Usual Adult Dose for Narcolepsy

• Initial Dose: 10 mg orally per day
• Maintenance Dose: May raise daily dose in 10 mg increments at weekly intervals until optimal response is obtained.

• The usual dose is 5 to 60 mg per day in divided doses, depending on the individual patient response.
• IR: Give the first dose on awakening; give 1 to 2 additional doses at intervals of 4 to 6 hours.
• ER/SR: May use this formulation for once-a-day dosage wherever appropriate.

Usual Pediatric Dose for Attention Deficit Disorder

Immediate-Release (IR):
Age 3 to 5 Years:

• Initial Dose: 2.5 mg orally per day
• Maintenance Dose: May raise daily dose in 2.5 mg increments at weekly intervals until optimal response is obtained.

• Initial Dose: 5 mg orally 1 or 2 times a day
• Maintenance Dose: May raise daily dose in 5 mg increments at weekly intervals until optimal response is obtained.
• Maximum Dose: Only in rare cases will it be necessary to exceed 40 mg per day.

• IR: Give the first dose on awakening; give 1 to 2 additional doses at intervals of 4 to 6 hours.
• ER/SR: May use this formulation for once-a-day dosage wherever appropriate.
• Where possible, occasionally interrupt drug administration to determine if continued therapy is required.

Usual Pediatric Dose for Narcolepsy

Age 6 to 11 Years:

• Initial Dose: 5 mg orally per day
• Maintenance Dose: May raise daily dose in 5 mg increments at weekly intervals until optimal response is obtained.

• Initial Dose: 10 mg orally per day
• Maintenance Dose: May raise daily dose in 10 mg increments at weekly intervals until optimal response is obtained.

• The usual dose is 5 to 60 mg per day in divided doses, depending on the individual patient response.
• IR: Give the first dose on awakening; give 1 to 2 additional doses at intervals of 4 to 6 hours.
• ER/SR: May use this formulation for once-a-day dosage wherever appropriate.
• Narcolepsy rarely occurs in children under 12 years of age.

Renal Dose Adjustments

Data not available.

Liver Dose Adjustments

Data not available.

Dose Adjustments

Narcolepsy Patients: Reduce dosage if bothersome adverse reactions (e.g., insomnia, anorexia) appear.

Precautions

US BOXED WARNINGS:

• Due to the high abuse potential, this drug should be prescribed/dispensed sparingly and particular attention should be paid to subjects possibly obtaining this drug for non-therapeutic use or distribution to others.
• Administering this drug for prolonged periods of time should be avoided as it may lead to drug dependence.
• Drug misuse may cause sudden death and serious cardiovascular adverse events.

• For ADHD treatment, the IR formulations are not recommended in patients younger than 3 years and the ER/SR formulation is not recommended in patients younger than 6 years.
• For narcolepsy treatment, all formulations of this drug are not recommended in patients younger than 6 years.

Dialysis

Data not available.

Other Comments

Administration Advice:

• Avoid late evening doses because of the potential for insomnia.
• Administer this drug at the lowest effective dosage, and individually adjust dosage.
• Take tablet doses at the same times on each day preferably with or immediately after meals.

• Store this drug between 20 to 25 degrees Celsius (68 to 77 Fahrenheit) and dispense in a tight, light-resistant container.

• Individual patient response to amphetamines varies widely: toxic symptoms can occur at doses as low as 2 mg but are rare with doses of less than 15 mg; 30 mg can produce severe reactions yet doses of 400 to 500 mg are not necessarily fatal.
• Overdosage: Management is largely symptomatic and may include gastric lavage, activated charcoal, a cathartic, and sedation; insufficient data is available to recommend the use of hemodialysis or peritoneal dialysis.

• Cardiovascular: Blood pressure, heart rate, changes in fingers and toes
• General: Signs of abuse/dependence
• Musculoskeletal: Growth (height, weight, appetite)
• Psychiatric: New or worsening psychiatric disorders, including aggressive behavior/hostility, depression, psychosis, mania, and suicidal thoughts or behavior

• Avoid driving and other potentially dangerous activities such as operating machinery until you know how this drug affects you.
• Contact your healthcare provider if you experience any of the following on your fingers or toes during treatment: unexplained wounds, new numbness, pain, skin color change, or temperature sensitivity.

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