# QuilliChew ER ### (methylphenidate hydrochloride) **[QuilliChew ER](https://wiki.joshnp.com/books/drug-library/page/quillichew-er)** (methylphenidate hydrochloride); CII
[**Full Prescribing Information**](https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=defc1205-8e90-4b1e-b862-05e4c35c7364&type=display)[**DailyMed Drug Information**](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=defc1205-8e90-4b1e-b862-05e4c35c7364)
--- ### **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](https://wiki.joshnp.com/link/38), [Cotempla XR-ODT](https://wiki.joshnp.com/link/12) or [Quillivant XR](https://wiki.joshnp.com/link/28). - **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](https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/othermedications/). --- ### **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