dextroamphetamine sulfate 5 mg Capsule, Extended Release, 90-count
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Central Nervous System Stimulant class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Dextroamphetamine is used to control symptoms of attention deficit hyperactivity disorder (ADHD; more difficulty focusing, controlling actions, and remaining still or quiet than other people who are the same age) and to treat narcolepsy (a sleep disorder that causes excessive daytime sleepiness and sudden attacks of sleep). Dextroamphetamine is in a class of medications called central nervous system stimulants. It works by changing the amounts of certain natural substances in the brain.
Read the full MedlinePlus article ↗- It sounds counterintuitive, but stimulants actually calm things down for many people with ADHD. Dextroamphetamine boosts dopamine and norepinephrine — two brain chemicals involved...
- What exactly does dextroamphetamine do, and why does a stimulant help with ADHD?
- The most common ones are decreased appetite, trouble sleeping, and headache — and decreased appetite is very common, especially early on. Taking doses too late in the day tends to...
- What are the most common side effects I should expect?
Patient education
Supplement & herbal interactions
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💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.962 | $86.56 / 90 capsules |
| Medicaid paysCMS SDUD · 12 mo | $1.24 | $111.76 / 90 capsules |
| Medicare drug plans payPart D · Q2 2026 | $1.43 | $128.71 / 90 capsules |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Dextroamphetamine Sulfate Extended-Release 5 mg 00115-9927-10 | Amneal | 90 capsules | $0.822 | AB | FDA listed | save 15% |
| Dextroamphetamine Sulfate Extended-Release 5 mg 00406-8960-01 | SpecGx | 100 capsules | $0.962 | AB | Availability likely | — |
| dextroamphetamine sulfate 5 mgthis 45963-0303-09 | Actavis | 90 capsules | $0.962 | AB | Availability likely | — |
| Dexedrine Spansule 5 mg 64896-0673-10 | Amneal | 90 capsules | — | AB | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 45963-0303-09 You're viewing this | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (45963-303-09) | 2014-06-19 | Active |
📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: ABUSE, MISUSE, AND ADDICTION Dextroamphetamine sulfate extended-release capsule 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 d extroamphetamine sulfate extended-release capsules , 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 dextroamphetamine sulfate extended-release capsules , assess each patient’s risk for abuse, misuse, and addiction.
Educate patients and their families about these risks, proper storage of the drug, and proper disposal of any unused drug. Throughout dextroamphetamine sulfate extended-release capsules treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction [see Warnings and Drug Abuse and Dependence] .
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Dextroamphetamine sulfate extended-release capsules are 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 the 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 extended-release 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. Limitations of Use The use of dextroamphetamine sulfate extended-release capsules is not recommended in pediatric patients younger than 6 years of age because they had higher plasma exposure and a higher incidence of adverse reactions (e.g., weight loss) than patients 6 years and older at the same dosage [see Precautions, Pediatric Use] .
⏱️ Dosage and Administration ▾
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. Prior to treating patients with dextroamphetamine sulfate extended-release capsules, 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].
Narcolepsy Usual dose is 5 mg 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 extended-release 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.
⛔ Contraindications ▾
CONTRAINDICATIONS In patients known to be hypersensitive to amphetamine, or other components of dextroamphetamine sulfate extended-release. 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 ▾
WARNINGS Abuse, Misuse, and Addiction Dextroamphetamine sulfate extended-release capsule has a high potential for abuse and misuse. The use of dextroamphetamine sulfate extended-release capsules exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Dextroamphetamine sulfate extended-release capsules can be diverted for non-medical use into illicit channels or distribution [see Drug Abuse and Dependence] .
Misuse and abuse of CNS stimulants, including dextroamphetamine sulfate extended-release capsules 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 dextroamphetamine sulfate extended-release capsules, assess each patient’s risk for abuse, misuse, and addiction. Educate patients and their families about these risks and proper disposal of any unused drug.
Advise patients to store amphetamine sulfate in a safe place, preferably locked, and instruct patients to not give dextroamphetamine sulfate extended-release capsules to anyone else. Throughout dextroamphetamine sulfate extended-release capsules treatment, reassess each patient’s risk of abuse, misuse, and addiction and frequently monitor for signs and symptoms of abuse, misuse, and addiction. Risks to Patients with Serious Cardiac Disease Sudden death has been reported in patients with structural cardiac abnormalities or other serious cardiac disease who are treated with CNS stimulants at the recommended ADHD dosages.
