divalproex sodium (Rx)

Brand and Other Names:Depakote, Depakote ER, more...Depakote Sprinkles
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

Dosages expressed as valproic acid equivalents

tablet, delayed-release (Depakote)

  • 125mg
  • 250mg
  • 500mg

tablet, extended-release (Depakote ER)

  • 250mg
  • 500mg

capsule (Depakote Sprinkles)

  • 125mg

Mania

Indicated for treatment of manic episodes associated with bipolar disorder

Depakote initial dose: 750 mg/day PO in divided doses

Depakote ER initial dose: 25 mg/kg PO once daily Increase as rapidly as possible to achieve the lowest therapeutic dose that provides desired clinical effect or plasma concentration

Not to exceed 60 mg/kg/day

Epilepsy

Complex partial seizures: Indicated as monotherapy and adjunctive therapy for complex partial seizures that occur either in isolation or in association with other types of seizures

Simple and complex absence seizures: Also indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types that include absence seizures

10-15 mg/kg/day PO initially; may increase by 5-10 mg/kg/week to achieve optimal clinical response; not to exceed 60 mg/kg/day

Depakote: If daily dose >250 mg, give as divided dose

Migraine Prophylaxis

Indicated for prophylaxis of migraine headaches; there is no evidence of use for acute treatment

Depakote initial dose: 250 mg PO BID for 1 week

Depakote ER initial dose: 500 mg PO qDay for 1 week

May increase dose up to 1000 mg/day if needed

Dosage Modifications

Conversion to monotherapy: Decrease concomitant antiepilepsy drug dosage ~25% q2weeks

Renal impairment

  • No adjustment necessary; protein binding is reduced and may cause measurement of total valproate concentrations to be inaccurate

Hepatic impairment

  • Administer lower doses
  • Contraindicated in severe impairment

Dosing Considerations

Monitor LFT's

Conversion from Depakote to Depakote ER: Administered Depakote ER once daily using a dose 8-20% higher than the total daily dose of Depakote

Therapeutic range

  • Low serum albumin levels may cause an increase in unbound drug (while total concentration may appear normal)
  • Epilepsy: 50-100 mcg/mL total valproate
  • Mania: 50-125 mcg/mL total valproate; maximum concentrations generally achieved within 14 days

Administration

Swallow whole, do not chew or crush

Capsules may be opened and sprinkled on spoonful of soft food immediately before administration

If dose is skipped, do not double next dose

Depakote or Depakote Sprinkles: If daily dose >250 mg, give as divided dose

Depakote ER: Administer once daily

Dosage Forms & Strengths

Dosages expressed as valproic acid equivalents

tablet, delayed-release (Depakote)

  • 125mg
  • 250mg
  • 500mg

tablet, extended-release (Depakote ER)

  • 250mg
  • 500mg

capsule (Depakote Sprinkles)

  • 125mg

Epilepsy

Complex partial seizures: Indicated as monotherapy and adjunctive therapy for complex partial seizures that occur either in isolation or in association with other types of seizures

Simple and complex absence seizures: Also indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types that include absence seizures

<10 years: Safety and efficacy not established

10-15 mg/kg/day PO initially; may increase by 5-10 mg/kg/week to achieve optimal clinical response; not to exceed 60 mg/kg/day

Dosage Modifications

Conversion to monotherapy: Decrease concomitant antiepilepsy drug dosage ~25% q2weeks

Renal impairment

  • No adjustment necessary; protein binding is reduced and may cause measurement of total valproate concentrations to be inaccurate

Hepatic impairment

  • Administer lower doses
  • Contraindicated in severe impairment

Dosing Considerations

Monitor LFT's

Conversion from Depakote to Depakote ER: Administered Depakote ER once daily using a dose 8-20% higher than the total daily dose of Depakote

Therapeutic range

  • Low serum albumin levels may cause an increase in unbound drug (while total concentration may appear normal)
  • Epilepsy: 50-100 mcg/mL total valproate
  • Mania: 50-125 mcg/mL total valproate; maximum concentrations generally achieved within 14 days

Administration

Swallow whole, do not chew or crush

Capsules may be opened and sprinkled on spoonful of soft food immediately before administration

If dose is skipped, do not double next dose

Depakote or Depakote Sprinkles: If daily dose >250 mg, give as divided dose

Depakote ER: Administer once daily

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Interactions

Interaction Checker

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      Serious - Use Alternative

        Significant - Monitor Closely

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            Contraindicated (0)

              Serious - Use Alternative (5)

              • bremelanotide

                bremelanotide will decrease the level or effect of divalproex sodium by Other (see comment). Avoid or Use Alternate Drug. Bremelanotide may slow gastric emptying and potentially reduces the rate and extent of absorption of concomitantly administered oral medications. Avoid use when taking any oral drug that is dependent on threshold concentrations for efficacy. Interactions listed are representative examples and do not include all possible clinical examples.

