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Uses

Attention Deficit Hyperactivity Disorder

Used as an adjunct to psychological, educational, social, and other remedial measures in the treatment of attention deficit hyperactivity disorder (ADHD) (hyperkinetic disorder, hyperkinetic syndrome of childhood, minimal brain dysfunction).

Can be used for ADHD in pediatric (children, adolescents) as well as adult patients.

Almost all studies comparing behavioral therapy versus stimulants alone have shown a much stronger therapeutic effect from stimulants than from behavioral therapy, and stimulants (e.g., amphetamines, methylphenidate) remain the drugs of choice for the management of ADHD.

Drug therapy is not indicated in all patients with ADHD, and such therapy should be considered only after a complete evaluation including medical history has been performed.

Use should depend on age, adequate diagnosis (based on medical, special psychological, educational, and social resources), and the clinician’s assessment of the severity and duration of symptoms and should not depend solely on one or more behavioral characteristics.

Not recommended for ADHD symptoms associated with acute stress reactions.

Narcolepsy

Used as a stimulant to reduce daytime sleepiness in the management of narcolepsy.

Amphetamines remain the mainstay of treatment for narcolepsy based on a long record of clinical experience.

Tolerance to the clinical effects may develop with long-term therapy, particularly at high dosages.

Exogenous Obesity

Has been used as an adjunct to caloric restriction and behavioral modification in the short-term treatment of exogenous obesity†. However, because of the limited efficacy (short-lived) and risk of abuse, such use no longer is included in the FDA-approved labeling and is discouraged.

The anorexigenic effect appears to be temporary, seldom lasting more than a few weeks, and tolerance may occur.

Obesity usually is a chronic disease, and short-term or intermittent therapy with anorexigenic drugs is unlikely to maintain a long-term benefit.

Dosage and Administration

Administration

Oral Administration

Conventional Tablets

Administer initial dose on awakening. When daily dosage is administered in 2 or 3 divided doses, administer the doses at intervals of 4–6 hours. Because of potential for insomnia, avoid administering doses in the late evening.

Extended-release Capsules

Administer on awakening. Because of potential for insomnia, avoid administering in the afternoon.

Administer capsules with or without food; capsules may be swallowed intact or the entire contents of a capsule(s) may be sprinkled on a small amount of applesauce immediately prior to administration. Do not subdivide the capsule contents. Do not chew or crush the pellets contained in the capsules and do not store the sprinkle/food mixture for later use.

Dosage

Fixed-combination extended-release capsules containing various salts of amphetamine and dextroamphetamine can be substituted for their respective conventional short-acting preparations if less-frequent daily dosing is desirable.

Dosage of fixed-combination preparations containing various salts of amphetamine and dextroamphetamine is expressed as total amphetamine base equivalence.

Adjust dosage according to individual response and tolerance; the smallest dose required to produce the desired response should always be used.

When possible, therapy should be interrupted occasionally to determine if there is a recurrence of behavioral symptoms sufficient to require continued treatment.

Pediatric Patients

Attention Deficit Hyperactivity Disorder

Dosage titration usually requires 2–4 weeks.

Conventional Tablets

Oral

Dosing in pediatric patients may begin with once-daily administration in the early morning, adding a noon dose if the effect does not last throughout the school day. Increasing the morning dose may extend its duration. A third dose may be added at around 4 p.m. if necessary.

Children 3–5 years of age: Initially, 2.5 mg daily; the daily dosage is increased in 2.5-mg increments at weekly intervals until the optimum response is attained.

Children ≥6 years of age: Initially, 5 mg once or twice daily; the daily dosage is increased in 5-mg increments at weekly intervals until the optimum response is attained. Total daily dosage rarely should exceed 40 mg.

Extended-release Capsules (Adderall XR^®)

Oral

Children 6–12 years of age: Initially, 10 mg once daily; daily dosage may be increased in 5- or 10-mg increments at weekly intervals to a maximum dosage of 30 mg daily. Alternatively, initiate with 5 mg once daily when lower initial dosage is appropriate.

