serdexmethylphenidate/dexmethylphenidate (Rx)

Brand and Other Names:Azstarys
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

serdexmethylphenidate/dexmethylphenidate

capsule: Schedule II

  • 26.1mg/5.2mg
  • 39.2mg/7.8mg
  • 52.3mg/10.4mg
  • Dexmethylphenidate is a Schedule II controlled substance; controlled substance schedule pending for serdexmethylphenidate

Attention Deficit Hyperactivity Disorder

Indicated for attention-deficit hyperactivity disorder (ADHD)

Initial: 39.2 mg/7.8 mg PO qAM

After 1 week: Increase to 52.3 mg/10.4 mg PO qAM

Not to exceed 52.3 mg/10.4 mg PO qAM

Dosage Modifications

Renal impairment

  • No experience with use in renal impairment
  • Since renal clearance is not an important route of serdexmethylphenidate or methylphenidate elimination, renal impairment is expected to have little effect on the pharmacokinetics

Hepatic impairment

  • No experience with use in hepatic impairment

Dosing Considerations

Pretreatment screening

  • Assess for presence of cardiac disease by performing careful history, family history of sudden death or ventricular arrhythmia, and physical examination
  • Assess risk for abuse and dependence before prescribing and while on therapy; maintain careful prescription records, educate patients about abuse, monitor for signs of abuse and overdose, and periodically reevaluate need for long-term use
  • Screen for preexisting psychosis (eg, behavior disturbance, thought disorder, manic or mixed mood disorder)

Dosage Forms & Strengths

serdexmethylphenidate/dexmethylphenidate

capsule: Schedule II

  • 26.1mg/5.2mg
  • 39.2mg/7.8mg
  • 52.3mg/10.4mg
  • Dexmethylphenidate is a Schedule II controlled substance; controlled substance schedule pending for serdexmethylphenidate

Attention Deficit Hyperactivity Disorder

Indicated for attention-deficit hyperactivity disorder (ADHD) in patients aged ≥6 years

<6 years: Safety and efficacy not established

6-12 years

  • Initial: 39.2 mg/7.8 mg PO qAM
  • After 1 week: May increase to 52.3 mg/10.4 mg PO qAM OR decrease to 26.1 mg/5.2 PO qAM, depending on response and tolerability
  • Not to exceed 52.3 mg/10.4 mg PO qAM

13-17 years

  • Initial: 39.2 mg/7.8 mg PO qAM
  • After 1 week: Increase to 52.3 mg/10.4 mg PO qAM
  • Not to exceed 52.3 mg/10.4 mg PO qAM

Dosage Modifications

Renal impairment

  • No experience with use in renal impairment
  • Since renal clearance is not an important route of serdexmethylphenidate or methylphenidate elimination, renal impairment is expected to have little effect on the pharmacokinetics

Hepatic impairment

  • No experience with use in hepatic impairment

Dosing Considerations

Pretreatment screening

  • Assess for presence of cardiac disease by performing careful history, family history of sudden death or ventricular arrhythmia, and physical examination
  • Assess risk for abuse and dependence before prescribing and while on therapy; maintain careful prescription records, educate patients about abuse, monitor for signs of abuse and overdose, and periodically reevaluate need for long-term use
  • Screen for preexisting psychosis (eg, behavior disturbance, thought disorder, manic or mixed mood disorder)
Next:

Interactions

Interaction Checker

and serdexmethylphenidate/dexmethylphenidate

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      Serious - Use Alternative

        Significant - Monitor Closely

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            Contraindicated (10)

            • iobenguane I 123

              serdexmethylphenidate/dexmethylphenidate decreases effects of iobenguane I 123 by receptor binding competition. Contraindicated. If clinically appropriate, discontinue drugs that compete for NE receptor sites for at least 5 half-lives; may cause false-negative imaging results.

            • isocarboxazid

              isocarboxazid increases effects of serdexmethylphenidate/dexmethylphenidate by pharmacodynamic synergism. Contraindicated. Risk of acute hypertensive episode.

            • linezolid

              linezolid increases effects of serdexmethylphenidate/dexmethylphenidate by pharmacodynamic synergism. Contraindicated. Risk of acute hypertensive episode.

            • phenelzine

              phenelzine increases effects of serdexmethylphenidate/dexmethylphenidate by pharmacodynamic synergism. Contraindicated. Risk of acute hypertensive episode.

            • procarbazine

              procarbazine increases effects of serdexmethylphenidate/dexmethylphenidate by pharmacodynamic synergism. Contraindicated. Risk of acute hypertensive episode.

            • rasagiline

              rasagiline increases effects of serdexmethylphenidate/dexmethylphenidate by pharmacodynamic synergism. Contraindicated. Risk of acute hypertensive episode. Dexmethylphenidate use is contraindicated during treatment with MAOIs and also within a minimum of 14 days following discontinuation of treatment with an MAOI.

            • safinamide

              serdexmethylphenidate/dexmethylphenidate, safinamide. Either increases toxicity of the other by serotonin levels. Contraindicated. Concomitant use could result in life-threatening serotonin syndrome.

            • selegiline

              selegiline increases effects of serdexmethylphenidate/dexmethylphenidate by pharmacodynamic synergism. Contraindicated. Risk of acute hypertensive episode. Dexmethylphenidate use is contraindicated during treatment with MAOIs and also within a minimum of 14 days following discontinuation of treatment with an MAOI.

            • selegiline transdermal

              selegiline transdermal increases effects of serdexmethylphenidate/dexmethylphenidate by pharmacodynamic synergism. Contraindicated. Risk of acute hypertensive episode.

            • tranylcypromine

              tranylcypromine increases effects of serdexmethylphenidate/dexmethylphenidate by pharmacodynamic synergism. Contraindicated. Risk of acute hypertensive episode.

            Serious - Use Alternative (32)

            • amitriptyline

              amitriptyline, serdexmethylphenidate/dexmethylphenidate. Other (see comment). Avoid or Use Alternate Drug. Comment: Tricyclic antidepressants increase or decrease effects of sympathomimetics, by blocking reuptake of NE, or blocking uptake of indirect sympathomimetics into the adrenergic neuron.