              • imipenem/cilastatin

                imipenem/cilastatin will decrease the level or effect of divalproex sodium by unknown mechanism. Avoid or Use Alternate Drug. Data from in vitro and animal studies suggest carbapenems may inhibit hydrolysis of the valproic acid glucuronide metabolite (VPA-g) back to valproic acid, thus decreasing the serum concentrations of valproic acid/divalproex sodium.

              • imipenem/cilastatin/relebactam

                imipenem/cilastatin/relebactam will decrease the level or effect of divalproex sodium by unknown mechanism. Avoid or Use Alternate Drug. Data from in vitro and animal studies suggest carbapenems may inhibit hydrolysis of the valproic acid glucuronide metabolite (VPA-g) back to valproic acid, thus decreasing the serum concentrations of valproic acid/divalproex sodium.

              • meropenem/vaborbactam

                meropenem/vaborbactam decreases levels of divalproex sodium by unknown mechanism. Avoid or Use Alternate Drug. Risk of seizures. If administration of meropenem/vaborbactam is necessary, then supplemental anticonvulsant therapy should be considered.

              • metoclopramide intranasal

                divalproex sodium, metoclopramide intranasal. Either increases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: Avoid use of metoclopramide intranasal or interacting drug, depending on importance of drug to patient.

              Monitor Closely (8)

              • cenobamate

                cenobamate, divalproex sodium. Either increases effects of the other by sedation. Use Caution/Monitor.

              • ferric maltol

                ferric maltol, divalproex sodium. Either increases levels of the other by unspecified interaction mechanism. Modify Therapy/Monitor Closely. Coadministration of ferric maltol with certain oral medications may decrease the bioavailability of either ferric maltol and some oral drugs. For oral drugs where reductions in bioavailability may cause clinically significant effects on its safety or efficacy, separate administration of ferric maltol from these drugs. Duration of separation may depend on the absorption of the medication concomitantly administered (eg, time to peak concentration, whether the drug is an immediate or extended release product).

              • lamotrigine

                divalproex sodium will increase the level or effect of lamotrigine by decreasing metabolism. Modify Therapy/Monitor Closely.

              • lemborexant

                divalproex sodium will increase the level or effect of lemborexant by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Lower nightly dose of lemborexant recommended if coadministered with weak CYP3A4 inhibitors. See drug monograph for specific dosage modification.

              • lomustine

                divalproex sodium will increase the level or effect of lomustine by decreasing metabolism. Use Caution/Monitor. Coadministration of valproic acid may inhibit metabolism and increase the toxicity of lomustine.

              • midazolam intranasal

                midazolam intranasal, divalproex sodium. Either increases toxicity of the other by pharmacodynamic synergism. Modify Therapy/Monitor Closely. Concomitant use of barbiturates, alcohol, or other CNS depressants may increase risk of hypoventilation, airway obstruction, desaturation, or apnea and may contribute to profound and/or prolonged drug effect.

              • osilodrostat

                osilodrostat will decrease the level or effect of divalproex sodium by affecting hepatic enzyme CYP2C19 metabolism. Use Caution/Monitor.

              • ustekinumab

                ustekinumab, divalproex sodium. Other (see comment). Use Caution/Monitor. Comment: Formation of CYP450 enzymes can be altered by increased levels of certain cytokines during chronic inflammation; thus, normalizing the formation of CYP450 enzymes. Upon initiation or discontinuation of ustekinumab in patients who are receiving concomitant CYP450 substrates, particularly those with a narrow therapeutic index, consider monitoring for therapeutic effect.

