Depakote: Effective Mood Stabilizer and Anticonvulsant Therapy
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Synonyms
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Depakote (divalproex sodium) is an established anticonvulsant and mood-stabilizing medication with multiple FDA-approved indications. It functions through several mechanisms, primarily involving increased gamma-aminobutyric acid (GABA) levels and modulation of voltage-gated sodium channels. This medication is widely prescribed by neurologists and psychiatrists for its demonstrated efficacy in managing complex neurological and psychiatric conditions. Proper patient selection, dosing, and monitoring are critical to maximizing therapeutic benefits while minimizing risks.
Features
- Available in delayed-release tablets, extended-release tablets, and sprinkle capsules
- Contains divalproex sodium, a stable coordination compound of sodium valproate and valproic acid
- Multiple strengths: 125 mg, 250 mg, and 500 mg delayed-release tablets; 500 mg extended-release tablets
- Bioequivalent formulations with different release profiles for individualized dosing
- FDA-approved for epilepsy, migraine prevention, and bipolar disorder
- Therapeutic drug monitoring recommended (target range: 50-125 mcg/mL)
Benefits
- Provides effective seizure control in multiple epilepsy types including complex partial seizures
- Demonstrates robust efficacy in acute manic episodes and maintenance therapy for bipolar disorder
- Reduces frequency and severity of migraine headaches when used prophylactically
- Offers flexible dosing formulations to accommodate individual patient needs
- Established long-term safety profile when appropriately monitored
- May be used as monotherapy or adjunctive treatment depending on clinical indication
Common use
Depakote is primarily indicated for the treatment of epilepsy, specifically complex partial seizures that occur alone or in association with other seizure types. In psychiatric practice, it is approved for the treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features, and for maintenance therapy to prevent recurrence. Additionally, it is prescribed for prophylaxis of migraine headaches. Off-label uses include treatment of neuropathic pain, agitation in dementia, and impulse control disorders, though evidence for these applications varies.
Dosage and direction
Dosing must be individualized based on therapeutic response and tolerability. For epilepsy in adults: initial dose of 10-15 mg/kg/day, increasing by 5-10 mg/kg/week until optimal clinical response is achieved. Maximum recommended dose is 60 mg/kg/day. For bipolar disorder: initial dose of 750 mg daily in divided doses, with rapid titration to achieve clinical effect. Target dose typically ranges from 1000-2500 mg daily. For migraine prophylaxis: start with 250 mg twice daily, may increase to 1000 mg daily. Extended-release tablets are administered once daily, while delayed-release formulations require divided dosing. Always take with food to minimize gastrointestinal upset.
Precautions
Hepatotoxicity risk requires baseline and periodic liver function tests. Pancreatitis, though rare, can be fatal; monitor for symptoms including abdominal pain, nausea, and vomiting. Thrombocytopenia and other hematologic abnormalities may occur; obtain baseline CBC and monitor periodically. Hyperammonemia may develop with or without elevated liver enzymes. Teratogenic risk necessitates effective contraception in women of childbearing potential. Weight gain, hair loss, and tremor are common dose-related effects. Elderly patients may experience increased sedation and require lower doses. Regular monitoring of valproate levels is recommended, especially during dose adjustments or when adding interacting medications.
Contraindications
Depakote is contraindicated in patients with known hypersensitivity to valproate products. It must not be used in patients with significant hepatic impairment or urea cycle disorders due to risk of hyperammonemic encephalopathy. Contraindicated in patients with known mitochondrial disorders caused by POLG mutations due to increased risk of acute liver failure. Should not be administered to pregnant women for migraine prophylaxis. Avoid use in patients with history of pancreatitis unless no alternative exists. Not recommended for patients with severe thrombocytopenia or bleeding disorders.
Possible side effect
Common adverse effects (≥10%): nausea, vomiting, diarrhea, abdominal pain, drowsiness, dizziness, tremor, alopecia, weight gain. Less common effects (1-10%): thrombocytopenia, increased liver enzymes, rash, euphoria, depression, emotional lability. Rare but serious effects (<1%): hepatic failure, pancreatitis, hyperammonemic encephalopathy, Stevens-Johnson syndrome, toxic epidermal necrolysis, polycystic ovary syndrome. Neurological effects may include ataxia, nystagmus, and diplopia. Endocrine effects may include irregular menses and thyroid function abnormalities. Most side effects are dose-dependent and may improve with dosage reduction.
Drug interaction
Depakote exhibits numerous clinically significant interactions. It inhibits the metabolism of phenobarbital, lamotrigine, and carbamazepine-epoxide, requiring dose adjustments. Coadministration with clonazepam may precipitate absence status. Aspirin, felbamate, and erythromycin may increase valproate levels. Carbamazepine, phenytoin, and rifampin decrease valproate levels through enzyme induction. Valproate may potentiate CNS depressants including alcohol, benzodiazepines, and opioids. Warfarin metabolism may be affected, requiring increased INR monitoring. Interaction with other protein-bound drugs may occur due to displacement from binding sites. A comprehensive medication review is essential before initiation.
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. Do not double the dose to make up for a missed administration. For patients taking multiple daily doses, if more than 4 hours have passed since the missed dose time, skip that dose and resume the regular schedule. For once-daily extended-release formulations, take the missed dose if remembered within 12 hours of the scheduled time. Consistent daily administration is crucial for maintaining therapeutic levels, particularly in seizure control. Patients should be advised to maintain a dosing diary if adherence problems persist.
Overdose
Valproate overdose represents a medical emergency with potential fatality. Symptoms may include somnolence, heart block, deep coma, and metabolic abnormalities including hypernatremia. Cerebral edema and intracranial hypertension have been reported. Hemodialysis is effective in removing valproate and should be considered in severe intoxication (levels >850 mcg/mL) or with significant CNS depression. Multiple-dose activated charcoal may be beneficial. Supportive care includes airway protection, cardiovascular monitoring, and correction of metabolic disturbances. Naloxone has reversed CNS depression in some cases. Specific levels do not always correlate with clinical severity, so treatment should be based on clinical presentation.
Storage
Store at controlled room temperature (20-25°C or 68-77°F) with excursions permitted between 15-30°C (59-86°F). Keep container tightly closed and protect from moisture. Delayed-release tablets and sprinkle capsules should be stored in their original packaging. Do not remove desiccant from bottles. Keep out of reach of children and pets. Do not use if tablets show signs of deterioration or discoloration. Extended-release tablets should not be crushed or chewed. Unused medication should be disposed of properly through medication take-back programs and not flushed down toilets.
Disclaimer
This information is for educational purposes only and does not constitute medical advice. Treatment decisions must be made by qualified healthcare professionals based on individual patient circumstances. The prescribing physician should be consulted for specific dosing, monitoring, and safety information. This summary does not include all possible uses, directions, precautions, or adverse effects. Patients should not alter or discontinue medication without medical supervision. Healthcare providers should reference the full prescribing information for complete details.
Reviews
Clinical studies demonstrate Depakote’s efficacy across its approved indications. In epilepsy trials, 34% of patients achieved ≥50% reduction in complex partial seizure frequency versus 13% with placebo. Bipolar disorder studies show significant improvement in manic symptoms compared to placebo, with response rates of 48% versus 34%. Migraine prophylaxis trials demonstrate ≥50% reduction in headache frequency in 44% of patients versus 21% with placebo. Long-term observational studies confirm maintained efficacy with appropriate monitoring. Most reviews note the importance of careful patient selection and monitoring, particularly regarding hepatic, hematologic, and metabolic parameters. Patient-reported outcomes indicate satisfaction with efficacy but note concerns regarding weight gain and other metabolic effects.