            • amoxapine

              amoxapine, serdexmethylphenidate/dexmethylphenidate. Other (see comment). Avoid or Use Alternate Drug. Comment: Tricyclic antidepressants increase or decrease effects of sympathomimetics, by blocking reuptake of NE, or blocking uptake of indirect sympathomimetics into the adrenergic neuron.

            • benzhydrocodone/acetaminophen

              benzhydrocodone/acetaminophen, serdexmethylphenidate/dexmethylphenidate. Either increases toxicity of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Profound sedation, respiratory depression, coma, and death may result if coadministered. Reserve concomitant prescribing of these drugs in patients for whom other treatment options are inadequate. Limit dosages and durations to the minimum required. Monitor closely for signs of respiratory depression and sedation.

            • bromocriptine

              bromocriptine, serdexmethylphenidate/dexmethylphenidate. Mechanism: pharmacodynamic synergism. Contraindicated. Additive vasospasm; risk of hypertension.

            • cabergoline

              cabergoline, serdexmethylphenidate/dexmethylphenidate. Mechanism: pharmacodynamic synergism. Contraindicated. Additive vasospasm; risk of hypertension.

            • clomipramine

              clomipramine, serdexmethylphenidate/dexmethylphenidate. Other (see comment). Avoid or Use Alternate Drug. Comment: Tricyclic antidepressants increase or decrease effects of sympathomimetics, by blocking reuptake of NE, or blocking uptake of indirect sympathomimetics into the adrenergic neuron.

            • desflurane

              desflurane increases toxicity of serdexmethylphenidate/dexmethylphenidate by Mechanism: unknown. Avoid or Use Alternate Drug. Risk of V tach, HTN.

            • desipramine

              desipramine, serdexmethylphenidate/dexmethylphenidate. Other (see comment). Avoid or Use Alternate Drug. Comment: Tricyclic antidepressants increase or decrease effects of sympathomimetics, by blocking reuptake of NE, or blocking uptake of indirect sympathomimetics into the adrenergic neuron.

            • dihydroergotamine

              dihydroergotamine, serdexmethylphenidate/dexmethylphenidate. Mechanism: pharmacodynamic synergism. Contraindicated. Additive vasospasm; risk of hypertension.

            • dihydroergotamine intranasal

              dihydroergotamine intranasal, serdexmethylphenidate/dexmethylphenidate. Mechanism: pharmacodynamic synergism. Contraindicated. Additive vasospasm; risk of hypertension.

            • dosulepin

              dosulepin, serdexmethylphenidate/dexmethylphenidate. Other (see comment). Avoid or Use Alternate Drug. Comment: Tricyclic antidepressants increase or decrease effects of sympathomimetics, by blocking reuptake of NE, or blocking uptake of indirect sympathomimetics into the adrenergic neuron.

            • doxapram

              doxapram increases effects of serdexmethylphenidate/dexmethylphenidate by pharmacodynamic synergism. Avoid or Use Alternate Drug. Additive pressor effect.

            • doxepin

              doxepin, serdexmethylphenidate/dexmethylphenidate. Other (see comment). Avoid or Use Alternate Drug. Comment: Tricyclic antidepressants increase or decrease effects of sympathomimetics, by blocking reuptake of NE, or blocking uptake of indirect sympathomimetics into the adrenergic neuron.

            • enflurane

              enflurane increases toxicity of serdexmethylphenidate/dexmethylphenidate by Mechanism: unknown. Avoid or Use Alternate Drug. Avoid use of serdexymethylphenidate/dexmethylphenidate in patients being treated with anesthetics on day of surgery.

            • ergoloid mesylates

              ergoloid mesylates, serdexmethylphenidate/dexmethylphenidate. Mechanism: pharmacodynamic synergism. Contraindicated. Additive vasospasm; risk of hypertension.

            • ergotamine

              ergotamine, serdexmethylphenidate/dexmethylphenidate. Mechanism: pharmacodynamic synergism. Contraindicated. Additive vasospasm; risk of hypertension.

            • ether

              ether increases toxicity of serdexmethylphenidate/dexmethylphenidate by Mechanism: unknown. Avoid or Use Alternate Drug. Risk of V tach, HTN.

            • imipramine

              imipramine, serdexmethylphenidate/dexmethylphenidate. Other (see comment). Avoid or Use Alternate Drug. Comment: Tricyclic antidepressants increase or decrease effects of sympathomimetics, by blocking reuptake of NE, or blocking uptake of indirect sympathomimetics into the adrenergic neuron.

            • iobenguane I 131

              serdexmethylphenidate/dexmethylphenidate will decrease the level or effect of iobenguane I 131 by Other (see comment). Avoid or Use Alternate Drug. Based on the mechanism of action of iobenguane, drugs that reduce catecholamine uptake or that deplete catecholamine stores may interfere with iobenguane uptake into cells, and thus, reduce iobenguane efficacy. Discontinue interfering drugs for at least 5 half-lives before administration of either the dosimetry or an iobenguane dose. Do not administer these drugs until at least 7 days after each iobenguane dose.

            • isoflurane

              isoflurane increases toxicity of serdexmethylphenidate/dexmethylphenidate by Mechanism: unknown. Avoid or Use Alternate Drug. Risk of V tach, HTN.

            • levomilnacipran

              serdexmethylphenidate/dexmethylphenidate and levomilnacipran both increase serotonin levels. Avoid or Use Alternate Drug.

            • lofepramine

              lofepramine, serdexmethylphenidate/dexmethylphenidate. Other (see comment). Avoid or Use Alternate Drug. Comment: Tricyclic antidepressants increase or decrease effects of sympathomimetics, by blocking reuptake of NE, or blocking uptake of indirect sympathomimetics into the adrenergic neuron.

            • maprotiline

              maprotiline, serdexmethylphenidate/dexmethylphenidate. Other (see comment). Avoid or Use Alternate Drug. Comment: Tricyclic antidepressants increase or decrease effects of sympathomimetics, by blocking reuptake of NE, or blocking uptake of indirect sympathomimetics into the adrenergic neuron.

