Dextroamphetamine Sulfate
Tablet · Oral
Uses
Dextroamphetamine sulfate is indicated in: Narcolepsy Attention Deficit Disorder with Hyperactivity As an integral part of a total treatment program that typically includes other measures (psychological, educational, social) for patients (ages 6 years to 16 years) with this syndrome. A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. The symptoms must cause clinically significant impairment, e.g., in social, academic, or occupational functioning, and be present in 2 or more settings, e.g., school (or work) and at home. The symptoms must not be better accounted for by another mental disorder. For the Inattentive Type, at least 6 of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. For the Hyperactive-Impulsive Type, at least 6 of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; “on the go”; excessive talking; blurting answers; can’t wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met. Special Diagnostic Considerations Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use of medical and special psychological, educational, and social resources. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the patient and not solely on the presences of the required number of DSM-IV characteristics. Need for Comprehensive Treatment Program Dextroamphetamine sulfate is indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social) for patients with this syndrome. Drug treatment may not be indicated for all patients with this syndrome. Stimulants are not intended for use in patients who exhibit symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is often helpful. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician’s assessment of the chronicity and severity of the patient’s symptoms.
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 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. Extended-release capsules may be used for once-a-day dosage wherever appropriate. Attention Deficit Disorder with Hyperactivity The extended-release capsule formulation is not recommended for pediatric patients younger than 6 years of age. 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 optimal response is obtained. Only in rare cases will it be necessary to exceed a total of 40 mg per day. Extended-release capsules may be used for once-a-day dosage wherever appropriate. Where possible, drug administration should be interrupted occasionally to determine if there is a recurrence of behavioral symptoms sufficient to require continued therapy.
Contraindications
Advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympathomimetic amines, glaucoma. Agitated states. Patients with a history of drug abuse. Known hypersensitivity or idiosyncrasy to amphetamine. In patients known to be hypersensitive to amphetamine, or other components of dextroamphetamine sulfate. Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products [see Adverse Reactions ]. 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 Warnings and Drug Interactions ].
Warnings
Serious Cardiovascular Events Sudden Death in Patients with Pre-existing Structural Cardiac Abnormalities or Other Serious Heart Problems Children and Adolescents Sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems. Although some serious heart problems alone carry an increased risk of sudden death, stimulant products generally should not be used in children or adolescents with known serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant drug. Adults Sudden deaths, stroke, and myocardial infarction have been reported in adults taking stimulant drugs at usual doses for ADHD. Although the role of stimulants in these adult cases is also unknown, adults have a greater likelihood than children of having serious structural cardiac abnormalities, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems. Adults with such abnormalities should also generally not be treated with stimulant drugs [see Contraindications ]. Hypertension and Other Cardiovascular Conditions Stimulant medications cause a modest increase in average blood pressure (about 2 mmHg to 4 mmHg) and average heart rate (about 3 bpm to 6 bpm), and individuals may have larger increases. While the mean changes alone would not be expected to have short-term consequences, all patients should be monitored for larger changes in heart rate and blood pressure. Caution is indicated in treating patients whose underlying medical conditions might be compromised by increases in blood pressure or heart rate, e.g., those with pre-existing hypertension, heart failure, recent myocardial infarction, or ventricular arrhythmia [see Contraindications ]. Assessing Cardiovascular Status in Patients Being Treated with Stimulant Medications Children, adolescents, or adults who are being considered for treatment with stimulant medications should have a careful history (including assessment for a family history of sudden death or ventricular arrhythmia) and physical exam to assess for the presence of cardiac disease, and should receive further cardiac evaluation if findings suggest such disease (e.g., electrocardiogram and echocardiogram). Patients who develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease during stimulant treatment should undergo a prompt cardiac evaluation. Psychiatric Adverse Events Pre-Existing Psychosis Administration of stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder. Bipolar