QuilliChew ER

(methylphenidate hydrochloride)
QuilliChew ER (methylphenidate hydrochloride); CII
Full Prescribing Information
DailyMed Drug Information
Summary
QuilliChew ER is a medium-acting methylphenidate supplied as a cherry-flavoured extended-release chewable tablet, dosed from age 6 with no upper age limit. Drug is ion-bound to resin, and the 20 mg and 30 mg tablets are functionally scored, making it the only long-acting methylphenidate here that can be halved. It contains aspartame and therefore phenylalanine. Schedule II; brand only.
Forms & Strengths
Extended-release chewable tablets (cherry; 20 mg and 30 mg functionally scored, 40 mg not): 20 mg, 30 mg, 40 mg
Dosing
Age: >= 6y; no upper limit
Onset: ~ 45 minutes
Duration: up to 8 hours
Release Profile: 30% IR / 70% ER via drug ion-bound to resin
Initial Dose: 20 mg once daily in the morning
Titration: 10, 15 or 20 mg every 7 days, up or down
Max Dose: 60 mg/day
Considerations: The 20 mg and 30 mg tablets are halved to give the 10 mg and 15 mg steps; the 40 mg is not scored. It contains aspartame, giving 3 to 6 mg of phenylalanine per tablet.
Pharmacology
Mechanism: Blocks presynaptic dopamine and norepinephrine reuptake at DAT and NET; does not meaningfully promote catecholamine release at therapeutic doses
Delivery / Release: 30% IR / 70% ER. Drug exchanges off resin along the gut; plasma declines monophasically, with no second peak. Median Tmax ~5 hours.
Metabolism: De-esterified to ritalinic acid, inactive. No CYP pathway. Terminal half-life ~5.2 hours; ~90% recovered in urine.
Class Positioning: The shortest-acting product here; the deciding factor is the 8-hour ceiling, not the chewable format. For afternoon homework use Aptensio XR, Cotempla XR-ODT or Quillivant XR.
Alcohol: at 40% alcohol, about 90% of the tablet released within half an hour, the fastest dose dumping of any product here. The Medication Guide says do not drink.
Indications
ADHD (ICD-10: F90.0, F90.1, F90.2, F90.8, F90.9): patients 6 y/o and older
Off-Label Uses
Narcolepsy (ICD-10: G47.411, G47.419): IR methylphenidate carries this indication, QuilliChew ER does not. Limited data.
ADHD in children under 6 years (ICD-10: F90.x): the label records evidence against. Higher exposure than older children at the same dose, and more adverse reactions including weight loss. (AHRQ 2024)
Coverage past 8 hours: this product's own trial measured 10, 12 and 13 hours and found no separation. Insufficient.
Adolescents and adults: the efficacy study enrolled 90 children aged 6 to 12. Limited data.
Splitting the 40 mg tablet: it is not scored and there is no basis for a half 40 mg dose. Insufficient.
Contraindications & Warnings
Boxed Warning: Abuse, misuse and addiction, with overdose and death. Assess abuse risk before prescribing and reassess throughout treatment.
Contraindicated:
Hypersensitivity to methylphenidate; angioedema and anaphylaxis reported
MAOI use, current or within 14 days: hypertensive crisis
Phenylketonuria, specific to this product: contains aspartame, giving 3, 4.5 and 6 mg of phenylalanine in the 20, 30 and 40 mg tablets. Add it to the daily total.
Use with caution:
Structural cardiac abnormality, cardiomyopathy, arrhythmia or coronary disease: avoid
Pre-existing hypertension: mean rises 2 to 4 mmHg and 3 to 6 bpm
Psychotic or bipolar disorder: exacerbation and treatment-emergent mania
Personal or family history of tics or Tourette's syndrome
Significant hyperopia or angle-closure risk: refer to ophthalmology
Substance use disorder in patient or household; a cherry chewable raises the storage stakes
Screen before starting:
Cardiac history and exam plus family history of sudden death; mandatory in section 2.1
Tics or Tourette's, personal and family, with clinical evaluation; also mandatory
Phenylketonuria status, and if present the current daily phenylalanine allowance
Mania risk factors; abuse and diversion risk in patient and household
Baseline height, weight, blood pressure and heart rate
Drug Interactions
MAOIs (phenelzine, tranylcypromine, selegiline, linezolid, methylene blue): hypertensive crisis. Contraindicated within 14 days.
Antihypertensives: effectiveness reduced. Increase BP monitoring and adjust the antihypertensive.
Halogenated anesthetics (sevoflurane, isoflurane, desflurane): intraoperative BP and HR surge. Hold on the day of surgery.
Risperidone: EPS may increase when either dose changes in either direction. Monitor across any titration.
Serotonergic agents (SSRIs, SNRIs, TCAs, triptans, tramadol): serotonin syndrome in postmarketing reports only. Counsel on symptoms rather than avoiding.
Alcohol: about 90% released within half an hour at 40% alcohol, the fastest dose dumping here. The label says avoid; counsel adolescents explicitly.
Gastric pH modulators (H2-blockers, PPIs): not on this label, though the sibling resin product restricts them. Uncharacterised here.
Administration
Once daily in the morning, with or without food. A high-fat meal does not delay it; Cmax rises about 20%.
Halving: the 20 mg and 30 mg tablets break to give 10 mg and 15 mg. The 40 mg is not scored and must not be broken.
Chewing: the extended-release fraction sits on resin rather than in a coating, so chewing does not destroy it.
Missed dose: skip one that would land in the afternoon and never double up.
Avoid late-day dosing; a late-morning dose is not clear of bedtime.