            • methoxyflurane

              methoxyflurane increases toxicity of serdexmethylphenidate/dexmethylphenidate by Mechanism: unknown. Avoid or Use Alternate Drug. Risk of V tach, HTN.

            • methylergonovine

              methylergonovine, serdexmethylphenidate/dexmethylphenidate. Mechanism: pharmacodynamic synergism. Contraindicated. Additive vasospasm; risk of hypertension.

            • nortriptyline

              nortriptyline, serdexmethylphenidate/dexmethylphenidate. Other (see comment). Avoid or Use Alternate Drug. Comment: Tricyclic antidepressants increase or decrease effects of sympathomimetics, by blocking reuptake of NE, or blocking uptake of indirect sympathomimetics into the adrenergic neuron.

            • ozanimod

              ozanimod increases toxicity of serdexmethylphenidate/dexmethylphenidate by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Avoid or Use Alternate Drug. Because the active metabolite of ozanimod inhibits MAO-B in vitro, there is a potential for serious adverse reactions, including hypertensive crisis. Therefore, coadministration of ozanimod with drugs that can increase norepinephrine or serotonin is not recommended. Monitor for hypertension with concomitant use.

            • protriptyline

              protriptyline, serdexmethylphenidate/dexmethylphenidate. Other (see comment). Avoid or Use Alternate Drug. Comment: Tricyclic antidepressants increase or decrease effects of sympathomimetics, by blocking reuptake of NE, or blocking uptake of indirect sympathomimetics into the adrenergic neuron.

            • sevoflurane

              sevoflurane increases toxicity of serdexmethylphenidate/dexmethylphenidate by Mechanism: unknown. Avoid or Use Alternate Drug. Risk of V tach, HTN.

            • trazodone

              trazodone, serdexmethylphenidate/dexmethylphenidate. Other (see comment). Avoid or Use Alternate Drug. Comment: Tricyclic antidepressants increase or decrease effects of sympathomimetics, by blocking reuptake of NE, or blocking uptake of indirect sympathomimetics into the adrenergic neuron.

            • trimipramine

              trimipramine, serdexmethylphenidate/dexmethylphenidate. Other (see comment). Avoid or Use Alternate Drug. Comment: Tricyclic antidepressants increase or decrease effects of sympathomimetics, by blocking reuptake of NE, or blocking uptake of indirect sympathomimetics into the adrenergic neuron.

            • yohimbe

              yohimbe, serdexmethylphenidate/dexmethylphenidate. Mechanism: pharmacodynamic synergism. Contraindicated. Risk of acute hypertensive episode.

            Monitor Closely (65)

            • albuterol

              albuterol and serdexmethylphenidate/dexmethylphenidate both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

            • arformoterol

              arformoterol and serdexmethylphenidate/dexmethylphenidate both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

            • bambuterol

              bambuterol and serdexmethylphenidate/dexmethylphenidate both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

            • benzphetamine

              serdexmethylphenidate/dexmethylphenidate and benzphetamine both decrease sedation. Use Caution/Monitor.

              benzphetamine and serdexmethylphenidate/dexmethylphenidate both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

            • bromocriptine

              bromocriptine, serdexmethylphenidate/dexmethylphenidate. Either increases effects of the other by pharmacodynamic synergism. Use Caution/Monitor. Hypertension, V tach.

            • buprenorphine subdermal implant

              serdexmethylphenidate/dexmethylphenidate, buprenorphine subdermal implant. Either increases toxicity of the other by serotonin levels. Use Caution/Monitor. Concomitant use could result in life-threatening serotonin syndrome. If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation, and during dose adjustment of the serotonergic drug. Discontinue buprenorphine if serotonin syndrome is suspected.

            • buprenorphine, long-acting injection

              serdexmethylphenidate/dexmethylphenidate, buprenorphine, long-acting injection. Either increases toxicity of the other by serotonin levels. Use Caution/Monitor. Concomitant use could result in life-threatening serotonin syndrome. If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation, and during dose adjustment of the serotonergic drug. Discontinue buprenorphine if serotonin syndrome is suspected.

            • captopril

              serdexmethylphenidate/dexmethylphenidate decreases effects of captopril by pharmacodynamic antagonism. Use Caution/Monitor. Methylphenidate may diminish antihypertensive effect of captopril.

            • chlorpromazine

              chlorpromazine, serdexmethylphenidate/dexmethylphenidate. Mechanism: unknown. Use Caution/Monitor. Risk of cardiac arrhythmia or sudden death, more likely w/thioridazine than other phenothiazines. Interaction more likely in certain predisposed pts. only.

            • cimetidine

              cimetidine will increase the level or effect of serdexmethylphenidate/dexmethylphenidate by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Applies only to extended release formulation

            • citalopram

              serdexmethylphenidate/dexmethylphenidate increases effects of citalopram by decreasing metabolism. Use Caution/Monitor. Potential risk for serotonin syndrome or neuroleptic malignant syndrome-like reactions, caution should be observed during coadministration.

            • clonidine

              serdexmethylphenidate/dexmethylphenidate increases toxicity of clonidine by unknown mechanism. Use Caution/Monitor.