Illness Particular care should be taken in using stimulants to treat ADHD in patients with comorbid bipolar disorder because of concern for possible induction of a mixed/manic episode in such patients. Prior to initiating treatment with a stimulant, patients with comorbid depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression. Emergence of New Psychotic or Manic Symptoms Treatment emergent psychotic or manic symptoms, e.g., hallucinations, delusional thinking, or mania in children and adolescents without a prior history of psychotic illness or mania can be caused by stimulants at usual doses. If such symptoms occur, consideration should be given to a possible causal role of the stimulant, and discontinuation of treatment may be appropriate. In a pooled analysis of multiple short-term, placebo-controlled studies, such symptoms occurred in about 0.1% (4 patients with events out of 3,482 exposed to methylphenidate or amphetamine for several weeks at usual doses) of stimulant-treated patients compared to 0 in placebo-treated patients. Aggression Aggressive behavior or hostility is often observed in children and adolescents with ADHD, and has been reported in clinical trials and the postmarketing experience of some medications indicated for the treatment of ADHD. Although there is no systematic evidence that stimulants cause aggressive behavior or hostility, patients beginning treatment for ADHD should be monitored for the appearance of, or worsening of, aggressive behavior or hostility. Long-Term Suppression of Growth Careful follow-up of weight and height in children ages 7 to 10 years who were randomized to either methylphenidate or non-medication treatment groups over 14 months, as well as in naturalistic subgroups of newly methylphenidate-treated and non-medication treated children older than 36 months (to the ages of 10 to 13 years), suggests that consistently medicated children (i.e. treatment for 7 days per week throughout the year) have a temporary slowing in growth rate (on average, a total of about 2 cm less growth in height and 2.7 kg less growth in weight over 3 years), without evidence of growth rebound during this period of development. Published data are inadequate to determine whether chronic use of amphetamines may cause a similar suppression of growth, however, it is anticipated that they likely have this effect as well. Therefore, growth should be monitored during treatment with stimulants, and patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted. Seizures There is some clinical evidence that stimulants may lower the convulsive threshold in patients with prior history of seizures, in patients with prior EEG abnormalities in absence of seizures, and, very rarely, in patients without a history of seizures and no prior EEG evidence of seizures. In the presence of seizures, the drug should be discontinued.
Precautions
General The least amount feasible should be prescribed or dispensed at 1 time in order to minimize the possibility of overdosage. Information for Patients Amphetamines may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or vehicles; the patient should therefore be cautioned accordingly. Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with dextroamphetamine and should counsel them in its appropriate use. A patient Medication Guide is available for dextroamphetamine sulfate extended-release capsules. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document. Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud’s phenomenon] Instruct patients beginning treatment with dextroamphetamine sulfate about the risk of peripheral vasculopathy, including Raynaud’s phenomenon, and associated signs and symptoms: fingers or toes may feel numb, cool, painful, and/or may change color from pale, to blue, to red. Instruct patients to report to their physician any new numbness, pain, skin color change, or sensitivity to temperature in fingers or toes. Instruct patients to call their physician immediately with any signs of unexplained wounds appearing on fingers or toes while taking dextroamphetamine sulfate. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients. Drug Interactions Acidifying Agents Lower blood levels and efficacy of amphetamines. Increase dose based on clinical response. Examples of acidifying agents include gastrointestinal acidifying agents (e.g., guanethidine, reserpine, glutamic acid hydrochloride, ascorbic acid) and urinary acidifying agents (e.g., ammonium chloride, sodium acid phosphate, methenamine salts). Adrenergic Blockers Adrenergic blockers are inhibited by amphetamines. Alkalinizing Agents Increase blood levels and potentiate the action of amphetamine. Co-administration of dextroamphetamine sulfate and gastrointestinal alkalinizing agents should be avoided. Examples of alkalinizing agents include gastrointestinal alkalinizing agents (e.g., sodium bicarbonate) and urinary alkalinizing agents (e.g. acetazolamide, some thiazides). Tricyclic Antidepressants May enhance the activity of tricyclic or sympathomimetic agents causing striking and sustained increases in the concentration of d-amphetamine in the brain; cardiovascular effects can be potentiated. Monitor frequently and adjust or use alternative therapy based on clinical response. Examples of tricyclic antidepressants include desipramine, protriptyline. CYP2D6 Inhibitors The concomitant use of dextroamphetamine