Methylphenidate XR-ODT

FDA label

Read the full label on DailyMed ↗

Titration Increase weekly in increments of 8.6-17.3 mg

Renal Undefined

Hepatic Undefined

Instructions

• Give once daily in the morning; take consistently with or without food
• Do not remove tablet from blister until just prior to dosing; use dry hands
• Place whole tablet on tongue and allow to disintegrate without chewing or crushing; no liquid needed
• If no improvement after appropriate dose adjustment over 1 month, discontinue

Available strengths

• ODT 8.6, 17.3, 25.9 mg
• cap 20, 40, 60, 80, 100 mg
• tab 5, 10, 20 mg
• ER cap 10, 15, 20, 30, 40, 50, 60, 80, 100 mg
• ER tab 10, 18, 20, 27, 36, 45, 54, 63, 72 mg
• chew tab 2.5, 5, 10, 20, 30, 40 mg
• ER susp 600 mg/120 mL
• ER susp 750 mg/150 mL
• + 5 other marketed forms not shown

Contraindications

• Concurrent MAOI, or use of an MAOI within the preceding 14 days (risk of hypertensive crisis)

Cautions

• Serious cardiac disease — avoid (sudden death)
• Increased blood pressure and heart rate — monitor
• Psychiatric adverse reactions; screen for bipolar risk
• Priapism
• Peripheral vasculopathy, including Raynaud's phenomenon
• Long-term growth suppression in pediatric patients
• Acute angle closure glaucoma; increased IOP
• Motor/verbal tics and worsening of Tourette's

Adverse reactions

• Appetite decreased, insomnia, nausea, vomiting, dyspepsia, abdominal pain, weight decreased, anxiety, dizziness, irritability, affect lability, tachycardia, blood pressure increased (from methylphenidate product data)

Pregnancy Data insufficient to inform risk; CNS stimulants may reduce placental perfusion; pregnancy exposure registry available

Lactation Methylphenidate present in human milk (infant dose 0.16-0.7% of maternal); monitor infant for agitation, insomnia, anorexia, reduced weight gain