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Focalin
dexmethylphenidate hydrochloride
Black Box Warnings .
Abuse, Misuse, and Addiction
CNS stimulants have high potential for abuse and misuse, can lead to substance use disorder, including addiction; misuse and abuse can result in overdose and death, risk incr. with higher doses or unapproved administration methods; assess risk for abuse, misuse, and addiction before prescribing and throughout tx; educate patients and families about risks and proper drug storage and disposal; monitor frequently for signs/symptoms of abuse, misuse, and addiction during tx
Adult Dosing .
Dosage forms: TAB: 2.5 mg, 5 mg, 10 mg
ADHD
- [2.5-10 mg PO bid]
- Start: 2.5 mg PO bid, then may incr. by 2.5-5 mg/day q7 days; Max: 20 mg/day; Info: duration 4-5h; space doses at least 4h apart; to convert from methylphenidate, start at 50% of current methylphenidate daily dose
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
- Dosage forms: TAB: 2.5 mg, 5 mg, 10 mg
ADHD
- [6 yo and older]
- Dose: 2.5-10 mg PO bid; Start: 2.5 mg PO bid, then may incr. by 2.5-5 mg/day q7 days; Max: 20 mg/day; Info: duration 4-5h; space doses at least 4h apart; to convert from methylphenidate, start at 50% of current methylphenidate daily dose
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 within 14 days
- cardiac disease, severe
- cardiac abnormality, structural
- arrhythmia, severe
- cardiomyopathy
- CAD
- caution: peds patients (ER form)
- caution: HTN
- caution: psychosis
- caution: bipolar disorder
- caution: bipolar disorder risk
- caution: Tourette syndrome
- caution: Tourette syndrome family history
- caution: tic disorder
- caution: tic disorder family history
- caution: glaucoma risk, angle-closure
- caution: glaucoma, open-angle
- caution: IOP incr.
- caution: seizure history
- caution: seizure risk
- caution: substance abuse risk
Drug Interactions .
Overview
dexmethylphenidate
CNS stimulant
- hypertensive effects
- lowers seizure threshold
- serotonergic effects
- tachycardia
- serdexmethylphenidate is the prodrug of dexmethylphenidate; similar interactions anticipated
- add MAO inhibitor to Interaction Check if recent (14 days) use
Contraindicated
- benzphetamine
- isocarboxazid
- linezolid
- methylene blue injection
- phendimetrazine
- phenelzine
- safinamide
- selegiline transdermal
- tranylcypromine
- yohimbe
Avoid/Use Alternative
- albuterol
- aldesleukin
- alfentanil
- amifampridine
- amphetamine
- buprenorphine
- butorphanol
- citalopram
- clomipramine
- codeine
- cyclobenzaprine
- desipramine
- desvenlafaxine
- dextroamphetamine
- dihydrocodeine
- dronabinol
- duloxetine
- ephedra
- epinephrine inhaled
- escitalopram
- fentanyl
- fluoxetine
- fluvoxamine
- furosemide
- gepirone
- granisetron
- hydrocodone
- hydromorphone
- imipramine
- isoniazid
- landiolol
- levomilnacipran
- levorphanol
- lisdexamfetamine
- lithium
- meperidine
- metaxalone
- methadone
- methamphetamine
- methylene blue oral
- methylphenidate
- midodrine
- milnacipran
- mirtazapine
- morphine
- nalbuphine
- nortriptyline
- oliceridine
- ondansetron
- opium
- oxycodone
- oxymorphone
- paroxetine
- pentazocine
- procarbazine
- rasagiline
- remifentanil
- selegiline
- sertraline
- sufentanil
- tapentadol
- tedizolid
- tramadol
- trimipramine
- venlafaxine
- vilazodone
- 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
- atogepant
- atomoxetine
- atropine ophthalmic
- axitinib
- azilsartan medoxomil
- benazepril
- betamethasone
- betaxolol
- bevacizumab
- bismuth subsalicylate
- bisoprolol
- black cohosh
- 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
- diethylpropion
- diflunisal
- dihydroergotamine
- diltiazem
- dobutamine
- dopamine
- doxapram
- doxazosin
- doxepin
- doxepin topical
- droxidopa
- eletriptan
- enalapril
- enalaprilat
- ephedrine injection
- ephedrine oral
- epinephrine
- eplerenone
- epoetin alfa
- eptinezumab
- erenumab
- ergotamine
- esketamine
- esmolol
- estetrol (contraceptive)
- estradiol (contraceptive)
- ethacrynic acid
- ethanol (alcoholic beverage)
- ethinyl estradiol (contraceptive)
- etodolac
- etrasimod
- felodipine
- fenfluramine
- fenoldopam
- fenoprofen
- fingolimod
- fludrocortisone
- flurbiprofen
- formoterol inhaled
- fosinopril
- fostamatinib
- fremanezumab
- frovatriptan
- fruquintinib
- galcanezumab
- glycopyrrolate
- guanfacine
- hoodia
- hydralazine
