Relexxii (methylphenidate hydrochloride) is an extended-release, central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). It is approved for use in pediatric patients aged 6 years and older, as well as adults up to age 65.
As a Schedule II controlled substance, Relexxii contains a boxed warning due to its high potential for abuse, misuse, and physical dependence.
🧬 Mechanism of Action & Technology
Relexxii utilizes specialized Osmodex osmotic drug delivery technology to achieve a dual-release profile that manages symptoms for up to 12 hours:
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- Immediate Release: The outer coating contains an immediate-release drug layer that dissolves within 1 hour to provide quick morning relief.
- Extended Release: The internal core utilizes osmotic pressure to steadily push out the remaining methylphenidate at a controlled rate throughout the day.
- Elimination: The biologically inert tablet shell does not dissolve completely and is excreted naturally in the stool.
💊 Dosage Forms and Strengths : Relexxii (methylphenidate ER)
Relexxii comes in seven strengths (18 mg to 72 mg) for once-daily, morning, with or without food, administration. Crucially, the tablets must be swallowed whole to avoid rapid, unsafe release.
🚫 Contraindications
Avoid if you have taken an MAOI within 14 days due to risk of fatal hypertensive crisis, or if you have a hypersensitivity to methylphenidate.
⚠️ Warnings and Precautions : Relexxii (methylphenidate ER)
Use with caution if you have structural cardiac abnormalities, or if you have a history of heart disease, due to risk of sudden death. Monitor for increased blood pressure/heart rate, and watch for potential psychiatric issues or vision problems.
📋 Common Adverse Reactions : Relexxii (methylphenidate ER)
Common side effects include abdominal pain in children and, in adults, decreased appetite, insomnia, and dry mouth.
For complete prescribing and safety details, consult the FDA DailyMed Relexxii Database Relexxii (methylphenidate ER)
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