              Minor (0)

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                Adverse Effects

                >10%

                Nausea (48%)

                Headache (31%)

                Asthenia (27%)

                Vomiting (27%)

                Somnolence (27%)

                Tremor (25%)

                Dizziness (25%)

                Abdominal pain (23%)

                Diplopia (16%)

                Diarrhea (13%)

                Anorexia (12%)

                Amblyopia/blurred vision (12%)

                Flu syndrome (12%)

                Infection (12%)

                1-10%

                Dyspepsia (8%)

                Ataxia (8%)

                Nystagmus (8%)

                Fever (6%)

                Emotional lability (6%)

                Thinking abnormal (6%)

                Alopecia (6%)

                Weight loss (6%)

                Constipation (5%)

                Amnesia (5%)

                Bronchitis (5%)

                Rhinitis (5%)

                Frequency Not Defined

                Cerebral pseudoatrophy (acute or subacute cognitive decline and behavioral changes (apathy or irritability)

                Postmarketing Reports

                Hair texture change

                Hair color change

                Photosensitivity

                Erythema multiforme

                Toxic epidermal necrolysis

                Stevens-Johnson syndrome

                Elevated testosterone level

                Hyperandrogenism

                Nail and nailbed disorders

                Weight gain

                Aspermia, azoospermia, decreased sperm count, decreased spermatozoa motility, male infertility, and abnormal spermatozoa morphology

                Paradoxical convulsion

                Parkinsonism

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                Warnings

                Black Box Warnings

                Hepatotoxicity

                • Hepatic failure resulting in fatalities has occurred
                • Children younger than 2 years are at increased risk for fatal hepatotoxicity, particularly patients on multiple anticonvulsants, as well as those with congenital metabolic disorders, severe seizure disorders accompanied by mental retardation, or organic brain disease
                • Increased risk of valproate-induced acute liver failure and resultant deaths in patients with hereditary neurometabolic syndromes caused by DNA mutations of the mitochondrial DNA polymerase-gamma (POLG) gene (eg, Alpers Huttenlocher Syndrome)
                • If used in children with these conditions, it should be administered with extreme caution as a sole agent
                • Hepatotoxicity usually occurs during the first 6 months of treatment and may be preceded by malaise, weakness, lethargy, facial edema, anorexia, and vomiting

                Teratogenicity

                • Do not use in women of childbearing age unless the drug is essential to the management of the medical condition; all non-pregnant women of childbearing potential should use effective birth control if taking valproate products (see Contraindications and Pregnancy sections)
                • May cause neural tube defects
                • Children exposed in utero have increased risk for lower cognitive test scores compared with those exposed in utero to other antiseizure medications
                • Alternative medications that have a lower risk for adverse birth outcomes should be considered
                • Patients should not stop taking valproate without talking to a health-care professional
                • Women should use effective contraception while taking valproate derivatives
                • Not for administration to treat women with epilepsy or bipolar disorder who are pregnant or who plan to become pregnant unless other medications have failed to provide adequate symptom control or are otherwise unacceptable

                Pancreatitis

                • Cases of life-threatening pancreatitis have been reported in children and adults
                • Some cases have been described as hemorrhagic with a rapid progression from initial symptoms to death

                Contraindications

                Hypersensitivity

                Liver disease, significant hepatic impairment

                Urea cycle disorders

                Mitochondrial disorders caused by mutations in mitochondrial DNA polymerase-gamma (POLG; eg, Alpers-Huttenlocher Syndrome) and children <2 years of age who are suspected of having a POLG-related disorder

                Migraine headache prevention in women who are pregnant or plan to become pregnant

                Cautions

                Probability of thrombocytopenia increases significantly at total trough valproate plasma concentrations exceed 110 mcg/mL in females and 135 mcg/mL in males

                Hepatotoxic (age <2 years, higher risk of fatal hepatotoxicity); see Black Box Warnings

                POLG mutations; see Contraindications and Black Box Warnings

                Discontinue if hyperammonemia/encephalopathy occurs; check ammonia level if emesis occurs or if the patient displays lethargy or abnormal behavior; evaluate patient for urea cycle disorder (see Contraindications) or hepatotoxicity (see Black Box Warnings);

                Pancreatitis, including fatalities reported (see Black Box Warnings)

                Hypothermia has been reported during valproate therapy with or without associated hyperammonemia; this adverse reaction can also occur in patients using concomitant topiramate

                In utero exposure increases risk for poor cognitive outcomes and anatomical malformations, compared with 3 other common AEDs (carbamazepine, lamotrigine, phenytoin); see Black Box Warnings

                Potential for thrombocytopenia, porphyria, and multiorgan hypersensitivity reaction (also known as drug reaction with eosinophilia and systemic symptoms or DRESS)

                May produce false-positive urine ketone test and alter TFTs

                Reversible cerebral and cerebellar atrophy reported; monitor motor and cognitive function routinely and assess for signs and symptoms of brain atrophy

                May cause CNS depression and impair physical or mental abilities

                Somnolence in the elderly can occur; divalproex dosage should be increased slowly and with regular monitoring for fluid and nutritional intake