            • dexfenfluramine

              serdexmethylphenidate/dexmethylphenidate and dexfenfluramine both decrease sedation. Use Caution/Monitor.

              dexfenfluramine and serdexmethylphenidate/dexmethylphenidate both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

            • dextroamphetamine

              serdexmethylphenidate/dexmethylphenidate and dextroamphetamine both decrease sedation. Use Caution/Monitor.

              serdexmethylphenidate/dexmethylphenidate and dextroamphetamine both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

            • diethylpropion

              serdexmethylphenidate/dexmethylphenidate and diethylpropion both decrease sedation. Use Caution/Monitor.

              serdexmethylphenidate/dexmethylphenidate and diethylpropion both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

            • dobutamine

              dobutamine and serdexmethylphenidate/dexmethylphenidate both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

            • dopamine

              serdexmethylphenidate/dexmethylphenidate and dopamine both decrease sedation. Use Caution/Monitor.

              serdexmethylphenidate/dexmethylphenidate and dopamine both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

            • dopexamine

              dopexamine and serdexmethylphenidate/dexmethylphenidate both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

            • droxidopa

              serdexmethylphenidate/dexmethylphenidate and droxidopa both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. May increase risk for supine hypertension

            • ephedrine

              ephedrine and serdexmethylphenidate/dexmethylphenidate both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

            • ephedrine (pulmonary)

              ephedrine (pulmonary) and serdexmethylphenidate/dexmethylphenidate both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

            • epinephrine

              epinephrine and serdexmethylphenidate/dexmethylphenidate both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

            • epinephrine inhaled

              serdexmethylphenidate/dexmethylphenidate, epinephrine inhaled. Either increases effects of the other by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

            • epinephrine racemic

              epinephrine racemic and serdexmethylphenidate/dexmethylphenidate both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

            • escitalopram

              serdexmethylphenidate/dexmethylphenidate increases effects of escitalopram by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • esketamine intranasal

              esketamine intranasal, serdexmethylphenidate/dexmethylphenidate. Either increases toxicity of the other by sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor. Closely monitor blood pressure with concomitant use of esketamine nasal with stimulants. .

            • eslicarbazepine acetate

              serdexmethylphenidate/dexmethylphenidate increases effects of eslicarbazepine acetate by decreasing metabolism. Use Caution/Monitor.

            • famotidine

              famotidine will increase the level or effect of serdexmethylphenidate/dexmethylphenidate by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Applies only to extended release formulation

            • fenfluramine

              serdexmethylphenidate/dexmethylphenidate and fenfluramine both decrease sedation. Use Caution/Monitor.

              serdexmethylphenidate/dexmethylphenidate and fenfluramine both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

            • fluphenazine

              fluphenazine, serdexmethylphenidate/dexmethylphenidate. Mechanism: unknown. Use Caution/Monitor. Risk of cardiac arrhythmia or sudden death, more likely w/thioridazine than other phenothiazines. Interaction more likely in certain predisposed pts. only.

            • formoterol

              formoterol and serdexmethylphenidate/dexmethylphenidate both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

            • hydralazine

              hydralazine, serdexmethylphenidate/dexmethylphenidate. Mechanism: pharmacodynamic antagonism. Use Caution/Monitor. Sympathomimetics can antagonize the activity of some antihypertensive agents.

              hydralazine, serdexmethylphenidate/dexmethylphenidate. Mechanism: pharmacodynamic synergism. Use Caution/Monitor. Risk of hypertension.

            • ibuprofen/famotidine

              ibuprofen/famotidine will increase the level or effect of serdexmethylphenidate/dexmethylphenidate by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Applies only to extended release formulation

            • isavuconazonium sulfate

              serdexmethylphenidate/dexmethylphenidate will increase the level or effect of isavuconazonium sulfate by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • isoproterenol

              isoproterenol and serdexmethylphenidate/dexmethylphenidate both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

            • levalbuterol

              levalbuterol and serdexmethylphenidate/dexmethylphenidate both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

            • lisdexamfetamine

              serdexmethylphenidate/dexmethylphenidate and lisdexamfetamine both decrease sedation. Use Caution/Monitor.

              serdexmethylphenidate/dexmethylphenidate and lisdexamfetamine both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

            • metaproterenol

              metaproterenol and serdexmethylphenidate/dexmethylphenidate both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

            • methamphetamine

              serdexmethylphenidate/dexmethylphenidate and methamphetamine both decrease sedation. Use Caution/Monitor.

              serdexmethylphenidate/dexmethylphenidate and methamphetamine both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

            • methyldopa

              methyldopa increases effects of serdexmethylphenidate/dexmethylphenidate by unknown mechanism. Use Caution/Monitor.

            • methylenedioxymethamphetamine

              serdexmethylphenidate/dexmethylphenidate and methylenedioxymethamphetamine both decrease sedation. Use Caution/Monitor.

              serdexmethylphenidate/dexmethylphenidate and methylenedioxymethamphetamine both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

            • methylphenidate

              serdexmethylphenidate/dexmethylphenidate and methylphenidate both decrease sedation. Use Caution/Monitor.

              serdexmethylphenidate/dexmethylphenidate and methylphenidate both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

              serdexmethylphenidate/dexmethylphenidate increases effects of methylphenidate by pharmacodynamic synergism. Use Caution/Monitor. Risk of acute hypertensive episode.

            • midodrine

              serdexmethylphenidate/dexmethylphenidate and midodrine both decrease sedation. Use Caution/Monitor.

              serdexmethylphenidate/dexmethylphenidate and midodrine both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

            • modafinil

              serdexmethylphenidate/dexmethylphenidate and modafinil both decrease sedation. Use Caution/Monitor.

            • norepinephrine

              norepinephrine and serdexmethylphenidate/dexmethylphenidate both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

            • oxytocin

              oxytocin increases effects of serdexmethylphenidate/dexmethylphenidate by pharmacodynamic synergism. Use Caution/Monitor.

            • perphenazine

              perphenazine, serdexmethylphenidate/dexmethylphenidate. Mechanism: unknown. Use Caution/Monitor. Risk of cardiac arrhythmia or sudden death, more likely w/thioridazine than other phenothiazines. Interaction more likely in certain predisposed pts. only.

            • phendimetrazine

              serdexmethylphenidate/dexmethylphenidate and phendimetrazine both decrease sedation. Use Caution/Monitor.

              serdexmethylphenidate/dexmethylphenidate and phendimetrazine both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

            • phentermine

              serdexmethylphenidate/dexmethylphenidate and phentermine both decrease sedation. Use Caution/Monitor.

              serdexmethylphenidate/dexmethylphenidate and phentermine both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

            • phenylephrine

              serdexmethylphenidate/dexmethylphenidate and phenylephrine both decrease sedation. Use Caution/Monitor.

              serdexmethylphenidate/dexmethylphenidate and phenylephrine both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

            • phenylephrine PO

              serdexmethylphenidate/dexmethylphenidate and phenylephrine PO both decrease sedation. Use Caution/Monitor.

              serdexmethylphenidate/dexmethylphenidate and phenylephrine PO both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

            • pirbuterol

              pirbuterol and serdexmethylphenidate/dexmethylphenidate both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

            • prochlorperazine

              prochlorperazine, serdexmethylphenidate/dexmethylphenidate. Mechanism: unknown. Use Caution/Monitor. Risk of cardiac arrhythmia or sudden death, more likely w/thioridazine than other phenothiazines. Interaction more likely in certain predisposed pts. only.

