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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

  1. 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
  2. LactMed. Methylphenidate. Drugs and Lactation Database, NICHD. 2025. https://www.ncbi.nlm.nih.gov/books/NBK501310/
  3. FDA. openFDA National Drug Code Directory, methylphenidate. 2026. https://api.fda.gov/drug/ndc.json?search=generic_name:%22methylphenidate%22
  4. AHRQ. ADHD diagnosis and treatment in children and adolescents. Comparative Effectiveness Review No. 267. 2024. https://www.ncbi.nlm.nih.gov/books/NBK602989/
  5. 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/
  6. DEA. Drug scheduling. Methylphenidate is a Schedule II controlled substance. https://www.dea.gov/drug-information/drug-scheduling
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