Dosing & Uses
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)
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
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.
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
Warnings
Black Box Warnings
This medication has a high potential for abuse and misuse, which can lead to development of substance use disorder, including addiction; misuse and abuse of CNS stimulants can result in overdose and death, and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection
Before prescribing this medication, assess each patient’s risk for abuse, misuse, and addiction; educate patients and their families about risks, proper storage of the drug, and proper disposal of any unused drug
Throughout treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction
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
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
Motor and verbal tics, and worsening of Tourette’s Syndrome
- CNS stimulants, including amphetamine sulfate, associated with onset or exacerbation of motor and verbal tics; worsening of Tourette’s syndrome also reported
- Before initiating therapy, assess family history and clinically evaluate patients for tics or Tourette’s syndrome; regularly monitor patients for emergence or worsening of tics or Tourette’s syndrome with therapy, and discontinue treatment if clinically appropriate
Acute angle closure glaucoma
- There have been reports of angle closure glaucoma associated with methylphenidate treatment
- Although mechanism not clear, treated patients considered at risk for acute angle closure glaucoma (eg, patients with significant hyperopia) should be evaluated by ophthalmologist
Increased intraocular pressure and glaucoma
- There have been reports of elevation of intraocular pressure (IOP) associated with methylphenidate treatment
- Prescribe therapy to patients with open-angle glaucoma or abnormally increased IOP only if benefit of treatment considered to outweigh risk; closely monitor treated patients with history of abnormally increased IOP or open-angle glaucoma
Abuse, misuse, and addiction
- This medication has a high potential for abuse and misuse; use exposes individuals to risks of abuse and misuse, which can lead to development of a substance use disorder, including addiction; this medication can be diverted for non-medical use into illicit channels or distribution
- Risk of overdose and death is increased with higher doses or unapproved methods of administration, such as snorting or injection
- Educate patients and their families about abuse, misuse, and addiction and proper disposal of any unused drug; advise patients to store amphetamine sulfate in a safe place, preferably locked, and instruct patients to not give medication to anyone else; throughout treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction
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
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.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%
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
Images
Formulary
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.
