Usual Adult Dose for Narcolepsy

Immediate-release tablets only: 5 to 60 mg orally per day in divided doses based on individual response

Comments:

• The first dose should be given on awakening; additional doses should be given at intervals of 4 to 6 hours; late evening doses should be avoided because of resulting insomnia.
• Individualize dose based on patient response; reduce dose if bothersome adverse reactions (e.g., insomnia, anorexia) appear.

Use: For the treatment of narcolepsy.

Usual Adult Dose for Obesity

Immediate-release tablets: 5 to 10 mg orally 30 to 60 minutes before meals
Maximum dose: 30 mg per day

Comments:

• Amphetamines are of limited usefulness for weight loss; potential risks should be weighed against limited usefulness.
• Amphetamines should be administered at the lowest effective dosage and dosage should be individually adjusted; late evening doses should be avoided because of resulting insomnia.

Use: As a short-term adjunct in regimen of weight reduction based on caloric restriction when other treatments have not worked (e.g., repeated diets, group programs, other drugs).

Usual Adult Dose for Attention Deficit Disorder

IMMEDIATE-RELEASE:
Initial dose: 5 mg orally once or twice a day

• Increase in 5 mg increments at weekly intervals until optimal response is achieved; doses may be given at intervals of 4 to 6 hours avoiding late day doses

Maintenance dose: 5 to 40 mg orally per day in divided doses

EXTENDED-RELEASE (XR, ER):
Adezenys XR oral disintegrating tablets (ODT): 12.5 mg orally once a day
Adzenys ER oral suspension (1.25 mg/mL): 12.5 mg orally once a day

Dyanavel XR oral suspension (2.5 mg/mL): Initial Dose: 2.5 or 5 mg orally once a day in the morning

• Increase in increments of 2.5 to 10 mg per day every 4 to 7 days until optimal response is obtained
• Maximum Dose: 20 mg orally per day

Comments:

• The extended-release products (ODTs and oral suspension) contain immediate and extended-release components.
• A total treatment program typically includes other remedial measures (e.g., psychological, educational, and social).
• Amphetamines should be administered at the lowest effective dose and dose should be individually adjusted; late evening doses should be avoided because of resulting insomnia.
• Amphetamine products should not be substituted on a mg-per-mg basis because of differing salt compositions and differing pharmacokinetic profiles; see dosage adjustment section for guidance on switching.

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

Usual Pediatric Dose for Narcolepsy

Age 6 to 11 Years: Immediate-release tablets only:
Initial Dose: 5 mg orally once a day

• Increase dose in 5 mg/day increments weekly until optimal response is achieved

Age 12 Years and Older: Immediate-release tablets only:
Initial Dose: 10 mg orally per day in divided doses

• Increase dose in 10 mg/day increments weekly until optimal response is achieved

Maintenance dose: 5 to 60 mg orally per day in divided doses based on individual response
Maximum dose: 60 mg per day

Comments:

• The first dose should be given on awakening; additional doses should be given at intervals of 4 to 6 hours; late evening doses should be avoided because of resulting insomnia.
• The dose should be individualized based on patient response; if bothersome adverse reactions develop (e.g., insomnia, anorexia), the dose should be reduced.
• Narcolepsy rarely occurs in children under 12 years of age.

Use: For the treatment of narcolepsy.

Usual Pediatric Dose for Obesity

Age 12 Years and Older: Immediate-release tablets only:

• Initial Dose: 5 mg orally 30 to 60 minutes before each meal
• Maximum Dose: 30 mg orally per day in divided doses

Comments:

• Amphetamines are of limited usefulness for weight loss; potential risks should be weighed against limited usefulness.
• Amphetamines should be administered at the lowest effective dosage and dosage should be individually adjusted; late evening doses should be avoided because of resulting insomnia.

Use: As a short-term adjunct in regimen of weight reduction based on caloric restriction when other treatments have not worked (e.g., repeated diets, group programs, other drugs).

