| [**Full Prescribing Information**](https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d&type=display) | [**DailyMed Drug Information**](https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=22d5fa47-b5b9-4fd9-980c-4eb88e95ae5d) |
Relexxii is a tablet-shaped version of Concerta, offering the same OROS delivery system and bioequivalence. It also comes in additional dosage strengths.
--- **Forms/Strengths** - **Tablets:** 18 mg, 27 mg, 36 mg, 45 mg, 54 mg, 63 mg, 72 mg --- ### **Dosing** - **Age:** ≥ 6 y/o - **Onset:** ~60 min - **Duration:** 8-12 hours - **Release Profile:** 20% IR, 80% CR via osmotic delivery - **Considerations:** Must be swallowed whole; the non-absorbable shell may pass in stool. Administer once daily in the morning, with or without food. Do not chew or crush the tablet. - **Initial Dose:** - **6-12 y/o:** 18 mg once daily in the morning - **13+ y/o:** 18 mg once daily in the morning - **Titration:** Increase by 18 mg/day at weekly intervals - **Max Dose:** - **6-12 y/o:** 54 mg/day - **13+ y/o:** 72 mg/day - **Adults:** 72 mg/day --- ### **Quick Facts** - Blocks dopamine/norepinephrine reuptake; improves focus, attention, and impulse control - Extended-release formulation with a unique multi-phase release for rapid onset and sustained effect - Once-daily dosing for consistent ADHD symptom management - 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**. - **Swallow the tablet whole with liquid**; do not chew, divide, or crush. - Avoid taking **late in the day** to prevent sleep disturbances. --- ### **Side Effects** - Common: Decreased appetite, headache, dry mouth, nausea, insomnia, anxiety, dizziness, weight loss, irritability, increased sweating. - Pediatric patients: Abdominal pain --- ### **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).