sulfate and CYP2D6 inhibitors may increase the exposure of dextroamphetamine sulfate 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 initiation and after a dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine sulfate and the CYP2D6 inhibitor [see Warnings , Overdosage ]. Examples of CYP2D6 Inhibitors include paroxetine and fluoxetine (also serotonergic drugs), quinidine, ritonavir. Serotonergic Drugs The concomitant use of dextroamphetamine 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 dextroamphetamine sulfate initiation or dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine sulfate and the concomitant serotonergic drug(s) [see Warnings and 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. MAO Inhibitors Concomitant use of MAOIs and CNS stimulants can cause hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure. Do not administer dextroamphetamine sulfate concomitantly or within 14 days after discontinuing MAOI [see Contraindications and Warnings ]. Examples of MAOIs include selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue. Proton Pump Inhibitors Time to maximum concentration (T max ) of amphetamine is decreased compared to when administered alone. Monitor patients for changes in clinical effect and adjust therapy based on clinical response. An example of a proton pump inhibitor is omeprazole. 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.
Side effects
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 phonic tics, and Tourette’s syndrome. Gastrointestinal Dryness of the mouth, unpleasant taste, diarrhea, constipation, 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. Skin and Subcutaneous Tissue Disorders Alopecia. To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Drug interactions
Drug Interactions Acidifying Agents Lower blood levels and efficacy of amphetamines. Increase dose based on clinical response. Examples of acidifying agents include gastrointestinal acidifying agents (e.g., guanethidine, reserpine, glutamic acid hydrochloride, ascorbic acid) and urinary acidifying agents (e.g., ammonium chloride, sodium acid phosphate, methenamine salts). Adrenergic Blockers Adrenergic blockers are inhibited by amphetamines. Alkalinizing Agents Increase blood levels and potentiate the action of amphetamine. Co-administration of dextroamphetamine sulfate and gastrointestinal alkalinizing agents should be avoided. Examples of alkalinizing agents include gastrointestinal alkalinizing agents (e.g., sodium bicarbonate) and urinary alkalinizing agents (e.g. acetazolamide, some thiazides). Tricyclic Antidepressants May enhance the activity of tricyclic or sympathomimetic agents causing striking and sustained increases in the concentration of d-amphetamine in the brain; cardiovascular effects can be potentiated. Monitor frequently and adjust or use alternative therapy based on clinical response. Examples of tricyclic antidepressants include desipramine, protriptyline. CYP2D6 Inhibitors The concomitant use of dextroamphetamine sulfate and CYP2D6 inhibitors may increase the exposure of dextroamphetamine sulfate 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 initiation and after a dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine sulfate and the CYP2D6 inhibitor [see Warnings , Overdosage ]. Examples of CYP2D6 Inhibitors include paroxetine and fluoxetine (also serotonergic drugs), quinidine, ritonavir. Serotonergic Drugs The concomitant use of dextroamphetamine 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 dextroamphetamine sulfate initiation or dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine sulfate and the concomitant serotonergic drug(s) [see Warnings and 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. MAO Inhibitors Concomitant use of MAOIs and CNS stimulants can cause hypertensive crisis. Potential outcomes include death, stroke, myocardial infarction, aortic dissection, ophthalmological complications, eclampsia, pulmonary edema, and renal failure. Do not administer dextroamphetamine sulfate concomitantly or within 14 days after discontinuing MAOI [see Contraindications and Warnings ]. Examples of MAOIs include selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue. Proton Pump Inhibitors Time to maximum concentration (T max ) of amphetamine is decreased compared to when administered alone. Monitor patients for changes in clinical effect and adjust therapy based on clinical response. An example of a proton pump inhibitor is omeprazole. 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 phenobarbital; co-administration of phenobarbital may produce a synergistic anticonvulsant action. Phenytoin Amphetamines may delay intestinal absorption of phenytoin; co-administration of phenytoin may produce a synergistic anticonvulsant action. Propoxyphene In cases of propoxyphene overdosage, amphetamine CNS stimulation is potentiated and fatal convulsions can occur. Veratrum Alkaloids Amphetamines inhibit the hypotensive effect of veratrum alkaloids. Drug/Laboratory Test Interactions Amphetamines can cause a significant elevation in plasma corticosteroid levels. This increase is greatest in the evening. Amphetamines may interfere with urinary steroid determinations. Carcinogenesis/Mutagenesis Mutagenicity studies and long-term studies in animals to determine the carcinogenic potential of dextroamphetamine sulfate have not been performed.
