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Relexxii
methylphenidate
Black Box Warnings .
Abuse, Misuse, and Addiction
CNS stimulants have high potential for abuse and misuse, can lead to substance use disorder, incl. addiction; misuse and abuse can result in overdose and death, risk incr. w/ higher doses or unapproved admin. methods; assess risk for abuse, misuse, and addiction before prescribing and throughout tx; educate pts and families about risks and proper drug storage and disposal; monitor frequently for s/sx of abuse, misuse, and addiction during tx
Adult Dosing .
Dosage forms: ER TAB: 18 mg, 27 mg, 36 mg, 45 mg, 54 mg, 63 mg, 72 mg
Special Note
- [strength clarification]
- Info: all strengths expressed as methylphenidate hydrochloride
- [formulation clarification]
- Info: methylphenidate ER products not interchangeable; do not substitute on a mg to mg basis
ADHD
- [18-65 yo]
- Dose: 18-72 mg PO qam; Start: 18-36 mg PO qam, may incr. by 18 mg/day q7 days; Max: 72 mg/day; Info: duration 12h; do not cut/crush/chew tab; see pkg insert for conversion from IR form
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
- Dosage forms: ER TAB: 18 mg, 27 mg, 36 mg, 45 mg, 54 mg, 63 mg, 72 mg
Special Note
- [strength clarification]
- Info: all strengths expressed as methylphenidate hydrochloride
- [formulation clarification]
- Info: methylphenidate ER products not interchangeable; do not substitute on a mg to mg basis
ADHD
- [6-12 yo]
- Dose: 18-54 mg PO qam; Start: 18 mg PO qam, may incr. by 18 mg/day q7 days; Max: 54 mg/day; Info: duration 12h; do not cut/crush/chew tab; see pkg insert for conversion from IR form
- [13-17 yo]
- Dose: 18-72 mg PO qam; Start: 18 mg PO qam, may incr. by 18 mg/day q7 days; Max: 2 mg/kg/day up to 72 mg/day; Info: duration 12h; do not cut/crush/chew tab; see pkg insert for conversion from IR form
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
- MAO inhibitor use w/in 14 days
- cardiac dz, severe
- cardiac abnormality, structural
- arrhythmia, severe
- cardiomyopathy
- CAD
- fructose intolerance, hereditary (30% IR/70% ER cap form)
- sucrase-isomaltase deficiency (30% IR/70% ER cap form)
- glucose-galactose malabsorption (30% IR/70% ER cap form)
- GI stricture, severe (qd ER tab form)
- dysphagia (IR chewable tab form)
- avoid: alcohol use (qd ER cap form)
- caution: hypersensitivity to tartrazine (some generic forms)
- caution: HTN
- caution: psychosis
- caution: bipolar disorder
- caution: bipolar disorder risk
- caution: Tourette syndrome
- caution: Tourette syndrome family hx
- caution: tic disorder
- caution: tic disorder family hx
- caution: glaucoma risk, angle-closure
- caution: glaucoma, open-angle
- caution: IOP incr.
- caution: seizure hx
- caution: seizure risk
- caution: substance abuse risk
- caution: PKU (phenylalanine-containing form)
Drug Interactions .
Overview
methylphenidate
CNS stimulant
- gastric pH sensitive
- hypertensive effects
- lowers seizure threshold
- serotonergic effects
- tachycardia
- add MAO inhibitor to Interaction Check if recent (14 days) use
Contraindicated
- benzphetamine
- isocarboxazid
- linezolid
- methylene blue injection
- phendimetrazine
- phenelzine
- rasagiline
- safinamide
- selegiline
- selegiline transdermal
- tranylcypromine
- yohimbe
Avoid/Use Alternative
- albuterol
- aldesleukin
- alfentanil
- aluminum hydroxide
- amifampridine
- amphetamine
- buprenorphine
- butorphanol
- calcium carbonate
- cimetidine
- citalopram
- clomipramine
- codeine
- cyclobenzaprine
- desipramine
- desvenlafaxine
- dexlansoprazole
- dexmethylphenidate
- dextroamphetamine
- dihydrocodeine
- dronabinol
- duloxetine
- ephedra
- epinephrine inhaled
- escitalopram
- esomeprazole
- ethanol
- famotidine
- fentanyl
- fluoxetine
- fluvoxamine
- furosemide
