Dextroamphetamine Sulfate - Dextroamphetamine Sulfate tablet prescribing information
WARNING: ABUSE, MISUSE, AND ADDICTION
Dextroamphetamine sulfate has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of CNS stimulants, including dextroamphetamine sulfate, can result in overdose and death (see OVERDOSAGE), and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection.
Before prescribing dextroamphetamine sulfate, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout dextroamphetamine sulfate treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction (see WARNINGS and DRUG ABUSE and DEPENDENCE)
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INDICATIONS AND USAGE
Dextroamphetamine Sulfate Tablets USP are indicated for:
- Narcolepsy .
- Attention Deficit Disorder with Hyperactivity , as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 to 16 years) with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted.
DOSAGE AND ADMINISTRATION
Amphetamines should be administered at the lowest effective dosage and dosage should be individually adjusted. Late evening doses should be avoided because of the resulting insomnia.
Narcolepsy
Usual dose is 5 mg to 60 mg per day in divided doses, depending on the individual patient response.
Narcolepsy seldom occurs in children under 12 years of age; however, when it does, dextroamphetamine sulfate may be used. The suggested initial dose for patients aged 6 to 12 years is 5 mg daily; daily dose may be raised in increments of 5 mg at weekly intervals until an optimal response is obtained. In patients 12 years of age and older, start with 10 mg daily; daily dosage may be raised in increments of 10 mg at weekly intervals until optimal response is obtained. If bothersome adverse reactions appear (e.g., insomnia or anorexia), dosage should be reduced. Give first dose on awakening; additional doses (1 or 2) at intervals of 4 to 6 hours.
Attention Deficit Disorder with Hyperactivity
Not recommended for pediatric patients under 3 years of age.
In pediatric patients from 3 to 5 years of age , start with 2.5 mg daily; daily dosage may be raised in increments of 2.5 mg at weekly intervals until optimal response is obtained.
In pediatric patients 6 years of age and older , start with 5 mg once or twice daily; daily dosage may be raised in increments of 5 mg at weekly intervals until optimal response is obtained. Only in rare cases will it be necessary to exceed a total of 40 mg per day.
Give first dose on awakening; additional doses (1 or 2) at intervals of 4 to 6 hours.
Where possible, drug administration should be interrupted occasionally to determine if there is a recurrence of behavioral symptoms sufficient to require continued therapy. Prior to treating patients with dextroamphetamine sulfate tablets assess:
- for the presence of cardiac disease (i.e., perform a careful history, family history of sudden death or ventricular arrhythmia, and physical exam) [see WARNINGS].
- the family history and clinically evaluate patients for motor or verbal tics or Tourette’s syndrome [see WARNINGS].
CONTRAINDICATIONS
Known hypersensitivity to amphetamine products. During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result).
ADVERSE REACTIONS
Cardiovascular
Palpitations, tachycardia, elevation of blood pressure. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use.
Central Nervous System
Psychotic episodes at recommended doses (rare), overstimulation, restlessness, dizziness, insomnia, euphoria, dyskinesia, dysphoria, tremor, headache, exacerbation of motor and verbal tics and Tourette’s syndrome.
Gastrointestinal
Dryness of the mouth, unpleasant taste, diarrhea, constipation, intestinal ischemia and other gastrointestinal disturbances. Anorexia and weight loss may occur as undesirable effects.
Allergic
Urticaria.
Endocrine
Impotence, changes in libido, frequent or prolonged erections.
Musculoskeletal
Rhabdomyolysis
DESCRIPTION
Dextroamphetamine sulfate is the dextro isomer of the compound d,l -amphetamine sulfate, a sympathomimetic amine of the amphetamine group. Chemically, dextroamphetamine is d- alpha-methylphenethylamine, and is present in all forms of dextroamphetamine sulfate as the neutral sulfate. The structural formula is as follows:
(C 9 H 13 N) 2 . H 2 SO 4 M.W. 368.49
Inactive Ingredients
Colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose and pregelatinized starch (botanical source: maize).
The 5 mg also contains D&C yellow no. 10 aluminum lake and FD&C red no. 40 aluminum lake. The 10 mg also contains FD&C red no. 40 aluminum lake and FD&C yellow no. 6 aluminum lake.
CLINICAL PHARMACOLOGY
Amphetamines are non-catecholamine, sympathomimetic amines with CNS stimulant activity. Peripheral actions include elevations of systolic and diastolic blood pressures and weak bronchodilator and respiratory stimulant action.
There is neither specific evidence which clearly establishes the mechanism whereby amphetamines produce mental and behavioral effects in children, nor conclusive evidence regarding how these effects relate to the condition of the central nervous system.
Pharmacokinetics
The pharmacokinetics of the tablet and sustained-release capsule were compared in 12 healthy subjects. The extent of bioavailability of the sustained-release capsule was similar compared to the immediate-release tablet. Following administration of three 5 mg tablets, average maximal dextroamphetamine plasma concentrations (C max ) of 36.6 ng/mL were achieved at approximately 3 hours. Following administration of one 15 mg sustained-release capsule, maximal dextroamphetamine plasma concentrations were obtained approximately 8 hours after dosing. The average C max was 23.5 ng/mL. The average plasma T 1/2 was similar for both the tablet and sustained-release capsule and was approximately 12 hours.
In 12 healthy subjects, the rate and extent of dextroamphetamine absorption were similar following administration of the sustained-release capsule formulation in the fed (58 to 75 gm fat) and fasted state.
HOW SUPPLIED
Dextroamphetamine Sulfate Tablets are available as:
5 mg: Peach, round, flat faced, beveled edge tablets, debossed “N” left of bisect “27” on one side and plain on the other side having functional score. Available in bottles of 100 (NDC: 11534-188-01) and 1,000 (NDC: 11534-188-03).
10 mg: Pink, round, flat faced, beveled edge tablets, debossed “N” left of bisect “28” on one side and plain on the other side having functional score. Available in bottles of 100 (NDC: 11534-189-01) and 1,000 (NDC: 11534-189-03).
Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature].
Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Manufactured & Distributed By: Sunrise Pharmaceutical, Inc. Rahway, NJ 07065
Rev. 09/2024 5359/04
