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divalproex sodium
generic
Black Box Warnings .
Hepatotoxicity
serious or fatal hepatic failure has occurred, usually during 1st 6mo of tx; pts <2 yo at incr. risk of fatal hepatotoxicity, especially if multiple anticonvulsant tx, congenital metabolic disorder, severe seizure disorder w/ intellectual disability, or organic brain dz; in pts <2 yo, weigh benefit vs. risk, use w/ extreme caution and as monotherapy; incidence of fatal hepatotoxicity decr. considerably in progressively older pt groups; hepatotoxicity may be preceded by malaise, weakness, lethargy, facial edema, anorexia, vomiting and loss of seizure control; monitor s/sx incl. LFTs at baseline, then frequently, esp. during 1st 6mo of tx
Increased Hepatotoxicity Risk in Mitochondrial Dz
incr. risk of acute liver failure and death in pts w/ hereditary neurometabolic syndromes caused by mitochondrial DNA polymerase gamma (POLG) gene mutations (e.g. Alpers Huttenlocher Syndrome); contraindicated in pts w/ POLG-related mitochondrial disorders and in pts <2 yo w/ suspected hereditary mitochondrial dz; in pts >2 yo w/ suspected mitochondrial disorder, use only if failed other anticonvulsant tx and monitor hepatotoxicity s/sx incl. LFTs regularly; perform POLG mutation screening per current clinical practice
Fetal Risk
can cause major congenital malformations incl. neural tube defects, decr. IQ scores, neurodevelopmental disorders after in utero exposure; contraindicated for migraine prophylaxis use in pregnancy and women of reproductive potential w/o effective contraception; should not be used for epilepsy or bipolar disorder use in pregnancy and women planning to become pregnant unless other tx options have failed or are unacceptable; women should use effective contraception during tx
Pancreatitis
life-threatening pancreatitis, incl. hemorrhagic cases w/ rapid progression from initial sx to death reported in children and adults; cases reported shortly after initial use as well as after several years of use; advise pts to promptly report s/sx incl. abdominal pain, nausea, vomiting, and/or anorexia; D/C tx if pancreatitis diagnosis and start alternative tx as clinically indicated
Adult Dosing .
Dosage forms: DR CAP: 125 mg; DR TAB: 125 mg, 250 mg, 500 mg; ER TAB: 250 mg, 500 mg
Special Note
- [formulation clarification]
- Info: divalproex sodium ER and DR tabs not bioequivalent; incr. total daily dose by 8-20% if switching from DR tab to ER tab
partial seizures, complex
- [delayed-release form]
- Dose: 30-60 mg/kg/day PO divided bid-tid; Start: 10-15 mg/kg/day PO divided qd-tid, incr. by 5-10 mg/kg/day q7 days; Max: 60 mg/kg/day; Info: decr. start dose and titrate slowly in elderly pts; adjust dose based on tx response and serum levels; divide doses >250 mg/day; give w/ food; taper dose gradually to D/C
- [extended-release form]
- Dose: 30-60 mg/kg/dose ER PO qd; Start: 10-15 mg/kg/dose ER PO qd, incr. by 5-10 mg/kg/day q7 days; Max: 60 mg/kg/day ER; Info: decr. start dose and titrate slowly in elderly pts; adjust dose based on tx response and serum levels; give w/ food; do not cut/crush/chew ER tab; taper dose gradually to D/C
absence seizures, simple and complex
- [delayed-release form]
- Dose: 30-60 mg/kg/day PO divided bid-tid; Start: 15 mg/kg/day PO divided qd-tid, incr. by 5-10 mg/kg/day q7 days; Max: 60 mg/kg/day; Info: decr. start dose and titrate slowly in elderly pts; adjust dose based on tx response and serum levels; divide doses >250 mg/day; give w/ food; taper dose gradually to D/C
