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Depakote ER (divalproex sodium)

BOXED WARNING

Fatal hepatic failure may occur, usually during first 6 months of treatment. Serious/fatal hepatotoxicity may be preceded by nonspecific symptoms (eg, malaise, weakness, lethargy, facial edema, anorexia, vomiting) or loss of seizure control in patients with epilepsy; monitor closely. Monitor LFTs prior to therapy and at frequent intervals thereafter, especially during first 6 months of treatment. Increased risk of developing fatal hepatotoxicity in children <2 yrs of age, especially if on multiple anticonvulsants, with congenital metabolic disorders, severe seizure disorders with mental retardation, and organic brain disease; use with extreme caution and as a sole agent. Increased risk of drug-induced acute liver failure and resultant death in patients with hereditary neurometabolic syndromes caused by DNA mutations of the mitochondrial DNA polymerase gamma (POLG) gene (eg, Alpers-Huttenlocher syndrome). Contraindicated in patients known to have mitochondrial disorders caused by POLG mutations and children <2 yrs of age who are clinically suspected of having a mitochondrial disorder. In patients >2 yrs of age who are clinically suspected of having a hereditary mitochondrial disease, drug should only be used after other anticonvulsants have failed; closely monitor for the development of acute liver injury with regular clinical assessments and serum liver testing. May cause major congenital malformations, particularly neural tube defects (eg, spina bifida). May cause decreased IQ scores following in utero exposure. Contraindicated in pregnant women treated for prophylaxis of migraine; should only be used to treat pregnant women with epilepsy or bipolar disorder if other medications have failed to control their symptoms or are otherwise unacceptable. Do not administer to a woman of childbearing potential unless the drug is essential to the management of her medical condition; use effective contraception. Life-threatening pancreatitis reported; d/c if pancreatitis is diagnosed and initiate appropriate treatment.

View FDA-Approved Full Prescribing Information for Depakote ER

THERAPEUTIC CLASS

Valproate compound

DEA CLASS

RX

INDICATIONS

Treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features. In adults and children ≥10 yrs of age, monotherapy and adjunctive treatment of complex partial seizures, simple/complex absence seizures, and adjunct for multiple seizure types that include absence seizures. Migraine headache prophylaxis.

ADULT DOSAGE

Mania

Initial: 25mg/kg qd
Max: 60mg/kg/day

Epilepsy

Complex Partial Seizures:
Initial: 10-15mg/kg/day
Titrate: Increase by 5-10mg/kg/week
Max: 60mg/kg/day

Simple/Complex Absence Seizures:
Initial: 15mg/kg/day
Titrate: Increase weekly by 5-10mg/kg/day
Max: 60mg/kg/day

Migraine

Prophylaxis:
Initial: 500mg qd for 1 week
Titrate: Increase to 1000mg qd

Conversions

Conversion from Depakote to Depakote ER:
Depakote 500-625mg/day: 750mg Depakote ER
Depakote 750-875mg/day: 1000mg Depakote ER
Depakote 1000-1125mg/day: 1250mg Depakote ER
Depakote 1250-1375mg/day: 1500mg Depakote ER
Depakote 1500-1625mg/day: 1750mg Depakote ER
Depakote 1750mg/day: 2000mg Depakote ER
Depakote 1875-2000mg/day: 2250mg Depakote ER
Depakote 2125-2250mg/day: 2500mg Depakote ER
Depakote 2375mg/day: 2750mg Depakote ER
Depakote 2500-2750mg/day: 3000mg Depakote ER
Depakote 2875mg/day: 3250mg Depakote ER
Depakote 3000-3125mg/day: 3500mg Depakote ER

PEDIATRIC DOSAGE

Epilepsy

≥10 Years:
Complex Partial Seizures:
Initial: 10-15mg/kg/day
Titrate: Increase by 5-10mg/kg/week
Max: 60mg/kg/day

Simple/Complex Absence Seizures:
Initial: 15mg/kg/day
Titrate: Increase weekly by 5-10mg/kg/day
Max: 60mg/kg/day

Conversions

Conversion from Depakote to Depakote ER:
Depakote 500-625mg/day: 750mg Depakote ER
Depakote 750-875mg/day: 1000mg Depakote ER
Depakote 1000-1125mg/day: 1250mg Depakote ER
Depakote 1250-1375mg/day: 1500mg Depakote ER
Depakote 1500-1625mg/day: 1750mg Depakote ER
Depakote 1750mg/day: 2000mg Depakote ER
Depakote 1875-2000mg/day: 2250mg Depakote ER
Depakote 2125-2250mg/day: 2500mg Depakote ER
Depakote 2375mg/day: 2750mg Depakote ER
Depakote 2500-2750mg/day: 3000mg Depakote ER
Depakote 2875mg/day: 3250mg Depakote ER
Depakote 3000-3125mg/day: 3500mg Depakote ER

DOSING CONSIDERATIONS

Concomitant Medications
Complex Partial Seizures:
Conversion to Monotherapy: Reduce concomitant antiepilepsy drugs by 25% every 2 weeks; begin reduction at initiation of Depakote ER, or delay by 1-2 weeks

Elderly
Reduce initial dose and titrate slowly

Adverse Reactions
Thrombocytopenia: Probability increases significantly at total valproate concentrations of ≥110mcg/mL (females) or ≥135mcg/mL (males)

ADMINISTRATION

Oral route

Swallow whole; do not crush or chew

HOW SUPPLIED

Tab, Extended-Release: 250mg, 500mg

CONTRAINDICATIONS

Hepatic disease, significant hepatic dysfunction, known urea cycle disorder (UCD). Mitochondrial disorders caused by mutations in mitochondrial POLG (eg, Alpers-Huttenlocher syndrome) and children <2 yrs of age who are suspected of having a POLG-related disorder. Prophylaxis of migraine headaches in pregnant women.

