Dextroamphetamine Sulfate

INDICATIONS AND USAGE Dextroamphetamine Sulfate Tablets USP are indicated for: 1. Narcolepsy. 2. 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 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 tablets 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 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 an 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 an 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 an 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). Patients with pheochromocytoma or a history of pheochromocytoma. Serious reactions, including elevated blood pressure and tachyarrhythmia, have been reported in patients with pheochromocytoma or a history of pheochromocytoma who received an amphetamine product.

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. Increased intraocular pressure and glaucoma. To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug Interactions MAO Inhibitors – MAOI antidepressants, as well as a metabolite 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 dextroamphetamine sulfate tablets 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 dextroamphetamine sulfate tablets initiation or dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine sulfate tablets and the concomitant serotonergic drug(s) ( see WARNINGS , PRECAUTIONS ). Examples of serotonergic drugs include selective serotonin reuptake inhibitors (SSRI), serotonin norepinephrine reuptake inhibitors (SNRI), triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John’s Wort. CYP2D6 Inhibitors – The concomitant use of dextroamphetamine sulfate tablets and CYP2D6 inhibitors may increase the exposure of dextroamphetamine sulfate tablets compared to the use of the drug alone and increase the risk of serotonin syndrome. Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome particularly during dextroamphetamine sulfate tablets initiation and after a dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine sulfate tablets and the CYP2D6 inhibitor ( see WARNINGS , OVERDOSAGE ). Acidifying Agents – Gastrointestinal acidifying agents (guanethidine, reserpine, glutamic acid HCl, ascorbic acid, fruit juices, etc.) lower absorption of amphetamines. Urinary acidifying agents (ammonium chloride, sodium acid phosphate, etc.) increase the concentration of the ionized species of the amphetamine molecule, thereby increasing urinary excretion. Both groups of agents lower blood levels and efficacy of amphetamines. Adrenergic Blockers – Adrenergic blockers are inhibited by amphetamines. Alkalinizing Agents – Gastrointestinal alkalinizing agents (sodium bicarbonate, etc.) increase absorption of amphetamines. Urinary alkalinizing agents (acetazolamide, some thiazides) increase the concentration of the non-ionized species of the amphetamine molecule, thereby decreasing urinary excretion. Both groups of agents increase blood levels and, therefore, potentiate the actions of amphetamines. Antidepressants, Tricyclic – Amphetamines may enhance the activity of tricyclic or sympathomimetic agents; d -amphetamine with desipramine or protriptyline and possibly other tricyclics cause striking and sustained increases in the concentration of d -amphetamine in the brain; cardiovascular effects can be potentiated. Antihistamines – Amphetamines may counteract the sedative effect of antihistamines. Antihypertensives – Amphetamines may antagonize the hypotensive effects of antihypertensives. Chlorpromazine – Chlorpromazine blocks dopamine and norepinephrine reuptake, thus inhibiting the central stimulant effects of amphetamines, and can be used to treat amphetamine poisoning. Ethosuximide – Amphetamines may delay intestinal absorption of ethosuximide. Haloperidol – Haloperidol blocks dopamine and norepinephrine reuptake, thus inhibiting the central stimulant effects of amphetamines. Lithium Carbonate – The stimulatory effects of amphetamines may be inhibited by lithium carbonate. Meperidine – Amphetamines potentiate the analgesic effect of meperidine. Methenamine Therapy – Urinary excretion of amphetamines is increased, and efficacy is reduced, by acidifying agents used in methenamine therapy. Norepinephrine – Amphetamines enhance the adrenergic effect of norepinephrine. Phenobarbital – Amphetamines may delay intestinal absorption of phenob …

DESCRIPTION Dextroamphetamine sulfate, USP 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, USP 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 Each tablet, for oral administration, contains dextroamphetamine sulfate, USP in either 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg or 30 mg. Each tablet also contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, microcrystalline cellulose and stearic acid. The 5 mg tablets also contain D&C RED #27 and FD&C Yellow #6. The 7.5 mg tablets also contain FD&C Blue #1 and D&C Yellow #10. The 10 mg tablets also contain FD&C Red #40, FD&C Yellow #6 and FD&C Blue #2. The 15 mg tablets also contain FD&C Blue #1, FD&C Blue #2, and FD&C Red #40. The 20 mg tablets also contain FD&C Blue #1 and D&C Red #27. The 30 mg tablets also contain D&C Yellow #10.

OVERDOSAGE Clinical Effects of Overdose Overdose of CNS stimulants is characterized by the following sympathomimetic effects: • Cardiovascular effects including tachyarrhythmias, and hypertension or hypotension. Vasospasm, myocardial infarction, or aortic dissection may precipitate sudden cardiac death. Takotsubo cardiomyopathy may develop. • CNS effects including psychomotor agitation, confusion, and hallucinations. Serotonin syndrome, seizures, cerebral vascular accidents, and coma may occur. • Life-threatening hyperthermia (temperatures greater than 104°F) and rhabdomyolysis may develop. •Posterior reversible encephalopathy syndrome (PRES) symptoms including headache, altered mental status, hypertension, seizures, and visual disturbances including blindness have occurred in the setting of an amphetamine product overdose. Symptoms of PRES are usually reversible but may evolve into ischemic stroke or cerebral hemorrhage. Diagnosis of PRES should be confirmed by radiological procedure (e.g., MRI). Overdose Management Consider the possibility of multiple drug ingestion. D-amphetamine is not dialyzable. Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.

HOW SUPPLIED Dextroamphetamine Sulfate Tablets USP are available as: 2.5 mg: White, uncoated oval tablet, debossed with ' WL ' on one side and ' 2.5 ' on the other side of the tablet. Available in bottle of 30 (NDC 75826-120-30) and bottle of 100 (NDC 75826-120-10). 5 mg: Pink, uncoated oval tablet, debossed with ‘5’ on one side and on other side scored and debossed ‘W’ on one side of score and “L” on the other side of the score. Available in bottle of 30 (NDC 75826-121-30) and bottle of 100 (NDC 75826-121-10). 7.5 mg: Light Green, uncoated oval tablet, debossed with ' WL ' on one side and ' 7.5 ' on the other side of the tablet. Available in bottle of 30 (NDC 75826-122-30) and bottle of 100 (NDC 75826-122-10). 10 mg: Peach, uncoated oval tablet, debossed with ‘10’ on one side and on other side scored and debossed “W” on one side of score and “L” on other side of the score. Available in bottle of 30 (NDC 75826-123-30) and bottle of 100 (NDC 75826-123-10). 15 mg: Light Blue, uncoated oval tablet, debossed with ' WL ' on one side and ' 15 ' on the other side of the tablet. Available in bottle of 30 (NDC 75826-124-30) and bottle of 100 (NDC 75826-124-10). 20 mg; Purple, uncoated oval tablet, debossed with ' WL ' on one side and ' 20 ' on the other side of the tablet. Available in bottle of 30 (NDC 75826-125-30) and bottle of 100 (NDC 75826-125-10). 30 mg: Light yellow, uncoated oval tablet, debossed with ' WL ' on one side and ' 30 ' on the other side of the tablet. Available in bottle of 30 (NDC 75826-126-30) and bottle of 100 (NDC 75826-126-10). Store at 20° to 25°C (68° to 77°F) [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. DEA Order Form Required. Manufactured By: Winder Laboratories LLC Winder, GA 30680 RLS.119.99-3.0 Rev. 05/2025