Overdosage
Manifestations of amphetamine overdose include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, panic states, hyperpyrexia and rhabdomyolysis. Fatigue and depression usually follow the central nervous system stimulation. Serotonin syndrome has also been reported. Cardiovascular effects include arrhythmias, hypertension or hypotension and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhea and abdominal cramps. Fatal poisoning is usually preceded by convulsions and coma. Treatment Consult with a Certified Poison Control Center for up to date guidance and advice.
Description
Dextroamphetamine sulfate 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 as the neutral sulfate. Structural formula: Each extended-release capsule is so prepared that an initial dose is released promptly and the remaining medication is released gradually over a prolonged period. Each capsule, with brown cap and natural body, contains 5 mg, 10 mg or 15 mg dextroamphetamine sulfate. The 5 mg capsule is imprinted in white with IX and 5 mg on the brown cap and is imprinted in white with 673 and 5 mg on the natural body. The 10 mg capsule is imprinted in white with IX and 10 mg on the brown cap and is imprinted in white with 674 and 10 mg on the natural body. The 15 mg capsule is imprinted in white with IX and 15 mg on the brown cap and is imprinted in white with 675 and 15 mg on the natural body. Product reformulation in 1996 has caused a minor change in the color of the time-released pellets within each capsule. Inactive ingredients now consist of cetyl alcohol, D&C Yellow No. 10, dibutyl sebacate, ethylcellulose, FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, gelatin, hypromellose, polyethylene glycol, povidone, sodium lauryl sulfate, sugar spheres, and trace amounts of other inactive ingredients. structural formula for amphetamine sulfate
How supplied
Dextroamphetamine Sulfate Extended-Release Capsules are supplied as follows: Dextroamphetamine Sulfate Extended-Release Capsules, 5 mg: Each capsule, with brown cap and natural body, contains dextroamphetamine sulfate. The 5 mg capsule is imprinted in white with IX and 5 mg on the brown cap and is imprinted in white with 673 and 5 mg on the natural body. They are available as: Bottles of 90: NDC 0115-9927-10 Dextroamphetamine Sulfate Extended-Release Capsules, 10 mg: Each capsule, with brown cap and natural body, contains dextroamphetamine sulfate. The 10 mg capsule is imprinted in white with IX and 10 mg on the brown cap and is imprinted in white with 674 and 10 mg on the natural body. They are available as: Bottles of 90: NDC 0115-9928-10 Dextroamphetamine Sulfate Extended-Release Capsules, 15 mg: Each capsule, with brown cap and natural body, contains dextroamphetamine sulfate. The 15 mg capsule is imprinted in white with IX and 15 mg on the brown cap and is imprinted in white with 675 and 15 mg on the natural body. They are available as: Bottles of 90: NDC 0115-9929-10 Store at controlled room temperature between 20° to 25°C (68° to 77°F) [See USP]. Dispense in a tight, light-resistant container. Manufactured by: Catalent Pharma Solutions Winchester, KY 40391 Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 03-2019-00 For additional copies of the printed medication guide, please visit www.amneal.com or contact us at 1-877-835-5472.
