Dexmethylphenidate XR
FOCALIN XR
Pronunciation: dex-meth-il-FEN-i-dayt
“A star is Sir”
Ball and chain" must be clipped
Scantron → methylphenidate product
What it isDexmethylphenidate XR (FOCALIN XR, 2005) inhibits dopamine and norepinephrine reuptake for ADHD; approved ages: 6-17, adults.
Why this oneThe active dextrorotatory isomer has 2x potency of MPH; 50% IR / 50% DR beads provide 8-12 h (Carlat Table 1) coverage and are sprinklable.
What limits itAppetite loss, insomnia, and blood-pressure elevation can limit use; abuse, misuse, and addiction are boxed risks.
FDA-approved for
- ADHD (2005)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Attention Deficit Hyperactivity Disorder (ADHD) | Pediatric patients 6–17 years | 5 mg QD in the morning (methylphenidate-naïve); or ½ current total daily methylphenidate dose | Titrate weekly by 5 mg | 30 mg/day |
| Attention Deficit Hyperactivity Disorder (ADHD) | Adults | 10 mg QD in the morning (methylphenidate-naïve); or ½ current total daily methylphenidate dose | Titrate weekly by 10 mg | 40 mg/day |
Titration Titrate weekly
Renal Not studied; minimal renal elimination, so little effect expected
Hepatic Undefined
Instructions
- Take once daily in the morning with or without food
- Swallow whole or open capsule and sprinkle entire contents on applesauce, consumed immediately without chewing
- Do not divide the dose; not recommended below 6 years of age
Available strengths
- ER cap 5, 10, 15, 20, 25, 30, 35, 40 mg
- tab 2.5, 5, 10 mg
Contraindications
- Concomitant treatment with monoamine oxidase inhibitors (MAOIs), or use of an MAOI within the preceding 14 days, because of the risk of hypertensive crises
Cautions
- Serious cardiac disease — avoid in structural cardiac abnormalities/serious cardiac disease (sudden death reported)
- Increased blood pressure and heart rate
- Psychiatric adverse reactions — exacerbation of psychosis, mania, new psychotic/manic symptoms
- Priapism
- Peripheral vasculopathy, including Raynaud's phenomenon
- Long-term suppression of growth in pediatric patients
- Acute angle closure glaucoma; increased intraocular pressure
- Motor/verbal tics and worsening of Tourette's syndrome
Adverse reactions
- Pediatric (6–17 y): dyspepsia, decreased appetite, headache, anxiety
- Adults: dry mouth, dyspepsia, headache, pharyngolaryngeal pain, anxiety
Pregnancy Published data have not identified a drug-associated risk of major birth defects/miscarriage; CNS stimulants may cause vasoconstriction/decreased placental perfusion.
Lactation Methylphenidate present in human milk (low infant dose); monitor breastfed infants for agitation, insomnia, anorexia, reduced weight gain.
Cost
| Strength | #/mo | generic $/mo | CostPlus | |
|---|---|---|---|---|
| 5 mg | ER cap | 4 q-wk | $4.05 | not offered |
| 10 mg | ER cap | 4 q-wk | $5.81 | not offered |
| 15 mg | ER cap | 4 q-wk | $3.19 | not offered |
| 20 mg | ER cap | 4 q-wk | $6.77 | not offered |
| 25 mg | ER cap | 4 q-wk | $7.03 | not offered |
| 30 mg | ER cap | 4 q-wk | $6.24 | not offered |
| 35 mg | ER cap | 4 q-wk | $8.29 | not offered |
| 40 mg | ER cap | 4 q-wk | $6.63 | not offered |
Other forms: Dex methylphenidate (FOCALIN)
Available combined with: azstarys
⚠ BOXED WARNING
- Abuse, misuse and addiction
Classes and tags
Clinical profile
Legacy pregnancy categoryC
Defining liabilityCardiovascular stimulation, appetite suppression, insomnia, misuse and stimulant-induced psychosis.