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Quillivant XR

(methylphenidate hydrochloride)

Quillivant XR (methylphenidate hydrochloride); CII

Full Prescribing Information DailyMed Drug Information

Summary

Quillivant XR is a long-acting methylphenidate supplied as a banana-flavoured powder the pharmacist reconstitutes into an extended-release oral suspension, dosed from age 6 with no upper limit. Drug is ion-bound to resin held in suspension, giving a full school-day profile as a liquid. It is the only long-acting methylphenidate dosed by the millilitre. Schedule II; brand only.

Forms & Strengths

  • Extended-release oral suspension (banana, contains sucrose; reconstituted from powder): 25 mg/5 mL, that is 5 mg/mL

Dosing

  • Age: >= 6y; no upper limit
  • Onset: ~ 45 minutes
  • Duration: up to 12 hours
  • Release Profile: 20% IR / 80% ER via drug ion-bound to suspended resin
  • Initial Dose: 20 mg, which is 4 mL, once daily in the morning
  • Titration: 10 - 20 mg every 7 days
  • Max Dose: 60 mg/day, which is 12 mL
  • Considerations: Shake vigorously at least 10 seconds before every dose or the dose drawn will be wrong. The reconstituted suspension is stable 4 months at room temperature.

Pharmacology

  • Mechanism: Blocks presynaptic dopamine and norepinephrine reuptake at DAT and NET; does not meaningfully promote catecholamine release at therapeutic doses
  • Delivery / Release: 20% IR / 80% ER. Drug is complexed to resin particles that settle, which is why the bottle must be shaken before every dose. Median Tmax about 4 hours.
  • Metabolism: De-esterified to ritalinic acid, inactive. No CYP pathway. Terminal half-life ~5.2 h in children, ~5.6 h in adults; ~90% recovered in urine.
  • Class Positioning: The only full-day methylphenidate that is a true liquid with a continuous dose. Same 12 hours as Cotempla XR-ODT but with millilitre granularity; QuilliChew ER covers 8 hours.

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, Quillivant XR 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)
  • Weight-based or mg/kg dosing: the ladder is fixed at 20 mg for everyone 6 and above. Insufficient.
  • Enteral feeding tube: not studied; a resin suspension is a plausible tube-blocking hazard. Insufficient.
  • Adolescents and adults: the efficacy study enrolled 45 children aged 6 to 12. Limited data.

Contraindications & Warnings

  • Boxed Warning: Abuse, misuse and addiction, with overdose and death; risk rises with dose and non-oral routes. 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
  • 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; tic ran 2% against 0% on placebo
    • Significant hyperopia or angle-closure risk: refer to ophthalmology
    • Substance use disorder in patient or household; a sweet liquid is the most accessible presentation here
  • 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
    • Whether the caregiver can shake the bottle and draw an accurate volume daily
    • 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: the label says avoid it; exposure rose about 20% at 20% alcohol, smaller than the bead and chewable products.
  • Gastric pH modulators (H2-blockers, PPIs): not on this label, though the sibling resin product Cotempla XR-ODT restricts them. Uncharacterised here.

Administration

  • Reconstitution is a pharmacist step: add the specified water volume, insert the adapter, shake 10 seconds, dispense in the original carton with the dispenser.
  • Shake vigorously at least 10 seconds before every dose; an unshaken bottle runs weak early and strong late.
  • Beyond-use date 4 months. Have the pharmacy date the bottle. Store at room temperature, not refrigerated.
  • Once daily in the morning. Food does not delay it; a high-fat meal shortens Tmax by about an hour.
  • Measure with the supplied dispenser, never a kitchen spoon; milligrams divided by five gives millilitres.
  • Missed dose: give the next as scheduled; never double up or dose late in the day.
  • Switching from another methylphenidate: re-titrate from 20 mg weekly, never mg-per-mg.
  • Store locked; a palatable liquid is the easiest form for an unintended child to swallow.

Side Effects

  • Common, this product (45 patients, 6 to 12 y): affect lability 9% vs 2%, excoriation 4% vs 0%, and insomnia, tic, decreased appetite, vomiting, rash each 2% vs 0%.
  • Common, pooled methylphenidate: decreased appetite and weight, nausea, abdominal pain, insomnia, anxiety, irritability, dizziness, tremor, raised BP and heart rate.
  • 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

  • Shaking technique: at the first follow-up and any unexplained change in effect, have the caregiver show how they shake. Effect drifting across the month is the signature failure.
  • Beyond-use date and dose volume: check the reconstitution date and the millilitres drawn at every refill and dose change. A misread dispenser is a silent halving or doubling.
  • Affect lability: ask at every visit. The highest signal in this product's own trial, 9% against 2%.
  • 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. Crossing two percentile lines is a labeled trigger to interrupt.
  • Appetite, sleep, psychiatric and tics: at every visit and after each dose increase; inspect fingers and toes for colour change or ulceration.
  • Abuse and diversion: reconcile volume remaining against days elapsed at each refill and check the PDMP. A boxed-warning obligation.
  • 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.
  • Down-titration is smoother than on any solid: 1 mL, that is 5 mg, steps.
  • Reduce or discontinue for paradoxical worsening or adverse reactions.
  • Drug holidays are reasonable where growth limits treatment, but a long one outlasts the bottle.
  • Priapism has been reported during drug holidays and on discontinuation.

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:

    • Shaking hard for a full 10 seconds before every dose. Count it out loud with them once; a poorly shaken bottle runs weak then strong across the month.
    • The 4-month limit from the reconstitution date, room-temperature storage, and using only the supplied dispenser: 1 mL is 5 mg.
    • The flavour being banana, so a child who has refused banana medicines will refuse this.
    • Emotional swings being a recognised effect of this product, manageable by dose. Move the largest meal to breakfast and the evening.
    • Locked storage; a toddler can drink a large amount of a sweet liquid quickly.

  • 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.
    • A new or markedly worse tic, or a new vocal tic.
    • Weight loss, clothes fitting more loosely, or a marked change in emotional control.
    • A painful erection lasting more than a few hours.
    • Yellowing of the eyes or skin, dark urine, or new eye pain with halos around lights.
    • Any amount swallowed by a child it was not prescribed for.

References

  1. DailyMed. Quillivant XR (methylphenidate hydrochloride) for extended-release oral suspension prescribing information. NextWave Pharmaceuticals Inc. 2026. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c2dc2109-44a6-4797-b04e-18761dd9d45a
  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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