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Xelstrym

(generic)

Full Prescribing Information DailyMed Drug Information

Forms/Strengths

  • Transdermal system: 4.5 mg/9 hours, 9 mg/9 hours, 13.5 mg/9 hours, 18 mg/9 hours

Dosing

  • Age: ≥ 6 y/o
  • Onset: Approximately 2 hours after application
  • Duration: 9-hour wear time; continuous release for 9-12 hours
  • Considerations: Apply the patch to the hip, upper arm, chest, upper back, or flank area 2 hours before the effect is needed. Rotate application sites with each new patch. Do not use more than one patch in a 24-hour period. Do not substitute for other amphetamine products on a milligram-per-milligram basis.
  • Initial Dose:
    • Pediatric (6-17 y/o): 4.5 mg/9 hours daily
    • Adults: 9 mg/9 hours daily
  • Titration: 4.5 mg/9 hours weekly
  • Max Dose: 18 mg/9 hours
    • Severe Renal Impairment: 13.5 mg/9 hours
    • End-Stage Renal Disease (ESRD): 9 mg/9 hours

Quick Facts

  • Increases synaptic dopamine and norepinephrine by promoting presynaptic release and inhibiting reuptake
  • Enhances focus, attention, and impulse control
  • Extended-release capsule with a multi-phase release profile for rapid onset and sustained effect
  • Unique formulation for consistent plasma levels throughout the day
  • Common side effects: decreased appetite, insomnia, headache, gastrointestinal discomfort

Indications

  •  ADHD (ICD-10: F90.0)

Off-Label Uses

  •  N/A

How to Take

  • Apply one patch daily to clean, dry, intact skin.
  • Apply to the hip, upper arm, chest, flank, or upper back—rotate application sites daily.
  • Press firmly for at least 30 seconds to ensure full adhesion.
  • Wear the patch for 9 hours and remove it after the prescribed duration.
  • Avoid cutting or altering the patch, as this may affect drug release.
  • Wash hands after applying or removing the patch.

Side Effects

  • Common: decreased appetite, headache, insomnia, tic, abdominal pain, vomiting, nausea, irritability, increased blood pressure, and increased heart rate

Monitoring / Labs

  • Cardiovascular: Baseline and routine monitoring of heart rate and blood pressure.
  • Growth in Pediatrics: Regular monitoring of height and weight to detect growth suppression.
  • Psychiatric Symptoms: Observe for mood changes, anxiety, or psychosis.
  • Abuse Potential: Monitor for misuse or diversion.

Education

  • When to Call the Doctor:

    • Severe mood changes, aggression, or suicidal thoughts.
    • Chest pain, rapid heartbeat, shortness of breath (cardiovascular concerns).
    • Uncontrolled movements, tics, or worsening anxiety.
    • Skin irritation, blistering, or severe redness at the application site.
    • Numbness, coldness, or color changes in fingers or toes (circulatory issues).
    • Unexplained weight loss or delayed growth in pediatric patients.
  • Safety Tips:

    • Monitor blood pressure and heart rate, especially in patients with cardiovascular risk.
    • Use caution in patients with anxiety, bipolar disorder, or psychosis, as symptoms may worsen.
    • Avoid external heat sources (e.g., heating pads, electric blankets, hot tubs) as heat can increase drug absorption.
    • Ensure adequate hydration and nutrition, as appetite suppression is common.
    • If the patch falls off, replace with a new one but remove at the usual time.
  • Parent Tips for Pediatric Patients:

    • Encourage a nutrient-dense diet to counteract appetite suppression.
    • Administer in the morning before school for optimal effect.
    • Monitor school performance and behavioral changes.
    • Observe for sleep disturbances; adjust timing if necessary.
    • Communicate regularly with teachers and caregivers about medication effects.
    • Dispose of used patches safely by folding them in half and placing them in a secure disposal container.

Additional Information

  • Contraindications:

    • Hypersensitivity to amphetamines or formulation components.
    • Use within 14 days of MAOI therapy (risk of hypertensive crisis).
    • Symptomatic cardiovascular disease, moderate-to-severe hypertension, hyperthyroidism, glaucoma.
    • History of substance use disorder, unless benefits outweigh risks.
  • Pregnancy:

    • Category C; use only if benefits outweigh risks.
    • May cause neonatal withdrawal symptoms or low birth weight.
  • Lactation:

    • Excreted in breast milk; not recommended due to potential infant exposure.
  • Drug Interactions:

    • Serotonergic drugs (e.g., SSRIs, SNRIs, MAOIs) increase serotonin syndrome risk.
    • Acidifying agents (e.g., ascorbic acid) may reduce drug absorption.
    • Alkalinizing agents (e.g., sodium bicarbonate) may increase amphetamine levels.
    • May potentiate hypertensive effects of certain medications (e.g., decongestants, beta-agonists)