                Not for administration to post-traumatic seizure prophylaxis in patients with acute head trauma (increased mortality reported when used)

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                Pregnancy & Lactation

                Pregnancy

                A pregnancy exposure registry monitors pregnancy outcomes in women exposed to antiepileptic drugs (AEDs), during pregnancy; encourage women on therapy during pregnancy to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling toll-free 1-888-233-2334 or visiting the website, http://www.aedpregnancyregistry.org/.; must be done by the patient herself

                Contraindicated for use in prophylaxis of migraine headaches in women who are pregnant and in women of childbearing potential who are not using effective contraception; for epilepsy or bipolar disorder, drug should not be used to treat women who are pregnant or who plan to become pregnant unless other medications have failed to provide adequate symptom control or are otherwise unacceptable

                Women with epilepsy who become pregnant while taking valproate should not discontinue therapy abruptly, as this can precipitate status epilepticus with resulting maternal and fetal hypoxia and threat to life; discontinuation of the drug may be considered prior to and during pregnancy in individual cases if seizure disorder severity and frequency do not pose serious threat to patient

                Maternal valproate use during pregnancy for any indication increases risk of congenital malformations, particularly neural tube defects including spina bifida, but also malformations involving other body systems (e.g., craniofacial defects including oral clefts, cardiovascular malformations, hypospadias, limb malformations)

                Risk is dose-dependent; a threshold dose below which no risk exists cannot be established; valproate polytherapy with other AEDs has been associated with increased frequency of congenital malformations compared with AED monotherapy; risk of major structural abnormalities is greatest during first trimester; however, other serious developmental effects can occur with valproate use throughout pregnancy

                There have been reports of hypoglycemia in neonates and fatal cases of hepatic failure in infants following maternal use of valproate during pregnancy

                Pregnant women taking valproate may develop hepatic failure or clotting abnormalities including thrombocytopenia, hypofibrinogenemia, and/or decrease in other coagulation factors, which may result in hemorrhagic complications in the neonate including death

                Evidence suggests that folic acid supplementation prior to conception and during the first trimester of pregnancy decreases risk for congenital neural tube defects in general population; not known whether risk of neural tube defects or decreased IQ in offspring of women receiving valproate is reduced by folic acid supplementation; dietary folic acid supplementation both prior to conception and during pregnancy should be routinely recommended for patients using valproate

                There have been reports of male infertility coincident with valproate therapy; in animal studies, oral administration at clinically relevant doses resulted in adverse reproductive effects in males

                Lactation

                Drug is excreted in human milk; data in the published literature describe presence of valproate in human milk; there are no data to assess effects of drug on milk production or excretion

                Developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from drug or from underlying maternal condition

                Monitor breastfed infant for signs of liver damage including jaundice and unusual bruising or bleeding; there have been reports of hepatic failure and clotting abnormalities in offspring of women who used valproate during pregnancy

                Pregnancy Categories

                A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

                B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

                C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

                D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

                X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

                NA: Information not available.

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                Pharmacology

                Mechanism of Action

                May increase levels of the inhibitory neurotransmitter gamma-aminobutyric acid (GABA) in brain; may enhance or mimic action of GABA at postsynaptic receptor sites; may also inhibit sodium and calcium channels

                Divalproex sodium is a stable co-ordination compound comprised of sodium valproate and valproic acid in a 1:1 molar relationship and formed during the partial neutralization of valproic acid with 0.5 equivalent of sodium hydroxide

                Absorption

                Equivalent oral doses of Depakote (divalproex sodium) products and Depakene (valproic acid) capsules deliver equivalent quantities of valproate ion systemically, although the rate of valproate ion absorption may vary with the formulation administered (liquid, solid, or sprinkle), conditions of use (eg, fasting or postprandial) and the method of administration

                These differences should be of minor clinical importance

                Peak plasma time: 4 hr (tablet); 3.3 hr (sprinkles); 4-17 hr (ER tablet)

                Food decreases rate of absorption

                Distribution

                Protein bound: Concentration dependent; free fraction increases from ~10% at 40 mcg/mL to 18.5% at 130 mcg/mL

                Protein binding reduced in the elders, chronic hepatic diseases, renal impairment, or with drug that cause displacement (aspirin)

                CSF: Approximate unbound concentration in plasma (~10% of total concentration) Vd: 11 L/1.73 m2 (total valproate); 92 L/1.73 m2 (free valproate)

