QuilliChew ER (methylphenidate ER chewable) Full Prescribing Information DailyMed Drug Information Forms/Strengths Chewables (Cherry-flavored): 20 mg, 30 mg, 40 mg Dosing Age: ≥ 6 y/o Onset: ~ 45 min Duration: up to 8 hours Release Profile: 30% IR, 70% ER Considerations: Cherry-flavored; may be taken with or without food. Long-acting chewable tablet. The 20 mg and 30 mg tablets may be split in half. Initial Dose: 20 mg Titration: 10-20 mg weekly Max Dose: 60 mg/day Quick Facts Blocks dopamine/norepinephrine reuptake; enhances focus, attention, and impulse control Extended-release chewable tablet with dual-phase release for immediate onset and sustained effect Unique chewable formulation; ideal for patients with swallowing difficulties Common side effects: decreased appetite, insomnia, headache, gastrointestinal discomfort Indications   ADHD (ICD-10: F90.0) Off-Label Uses  N/A How to Take Take once daily in the morning to minimize the risk of insomnia. Can be taken with or without food ; high-fat meals may delay absorption. Chew the tablet thoroughly before swallowing—do not swallow whole. Avoid taking late in the day to prevent sleep disturbances. Side Effects   Common: Decreased appetite, insomnia, nausea, vomiting, abdominal pain, weight loss, anxiety, dizziness, irritability, tachycardia, increased blood pressure Serious: Cardiac events, psychiatric symptoms, priapism, peripheral vasculopathy, growth suppression Monitoring / Labs Cardiovascular : Baseline and routine monitoring of heart rate and blood pressure. Growth in Pediatrics : Regular monitoring of height and weight to detect growth suppression. Psychiatric Symptoms : Observe for mood changes, anxiety, or psychosis. Abuse Potential : Monitor for misuse or diversion. Education When to Call the Doctor: Severe mood changes, aggression, or suicidal thoughts . Chest pain, rapid heartbeat, shortness of breath ( cardiovascular concerns ). Uncontrolled movements, tics, or worsening anxiety. Numbness, coldness, or color changes in fingers or toes ( circulatory issues ). Unexplained weight loss or delayed growth in pediatric patients . Safety Tips: Monitor blood pressure and heart rate , especially in patients with cardiovascular risk. Use caution in patients with anxiety, bipolar disorder, or psychosis , as symptoms may worsen. Avoid caffeine and other stimulants , which may amplify side effects. Ensure adequate hydration and nutrition , as appetite suppression is common. Tapering may be required if discontinuing after long-term use. Parent Tips for Pediatric Patients: Encourage a nutrient-dense diet to counteract appetite suppression. Administer in the morning before school for optimal effect. Monitor school performance and behavioral changes . Observe for sleep disturbances ; adjust timing if necessary. Communicate regularly with teachers and caregivers about medication effects. Additional Information Contraindications: Hypersensitivity to methylphenidate or formulation components. Use within 14 days of MAOI therapy (risk of hypertensive crisis). Symptomatic cardiovascular disease, moderate-to-severe hypertension, hyperthyroidism, glaucoma . History of substance use disorder , unless benefits outweigh risks. Pregnancy: Category C ; use only if benefits outweigh risks. May cause neonatal withdrawal symptoms or low birth weight . Lactation: Excreted in breast milk ; not recommended due to potential infant exposure. Drug Interactions: Serotonergic drugs (e.g., SSRIs, SNRIs, MAOIs) increase serotonin syndrome risk . Acidifying agents (e.g., ascorbic acid) may reduce drug absorption. Alkalinizing agents (e.g., sodium bicarbonate) may increase methylphenidate levels. May potentiate hypertensive effects of certain medications (e.g., decongestants, beta-agonists).