- gepirone
- granisetron
- hydrocodone
- hydromorphone
- imipramine
- isoniazid
- landiolol
- lansoprazole
- levomilnacipran
- levorphanol
- lisdexamfetamine
- lithium
- magnesium carbonate
- magnesium hydroxide
- magnesium oxide
- meperidine
- metaxalone
- methadone
- methamphetamine
- methylene blue oral
- midodrine
- milnacipran
- mirtazapine
- morphine
- nalbuphine
- nizatidine
- nortriptyline
- oliceridine
- omeprazole
- ondansetron
- opium
- oxycodone
- oxymorphone
- pantoprazole
- paroxetine
- pentazocine
- procarbazine
- rabeprazole
- remifentanil
- sertraline
- sodium bicarbonate
- sodium citrate
- sodium zirconium cyclosilicate
- sufentanil
- tapentadol
- tipranavir
- tramadol
- trimipramine
- venlafaxine
- vilazodone
- vonoprazan
- vortioxetine
- ziprasidone
Monitor/Modify Tx
- 5-HTP
- abiraterone acetate
- acebutolol
- albuterol inhaled
- aliskiren
- almotriptan
- amiloride
- amitriptyline
- amlodipine
- amoxapine
- angiotensin II
- aprocitentan
- arformoterol inhaled
- armodafinil
- asciminib
- atenolol
- atropine
- atropine ophthalmic
- axitinib
- azilsartan medoxomil
- benazepril
- benztropine
- betamethasone
- betaxolol
- bevacizumab
- bismuth subsalicylate
- bisoprolol
- brigatinib
- bromocriptine
- budesonide
- bumetanide
- bupropion
- buspirone
- cabozantinib
- caffeine
- caffeine citrate
- candesartan cilexetil
- cannabis
- captopril
- carbamazepine
- carfilzomib
- carvedilol
- celecoxib
- chlorothiazide
- chlorthalidone
- clevidipine
- clonidine
- cocaine
- copanlisib
- corticotropin
- cortisone
- cyclosporine
- danazol
- darbepoetin alfa
- deflazacort
- desflurane
- desmopressin
- dexamethasone
- dextromethorphan
- diclofenac
- diclofenac topical
- dicyclomine
- diethylpropion
- diflunisal
- dihydroergotamine
- diltiazem
- dobutamine
- dopamine
- doxapram
- doxazosin
- doxepin
- doxepin topical
- droxidopa
- eletriptan
- enalapril
- enalaprilat
- enzalutamide
- ephedrine injection
- ephedrine oral
- epinephrine
- eplerenone
- epoetin alfa
- erenumab
- ergotamine
- esketamine
- esmolol
- estetrol (contraceptive)
- estradiol (contraceptive)
- ethacrynic acid
- ethinyl estradiol (contraceptive)
- etodolac
- etrasimod
- felodipine
- fenfluramine
- fenoldopam
- fenoprofen
- fingolimod
- fludrocortisone
- flurbiprofen
- formoterol inhaled
- fosinopril
- fosphenytoin
- fostamatinib
- frovatriptan
- fruquintinib
- glycopyrrolate
- guanfacine
- hoodia
- hydralazine
- hydrochlorothiazide
- hydrocortisone
- hyoscyamine
- ibrutinib
- ibuprofen
- indapamide
- indomethacin
- iohexol
- iopamidol
- irbesartan
- isoflurane
- isoproterenol
- isradipine
- ketamine
- ketoprofen
- ketorolac
- labetalol
- lanreotide
- lasmiditan
- leflunomide
- lenvatinib
- levalbuterol inhaled
- levothyroxine
- licorice
- lifileucel
- liothyronine
- lisinopril
- lorlatinib
- losartan
- lumacaftor/ivacaftor
- luspatercept
- magnesium salicylate
- meclofenamate
- mefenamic acid
- meloxicam
- methoxy polyethylene glycol-epoetin beta
- methscopolamine
- methyldopa
- methylergonovine
- methylprednisolone
- metoclopramide
- metolazone
- metoprolol
- minoxidil
- mirabegron
- modafinil
- moexipril
- nabumetone
- nadolol
- naproxen
- naratriptan
- naxitamab
- nebivolol
- nefazodone
- nicardipine
- nifedipine
- nimodipine
- niraparib
- nisoldipine
- norepinephrine
- olmesartan medoxomil
- olodaterol inhaled
- orphenadrine
- osilodrostat
- oxaprozin
- oxymetazoline nasal
- oxytocin
- ozanimod
- palonosetron
- pazopanib
- perindopril
- pexidartinib
- phenoxybenzamine
- phentermine
- phentolamine
- phenylephrine
- phenylephrine injection
- phenylephrine nasal
- phenylephrine ophthalmic
- phenylephrine rectal
- phenytoin
- pindolol
- piroxicam
- ponatinib
- ponesimod
- pralsetinib
- prazosin
- prednisolone
- prednisone
- primidone
- propranolol
