Introduction
QuilliChew ER (methylphenidate hydrochloride) is an extended-release, chewable formulation indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). This unique formulation combines the established efficacy of methylphenidate with a patient-friendly administration option, particularly beneficial for pediatric patients who have difficulty swallowing tablets or capsules.
Mechanism of Action
Methylphenidate is a central nervous system (CNS) stimulant that blocks the reuptake of norepinephrine and dopamine into presynaptic neurons, increasing their availability in the extraneuronal space. The exact mechanism in ADHD treatment is not fully established but is believed to involve cortical stimulation and possible activation of the brainstem arousal system and cortex.
Indications
- Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older
- As part of a comprehensive treatment program that may include psychological, educational, and social interventions
Dosage and Administration
Initial Dose: 20 mg once daily in the morning Dose Titration: May increase by 10-20 mg weekly based on response and tolerability Maximum Dose: 60 mg daily (safety of doses above 60 mg daily has not been established) Administration:- Chew tablet completely before swallowing
- May be taken with or without food
- Do not crush or swallow whole tablets
- Administer once daily in the morning
- Renal Impairment: Use with caution; no specific dosage recommendations
- Hepatic Impairment: Use with caution; no specific dosage recommendations
- Geriatric Patients: Not studied in elderly patients
- Pediatric Patients: Safety established for ages 6-17 years
Pharmacokinetics
Absorption: Bioavailability approximately 30%; peak concentrations reached in approximately 5 hours Distribution: Volume of distribution approximately 15 L/kg; protein binding 10-33% Metabolism: Primarily metabolized by carboxylesterase CES1A1 to ritalinic acid Elimination: Half-life approximately 3.5 hours; excreted primarily in urine (80%) with 1-3% excreted unchangedContraindications
- Known hypersensitivity to methylphenidate or other product components
- Patients with glaucoma
- Patients with motor tics or family history or diagnosis of Tourette's syndrome
- During treatment with monoamine oxidase inhibitors (MAOIs), or within 14 days of discontinuing MAOI therapy
Warnings and Precautions
Boxed Warning: Potential for abuse and dependence. Assess risk of abuse prior to prescribing and monitor for signs of abuse and dependence during therapy. Additional Warnings:- Serious cardiovascular events including sudden death, stroke, and myocardial infarction
- Blood pressure and heart rate increases requiring monitoring
- Psychiatric adverse reactions including exacerbation of psychotic symptoms
- Priapism (prolonged and painful erections)
- Peripheral vasculopathy including Raynaud's phenomenon
- Long-term suppression of growth in pediatric patients
Drug Interactions
Significant Interactions:- MAOIs: Risk of hypertensive crisis (contraindicated)
- Antihypertensive drugs: May decrease effectiveness
- Warfarin: May alter anticoagulant response
- Clonidine: Serious adverse events reported (use with caution)
- Serotonergic drugs: Risk of serotonin syndrome
Adverse Effects
Common Adverse Reactions (≥5%):- Decreased appetite (25%)
- Insomnia (15%)
- Anxiety (8%)
- Weight decreased (7%)
- Irritability (6%)
- Nausea (5%)
- Cardiovascular events
- Psychiatric adverse reactions
- Priapism
- Peripheral vasculopathy
- Growth suppression
Monitoring Parameters
Baseline:- Complete medical history including cardiovascular assessment
- Height and weight
- Blood pressure and heart rate
- Assessment for personal or family history of psychiatric disorders
- Blood pressure and heart rate at each dose adjustment and periodically during treatment
- Height and weight every 3-6 months in pediatric patients
- Monitoring for signs of abuse and dependence
- Assessment for emergence of new psychiatric symptoms
- Evaluation for peripheral vasculopathy symptoms
Patient Education
Key Points:- Take medication exactly as prescribed; do not adjust dose without medical supervision
- Chew tablet completely before swallowing; do not swallow whole
- Report any chest pain, shortness of breath, or fainting immediately
- Monitor for changes in mood or behavior
- Be aware of potential for decreased appetite and weight changes
- Avoid alcohol during treatment
- Store medication securely to prevent misuse
- Report any prolonged or painful erections immediately
- Take in the morning to avoid interference with sleep
- May be taken with food if gastrointestinal upset occurs
- Keep regular follow-up appointments for monitoring
References
1. QuilliChew ER [package insert]. Irvine, CA: Tris Pharma, Inc.; 2021. 2. Wolraich ML, Hagan JF Jr, Allan C, et al. Clinical Practice Guideline for the Diagnosis, Evaluation, and Treatment of Attention-Deficit/Hyperactivity Disorder in Children and Adolescents. Pediatrics. 2019;144(4):e20192528. 3. Cortese S, Adamo N, Del Giovane C, et al. Comparative efficacy and tolerability of medications for attention-deficit hyperactivity disorder in children, adolescents, and adults: a systematic review and network meta-analysis. Lancet Psychiatry. 2018;5(9):727-738. 4. Drug Enforcement Administration. Methylphenidate (Street Names: R-ball, Skippy, The Smart Drug, Vitamin R). 2020. 5. Pliszka S; AACAP Work Group on Quality Issues. Practice parameter for the assessment and treatment of children and adolescents with attention-deficit/hyperactivity disorder. J Am Acad Child Adolesc Psychiatry. 2007;46(7):894-921.
Note: This monograph provides general information and should not replace professional medical advice. Always consult with a qualified healthcare provider for personalized medical guidance.