Amphetamine Sulfate Tablets

INDICATIONS AND USAGE Amphetamine sulfate tablets 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.

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.

Pregnancy Teratogenic Effects Dextroamphetamine sulfate has been shown to have embryotoxic and teratogenic effects when administered to A/Jax mice and C57BL mice in doses approximately 41 times the maximum human dose. Embryotoxic effects were not seen in New Zealand white rabbits given the drug in doses 7 times the human dose nor in rats given 12.5 times the maximum human dose. There are no adequate and well-controlled studies in pregnant women. Amphetamine sulfate tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

ABUSE MISUSE AND ADDICTION Amphetamine sulfate tablets 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 tablets has a high potential for abuse and misuse. The use of amphetamine sulfate tablets 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 tablets. can result in overdose and death (see OVER.DOSAGE ). and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing amphetamine sulfate tablets, 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 ).