                Metabolism

                Divalproex sodium dissociates to the valproate ion in the GI tract

                Valproate metabolized in liver by glucuronidation (30-50%) and mitochondrial beta-oxidation (40%) <15-20% is eliminated by other oxidative mechanisms

                Elimination

                Half-life: 9-16 hr (dose dependent)

                Total body clearance: 0.56 L/hr/1.73 m2 (total valproate); 4.6 L/hr/1.73 m2 (free valproate)

                Excretion: <3% excreted unchanged in urine

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                Images

                BRAND FORM. UNIT PRICE PILL IMAGE
                divalproex oral
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                250 mg tablet
                divalproex oral
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                250 mg tablet
                divalproex oral
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                500 mg tablet
                divalproex oral
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                500 mg tablet
                divalproex oral
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                250 mg tablet
                divalproex oral
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                125 mg capsule
                divalproex oral
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                500 mg tablet
                divalproex oral
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                250 mg tablet
                divalproex oral
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                250 mg tablet
                divalproex oral
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                500 mg tablet
                divalproex oral
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                500 mg tablet
                divalproex oral
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                250 mg tablet
                divalproex oral
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                125 mg tablet
                divalproex oral
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                125 mg capsule
                divalproex oral
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                500 mg tablet
                divalproex oral
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                250 mg tablet
                divalproex oral
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                250 mg tablet
                divalproex oral
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                500 mg tablet
                divalproex oral
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                250 mg tablet
                divalproex oral
                -
                125 mg capsule
                divalproex oral
                -
                500 mg tablet
                divalproex oral
                -
                125 mg capsule
                divalproex oral
                -
                500 mg tablet
                divalproex oral
                -
                500 mg tablet
                divalproex oral
                -
                250 mg tablet
                divalproex oral
                -
                125 mg tablet
                divalproex oral
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                500 mg tablet
                divalproex oral
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                250 mg tablet
                divalproex oral
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                500 mg tablet
                divalproex oral
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                500 mg tablet
                divalproex oral
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                250 mg tablet
                divalproex oral
                -
                125 mg tablet
                divalproex oral
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                125 mg tablet
                Depakote Sprinkles oral
                -
                125 mg capsule
                Depakote ER oral
                -
                250 mg tablet
                Depakote ER oral
                -
                500 mg tablet
                Depakote oral
                -
                125 mg tablet
                Depakote oral
                -
                250 mg tablet
                Depakote oral
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                500 mg tablet

                Copyright © 2010 First DataBank, Inc.

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                Patient Handout

                Patient Education
                divalproex oral

                DIVALPROEX SODIUM EXTENDED-RELEASE - ORAL

                (dye-VAL-pro-ex)

                COMMON BRAND NAME(S): Depakote ER

                WARNING: Rarely, this medication has caused serious (sometimes fatal) liver problems, usually within the first 6 months of starting treatment. Laboratory tests should be performed before you start treatment and periodically during treatment, especially within the first 6 months, to monitor this side effect.The risk of serious liver problems is increased in children younger than 2 years, especially if they have an inherited metabolic disorder, severe seizure disorder with mental retardation, organic brain disease, or if they take more than one seizure medication. Talk with the doctor about the risks and benefits of using this medication in children younger than 2 years.Due to an increased risk for liver problems, people with certain inherited metabolic disorders (such as Alpers-Huttenlocher syndrome) should not use this medication. Children younger than 2 years who might have these disorders should not use this medication. Children older than 2 years who might have these disorders should be closely monitored during treatment with divalproex sodium. Talk to your doctor for details.This medication has rarely caused severe (sometimes fatal) disease of the pancreas (pancreatitis). This may occur at any time during treatment and can quickly worsen.Tell your doctor right away if you develop symptoms of liver problems or pancreatitis such as unusual tiredness, weakness, swelling of the face, stomach/abdominal pain, loss of appetite, dark urine, yellowing eyes/skin, or persistent nausea/vomiting.Taking this medication during pregnancy can cause birth defects, may lower your child's IQ, and may increase the risk of your child having certain brain/mental disorders (such as autism, attention deficit/hyperactivity disorder). Women of childbearing age should discuss the risks and benefits of this medication, other treatment options, and use of reliable forms of birth control with their doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately talk to your doctor. If you are taking divalproex sodium only to prevent migraine headaches, this medication must not be used during pregnancy. If you are taking divalproex sodium to treat seizures or mental/mood problems (such as bipolar disorder), do not stop taking this medication unless directed by your doctor. Untreated seizures and mental/mood problems (such as bipolar disorder) are serious conditions that can harm both a pregnant woman and her unborn baby.