            • promazine

              promazine, serdexmethylphenidate/dexmethylphenidate. Mechanism: unknown. Use Caution/Monitor. Risk of cardiac arrhythmia or sudden death, more likely w/thioridazine than other phenothiazines. Interaction more likely in certain predisposed pts. only.

            • promethazine

              promethazine, serdexmethylphenidate/dexmethylphenidate. Mechanism: unknown. Use Caution/Monitor. Risk of cardiac arrhythmia or sudden death, more likely w/thioridazine than other phenothiazines. Interaction more likely in certain predisposed pts. only.

            • propylhexedrine

              serdexmethylphenidate/dexmethylphenidate and propylhexedrine both decrease sedation. Use Caution/Monitor.

              serdexmethylphenidate/dexmethylphenidate and propylhexedrine both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

            • pseudoephedrine

              serdexmethylphenidate/dexmethylphenidate and pseudoephedrine both decrease sedation. Use Caution/Monitor.

              serdexmethylphenidate/dexmethylphenidate and pseudoephedrine both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

            • salmeterol

              salmeterol and serdexmethylphenidate/dexmethylphenidate both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

            • sodium zirconium cyclosilicate

              sodium zirconium cyclosilicate will increase the level or effect of serdexmethylphenidate/dexmethylphenidate by increasing gastric pH. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Check specific recommendations for drugs that exhibit pH-dependent solubility that may affect their systemic exposure and efficacy. In general, administer drugs at least 2 hr before or after sodium zirconium cyclosilicate. Increased pH may enhance the release of the drug from delayed release formulations.

            • solriamfetol

              serdexmethylphenidate/dexmethylphenidate and solriamfetol both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

            • terbutaline

              terbutaline and serdexmethylphenidate/dexmethylphenidate both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

            • thioridazine

              thioridazine, serdexmethylphenidate/dexmethylphenidate. Mechanism: unknown. Use Caution/Monitor. Risk of cardiac arrhythmia or sudden death, more likely w/thioridazine than other phenothiazines. Interaction more likely in certain predisposed pts. only.

            • trifluoperazine

              trifluoperazine, serdexmethylphenidate/dexmethylphenidate. Mechanism: unknown. Use Caution/Monitor. Risk of cardiac arrhythmia or sudden death, more likely w/thioridazine than other phenothiazines. Interaction more likely in certain predisposed pts. only.

            • xylometazoline

              serdexmethylphenidate/dexmethylphenidate and xylometazoline both decrease sedation. Use Caution/Monitor.

              serdexmethylphenidate/dexmethylphenidate and xylometazoline both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

            • yohimbine

              serdexmethylphenidate/dexmethylphenidate and yohimbine both decrease sedation. Use Caution/Monitor.

              serdexmethylphenidate/dexmethylphenidate and yohimbine both increase sympathetic (adrenergic) effects, including increased blood pressure and heart rate. Use Caution/Monitor.

            Minor (65)

            • acetazolamide

              serdexmethylphenidate/dexmethylphenidate increases effects of acetazolamide by decreasing metabolism. Minor/Significance Unknown.

            • amantadine

              amantadine, serdexmethylphenidate/dexmethylphenidate. Either increases effects of the other by pharmacodynamic synergism. Minor/Significance Unknown. Potential for additive CNS stimulation.

            • American ginseng

              American ginseng increases effects of serdexmethylphenidate/dexmethylphenidate by pharmacodynamic synergism. Minor/Significance Unknown.

            • amitriptyline

              serdexmethylphenidate/dexmethylphenidate increases effects of amitriptyline by decreasing metabolism. Minor/Significance Unknown.

            • amoxapine

              serdexmethylphenidate/dexmethylphenidate increases effects of amoxapine by decreasing metabolism. Minor/Significance Unknown.

            • antithrombin alfa

              serdexmethylphenidate/dexmethylphenidate increases effects of antithrombin alfa by decreasing metabolism. Minor/Significance Unknown.

            • antithrombin III

              serdexmethylphenidate/dexmethylphenidate increases effects of antithrombin III by decreasing metabolism. Minor/Significance Unknown.

            • argatroban

              serdexmethylphenidate/dexmethylphenidate increases effects of argatroban by decreasing metabolism. Minor/Significance Unknown.

            • bemiparin

              serdexmethylphenidate/dexmethylphenidate increases effects of bemiparin by decreasing metabolism. Minor/Significance Unknown.

            • bivalirudin

              serdexmethylphenidate/dexmethylphenidate increases effects of bivalirudin by decreasing metabolism. Minor/Significance Unknown.

            • carbamazepine

              serdexmethylphenidate/dexmethylphenidate increases effects of carbamazepine by decreasing metabolism. Minor/Significance Unknown.

            • clomipramine

              serdexmethylphenidate/dexmethylphenidate increases effects of clomipramine by decreasing metabolism. Minor/Significance Unknown.

            • clonazepam

              serdexmethylphenidate/dexmethylphenidate increases effects of clonazepam by decreasing metabolism. Minor/Significance Unknown.

            • dalteparin

              serdexmethylphenidate/dexmethylphenidate increases effects of dalteparin by decreasing metabolism. Minor/Significance Unknown.

            • desipramine

              serdexmethylphenidate/dexmethylphenidate increases effects of desipramine by decreasing metabolism. Minor/Significance Unknown.

            • desmopressin

              desmopressin increases effects of serdexmethylphenidate/dexmethylphenidate by pharmacodynamic synergism. Minor/Significance Unknown.

