VALPROIC ACID (DIVALPROEX SODIUM, SODIUM VALPROATE)
(val-proe′ic)
Depacon, Depakene, Depakote, Depakote ER, Depakote Sprinkle, Epival A, Stavzor
Classifications: ANTICONVULSANT; GAMMA-AMINOBUTYRIC ACID (GABA) INHIBITOR
Therapeutic: ANTICONVULSANT
Pregnancy Category: D
AVAILABILITY
Capsule; sprinkle capsule; delayed release tablet; syrup; solution for injection
ACTION & THERAPEUTIC EFFECT
Anticonvulsant with increased bioavailability of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA) to brain neurons. It may also suppress repetitive neuronal firing through inhibition of voltage-sensitive sodium channels. Depresses abnormal neuron discharges in the CNS, thus decreasing seizure activity.
USES
Alone or with other anticonvulsants in management of absence (petit mal) and mixed seizures; mania; migraine headache prophylaxis.
UNLABELED USES
Status epilepticus refractory to IV diazepam, petit mal variant seizures, febrile seizures in children, other types of seizures including psychomotor (temporal lobe), myoclonic, akinetic and tonic-clonic seizures, photosensitivity seizures, and those refractory to other anticonvulsants.
CONTRAINDICATIONS
Hypersensitivity to valproate sodium; hepatic disease or significant hepatic function impairment; urea cycle disorders. Hyperammonemia, encephalopathy; suicidal ideations; thrombocytopenia, patient with bleeding disorders or liver dysfunction or disease, cirrhosis, hepatitis; drug induced pancreatitis; congenital metabolic disorders, those with severe seizures, or on multiple anticonvulsant drugs; AIDS; mitochondrial disorders caused by mutations in mitochondrial DNA POLG and children younger than 2 y who are suspected of having a POLG-related disorder; fluid restriction or decreased food intake; pregnancy (category D); lactation.
CAUTIOUS USE
History of suicidal tendencies; history of kidney disease, renal impairment or failure; history of mild or moderate liver impairment; congenital metabolic disorders, those with severe epilepsy, use as sole anticonvulsant drug; HIV; hypoalbuminemia; organic brain syndrome or mental retardation; use as sore agent; older adults. Safe use in children with partial seizures younger than 10 y not established.
ROUTE & DOSAGE
Note: May need to increase dose when converting from immediate release to extended release products
Management of Seizures
Adult/Child (10 y or older): PO/IV 10–15 mg/kg/day in divided doses when total daily dose greater than 250 mg, increase at 1 wk intervals by 5–10 mg/kg/ day until seizures are controlled or adverse effects develop (max: 60 mg/kg/day) Conversion of PO to IV: Give normal dose in divided doses q6h
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| Nursing Implications for Valproate (Valproic) Acid |
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Migraine Headache Prophylaxis
Adult: PO 250 mg b.i.d. (max: 1000 mg/day) or Depakote ER 500 mg daily × 1 wk, may increase to 1000 mg daily
Mania
Adult: PO 750 mg/day administered in divided doses OR Extended release: 25 mg/kg/day
Hepatic Impairment
Dosage Adjustment
Dose reduction recommended
Renal Impairment Dosage Adjustment
Severe impairment may require close monitoring
ADMINISTRATION
Oral
- Give tablets and capsules whole; instruct patient to swallow whole and not to chew. Instruct to swallow sprinkle capsules whole or sprinkle entire contents on teaspoonful of soft food, and instruct to not chew food.
- Avoid using a carbonated drink as diluent for the syrup because it will release drug from delivery vehicle; free drug painfully irritates oral and pharyngeal membranes.
- Reduce gastric irritation by administering drug with food.
Intravenous
PREPARE: IV Infusion: Dilute each dose in 50 mL or more of D5W, NS, or LR.
ADMINISTER: IV Infusion: Give a single dose over at least 60 min (20 mg/min or less).
INCOMPATIBILITIES: Solution/additive: Should avoid mixing with other drugs. Y site: Vancomycin.
