# Quillivant XR ### (methylphenidate hydrochloride) **[Quillivant XR](https://wiki.joshnp.com/books/drug-library/page/quillivant-xr)** (methylphenidate hydrochloride); CII
[**Full Prescribing Information**](https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c2dc2109-44a6-4797-b04e-18761dd9d45a&type=display)[**DailyMed Drug Information**](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c2dc2109-44a6-4797-b04e-18761dd9d45a)
--- ### **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](https://wiki.joshnp.com/link/12) but with millilitre granularity; [QuilliChew ER](https://wiki.joshnp.com/link/27) 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](https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/othermedications/). --- ### **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