            • diazepam

              serdexmethylphenidate/dexmethylphenidate increases effects of diazepam by decreasing metabolism. Minor/Significance Unknown.

            • dosulepin

              serdexmethylphenidate/dexmethylphenidate increases effects of dosulepin by decreasing metabolism. Minor/Significance Unknown.

            • doxepin

              serdexmethylphenidate/dexmethylphenidate increases effects of doxepin by decreasing metabolism. Minor/Significance Unknown.

            • duloxetine

              serdexmethylphenidate/dexmethylphenidate increases effects of duloxetine by decreasing metabolism. Minor/Significance Unknown.

            • enoxaparin

              serdexmethylphenidate/dexmethylphenidate increases effects of enoxaparin by decreasing metabolism. Minor/Significance Unknown.

            • escitalopram

              serdexmethylphenidate/dexmethylphenidate increases effects of escitalopram by decreasing metabolism. Minor/Significance Unknown.

            • ethosuximide

              serdexmethylphenidate/dexmethylphenidate increases effects of ethosuximide by decreasing metabolism. Minor/Significance Unknown.

            • felbamate

              serdexmethylphenidate/dexmethylphenidate increases effects of felbamate by decreasing metabolism. Minor/Significance Unknown.

            • fluoxetine

              serdexmethylphenidate/dexmethylphenidate increases effects of fluoxetine by decreasing metabolism. Minor/Significance Unknown.

            • fondaparinux

              serdexmethylphenidate/dexmethylphenidate increases effects of fondaparinux by decreasing metabolism. Minor/Significance Unknown.

            • fosphenytoin

              serdexmethylphenidate/dexmethylphenidate increases effects of fosphenytoin by decreasing metabolism. Minor/Significance Unknown.

            • gabapentin

              serdexmethylphenidate/dexmethylphenidate increases effects of gabapentin by decreasing metabolism. Minor/Significance Unknown.

            • gabapentin enacarbil

              serdexmethylphenidate/dexmethylphenidate increases effects of gabapentin enacarbil by decreasing metabolism. Minor/Significance Unknown.

            • guarana

              guarana increases effects of serdexmethylphenidate/dexmethylphenidate by pharmacodynamic synergism. Minor/Significance Unknown.

            • heparin

              serdexmethylphenidate/dexmethylphenidate increases effects of heparin by decreasing metabolism. Minor/Significance Unknown.

            • imipramine

              serdexmethylphenidate/dexmethylphenidate increases effects of imipramine by decreasing metabolism. Minor/Significance Unknown.

            • lacosamide

              serdexmethylphenidate/dexmethylphenidate increases effects of lacosamide by decreasing metabolism. Minor/Significance Unknown.

            • lamotrigine

              serdexmethylphenidate/dexmethylphenidate increases effects of lamotrigine by decreasing metabolism. Minor/Significance Unknown.

            • lepirudin

              serdexmethylphenidate/dexmethylphenidate increases effects of lepirudin by decreasing metabolism. Minor/Significance Unknown.

            • levetiracetam

              serdexmethylphenidate/dexmethylphenidate increases effects of levetiracetam by decreasing metabolism. Minor/Significance Unknown.

            • levomilnacipran

              serdexmethylphenidate/dexmethylphenidate increases effects of levomilnacipran by decreasing metabolism. Minor/Significance Unknown.

            • lofepramine

              serdexmethylphenidate/dexmethylphenidate increases effects of lofepramine by decreasing metabolism. Minor/Significance Unknown.

            • lorazepam

              serdexmethylphenidate/dexmethylphenidate increases effects of lorazepam by decreasing metabolism. Minor/Significance Unknown.

            • maprotiline

              serdexmethylphenidate/dexmethylphenidate increases effects of maprotiline by decreasing metabolism. Minor/Significance Unknown.

            • methsuximide

              serdexmethylphenidate/dexmethylphenidate increases effects of methsuximide by decreasing metabolism. Minor/Significance Unknown.

            • mianserin

              serdexmethylphenidate/dexmethylphenidate increases effects of mianserin by decreasing metabolism. Minor/Significance Unknown.

            • milnacipran

              serdexmethylphenidate/dexmethylphenidate increases effects of milnacipran by decreasing metabolism. Minor/Significance Unknown.

            • nefazodone

              serdexmethylphenidate/dexmethylphenidate increases effects of nefazodone by decreasing metabolism. Minor/Significance Unknown.

            • nortriptyline

              serdexmethylphenidate/dexmethylphenidate increases effects of nortriptyline by decreasing metabolism. Minor/Significance Unknown.

            • oxcarbazepine

              serdexmethylphenidate/dexmethylphenidate increases effects of oxcarbazepine by decreasing metabolism. Minor/Significance Unknown.

            • paroxetine

              serdexmethylphenidate/dexmethylphenidate increases effects of paroxetine by decreasing metabolism. Minor/Significance Unknown.

            • phenindione

              serdexmethylphenidate/dexmethylphenidate increases effects of phenindione by decreasing metabolism. Minor/Significance Unknown.

            • phenobarbital

              serdexmethylphenidate/dexmethylphenidate increases effects of phenobarbital by decreasing metabolism. Minor/Significance Unknown.

            • phenytoin

              serdexmethylphenidate/dexmethylphenidate increases effects of phenytoin by decreasing metabolism. Minor/Significance Unknown.

            • primidone

              serdexmethylphenidate/dexmethylphenidate increases effects of primidone by decreasing metabolism. Minor/Significance Unknown.

            • protamine

              serdexmethylphenidate/dexmethylphenidate increases effects of protamine by decreasing metabolism. Minor/Significance Unknown.

            • protriptyline

              serdexmethylphenidate/dexmethylphenidate increases effects of protriptyline by decreasing metabolism. Minor/Significance Unknown.

            • rufinamide

              serdexmethylphenidate/dexmethylphenidate increases effects of rufinamide by decreasing metabolism. Minor/Significance Unknown.

            • sertraline

              serdexmethylphenidate/dexmethylphenidate increases effects of sertraline by decreasing metabolism. Minor/Significance Unknown.