Switching from another methylphenidate: re-titrate from 20 mg weekly, never mg-per-mg.
Store locked; treat it as a candy-shaped controlled substance. Dispose through a take-back program.
Side Effects
Common, pooled methylphenidate: decreased appetite and weight, nausea, abdominal pain, insomnia, anxiety, restlessness, irritability, dizziness, tremor, raised BP and heart rate. Appetite and insomnia dominate in practice.
Serious:
Sudden death with structural cardiac disease: avoid the drug rather than monitor through it
New psychosis or mania, ~0.1% pooled, including with no psychiatric history: consider discontinuing
Priapism, sometimes surgical, typically after a dose increase and also during drug holidays
Peripheral vasculopathy and Raynaud's with digital ulceration: assess digits each visit
Growth suppression: about 2 cm and 2.7 kg less over 3 years
Acute angle closure glaucoma; new or worsening tics and Tourette's: discontinue if appropriate
Hypersensitivity including angioedema and anaphylaxis
Postmarketing: severe hepatocellular injury, serotonin syndrome, seizures, rhabdomyolysis, pancytopenia
Monitoring & Labs
Afternoon coverage: ask at every visit what happens after school. No benefit past 8 hours was demonstrated, so an afternoon collapse is not a reason to raise the dose.
Phenylalanine load, in PKU only: recount the daily total at every dose change; 20 mg to 40 mg doubles it from 3 mg to 6 mg.
Half-tablet technique: at the first follow-up after any 10 or 15 mg step, confirm they halve a scored 20 or 30 mg tablet, not a 40 mg one.
Cardiovascular: BP and HR at baseline, at each dose change, and every 6 months.
Growth: height, weight and BMI at baseline and every 6 months; interrupting for failure to gain is a labeled instruction.
Appetite, sleep, psychiatric and tics: at every visit and after each dose increase; inspect digits for colour change or ulceration.
Abuse and diversion: at every refill, tablet count, check the PDMP, and ask where it is kept. A flavoured chewable is the easiest form to take by accident.
Laboratory: none required. Check LFTs only for jaundice, dark urine or unexplained fatigue. Discontinue if no improvement after one month of appropriate adjustment.
Discontinuation & Taper
Can be stopped abruptly at therapeutic doses; the label gives no taper schedule.
Withdrawal after prolonged use: dysphoria, fatigue, vivid dreams, sleep change, increased appetite. Do not read it as relapse.
Down-titration is easier than on other long-acting methylphenidates: 10 and 15 mg steps down as well as up.
Expect a daily offset at around 8 hours; that is the drug wearing off, not withdrawal. Reduce or discontinue for paradoxical worsening.
Drug holidays are reasonable where growth limits treatment; priapism has been reported during them.
Pregnancy & Lactation
Pregnancy: human data are insufficient to inform a drug-associated risk. Stimulant vasoconstriction may reduce placental perfusion. Background risk 2% to 4% and 15% to 20%. Weigh against untreated maternal ADHD.
Lactation: infant dose 0.16% to 0.7% of the maternal weight-adjusted dose; undetectable in infant plasma in every reported case. Monitor for agitation, poor feeding and reduced weight gain. Not a reason to stop breastfeeding. (LactMed 2025)
Lactation, milk supply: prolactin falls; large doses may interfere before supply is established. (LactMed 2025)
Exposure Registry: National Pregnancy Registry for Psychostimulants, 1-866-961-2388, womensmentalhealth.org.
Counseling Points
Counsel the family on:
The 8-hour window: the afternoon drop-off is designed in, not a sign the dose is too low.
Which tablet may be halved: the 20 mg and 30 mg are scored, the 40 mg is not and must be given whole.
It tasting like cherry and being chewed, so a sibling will eat it. Locked storage, not a high shelf. No food timing needed.
For adolescents, that spirits release about 90% of the tablet within half an hour. For PKU families, the phenylalanine per tablet and that it changes with the dose.
Moving the largest meal to breakfast and the evening. Sharing or selling a Schedule II medication is a felony.
Advise them to call for:
Chest pain, fainting, or a racing heart that does not settle.
New hallucinations, or suspicious or fearful thinking.
Numbness, coldness or colour change in fingers or toes, or an unexplained sore.
A new or markedly worse tic.
Weight loss, or clothes fitting more loosely.
A painful erection lasting more than a few hours.
Yellowing of the eyes or skin, dark urine, or new eye pain or vision change.
Any tablet taken by a child it was not prescribed for.
References
DailyMed. QuilliChew ER (methylphenidate hydrochloride) extended-release chewable tablets prescribing information. NextWave Pharmaceuticals Inc. 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=defc1205-8e90-4b1e-b862-05e4c35c7364
LactMed. Methylphenidate. Drugs and Lactation Database, NICHD. 2025. https://www.ncbi.nlm.nih.gov/books/NBK501310/
FDA. openFDA National Drug Code Directory, methylphenidate. 2026. https://api.fda.gov/drug/ndc.json?search=generic_name:%22methylphenidate%22
AHRQ. ADHD diagnosis and treatment in children and adolescents. Comparative Effectiveness Review No. 267. 2024. https://www.ncbi.nlm.nih.gov/books/NBK602989/
American Academy of Pediatrics. Clinical practice guideline for the diagnosis, evaluation, and treatment of ADHD in children and adolescents. Pediatrics. 2019. https://publications.aap.org/pediatrics/article/144/4/e20192528/81590/
DEA. Drug scheduling. Methylphenidate is a Schedule II controlled substance. https://www.dea.gov/drug-information/drug-scheduling