Amphetamine Sulfate
Generic Name: amphetamine sulfate
Brand Names:
Amphetamine Sulfate
DESCRIPTION Amphetamine Sulfate is a sympathomimetic amino of the amphetamine group. It is a white, odorless crystalline powder. It has a slightly bitter taste. Its solutions are acid to litmus, having a pH of 5 to 8. It is freely soluble in water, slightly soluble in alcohol and practically insoluble in ether. Each tablet, for oral administration contains 5 mg or 10 mg of amphetamine sulfate.
Overview
DESCRIPTION Amphetamine Sulfate is a sympathomimetic amino of the amphetamine group. It is a white, odorless crystalline powder. It has a slightly bitter taste. Its solutions are acid to litmus, having a pH of 5 to 8. It is freely soluble in water, slightly soluble in alcohol and practically insoluble in ether. Each tablet, for oral administration contains 5 mg or 10 mg of amphetamine sulfate.
Uses
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.
Dosage
DOSAGE AND ADMINISTRATION Regardless of indication, amphetamine should be administered at the lowest effective dosage and dosage should be individually adjusted. Late evening doses should be avoided because of resulting insomnia. Narcolepsy Usual dose is 5 to 60 milligrams 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, amphetamine sulfate tablets, USP may be used. The suggested initial dose for patients aged 6 to 12 is 5 mg daily; daily dose may be raised in increments of 5 mg at weekly intervals until optimal response obtained.
Side Effects
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.
Interactions
Drug Interactions MAO inhibitors - MAOI antidepressants, as well as a metabolic of furazolidone, slow amphetamine metabolism. This slowing potentiates amphetamines, increasing their effect on the release of norepinephrine and other monoamines from adrenergic nerve endings; this can cause headaches and other signs of hypertensive crisis. A variety of neurological toxic effects and malignant hyperpyrexia can occur, sometimes with fatal results. Serotonergic Drugs - The concomitant use of amphetamine sulfate and serotonergic drugs increases the risk of serotonin syndrome. Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome, particularly during amphetamine sulfate initiation or dosage increase.
Warnings
WARNING: ABUSE, MISUSE, AND ADDICTION Amphetamine 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 amphetamine 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. WARNINGS Abuse, Misuse, and Addiction Amphetamine sulfate has a high potential for abuse and misuse. The use of Amphetamine sulfate exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Amphetamine sulfate can be diverted for non-medical use into illicit channels or distribution (see DRUG ABUSE AND DEPENDENCE ). Misuse and abuse of CNS stimulants, including Amphetamine 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 Amphetamine sulfate, assess each patient's risk for abuse, misuse, and addiction. CONTRAINDICATIONS Known hypersensitivity to amphetamine products. During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result) (see WARNINGS ).
Storage
HOW SUPPLIED Amphetamine Sulfate Tablets, USP are functionally scored and supplied as follows: 10 mg: Blue, round shaped tablet, scored, debossed "A25" on one side, and quadrisect on the other side. NDC 71335-2990-1: 120 Tablets in a BOTTLE Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a well-closed container, as defined in the USP.
Frequently Asked Questions
What is Amphetamine Sulfate used for?▼
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.
What are the side effects of Amphetamine Sulfate?▼
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.
What are the important warnings for Amphetamine Sulfate?▼
WARNING: ABUSE, MISUSE, AND ADDICTION Amphetamine 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 amphetamine 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. WARNINGS Abuse, Misuse, and Addiction Amphetamine sulfate has a high potential for abuse and misuse. The use of Amphetamine sulfate exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Amphetamine sulfate can be diverted for non-medical use into illicit channels or distribution (see DRUG ABUSE AND DEPENDENCE ). Misuse and abuse of CNS stimulants, including Amphetamine 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 Amphetamine sulfate, assess each patient's risk for abuse, misuse, and addiction. CONTRAINDICATIONS Known hypersensitivity to amphetamine products. During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result) (see WARNINGS ).
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.