Usual Pediatric Dose for Attention Deficit Disorder

3 to 5 years:
IMMEDIATE-RELEASE: Oral Tablets and Oral Disintegrating Tablets (ODTs):
Initial dose: 2.5 mg orally once a day

• Increase in 2.5 mg increments at weekly intervals until optimal response is achieved; doses may be given at intervals of 4 to 6 hours; avoid late day doses

Maintenance dose: 5 to 40 mg orally per day in divided doses

6 years or older:
IMMEDIATE-RELEASE: Oral Tablets and ODTs:
Initial dose: 5 mg orally once or twice a day

• Increase in 2.5 to 5 mg increments at weekly intervals until optimal response is achieved; doses may be given at intervals of 4 to 6 hours; avoid late day doses

Maintenance dose: 2.5 to 40 mg orally per day in divided doses

EXTENDED-RELEASE (XR, ER):
Adezenys XR ODT and Adzenys ER oral suspension (1.25 mg/mL): Initial dose: 6.3 mg orally once a day

• Increase in increments of 3.1 mg or 6.3 mg at weekly intervals

Maximum dose 18.8 mg/day (6 to 12 years); 12.5 mg/day (over 13 years)
Dyanavel XR oral suspension (2.5 mg/mL): Initial Dose: 2.5 or 5 mg orally once a day in the morning

• Increase in increments of 2.5 to 10 mg/day every 4 to 7 days until optimal response is obtained
• Maximum Dose: 20 mg orally per day

Comments:

• The extended-release products (ODTs and oral suspension) contain immediate and extended-release components.
• A total treatment program typically includes other remedial measures (e.g., psychological, educational, and social).
• Amphetamines should be administered at the lowest effective dose and dose should be individually adjusted; late evening doses should be avoided because of resulting insomnia.
• Amphetamine products should not be substituted on a mg-per-mg basis because of differing salt compositions and differing pharmacokinetic profiles; see dosage adjustment section for guidance on switching.

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

Renal Dose Adjustments

Use with caution

Liver Dose Adjustments

Use with caution

Dose Adjustments

Elderly: Dose selection should be conservative starting at the low end of the dosing range and titrating slowly

SWITCHING FROM OTHER AMPHETAMINE PRODUCTS:

• Do not substitute on a mg-per-mg basis
• When switching from one amphetamine product to another, discontinue current treatment, and titrate new formulation using the titration schedule in the Usual Dosage Section
• Switching from Evekeo immediate-release tablets to Evekeo ODT can be done on a mg-per-mg basis

Dose equivalents of Adzenys XR oral suspension and ODTs to Adderall XR extended-release capsules (mixed salts of a single-entity amphetamine)

• Adzenys ER and XR 3.1 mg equivalent to Adderall XR 5 mg
• Adzenys ER and XR 6.3 mg equivalent to Adderall XR 10 mg
• Adzenys ER and XR 9.4 mg equivalent to Adderall XR 15 mg
• Adzenys ER and XR 12.5 mg equivalent to Adderall XR 20 mg
• Adzenys ER and XR 15.7 mg equivalent to Adderall XR 25 mg
• Adzenys ER and XR 18.8 mg equivalent to Adderall XR 30 mg

Dose Modifications Due to Drug Interactions:

• Agents that alter urinary pH can impact urinary excretion and alter blood levels of amphetamine; acidifying agents decrease blood levels of amphetamines, while alkalinizing agents may increase blood level of amphetamines; adjust amphetamine dose accordingly

Precautions

US BOXED WARNINGS: ABUSE AND DEPENDENCE

• Amphetamines have a high potential for abuse; administration for prolonged periods of time may lead to drug dependence and must be avoided. Particular attention should be paid to the possibility of obtaining this drug for non-therapeutic use or distribution to others, and therefore, these drugs should be prescribed or dispensed sparingly. Misuse of amphetamine may cause sudden death and serious cardiovascular adverse events.
• CNS stimulants including this drug, other amphetamine-containing products, and methylphenidate have a high potential for abuse and dependence. Assess risk of abuse prior to prescribing and monitor for signs of abuse and dependence during therapy.

