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Relexxii

(methylphenidate ER [OROS])

Full Prescribing Information DailyMed Drug Information

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).
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