Relexxii

(methylphenidate ER [OROS])

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).