CONTRAINDICATIONS:

• Concurrently, or within 14 days following administration of monoamine oxidase inhibitors including linezolid and IV methylene blue
• Patients with known hypersensitivity to active ingredient, any component of product
• Advanced arteriosclerosis; symptomatic cardiovascular disease; moderate to severe hypertension; hyperthyroidism; agitated states; drug abuse history; or idiosyncrasy to sympathomimetic amines (immediate-release oral tablet only)

Immediate-Release: Safety and efficacy for use as an anorectic agent have not been established in patients younger than 12 years; safety and efficacy for narcolepsy have not been established for patients younger than 6 years; safety and efficacy for treatment of ADHD have not been established in children younger than 3 years.

Extended-release Oral Disintegrating Tablets and Oral Suspension: Safety and efficacy have not been established in patients younger than 6 years.

Consult WARNINGS section for additional precautions.

US Controlled Substance: Schedule II

Dialysis

Data not available

Other Comments

Administration Advice:

• Take orally with or without food
• Morning dosing is preferred; avoid late evening doses because of resulting insomnia

Oral Disintegrating Tablets (ODT):

• Tablets should not be removed from blister pack until administration
• Using dry hands, tear along perforation, bend blister where indicated and peel back blister's labeled backing to take out tablet; tablet should not be pushed out through foil
• Place tablet on tongue and allow to disintegrate without chewing
• Tablet will disintegrate in saliva so that it can be swallowed; do not crush

Oral Suspension:

• Shake well before administration; measure dose with a calibrated measuring device
• Do not add to food or mix with other liquids before consuming
• Wash oral dispensing device after each use

Storage Requirements:

• Store suspension at room temperature in a well-closed container
• Store ODT tablets in rigid, plastic travel case once removed from carton

General:

• Regardless of indication, this drug should be administered at the lowest effective dose and dosage should be individualized according to the needs and responses of the patient.
• Where possible, interrupt dosing occasionally to determine if continued therapy is required.
• Racemic amphetamine differs from dextroamphetamine (d-isomer of racemic amphetamine) in that the l-isomer is more potent than the d-isomer in cardiovascular activity but much less potent in causing CNS excitatory effects, and the racemic mixture is less effective as an appetite suppressant.
• Amphetamines have been reported to exacerbate motor and phonic tics and Tourette's syndrome; clinical evaluation for tics and Tourette's syndrome should precede use of stimulant medications.

Monitoring:

• Prior to treatment, assess for the presence of cardiac disease (perform a careful history, including family history of sudden death or ventricular arrhythmia; physical exam)
• Prior to treatment, assess for risk of abuse
• Cardiovascular: Monitor blood pressure and heart rate; changes in fingers and toes
• Growth suppression: Monitor height and weight in pediatric patients
• Psychiatric: Monitor for signs of abuse/misuse; aggressive behavior/hostility, psychotic and manic symptoms

Patient Advice:

• Instruct patients/caregivers to read the US FDA-approved patient labeling (Medication Guide and Instructions for Use).
• Patients/caregivers should be instructed on proper administration and disposal; patients should understand that this drug is a controlled substance because it can be abused or lead to dependence.
• Patients/caregivers should understand there are serious cardiovascular risks, psychiatric risks, and long-term growth suppression risks associated with use of this drug; they should understand when they will need to immediately seek medical attention.
• Patients/caregivers should be instructed to notify their physician with any changes to their medication regimen including over the counter products and herbal supplements as there is a potential for drug interactions.
• Patients/caregivers should notify their physician if they become pregnant or intend to become pregnant or breastfeed.
• Patients taking extended-release formulations should avoid alcohol as consumption of alcohol may result in a more rapid release of the dose of amphetamine.

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