ADVERSE EFFECTS (≥1%) CNS:
Breakthrough seizures, sedation, drowsiness, dizziness, increased alertness, hallucinations, emotional upset, aggression; deep coma, death (with overdose). GI: Nausea, vomiting, indigestion (transient), hypersalivation, anorexia with weight loss, increased appetite with weight gain, abdominal cramps, diarrhea, constipation, liver failure, pancreatitis. Hematologic: Prolonged bleeding time, leukopenia, lymphocytosis, thrombocytopenia, hypofibrinogenemia, bone marrow depression, anemia. Skin: Skin rash, photosensitivity, transient hair loss, curliness or waviness of hair. Endocrine: Irregular menses, secondary amenorrhea. Metabolic: Hyperammonemia (usually asymptomatic) hyperammonemic encephalopathy in patients with urea
cycle disorders, pancreatitis. Respiratory: Pulmonary edema (with overdose).
DIAGNOSTIC TEST INTERFERENCE
Valproic acid produces false-positive results for urine ketones, elevated AST, ALT, LDH, and serum alkaline phosphatase, prolonged bleeding time, altered thyroid function tests.
INTERACTIONS
Drug: Alcohol and other CNS DEPRESSANTS potentiate depressant effects; other ANTICONVULSANTS, BARBITURATES increase or decrease anticonvulsant and BARBITURATE levels; haloperidol, loxapine, maprotiline, MAOIs, PHENOTHIAZINES, THIOXANTHENES, TRICYCLIC ANTIDEPRESSANTS can increase CNS depression or lower seizure threshold; aspirin, dipyridamole, warfarin increase risk of spontaneous bleeding; clonazepam may precipitate absence seizures; SALICYLATES, cimetidine, isoniazid may increase valproic acid levels and toxicity. Mefloquine can decrease valproic acid levels; meropenem may decrease valproic acid levels; cholestyramine may decrease absorption. Herbal: Ginkgo may decrease anticonvulsant effectiveness.
PHARMACOKINETICS
Absorption: Readily from GI tract. Peak: 1–4 h valproic acid; 3–5 h divalproex. Therapeutic Range: 50–100 mcg/mL. Distribution: Crosses placenta; distributed into breast milk. Metabolism: In liver. Elimination: Primarily in urine; small amount in feces and expired air. Half-Life: 5–20 h.
NURSING IMPLICATIONS
Black Box Warning
Valproic acid, sodium valproate, and divalproex sodium have been associated with severe hepatotoxicity, life-threatening pancreatitis, and fetal harm.
Assessment & Drug Effects
- Monitor patient alertness especially with multiple drug therapy for seizure control.
- Monitor patient carefully during dose adjustments and promptly report presence of adverse effects. Increased dosage is associated with frequency of adverse effects.
- Monitor for and report promptly S&S of pancreatitis (e.g., abdominal pain, nausea, vomiting, and/or anorexia).
- Multiple drugs for seizure control increase the risk of hyperammonemia, marked by lethargy, anorexia, asterixis, increased seizure frequency, and vomiting. Report such symptoms promptly to prescriber. If they persist with decreased dosage, the drug will be discontinued.
- Montior lab tests: Baseline LTFs, platelet count, bleeding time, coagulation parameters, and serum ammonia, then repeat at least q2mo, especially during the first 6 mo of therapy.
Patient & Family Education
- Women of childbearing age should be aware of the potential for birth defects should a pregnancy occur while taking this drug.
- Do not discontinue therapy abruptly; such action could result in loss of seizure control. Consult prescriber before you stop or alter dosage regimen.
- Notify prescriber promptly if spontaneous bleeding or bruising occurs (e.g., petechiae, ecchymotic areas, otorrhagia, epistaxis, melena).
- Withhold dose and notify prescriber for following symptoms: Visual disturbances, rash, jaundice, light-colored stools, protracted vomiting, diarrhea. Fatal liver failure has occurred in patients receiving this drug.
- Avoid alcohol and self-medication with other depressants during therapy.
- Consult prescriber before using any OTC drugs during anticonvulsant therapy, especially drugs containing aspirin or sedatives and medications for hay fever or other allergies.
- Do not drive or engage in potentially hazardous activities until response to drug is known.
Divalproex Sodium, consisting of a compound of sodium valproate and valproic acid in a 1:1 molar relationship in an enteric coated form, is a HDAC inhibitor used in the treatment of epilepsy. It acts via binding to and inhibiting gamma-aminobutyric acid (GABA) transaminase. Divalproex Sodium
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