            • sultiame

              serdexmethylphenidate/dexmethylphenidate increases effects of sultiame by decreasing metabolism. Minor/Significance Unknown.

            • tiagabine

              serdexmethylphenidate/dexmethylphenidate increases effects of tiagabine by decreasing metabolism. Minor/Significance Unknown.

            • tinzaparin

              serdexmethylphenidate/dexmethylphenidate increases effects of tinzaparin by decreasing metabolism. Minor/Significance Unknown.

            • topiramate

              serdexmethylphenidate/dexmethylphenidate increases effects of topiramate by decreasing metabolism. Minor/Significance Unknown.

            • trazodone

              serdexmethylphenidate/dexmethylphenidate increases effects of trazodone by decreasing metabolism. Minor/Significance Unknown.

            • trimipramine

              serdexmethylphenidate/dexmethylphenidate increases effects of trimipramine by decreasing metabolism. Minor/Significance Unknown.

            • valproic acid

              serdexmethylphenidate/dexmethylphenidate increases effects of valproic acid by decreasing metabolism. Minor/Significance Unknown.

            • venlafaxine

              serdexmethylphenidate/dexmethylphenidate increases effects of venlafaxine by decreasing metabolism. Minor/Significance Unknown.

            • yerba mate

              yerba mate increases effects of serdexmethylphenidate/dexmethylphenidate by pharmacodynamic synergism. Minor/Significance Unknown.

            • zonisamide

              serdexmethylphenidate/dexmethylphenidate increases effects of zonisamide by decreasing metabolism. Minor/Significance Unknown.

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            Adverse Effects

            ≥5%

            Clinical trials with other methylphenidate products in pediatric and adult patients with ADHD commonly reported (≥5% and at least twice the rate of placebo) the following:

            Decreased appetite

            Decreased weight

            Nausea

            Abdominal pain

            Dyspepsia

            Vomiting

            Insomnia

            Anxiety

            Affect lability

            Irritability

            Dizziness

            Increased blood pressure

            Tachycardia

            Postmarketing Reports

            Blood and lymphatic system disorders: Pancytopenia, thrombocytopenia, thrombocytopenic purpura

            Cardiac disorders: Angina pectoris, bradycardia, extrasystole, supraventricular tachycardia, ventricular extrasystole, palpitations, increased heart rate

            Eye disorders: Diplopia, mydriasis, visual impairment, blurred vision

            General disorders: Chest pain, chest discomfort, hyperpyrexia

            Gastrointestinal disorders: Dry mouth

            Hepatobiliary disorders: Hepatocellular injury, acute hepatic failure

            Immune system disorders: Hypersensitivity reactions such as angioedema, anaphylactic reactions, auricular swelling, bullous conditions, exfoliative conditions, urticaria, pruritus, rashes, eruptions, and exanthemas

            Investigations: Alkaline phosphatase increased, bilirubin increased, hepatic enzyme increased, platelet count decreased, white blood cell count abnormal

            Musculoskeletal, connective-tissue and bone disorders: Arthralgia, myalgia, muscle twitching, rhabdomyolysis, muscle cramps

            Nervous system: Convulsion, grand mal convulsion, dyskinesia, serotonin syndrome in combination with serotonergic drugs, nervousness, headache, tremor, drowsiness, vertigo

            Psychiatric disorders: Disorientation, libido changes, hallucination, hallucination auditory, hallucination visual, logorrhea, mania, restlessness, agitation

            Skin and subcutaneous tissue disorders: Alopecia, erythema, hyperhidrosis

            Urogenital system: Priapism

            Vascular disorders: Raynaud phenomenon

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            Warnings

            Black Box Warnings

            CNS stimulants, including serdexmethylphenidate/methylphenidate, other methylphenidate-containing products, and amphetamines, have a high potential for abuse and dependence

            Assess risk of abuse before prescribing and monitor for signs of abuse and dependence while on therapy

            Contraindications

            Known hypersensitivity to serdexmethylphenidate, methylphenidate, or other components; bronchospasm, rash, and pruritus reported with serdexmethylphenidate/methylphenidate; hypersensitivity reactions (eg, angioedema) and anaphylactic reactions reported in patients treated with other methylphenidate products

            Concomitant use with MAOIs or within 14 days following discontinuation with an MAOI

            Cautions

            CNS stimulants have a high potential for abuse and dependence; assess risks before prescribing and carefully monitor while on therapy

            Priapism, sometimes requiring surgical intervention, reported with methylphenidate in both pediatric and adults patients; not reported upon initiating, but may develop after some time on the drug (often subsequent to increased dose or during drug withdrawal); seek immediate medical attention for abnormally sustained or frequent and painful erections

            Peripheral vasculopathy, including Raynaud phenomenon, reported with CNS stimulants; signs and symptoms generally improve after dose reduction or discontinuation; observe for digital changes during treatment; further clinical evaluation (eg, rheumatology referral) may be necessary

            Monitor growth in pediatric patients during treatment with stimulants; patients who are not growing or gaining weight as expected may need to have their treatment interrupted

            Periodically reevaluate long-term use and adjust dose; periodically discontinue to assess patient's condition

            Serious cardiovascular reactions

            • CNS stimulants cause an increased blood pressure (mean increase ~2-4 mmHg) and heart rate (mean increase ~3-6 bpm); individuals may have larger increases; monitor all patients for hypertension and tachycardia; consider benefits and risks in patients for whom an increase in blood pressure would be problematic
            • Adults: Sudden death, stroke, and myocardial infarction reported with CNS stimulant treatment at recommended doses
            • Pediatric patients: Sudden death reported with structural cardiac abnormalities and other serious heart problems taking CNS stimulants at recommended doses for ADHD
            • Avoid use in patients with known structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, and other serious heart problems
            • Promptly evaluate patients who develop exertional chest pain, unexplained syncope, or arrhythmias during treatment