Label text from the FDA structured product label by Amneal Pharmaceuticals of New York LLC (revised Dec 31, 2023). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Dextroamphetamine Sulfate in 45 products
Dextroamphetamine Sulfate NDC products (45)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 45963-303 | Dextroamphetamine Sulfate 5 mg/1 Capsule, Extended Release | Actavis Pharma, Inc. | ANDA · DEA CII |
| 45963-304 | Dextroamphetamine Sulfate 10 mg/1 Capsule, Extended Release | Actavis Pharma, Inc. | ANDA · DEA CII |
| 45963-305 | Dextroamphetamine Sulfate 15 mg/1 Capsule, Extended Release | Actavis Pharma, Inc. | ANDA · DEA CII |
| 13107-036 | Dextroamphetamine Sulfate 10 mg/1 Tablet | Aurolife Pharma, LLC | ANDA · DEA CII |
| 13107-035 | Dextroamphetamine Sulfate 5 mg/1 Tablet | Aurolife Pharma, LLC | ANDA · DEA CII |
| 63629-2374 | Dextroamphetamine Sulfate 10 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 63629-2375 | Dextroamphetamine Sulfate 5 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 72162-1233 | Dextroamphetamine Sulfate 5 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 72162-1234 | Dextroamphetamine Sulfate 10 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 72162-2349 | Dextroamphetamine Sulfate 5 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 72162-2350 | Dextroamphetamine Sulfate 10 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 72162-2351 | Dextroamphetamine Sulfate 15 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 72162-2352 | Dextroamphetamine Sulfate 20 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 72162-2353 | Dextroamphetamine Sulfate 30 mg/1 Tablet | Bryant Ranch Prepack | ANDA · DEA CII |
| 27808-089 | Dextroamphetamine Sulfate 5 mg/1 Tablet | Cranbury Pharmaceuticals, LLC | ANDA · DEA CII |
| 27808-090 | Dextroamphetamine Sulfate 10 mg/1 Tablet | Cranbury Pharmaceuticals, LLC | ANDA · DEA CII |
| 10702-065 | Dextroamphetamine Sulfate 5 mg/1 Tablet | KVK-Tech, Inc. | ANDA · DEA CII |
| 10702-066 | Dextroamphetamine Sulfate 10 mg/1 Tablet | KVK-Tech, Inc. | ANDA · DEA CII |
| 43386-871 | Dextroamphetamine Sulfate 10 mg/1 Tablet | Lupin Pharmaceuticals,Inc. | ANDA · DEA CII |
| 43386-870 | Dextroamphetamine Sulfate 5 mg/1 Tablet | Lupin Pharmaceuticals,Inc. | ANDA · DEA CII |
| 66993-359 | Dextroamphetamine Sulfate 5 mg/5mL Solution | Prasco Laboratories | ANDA · DEA CII |
| 0406-8958 | Dextroamphetamine Sulfate 5 mg/1 Tablet | SpecGx LLC | ANDA · DEA CII |
| 0406-8959 | Dextroamphetamine Sulfate 10 mg/1 Tablet | SpecGx LLC | ANDA · DEA CII |
| 0406-8960 | Dextroamphetamine Sulfate 5 mg/1 Capsule, Extended Release | SpecGx LLC | ANDA · DEA CII |
| 0406-8961 | Dextroamphetamine Sulfate 10 mg/1 Capsule, Extended Release | SpecGx LLC | ANDA · DEA CII |
| 0406-8962 | Dextroamphetamine Sulfate 15 mg/1 Capsule, Extended Release | SpecGx LLC | ANDA · DEA CII |
| 11534-189 | Dextroamphetamine Sulfate 10 mg/1 Tablet | SUNRISE PHARMACEUTICAL, INC. | ANDA · DEA CII |
| 11534-188 | Dextroamphetamine Sulfate 5 mg/1 Tablet | SUNRISE PHARMACEUTICAL, INC. | ANDA · DEA CII |
| 0555-0953 | Dextroamphetamine Sulfate 10 mg/1 Tablet | Teva Pharmaceuticals USA, Inc. | ANDA · DEA CII |