- protriptyline
- pseudoephedrine
- quetiapine
- quinapril
- ramipril
- ramucirumab
- regorafenib
- ripretinib
- rizatriptan
- ropinirole
- rotigotine transdermal
- salmeterol inhaled
- salsalate
- SAMe
- selpercatinib
- sevoflurane
- siponimod
- solriamfetol
- sorafenib
- spironolactone
- St. John's wort
- sulindac
- sumatriptan
- sunitinib
- tacrolimus
- tagraxofusp
- telmisartan
- terazosin
- terbutaline
- teriflunomide
- testosterone
- thyroid
- timolol
- tivozanib
- tolmetin
- torsemide
- trametinib
- trandolapril
- trazodone
- triamcinolone
- triamterene
- trospium
- vadadustat
- valsartan
- vamorolone
- vandetanib
- vasopressin
- verapamil
- vilanterol inhaled
- viloxazine
- voclosporin
- warfarin
- ziv-aflibercept
- zolmitriptan
Caution Advised
- acetazolamide
- brivaracetam
- busulfan
- cannabidiol
- cenobamate
- chlorambucil
- clobazam
- clonazepam
- clorazepate
- clozapine
- diazepam
- eslicarbazepine acetate
- ethosuximide
- felbamate
- gabapentin
- ganaxolone
- ginseng, Asian
- hydroxychloroquine
- lacosamide
- lamotrigine
- levetiracetam
- lindane topical
- lorazepam
- magnesium citrate
- methsuximide
- midazolam
- oxcarbazepine
- perampanel
- phenobarbital
- polyethylene glycol
- polyethylene glycol/electrolytes
- pregabalin
- promethazine
- risperidone
- rufinamide
- sodium picosulfate
- stiripentol
- sulfate bowel prep
- tiagabine
- topiramate
- treosulfan
- valproic acid
- vigabatrin
- zonisamide
Adverse Reactions .
Serious Reactions
- dependency
- abuse
- psychosis
- mania
- aggressive behavior
- HTN
- MI
- stroke
- arrhythmia
- sudden death (pts w/ severe cardiac dz)
- seizures
- hypersensitivity rxn
- angioedema
- anaphylaxis
- exfoliative dermatitis
- erythema multiforme
- thrombocytopenic purpura
- blood dyscrasias
- priapism
- peripheral vasculopathy
- Raynaud phenomenon
- growth suppression (long-term use in peds pts)
- glaucoma
- rhabdomyolysis
- hepatotoxicity
- withdrawal sx if abrupt D/C (prolonged use)
Common Reactions
- anorexia
- headache
- xerostomia
- nausea
- insomnia
- anxiety
- abdominal pain
- dizziness
- weight loss
- irritability
- hyperhidrosis
- fever
- tachycardia
- vomiting
- nervousness
- palpitations
- restlessness
- URI
- tremor
- dyspepsia
- BP incr.
- HR incr.
- visual disturbance
- affect lability
- tics
Safety/Monitoring .
Monitoring Parameters
cardiac eval. at baseline; BP, HR; height, weight in peds at baseline, then periodically; ophthalmic exam if glaucoma risk; consider CBC w/ diff, Plt if prolonged tx
Look/Sound-Alike Drug Names
methylphenidate confused with: methadone; methamphetamine
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no known risk of teratogenicity based on limited human data; possible risk of maternal vasoconstriction and decr. placental perfusion based on drug's mechanism of action
Pregnancy Registry
encourage pts to enroll in National Pregnancy Registry for ADHD Medications at 1-866-961-2388 or www.womensmentalhealth.org/adhd-medications
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; no known risk of infant harm based on limited human data; no human data available, though theoretical decr. milk production based on decr. prolactin levels
Pharmacology .
Metabolism: de-esterification primarily; CYP450: none
Excretion: urine 78-97% (<1% unchanged), feces 1-3%; Half-life: 3.5h (IR tabs, adults), 2.5h (IR tabs, peds), 2.7h (IR solution, adults), 2.4-6.8h (ER forms)
Subclass: Attention Deficit Hyperactivity Disorder (ADHD) ; Norepinephrine-Dopamine Reuptake Inhibitors (NDRIs)
Mechanism of Action
exact mechanism of action unknown; stimulates CNS activity; blocks reuptake and increases release of norepinephrine and dopamine in extraneuronal space (sympathomimetic)
Formulary .
No Formulary Selected
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