WARNINGS/PRECAUTIONS

Caution with prior history of hepatic disease. D/C immediately if significant hepatic dysfunction (suspected or apparent) occurs. Reversible and irreversible cerebral and cerebellar atrophy reported; routinely monitor motor and cognitive functions, and evaluate continued use in the presence of suspected or apparent signs of brain atrophy. Cerebral atrophy reported in children exposed in utero. Increased risk of suicidal thoughts or behavior reported. Dose-related thrombocytopenia reported. Hyperammonemic encephalopathy reported in UCD patients; d/c and initiate treatment if symptoms develop. Prior to initiation of therapy, evaluate for UCD in high-risk patients (eg, history of unexplained encephalopathy, coma). Hyperammonemia reported and may be present despite normal LFTs. Measure ammonia levels if unexplained lethargy, vomiting, or mental status changes occur. Caution in elderly; monitor fluid/nutritional intake, and for dehydration, somnolence, and other adverse reactions. Altered thyroid function tests and urine ketone tests reported. Avoid abrupt discontinuation. May stimulate replication of HIV and cytomegalovirus. Multiorgan hypersensitivity reactions (rare) and hypothermia reported. Medication residue in stool reported; check valproate levels and monitor clinical condition, and consider alternative treatment if clinically indicated.

ADVERSE REACTIONS

Hepatotoxicity, pancreatitis, N/V, somnolence, dizziness, abdominal pain, dyspepsia, amblyopia/blurred vision, diarrhea, tremor, weight gain, back pain, alopecia, headache.

DRUG INTERACTIONS

Drugs that affect the level of expression of hepatic enzymes (eg, phenytoin, carbamazepine, phenobarbital, primidone) may increase valproate clearance; monitor valproate and concomitant drug concentrations whenever enzyme-inducing drugs are introduced or withdrawn. Concomitant use with aspirin decreases protein binding and inhibits metabolism of valproate; use with caution. Carbapenem antibiotics may reduce serum concentrations to subtherapeutic levels, resulting in loss of seizure control. Rifampin increases oral clearance; may require valproate dosage adjustment. Concomitant use with felbamate leads to an increase in valproate Cmax; may require decrease in valproate dosage. Reduces the clearance of amitriptyline and nortriptyline. Induces metabolism of carbamazepine. Inhibits metabolism of diazepam, ethosuximide, phenobarbital, and phenytoin; monitor drug serum concentrations and adjust dose appropriately. Breakthrough seizures reported with concomitant use with phenytoin. Use with clonazepam may induce absence status in patients with absence seizures. Increases T1/2 of lamotrigine; serious skin reactions reported. Concomitant use with topiramate has been associated with hyperammonemia, with or without encephalopathy, and hypothermia. May displace protein-bound drugs (eg, phenytoin, carbamazepine, tolbutamide, warfarin); monitor coagulation tests when coadministered with warfarin. May decrease clearance of zidovudine in HIV-seropositive patients.

PREGNANCY AND LACTATION

Category D (for epilepsy and for manic episodes with bipolar disorder) or X (for prophylaxis of migraine headaches), caution in nursing.

MECHANISM OF ACTION

Anticonvulsant; has not been established. Suggested to increase brain concentrations of gamma-aminobutyric acid.

PHARMACOKINETICS

Absorption: Bioavailability (90%); Tmax=4-17 hrs (median). Distribution: Vd=11L (total valproate), 92L (free valproate); found in breast milk. Metabolism: Liver; mitochondrial β-oxidation (major), glucuronidation. Elimination: Urine (30-50% glucuronide conjugate, <3% unchanged); T1/2=9-16 hrs (250-1000mg dose).

ASSESSMENT

Assess for hepatic dysfunction, history of hepatic disease, UCD, pancreatitis, history of hypersensitivity to the drug, mitochondrial disorders caused by mutations in mitochondrial POLG, children <2 yrs of age who are suspected of having a POLG-related disorders, other conditions where treatment is cautioned, pregnancy/nursing status, and possible drug interactions. Assess LFTs, CBC with platelet counts, and coagulation parameters.

MONITORING

Monitor for hypersensitivity reactions, multiorgan hypersensitivity reactions, pancreatitis, hepatotoxicity, hyperammonemia, hypothermia, drug-induced acute liver failure, acute liver injury, brain atrophy, emergence/worsening of depression, suicidality or unusual changes in behavior, medication residue in stool, and other adverse reactions. Monitor LFTs frequently, especially during first 6 months. Monitor fluid/nutritional intake, ammonia levels, CBC with platelets, and coagulation parameters in patients on warfarin.

PATIENT COUNSELING

Inform to take ud. Inform pregnant women and women of childbearing potential about the risk in pregnancy; advise to use effective contraception while on therapy and counsel about alternative therapeutic options. Advise to read medication guide. Instruct to notify physician if pregnant or intending to become pregnant. Encourage patients to enroll in North American Antiepileptic Drug Pregnancy Registry. Advise to notify physician if depression, suicidal thoughts, behavior, or thoughts about self-harm emerge; instruct to report behaviors of concern. Counsel about signs/symptoms of pancreatitis, hepatotoxicity, hyperammonemia, or hyperammonemic encephalopathy; advise to notify physician if any symptoms or adverse effects occur. Advise not to engage in hazardous activities (eg, driving/operating machinery) until the effects of the drug are known. Inform that a fever associated with other organ system involvement (eg, rash, lymphadenopathy) may be drug related; instruct to report to physician. Instruct patients to notify their physician if they notice a medication residue in the stool.

STORAGE

25°C (77°F); excursions permitted to 15-30°C (59-86°F).

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