- hydrochlorothiazide
- hydrocortisone
- hydroxocobalamin IV
- hyoscyamine
- ibrutinib
- ibuprofen
- indapamide
- indomethacin
- iohexol
- iopamidol
- irbesartan
- isoflurane
- isradipine
- ketamine
- ketoprofen
- ketorolac
- labetalol
- lanreotide
- leflunomide
- lenvatinib
- levalbuterol inhaled
- levothyroxine
- licorice
- lifileucel
- liothyronine
- liraglutide
- lisinopril
- lorlatinib
- losartan
- lumacaftor/ivacaftor
- lumateperone
- luspatercept
- magnesium salicylate
- meclofenamate
- mefenamic acid
- meloxicam
- methoxy polyethylene glycol-epoetin beta
- methyldopa
- methylergonovine
- methylprednisolone
- methyltestosterone
- metoclopramide
- metolazone
- metoprolol
- minoxidil
- mirabegron
- modafinil
- moexipril
- nabumetone
- nadolol
- naproxen
- naratriptan
- naxitamab
- nebivolol
- nefazodone
- nicardipine
- nifedipine
- nimodipine
- niraparib
- nisoldipine
- norepinephrine
- obinutuzumab
- 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
- pindolol
- piroxicam
- ponatinib
- ponesimod
- pralsetinib
- prazosin
- prednisolone
- prednisone
- propranolol
- protriptyline
- pseudoephedrine
- quetiapine
- quinapril
- ramipril
- ramucirumab
- regorafenib
- rimegepant
- 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
- ubrogepant
- vadadustat
- valsartan
- vamorolone
- vandetanib
- vasopressin
- verapamil
- vilanterol inhaled
- viloxazine
- voclosporin
- zavegepant
- ziv-aflibercept
- zolmitriptan
Caution Advised
- acetazolamide
- brivaracetam
- busulfan
- cannabidiol
- cenobamate
- chlorambucil
- clobazam
- clonazepam
- clorazepate
- clozapine
- diazepam
- eslicarbazepine acetate
- ethosuximide
- felbamate
- fosphenytoin
- gabapentin
- ganaxolone
- ginseng, Asian
- hydroxychloroquine
- lacosamide
- lamotrigine
- levetiracetam
- lorazepam
- magnesium citrate
- methsuximide
- midazolam
- oxcarbazepine
- perampanel
- phenobarbital
- phenytoin
- polyethylene glycol
- polyethylene glycol/electrolytes
- pregabalin
- primidone
- 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 (patients with severe cardiac disease)
- seizures
- hypersensitivity reaction
- angioedema
- anaphylaxis
- exfoliative dermatitis
- erythema multiforme
- thrombocytopenic purpura
- blood dyscrasia
- priapism
- peripheral vasculopathy
- Raynaud phenomenon
- growth suppression (long-term use in peds patients)
- weight loss (ER form use in peds patients)
- glaucoma
- rhabdomyolysis
- hepatotoxicity
- withdrawal symptoms if abrupt D/C (prolonged use)
Common Reactions
- anorexia
- headache
- anxiety
- dyspepsia
- xerostomia (ER form)
- throat pain (ER form)
- dizziness
- insomnia
- weight loss
- BP changes
- visual disturbance
- tics
Safety/Monitoring .
Monitoring Parameters
cardiac evaluation at baseline; BP, HR; height, weight in peds at baseline, then periodically; ophthalmic exam if glaucoma risk; consider CBC with diff, Plt if prolonged tx
Look/Sound-Alike Drug Names
Focalin confused with: Focalgin B
dexmethylphenidate hydrochloride extended release confused with: dextroamphetamine mixed salts extended release
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human data available, though no known risk of teratogenicity based on limited human data with methylphenidate; possible risk of delayed fetal ossification based on animal data at 3x MRHD; possible risk of vasoconstriction in pregnant patients and decr. placental perfusion based on drug's mechanism of action
Pregnancy Registry
encourage patients 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 human data available, though no known risk of infant harm based on limited human data with methylphenidate; no human data available, though theoretical decr. milk production based on decr. prolactin levels
Pharmacology .
Metabolism: for dexmethylphenidate: de-esterification primarily; CYP450: none
Excretion: for dexmethylphenidate: urine 90% (0.5% unchanged); Half-life: 2-4.5h
Subclass: Attention Deficit Hyperactivity Disorder (ADHD) ; Norepinephrine-Dopamine Reuptake Inhibitors (NDRIs)
Mechanism of Action
for dexmethylphenidate: 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
Manufacturer/Pricing .
Manufacturer: Novartis Pharmaceuticals Corp.
DEA/FDA: Schedule II
Retail Price
Estimated prices only. For current pricing, visit GoodRx.
oral tablet:
- 2.5 mg (90 ea): $64.00
- 5 mg (30 ea): $32.00
- 10 mg (60 ea): $85.00
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