| 0555-0952 | Dextroamphetamine Sulfate 5 mg/1 Tablet | Teva Pharmaceuticals USA, Inc. | ANDA · DEA CII |
| 52536-530 | Dextroamphetamine Sulfate 30 mg/1 Tablet | Wilshire Pharmaceuticals, Inc. | ANDA · DEA CII |
| 52536-520 | Dextroamphetamine Sulfate 20 mg/1 Tablet | Wilshire Pharmaceuticals, Inc. | ANDA · DEA CII |
| 52536-515 | Dextroamphetamine Sulfate 15 mg/1 Tablet | Wilshire Pharmaceuticals, Inc. | ANDA · DEA CII |
| 52536-510 | Dextroamphetamine Sulfate 10 mg/1 Tablet | Wilshire Pharmaceuticals, Inc. | ANDA · DEA CII |
| 52536-500 | Dextroamphetamine Sulfate 5 mg/1 Tablet | Wilshire Pharmaceuticals, Inc. | ANDA · DEA CII |
| 75826-122 | Dextroamphetamine Sulfate 7.5 mg/1 Tablet | Winder Laboratories LLC | ANDA · DEA CII |
| 75826-123 | Dextroamphetamine Sulfate 10 mg/1 Tablet | Winder Laboratories LLC | ANDA · DEA CII |
| 75826-126 | Dextroamphetamine Sulfate 30 mg/1 Tablet | Winder Laboratories LLC | ANDA · DEA CII |
| 75826-124 | Dextroamphetamine Sulfate 15 mg/1 Tablet | Winder Laboratories LLC | ANDA · DEA CII |
| 75826-125 | Dextroamphetamine Sulfate 20 mg/1 Tablet | Winder Laboratories LLC | ANDA · DEA CII |
| 75826-121 | Dextroamphetamine Sulfate 5 mg/1 Tablet | Winder Laboratories LLC | ANDA · DEA CII |
| 75826-120 | Dextroamphetamine Sulfate 2.5 mg/1 Tablet | Winder Laboratories LLC | ANDA · DEA CII |
| 0115-9929 | Dextroamphetamine Sulfate 15 mg/1 Capsule, Extended Release | Amneal Pharmaceuticals of New York LLC | NDA AUTHORIZED GENERIC · DEA CII |
| 0115-9928 | Dextroamphetamine Sulfate 10 mg/1 Capsule, Extended Release | Amneal Pharmaceuticals of New York LLC | NDA AUTHORIZED GENERIC · DEA CII |
| 0115-9927 | Dextroamphetamine Sulfate 5 mg/1 Capsule, Extended Release | Amneal Pharmaceuticals of New York LLC | NDA AUTHORIZED GENERIC · DEA CII |
Dextroamphetamine Sulfate recalls
- D-1448-2016 Aug 3, 2016 · Class II · Terminated
Failed Dissolution Specifications - D-0395-2015 Mar 11, 2015 · Class II · Terminated
Failed Dissolution Specifications - D-1408-2014 Jul 2, 2014 · Class II · Terminated
Failed Impurities/Degradation Specifications: this product is being recalled due to an out of specification test result for impurities during stability testing.
Frequently asked questions
What is Dextroamphetamine Sulfate used for?
Dextroamphetamine sulfate is indicated in: Narcolepsy Attention Deficit Disorder with Hyperactivity As an integral part of a total treatment program that typically includes other measures (psychological, educational, social) for patients (ages 6 years to 16 years) with this syndrome. A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of…
What are the side effects of Dextroamphetamine Sulfate?
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 phonic tics, and Tourette’s… See the full label for the complete list.
Who makes Dextroamphetamine Sulfate?
Dextroamphetamine Sulfate is listed by 13 labelers in the FDA NDC directory, including Actavis Pharma, Inc., Aurolife Pharma, LLC, Bryant Ranch Prepack, Cranbury Pharmaceuticals, LLC.
Has Dextroamphetamine Sulfate been recalled?
The FDA enforcement database lists 3 recalls for Dextroamphetamine Sulfate, most recently D-1448-2016 (class ii): Failed Dissolution Specifications