AMPHETAMINE SULFATE
Generic: AMPHETAMINE SULFATE
Basic Information
Manufacturer
Bryant Ranch Prepack
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
c00bbade-3dc8-422b-8cff-f85db408bdfc
Indications & Usage
INDICATIONS AND USAGE Amphetamine sulfate tablets, USP 5 mg and 10 mg 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 children with 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 the 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 not be warranted.
Exogenous Obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction for patients refractory to alternative therapy, e.g., repeated diets, group programs, and other drugs.
The limited usefulness of amphetamines (see CLINICAL PHARMACOLOGY ) should be weighed against possible risks inherent in use of the drug, such as those described below.
The diagnosis of the 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 not be warranted.
Exogenous Obesity as a short term (a few weeks) adjunct in a regimen of weight reduction based on caloric restriction for patients refractory to alternative therapy, e.g., repeated diets, group programs, and other drugs.
The limited usefulness of amphetamines (see CLINICAL PHARMACOLOGY ) should be weighed against possible risks inherent in use of the drug, such as those described below.
Adverse Reactions
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 when amphetamines are used for other than the anorectic effect.
Allergic Urticaria Endocrine Impotence, changes in libido, and frequent or prolonged erections.
Musculoskeletal Rhabdomyolysis
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 when amphetamines are used for other than the anorectic effect.
Allergic Urticaria Endocrine Impotence, changes in libido, and frequent or prolonged erections.
Musculoskeletal Rhabdomyolysis