 250 mg twice daily, with some patients requiring up to 1000 mg daily. Extended-release tablets are administered once daily, while delayed-release formulations are typically given in 2-4 divided doses. All doses should be taken with food to minimize gastrointestinal upset. Regular monitoring of serum valproate levels is essential, with therapeutic range generally considered 50-125 μg/mL.
Precautions
Hepatotoxicity risk necessitates baseline liver function tests and periodic monitoring, particularly during the first six months of therapy. Pancreatitis cases, including fatal hemorrhagic pancreatitis, have been reported and require immediate evaluation of abdominal symptoms. Thrombocytopenia, inhibition of platelet aggregation, and coagulation abnormalities may occur—monitor platelet counts and coagulation parameters before planned surgery. Hyperammonemia with or without encephalopathy has been reported, sometimes fatal; monitor ammonia levels in patients with unexplained lethargy or cognitive changes. Neural tube defects and other major malformations occur in approximately 1-2% of pregnancies exposed to valproate during the first trimester—use during pregnancy only if clearly needed. Monitor patients for emergence or worsening of depression, suicidal thoughts or behavior, and unusual changes in mood or behavior. Weight gain, hair loss, and tremor are common side effects requiring ongoing assessment.
Contraindications
Depakote is contraindicated in patients with known hypersensitivity to valproate, divalproex sodium, valproic acid, or any component of the formulation. It must not be used in patients with significant hepatic impairment or urea cycle disorders due to risk of hyperammonemic encephalopathy. Concomitant administration with other hepatotoxic drugs increases risk of liver damage and is generally contraindicated. Patients with known mitochondrial disorders caused by mutations in mitochondrial DNA polymerase γ (POLG) should not receive valproate due to increased risk of acute liver failure and death. The medication is contraindicated in pregnancy for migraine prevention and should be avoided for epilepsy or bipolar disorder unless other treatments have failed or are unacceptable.
Possible side effect
Common adverse reactions (≥5%) include nausea (31%), somnolence (30%), dizziness (25%), vomiting (25%), asthenia (21%), abdominal pain (17%), diarrhea (16%), dyspepsia (13%), anorexia (12%), weight gain (9%), tremor (25%), alopecia (13%), and amblyopia/blurred vision (8%). Serious side effects requiring immediate medical attention include hepatotoxicity (elevated LFTs, jaundice), pancreatitis (severe abdominal pain, nausea/vomiting), thrombocytopenia (bruising, bleeding), hyperammonemic encephalopathy (lethargy, confusion), suicidal ideation, and severe skin reactions. Long-term use may be associated with polycystic ovary syndrome in women, decreased bone mineral density, and cognitive impairment in children exposed in utero.
Drug interaction
Depakote exhibits numerous clinically significant interactions. It may increase serum concentrations of phenobarbital, primidone, phenytoin, carbamazepine epoxide, lamotrigine, diazepam, amitriptyline, nortriptyline, warfarin, and zidovudine. Conversely, drugs that induce hepatic enzymes (carbamazepine, phenytoin, phenobarbital, rifampin) may decrease valproate concentrations. Felbamate may both increase and decrease valproate levels. Aspirin, erythromycin, and antidepressants may displace valproate from protein binding sites. Valproate may decrease the efficacy of oral contraceptives. Concomitant use with clonazepam may induce absence status. Co-administration with topiramate may increase ammonia levels and risk of encephalopathy. Interaction with olanzapine may increase concentrations of both drugs.
Missed dose
If a dose is missed, it should be taken as soon as possible unless it is almost time for the next scheduled dose. In that case, the missed dose should be skipped and the regular dosing schedule resumed. Patients should never take a double dose to make up for a missed one, as this may increase the risk of side effects. For extended-release formulations taken once daily, if missed and remembered within 6 hours of the scheduled time, the dose should be taken immediately. If remembered later than 6 hours, the dose should be skipped and the next dose taken at the regular time. Maintaining consistent blood levels is particularly important for seizure control, so patients should discuss any pattern of missed doses with their healthcare provider.
Overdose
Valproate overdose presents a medical emergency with symptoms including somnolence, heart block, deep coma, and metabolic acidosis. Fatalities have occurred—maximum reported survival after acute overdose involved a dose of 24 grams. Hemodialysis and hemoperfusion have been used successfully. Naloxone has reversed the CNS depressant effects in some cases, but not consistently. Gastric lavage may be beneficial if performed soon after ingestion. Supportive measures should include maintaining adequate urinary output and monitoring cardiovascular function. Plasma valproate concentrations may not correlate with clinical severity due to delayed peak concentrations, particularly with extended-release formulations. Patients require hospitalization and monitoring for at least 24 hours due to potential delayed toxicity.
Storage
Store at controlled room temperature between 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C to 30°C (59°F to 86°F). Keep container tightly closed and protect from moisture. Delayed-release tablets should be kept in their original container with the dessicant canister to maintain stability. Keep all medications out of reach of children and pets. Do not use if the product appears discolored or shows signs of deterioration. Properly dispose of any unused or expired medication through take-back programs or following FDA-recommended disposal methods. Do not flush medications down the toilet unless specifically instructed to do so.
Disclaimer
This information is provided for educational purposes only and does not constitute medical advice. Depakote is available by prescription only and should be used under the supervision of a qualified healthcare professional. Individual response to medication may vary, and only a healthcare provider can determine the appropriate treatment based on specific medical circumstances. Patients should not discontinue or change their dosage without consulting their physician, as abrupt withdrawal may precipitate seizures or mood instability. Regular monitoring of blood levels, liver function, and complete blood counts is essential during treatment. The benefits and risks of therapy must be carefully evaluated for each individual patient.
Reviews
Clinical studies demonstrate Depakote’s efficacy with 45-60% of epilepsy patients achieving significant seizure reduction. In bipolar disorder trials, 48% of patients experiencing acute manic episodes showed marked improvement compared to 25% on placebo. Migraine studies report approximately 50% reduction in headache frequency in 43% of patients versus 21% on placebo. Patient-reported outcomes indicate satisfaction with symptom control but note concerns about weight gain (average 3-5 kg), hair thinning, and cognitive slowing. Long-term adherence rates approximate 65% at one year, with discontinuation primarily due to side effects rather than lack of efficacy. Neurologists and psychiatrists consistently rate Depakote as a valuable therapeutic option with predictable pharmacokinetics and established efficacy across multiple indications.