Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, Amphetamine Sulfate Prescribing Information
Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets have 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 saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets, can result in overdose and death (see
Before prescribing dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets, 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 saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction (see
Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy.
Regardless of indication, amphetamines should be administered at the lowest effective dosage, and dosage should be individually adjusted according to the therapeutic needs and response of the patient. Late evening doses should be avoided because of the resulting insomnia.
In patients known to be hypersensitive to amphetamine, or other components of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets.
Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products [see
Patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of stopping MAOIs (including MAOIs such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis [see
A single-entity amphetamine product combining the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d, l-amphetamine aspartate monohydrate.
EACH TABLET CONTAINS | 5 mg | 10 mg | 15 mg | 20 mg | 30 mg | |
Dextroamphetamine Saccharate | 1.25 mg | 2.5 mg | 3.75 mg | 5 mg | 7.5 mg | |
| Amphetamine Aspartate Monohydrate | 1.25 mg | 2.5 mg | 3.75 mg | 5 mg | 7.5 mg | |
Dextroamphetamine Sulfate, USP | 1.25 mg | 2.5 mg | 3.75 mg | 5 mg | 7.5 mg | |
Amphetamine Sulfate, USP | 1.25 mg | 2.5 mg | 3.75 mg | 5 mg | 7.5 mg | |
| Total Amphetamine Base Equivalence | 3.13 mg | 6.3 mg | 9.4 mg | 12.6 mg | 18.8 mg |
Inactive Ingredients: microcrystalline cellulose, maltodextrin, compressible sugar, corn starch, colloidal silicon dioxide, saccharin sodium and magnesium stearate. The 15 mg, 20 mg and 30 mg tablets contain FD&C Yellow #6 Aluminum Lake as a color additive.
Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. The mode of therapeutic action in Attention Deficit Hyperactivity Disorder (ADHD) is not known. Amphetamines are thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.