Methylphenidate ER (Relexxii)

FDA label

Read the full label on DailyMed ↗

Titration Increase in 18 mg increments at weekly intervals

Renal Undefined

Hepatic Undefined

Instructions

• Swallow whole with liquid; do not chew, divide, or crush
• Once daily in the morning, with or without food
• Avoid in patients with pre-existing severe GI narrowing (nondeformable tablet)
• Do not substitute mg-per-mg for other methylphenidate products; use conversion table when switching

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
• Potential for GI obstruction with nondeformable tablet
• Acute angle closure glaucoma; increased intraocular pressure
• May cause or worsen motor/verbal tics and Tourette's

Adverse reactions

• decreased appetite
• headache
• dry mouth
• nausea
• insomnia
• anxiety
• dizziness
• weight decreased
• irritability
• hyperhidrosis
• upper abdominal pain (pediatric)

Pregnancy Published data have not identified drug-associated risk of major birth defects or miscarriage; 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, anorexia, reduced weight gain.