Adolescents 13–17 years of age: Initially, 10 mg once daily. Increase to 20 mg once daily after 1 week if symptoms not adequately controlled. No evidence that dosages >20 mg daily provide any additional benefit.

When switching from conventional tablets to extended-release capsules, the total daily dosage may remain the same but may be given once daily.

Narcolepsy

When intolerable adverse effects occur (e.g., insomnia, anorexia), dosage should be reduced.

Conventional Tablets

Oral

Children 6–12 years of age: Initially, 5 mg daily; daily dosage is increased in 5-mg increments at weekly intervals until the optimum response is attained.

Children ≥12 years of age: Initially, 10 mg daily; daily dosage is increased in 10-mg increments at weekly intervals until the optimum response is attained.

Maintenance: Usually, 5–60 mg daily, depending on patient age and response, given in divided doses.

Adults

Attention Deficit Hyperactivity Disorder

Conventional Tablets

Dosage titration usually requires 2–4 weeks.

Oral

Initially, 5 mg once or twice daily; the daily dosage is increased in 5- to 10-mg increments at weekly intervals until the optimum response is attained. Total daily dosage rarely should exceed 40 mg.

Extended-release Capsules (Adderall XR^®)

Oral

20 mg once daily as initial therapy or when switching from other drugs. No evidence that dosages >20 mg daily provide any additional benefit.

When switching from conventional tablets to extended-release capsules, the total daily dosage may remain the same but may be given once daily.

Narcolepsy

When intolerable adverse effects occur (e.g., insomnia, anorexia), dosage should be reduced.

Conventional Tablets

Oral

Initially, 10 mg daily; daily dosage is increased in 10-mg increments at weekly intervals until the optimum response is attained.

Maintenance: Usually, 5–60 mg daily, depending on response, given in divided doses.

Prescribing Limits

Pediatric Patients

Attention Deficit Hyperactivity Disorder

Excessive dosage can cause pediatric patients to become overfocused on the medication or to appear dull or overly restricted. Rarely, psychotic reactions, mood disturbances, or hallucinations can occur.

Conventional Tablets

Oral

Dosage rarely should exceed a total daily dosage of 40 mg. Individual doses rarely should exceed 10 mg each in children <25 kg.

Long-term use has not been studied systematically. If used for long-term therapy, periodically reevaluate the usefulness of the drug.

Extended-release Capsules (Adderall XR^®)

Oral

Children 6–12 years of age: Dosages >30 mg daily have not been studied systematically.

Adolescents 13–17 years of age: Dosages up to 60 mg daily have been evaluated in clinical studies; however, no evidence that dosages >20 mg daily provide any additional benefit.

Long-term use (>3 weeks in children or >4 weeks in adolescents) has not been studied systematically. If used for long-term therapy, periodically reevaluate the usefulness of the drug.

Adults

Attention Deficit Hyperactivity Disorder

Conventional Tablets

Oral

Dosages up to 0.9 mg/kg daily but rarely exceeding 40 mg daily. Such higher doses may be more likely in adults than in school-aged children because of increased dosing frequency to cover a longer work day.

Tolerance is more likely with relatively high dosages.

Long-term use has not been studied systematically. If used for long-term therapy, periodically reevaluate the usefulness of the drug.

Extended-release Capsules (Adderall XR^®)

Oral

Dosages up to 60 mg daily have been evaluated in clinical studies; however, no evidence that dosages >20 mg daily provide any additional benefit.

Long-term use (>4 weeks) has not been studied systematically. If used for long-term therapy, periodically reevaluate the usefulness of the drug.

Special Populations

Dosage in Hepatic Impairment

No specific hepatic dosage recommendations.

Dosage in Renal Impairment

No specific renal dosage recommendations.

Geriatric Patients

No specific geriatric dosage recommendations.