                USES: This medication is used to treat seizure disorders, mental/mood conditions (such as manic phase of bipolar disorder), and to prevent migraine headaches. It works by restoring the balance of certain natural substances (neurotransmitters) in the brain.

                HOW TO USE: Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start taking divalproex sodium and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth once daily or as directed by your doctor. You may take it with food if stomach upset occurs. Do not crush or chew extended-release tablets. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.The dosage is based on your age, weight, medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day to keep the amount of medication in your blood constant.If this medication is used for seizures, do not stop taking it without consulting your doctor. Your condition may become worse if the drug is suddenly stopped. Your dose may need to be gradually decreased.Divalproex sodium does not relieve acute migraine headaches. Take other medications as directed by your doctor for acute attacks.Inform your doctor if your condition does not improve.

                SIDE EFFECTS: See also Warning section.Diarrhea, dizziness, drowsiness, hair loss, blurred/double vision, change in menstrual periods, ringing in the ears, shakiness (tremor), unsteadiness, weight changes may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.A small number of people who take anticonvulsants for any condition (such as seizure, bipolar disorder, pain) may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor right away if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.Severe (sometimes fatal) brain disorder (encephalopathy) has rarely occurred, particularly in patients with certain metabolic disorders (urea cycle disorders). Tell your doctor right away if you develop unexplained weakness, vomiting, or sudden mental/mood changes (such as confusion).Get medical help right away if you have any very serious side effects, including: chest pain, easy bruising/unexplained bleeding, fast/slow/irregular heartbeat, swelling of hands/feet, uncontrolled eye movement (nystagmus), feeling cold/shivering, rapid breathing, loss of consciousness.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: fever, swollen lymph nodes, rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

                PRECAUTIONS: See also Warning section.Before taking divalproex sodium, tell your doctor or pharmacist if you are allergic to it; or to valproic acid or valproate sodium; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, pancreatitis, certain metabolic disorders (such as urea cycle disorders, Alpers-Huttenlocher syndrome), alcohol abuse, bleeding problems, brain disease (dementia), kidney disease, dehydration, poor nutrition.To lower the chance of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).This drug may make you dizzy or drowsy or blur your vision. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Children younger than 6 years may be at greater risk for liver problems and pancreatitis.Older adults may be more sensitive to the side effects of this drug, especially drowsiness, dizziness, unsteadiness, or tremor. Drowsiness, dizziness, unsteadiness can increase the risk of falling.This medication is not recommended for use during pregnancy. It may harm an unborn baby. See also Warning section.This medication passes into breast milk. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.

                DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: certain antidepressants (e.g., amitriptyline, nortriptyline, phenelzine), certain antibiotics (carbapenems such as doripenem, imipenem), irinotecan, mefloquine, orlistat, other medications for seizure (e.g., ethosuximide, lamotrigine, phenytoin, rufinamide, topiramate), rifampin, vorinostat, warfarin, zidovudine.Low-dose aspirin, as prescribed by your doctor for specific medical reasons such as heart attack or stroke prevention (usually 81-162 milligrams a day), should be continued. Consult your doctor or pharmacist if you are using aspirin for any reason.Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, marijuana (cannabis), antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), and opioid pain relievers (such as codeine, hydrocodone).Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.This drug may affect certain lab tests (e.g., urine ketones). Make sure laboratory personnel and your doctors know you use this medication.

                OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: excessive drowsiness, coma, irregular/slow heartbeat.

                NOTES: Do not share this medication with others.Laboratory and/or medical tests (such as drug levels, liver function tests, complete blood counts, clotting tests) should be performed before you start treatment, periodically to monitor your progress, or to check for side effects. Consult your doctor for more details.

                MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

                STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

                MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

                Information last revised April 2021. Copyright(c) 2021 First Databank, Inc.

                IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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                Formulary

                FormularyPatient Discounts

                Adding plans allows you to compare formulary status to other drugs in the same class.

                To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

                Adding plans allows you to:

                • View the formulary and any restrictions for each plan.
                • Manage and view all your plans together – even plans in different states.
                • Compare formulary status to other drugs in the same class.
                • Access your plan list on any device – mobile or desktop.

                The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                Tier Description
                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                NC NOT COVERED – Drugs that are not covered by the plan.
                Code Definition
                PA Prior Authorization
                Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                QL Quantity Limits
                Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                ST Step Therapy
                Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                OR Other Restrictions
                Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.