Methylphenidate ER suspension

FDA label

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Titration Increase weekly (10–20 mg increments)

Renal Undefined

Hepatic Undefined

Instructions

• Vigorously shake bottle ≥10 seconds before each dose
• Once daily in the morning, with or without food
• Advise patients to avoid alcohol
• Do not substitute mg-per-mg for other methylphenidate products (discontinue prior product and re-titrate)

Available strengths

• susp 5 mg/mL
• 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
• ODT 8.6, 17.3, 25.9 mg
• chew tab 2.5, 5, 10, 20, 30, 40 mg
• ER susp 600 mg/120 mL
• + 5 other marketed forms not shown

Contraindications

• Concurrent treatment with an MAOI, or use of an MAOI within the preceding 14 days, because of the risk of hypertensive crisis.

Cautions

• Avoid in serious cardiac disease (sudden death risk)
• Increased blood pressure and heart rate — monitor
• Psychiatric reactions: may exacerbate psychosis or induce mania; screen before starting
• Priapism
• Peripheral vasculopathy, including Raynaud's phenomenon
• Long-term growth suppression in pediatric patients — monitor height/weight
• Acute angle closure glaucoma; increased intraocular pressure
• May cause or worsen motor/verbal tics and Tourette's

Adverse reactions

• appetite decreased
• insomnia
• nausea
• vomiting
• dyspepsia
• abdominal pain
• weight decreased
• anxiety
• dizziness
• irritability
• affect lability
• tachycardia
• blood pressure increased

Pregnancy Limited human data insufficient to inform risk; animal studies showed spina bifida in rabbits at 40× MRHD. CNS stimulants may decrease placental perfusion. Pregnancy 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.