Methylphenidate XR-ODT

COTEMPLA XR-ODT

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What it isExtended-release dopamine and norepinephrine reuptake inhibitor in an orally disintegrating tablet for ADHD (COTEMPLA XR-ODT, 2017; approved ages 6-17).

Why this oneIts 25% IR / 75% ER design gives 8-12 h (Carlat Table 1) of coverage without water or swallowing an intact tablet.

What limits itAbuse, appetite loss, insomnia, and blood-pressure elevation remain; moisture damages the tablet.

FDA-approved for

ADHD (2017)

FDA label

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BOXED WARNING High potential for abuse, misuse, and addiction; misuse/abuse of CNS stimulants can cause overdose and death.

FDA dosing	Population	Start	Target	Max
ADHD	Pediatric 6-17 yr	17.3 mg QD (morning)	titrate weekly by 8.6-17.3 mg	51.8 mg QD

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

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

⚠ BOXED WARNING