            Psychiatric adverse reactions

            • May exacerbate symptoms of behavior disturbance and thought disorder in patients with preexisting psychotic disorders
            • May induce manic or mixed mood episode; before prescribing, screen patients for risk factors for developing a manic episode (eg, comorbid or history of depressive symptoms, family history of suicide, bipolar disorder, or depression)
            • At recommended doses, CNS stimulants may cause psychotic or manic symptoms (eg, hallucinations, delusional thinking, mania) in patients without a prior history; if such symptoms occur, consider discontinuing drug

            Drug interaction overview

            • MAOIs
              • Contraindicated
              • Do not coadminister serdexmethylphenidate/methylphenidate with MAOIs or within 14 days after discontinuing MAOI treatment, owing to potential for hypertensive crisis
            • Antihypertensives
              • Monitor blood pressure and adjust antihypertensive dose as needed
              • Serdexmethylphenidate/methylphenidate may decrease effectiveness of antihypertensives
            • Halogenated anesthetics
              • Avoid serdexmethylphenidate/methylphenidate on day of surgery
              • Concomitant use of serdexmethylphenidate/methylphenidate with halogenated anesthetics (eg, halothane, isoflurane, enflurane, desflurane, sevoflurane) may increase risk of sudden blood pressure and heart rate increase during surgery
            • Risperidone
              • Monitor for extrapyramidal symptoms (EPSs)
              • Coadministration of methylphenidate with risperidone may increase risk of EPSs when there is dosage change (increased or decreased) of either or both medications
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            Pregnancy & Lactation

            Pregnancy

            Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Psychostimulants at 1-866-961-2388

            No data are available on use in pregnant females; dexmethylphenidate is the d-threo enantiomer of racemic methylphenidate; published studies and postmarketing reports on methylphenidate use during pregnancy have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes

            However, there may be risks to the fetus associated with the use of CNS stimulants use during pregnancy

            Clinical considerations

            • CNS stimulants can cause vasoconstriction and thereby decrease placental perfusion
            • No fetal and/or neonatal adverse reactions reported with therapeutic doses of methylphenidate during pregnancy; however, premature delivery and low-birth-weight infants reported in amphetamine-dependent mothers

            Lactation

            Serdexmethylphenidate: Data are unavailable on presence in human milk, effects on breastfed infants, or effects on milk production

            Dexmethylphenidate

            • Limited published literature, based on milk sampling from 7 mothers, reports methylphenidate is present in human milk, which resulted in infant doses of 0.16-0.7% of the maternal weight–adjusted dosage and a milk/plasma ratio ranging between 1.1 and 2.
            • There are no reports of adverse effects on breastfed infants and no effects on milk production

            Clinical considerations: Monitor breastfeeding infants for adverse reactions (eg, agitation, anorexia, reduced weight gain)

            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

            Dexmethylphenidate (d-MPH): CNS stimulant; blocks reuptake of norepinephrine and dopamine, causing an increase of their release into the extraneuronal space; mode of therapeutic action for ADHD is unknown

            Serdexmethylphenidate: Prodrug of d-MPH formulated with immediate-release d-MPH

            Absorption

            Peak plasma time: 2 hr (serdexmethylphenidate/d-MPH); 8 hr (serdexmethylphenidate alone)

            Peak plasma concentration: 14 ng/mL

            AUC: 186 hrng/mL

            Effect of food

            • No clinically meaningful differences in dexmethylphenidate exposure observed when administered after an overnight fast, with a high-fat, high-caloric meal, or sprinkled onto applesauce or water
            • Peak plasma time lengthened from 2 to 4-4.5 hr

            Distribution

            Protein bound

            • Serdexmethylphenidate: 56%
            • Dexmethylphenidate: 47%

            Vd

            • Serdexmethylphenidate: 29.3 L/kg
            • Dexmethylphenidate: 2.65 L/kg

            Metabolism

            Serdexmethylphenidate: Prodrug of dexmethylphenidate; likely converted to dexmethylphenidate mainly in lower GI tract; enzymes involved in conversion not identified

            Dexmethylphenidate: Metabolized primarily via de-esterification to dextro-alpha-phenyl-piperidine acetic acid (ie, dextro-ritalinic acid); ritalinic acid has little or no pharmacological activity

            Elimination

            Half-life

            • Serdexmethylphenidate: 5.7 hr
            • Dexmethylphenidate: 11.7 hr

            Clearance

            • Serdexmethylphenidate: 3.6 L/hr/kg (PO)
            • Dexmethylphenidate: 0.4 L/hr/kg (IV)

            Excretion

            • Serdexmethylphenidate: Urine 62% (0.4% unchanged); feces 37% (11% unchanged)
            • Ritalinic acid: ~63% of total recovered dose in urine and feces
            • Methylphenidate: Urine ~90%
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            Administration

            Oral Administration

            Administer in morning with or without food

            Unable to swallow capsule whole

            • Open and sprinkle entire contents into 50 mL of water or over 2 tablespoons of applesauce
            • Consume all drug/food mixture immediately or within 10 minutes of mixing
            • Do not store mixture for future use

            Switching from other methylphenidate products

            • If switching from other methylphenidate products, discontinue that treatment, and titrate serdexmethylphenidate/methylphenidate using titration schedule described
            • Do not substitute products on a milligram-per-milligram basis, owing to different pharmacokinetic profiles and composition

            Dose reduction and discontinuation

            • Reduce dose, or if necessary, discontinue drug, if paradoxical aggravation of symptoms or other adverse reactions occur
            • Periodically discontinue drug to assess pediatric patients’ conditions
            • Discontinue if improvement not observed after appropriate dosage adjustment over a 1-month period

            Storage

            • Store at 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF)
            • Protect from moisture
            • Dispense in tight container

            Disposal

            • Comply with local laws and regulations on drug disposal of CNS stimulants
            • Dispose of remaining, unused, or expired drug by a medicine take-back program or by an authorized collector registered with the Drug Enforcement Administration
            • If take-back program or authorized collector unavailable, mix drug with undesirable, nontoxic substance to make it less appealing to children and pets, then place in container (eg, sealed plastic bag) and discard in household trash
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            Images

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            Patient Handout

            A Patient Handout is not currently available for this monograph.
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            Formulary

            FormularyPatient Discounts

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            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.
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            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
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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.