Usual Adult Dose for Attention Deficit Disorder

IR:

• Initial Dose: 5 mg orally 1 or 2 times a day
• Maintenance Dose: Daily dose may be raised 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.

XR:
Patients starting treatment for the first time or switching from another medication:

• Initial Dose: 20 mg orally once a day

Comments:

• IR: The first dose should be given upon awakening; 1 to 2 additional doses should be given at intervals of 4 to 6 hours.
• Where possible, drug administration should be interrupted occasionally to determine if continued therapy is required.

Use: As part of a total treatment program for Attention Deficit Hyperactivity Disorder (ADHD).

Usual Adult Dose for Narcolepsy

IR:

• Initial Dose: 10 mg orally per day in divided doses
• Maintenance Dose: Daily dose may be raised in 10 mg increments at weekly intervals until optimal response is obtained.

Comments:

• The first dose should be given on awakening; 1 to 2 additional doses should be given at intervals of 4 to 6 hours.
• The usual dose is 5 to 60 mg per day in divided doses, depending on the individual patient response.
• Dosage should be reduced if bothersome adverse reactions (e.g., insomnia, anorexia) appear.

Use: Narcolepsy treatment

Usual Pediatric Dose for Attention Deficit Disorder

IR:
Age 3 to 5 Years:

• Initial Dose: 2.5 mg orally per day
• Maintenance Dose: Daily dose may be raised in 2.5 mg increments at weekly intervals until optimal response is obtained.

Age 6 to 17 Years:

• Initial Dose: 5 mg orally 1 or 2 times a day
• Maintenance Dose: Daily dose may be raised 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.

XR:
Age 6 to 12 Years (starting treatment for the first time or switching from another medication):

• Initial Dose: 5 or 10 mg orally once a day in the morning
• Maintenance Dose: Daily dose may be raised in 5 to 10 mg increments at weekly intervals.
• Maximum Dose: 30 mg/day

Age 13 to 17 Years (starting treatment for the first time or switching from another medication):

• Initial Dose: 10 mg orally once a day
• Maintenance Dose: Daily dose may be increased to 20 mg/day after one week if symptoms are not adequately controlled.
• Maximum Dose: 30 mg/day

Comments:

• IR: The first dose should be given on awakening; 1 to 2 additional doses should be given at intervals of 4 to 6 hours.
• Where possible, drug administration should be interrupted occasionally to determine if continued therapy is required.

Use: As part of a total treatment program for Attention Deficit Hyperactivity Disorder (ADHD).

Usual Pediatric Dose for Narcolepsy

IR:
Age 6 to 11 Years:

• Initial Dose: 5 mg orally per day in divided doses
• Maintenance Dose: Daily dose may be raised in 5 mg increments at weekly intervals until optimal response is obtained.

Age 12 Years and Older:

• Initial Dose: 10 mg orally per day in divided doses
• Maintenance Dose: Daily dose may be raised in 10 mg increments at weekly intervals until optimal response is obtained.

Comments:

• The first dose should be given on awakening; 1 to 2 additional doses should be given at intervals of 4 to 6 hours.
• The usual dose is 5 to 60 mg per day in divided doses, depending on the individual patient response.
• Dosage should be reduced if bothersome adverse reactions (e.g., insomnia, anorexia) appear.
• Narcolepsy rarely occurs in children under 12 years of age.

Use: Narcolepsy treatment

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

US BOXED WARNING:

• 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.

Long-term effects of amphetamines in children have not been well established.

• For ADHD treatment, the IR formulation is not recommended in children younger than 3 years and the XR formulation is not recommended in children younger than 6 years.
• For narcolepsy treatment, the IR formulation is not recommended in children younger than 6 years; the XR formulation is not indicated to treat this condition in children.

Consult WARNINGS section for additional precautions.

US Controlled Substance: Schedule II

Dialysis

Data not available

Other Comments

Administration Advice:

• Patients taking divided doses (e.g., 2 times a day) of the IR formulation may be switched to the XR formulation at the same total daily dose taken once a day.
• Regardless of indication, this drug should be administered at the lowest effective dose; dosage should be individualized according to patient needs and responses.
• Late evening doses should be avoided because of the potential for insomnia; afternoon doses also should be avoided if taking the XR formulation.
• This drug can be taken with or without food.
• XR capsules may be taken whole or capsule contents may be sprinkled on applesauce; the applesauce mixture should be consumed immediately without chewing.
• The dose of a single XR capsule should not be divided.

Storage Requirements:

• This drug should be stored between 20 to 25 degrees Celsius (68 to 77 Fahrenheit) and dispensed in a tight, light-resistant container.

General:

• Drug tablets contain d-amphetamine and l-amphetamine salts in a 3:1 ratio.
• 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; IV phentolamine has been suggested if acute severe hypertension occurs; chlorpromazine can antagonize the central stimulant effects; the prolonged release of mixed amphetamine salts in the XR formulation should be taken into consideration.

Monitoring:

• Cardiovascular: Blood pressure, heart rate, changes in fingers and toes
• General: Signs of abuse/dependence
• Musculoskeletal: Growth suppression
• Psychiatric: Aggressive behavior/hostility; psychotic and manic symptoms

Patient Advice:

• Avoid driving and other potentially dangerous activities such as operating machinery until you know how this drug affects you.
• Avoid drinking alcohol during treatment.
• 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.
• If a take-back program or authorized collectors are not available, dispose of this drug by mixing it with an undesirable, nontoxic substance and place it in a sealed plastic bag in the household trash.
• You should not use this drug to combat fatigue or to replace rest.

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