- [extended-release form]
- Dose: 30-60 mg/kg/dose ER PO qd; Start: 15 mg/kg/day ER PO qd, incr. by 5-10 mg/kg/day q7 days; Max: 60 mg/kg/day ER; Info: decr. start dose and titrate slowly in elderly pts; adjust dose based on tx response and serum levels; give w/ food; do not cut/crush/chew ER tab; taper dose gradually to D/C
bipolar disorder, acute manic
- [delayed-release form]
- Dose: 250-500 mg PO tid; Start: 250 mg PO tid, may incr. dose rapidly to lowest effective dose; Max: 60 mg/kg/day; Info: decr. start dose and titrate slowly in elderly pts; adjust dose based on tx response and serum levels; give w/ food; taper dose gradually to D/C
- [extended-release form]
- Dose: 25-60 mg/kg/dose ER PO qd; Start: 25 mg/kg/dose ER PO qd, may incr. dose rapidly to lowest effective dose; Max: 60 mg/kg/day ER; Info: decr. start dose and titrate slowly in elderly pts; adjust dose based on tx response and serum levels; give w/ food; do not cut/crush/chew ER tab; taper dose gradually to D/C
migraine prophylaxis
- [delayed-release form]
- Dose: 250-500 mg PO bid; Start: 250 mg PO bid; Info: decr. start dose and titrate slowly in elderly pts; give w/ food; taper dose gradually to D/C
- [extended-release form]
- Dose: 500-1000 mg ER PO qd; Start: 500 mg ER PO qd x1wk, then incr. to 1000 mg ER PO qd; Info: decr. start dose and titrate slowly in elderly pts; give w/ food; do not cut/crush/chew ER tab; taper dose gradually to D/C
renal dosing
- [no adjustment]
- renal impairment: no adjustment
- HD/PD: no adjustment; no supplement
hepatic dosing
- [see below]
- hepatic dz/significant impairment: contraindicated
Peds Dosing .
- Dosage forms: DR CAP: 125 mg; DR TAB: 125 mg, 250 mg, 500 mg; ER TAB: 250 mg, 500 mg
Special Note
- [formulation clarification]
- Info: divalproex sodium ER and DR tabs not bioequivalent; incr. total daily dose by 8-20% if switching from DR tab to ER tab
partial seizures, complex
- [delayed-release form, 10 yo and older]
- Dose: 30-60 mg/kg/day PO divided bid-tid; Start: 10-15 mg/kg/day PO divided qd-tid, incr. by 5-10 mg/kg/day q7 days; Max: 60 mg/kg/day; Info: adjust dose based on tx response and serum levels; divide doses >250 mg/day; give w/ food; taper dose gradually to D/C
- [extended-release form, 10 yo and older]
- Dose: 30-60 mg/kg/dose ER PO qd; Start: 10-15 mg/kg/dose ER PO qd, incr. by 5-10 mg/kg/day q7 days; Max: 60 mg/kg/day ER; Info: adjust dose based on tx response and serum levels; give w/ food; do not cut/crush/chew ER tab; taper dose gradually to D/C
absence seizures, simple and complex
- [delayed-release form, 10 yo and older]
- Dose: 30-60 mg/kg/day PO divided bid-tid; Start: 15 mg/kg/day PO divided qd-tid, incr. by 5-10 mg/kg/day q7 days; Max: 60 mg/kg/day; Info: adjust dose based on tx response and serum levels; divide doses >250 mg/day; give w/ food; taper dose gradually to D/C
- [extended-release form, 10 yo and older]
- Dose: 30-60 mg/kg/dose ER PO qd; Start: 15 mg/kg/dose ER PO qd, incr. by 5-10 mg/kg/day q7 days; Max: 60 mg/kg/day ER; Info: adjust dose based on tx response and serum levels; give w/ food; do not cut/crush/chew ER tab; taper dose gradually to D/C
renal dosing
- [no adjustment]
- renal impairment: no adjustment
- HD/PD: no adjustment; no supplement
hepatic dosing
- [see below]
- hepatic dz/significant impairment: contraindicated