Avoid dextroamphetamine sulfate extended-release capsule use in patients with known structural cardiac abnormalities, cardiomyopathy, serious cardiac arrhythmia, coronary artery disease, or other serious cardiac disease. Increased Blood Pressure and Heart Rate CNS stimulants cause an increase in blood pressure (mean increase about 2 to 4 mm Hg) and heart rate (mean increase about 3 to 6 bpm). Monitor all patients for potential tachycardia and hypertension.
Psychiatric Adverse Reactions Exacerbation of Pre-Existing Psychosis CNS stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder. Induction of a Manic Episode in Patients with Bipolar Disease CNS stimulants may induce a manic or mixed episode in patients. Prior to initiating treatment, screen patients for risk factors for developing a manic episode (e.g., comorbid or history of depressive symptoms or a family history of suicide, bipolar disorder, or depression).
New Psychotic or Manic Symptoms CNS stimulants, at recommended doses, may cause psychotic or manic symptoms (e.g., hallucinations, delusional thinking, or mania) in patients without a prior history of psychotic illness or mania. In a pooled analysis of multiple short-term, placebo-controlled studies of CNS stimulants, psychotic or manic symptoms occurred in approximately 0.1% of CNS stimulant-treated patients, compared with 0% of placebo-treated patients. If such symptoms occur, consideration discontinuing dextroamphetamine sulfate extended-release.
Long-Term Suppression of Growth in Pediatric Patients Dextroamphetamine sulfate extended-release capsule is not approved for use and is not recommended in pediatric patients below 6 years of age [see Precautions, Pediatric Use] . CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients, including dextroamphetamine sulfate extended-release. Closely monitor growth (weight and height) in dextroamphetamine sulfate extended-release-treated pediatric patients treated with CNS stimulants.
Pediatric patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted [see Precautions, Pediatric Use] . Seizures There is some clinical evidence that stimulants may lower the convulsive threshold in patients with prior history of seizures,…
🤒 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. 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 Teva at 1-888-838-2872 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 HCl, 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. Coadministration of dextroamphetamine sulfate extended-release 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 extended-release and CYP2D6 inhibitors may increase the exposure of dextroamphetamine sulfate extended-release 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 extended-release initiation and after a dosage increase.
If serotonin syndrome occurs, discontinue dextroamphetamine sulfate extended-release 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 extended-release 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 extended-release initiation or dosage increase. If serotonin syndrome occurs, discontinue dextroamphetamine sulfate extended-release 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 extended-release 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 amp…
🔄 Drug / Laboratory Test Interactions ▾
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.
🤰 Pregnancy ▾
Pregnancy Teratogenic Effects Dextroamphetamine sulfate extended-release 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. While there are no adequate and well-controlled studies in pregnant women, there has been 1 report of severe congenital bony deformity, tracheoesophageal fistula, and anal atresia (VATER association) in a baby born to a woman who took dextroamphetamine sulfate with lovastatin during the first trimester of pregnancy.
Dextroamphetamine sulfate extended-release should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic Effects Infants born to mothers dependent on amphetamines have an increased risk of premature delivery and low birth weight. Also, these infants may experience symptoms of withdrawal as demonstrated by dysphoria, including agitation, and significant lassitude.
🧒 Pediatric Use ▾
Pediatric Use The safety and effectiveness of Dextroamphetamine sulfate extended release have not been established in pediatric patients below the age of 6 years. In studies evaluating extended-release amphetamine products, patients 4 to <6 years of age had higher systemic amphetamine exposures than those observed in older pediatric patients at the same dosage. Pediatric patients 4 to <6 years of age also had a higher incidence of adverse reactions, including weight loss.
Clinical experience suggests that in psychotic children, administration of amphetamines may exacerbate symptoms of behavior disturbance and thought disorder. Amphetamines have been reported to exacerbate motor and phonic tics and Tourette’s syndrome. Therefore, clinical evaluation for tics and Tourette’s syndrome in children and their families should precede use of stimulant medications.
Data are inadequate to determine whether chronic administration of amphetamines may be associated with growth inhibition; therefore, growth should be monitored during treatment. Drug treatment is not indicated in all cases of Attention Deficit Disorder with Hyperactivity and should be considered only in light of the complete history and evaluation of the child. The decision to prescribe amphetamines should depend on the physician’s assessment of the chronicity and severity of the child’s symptoms and their appropriateness for his or her age.
Prescription should not depend solely on the presence of one or more of the behavioral characteristics. When these symptoms are associated with acute stress reactions, treatment with amphetamines is usually not indicated.
🆘 Overdosage ▾
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.
Overdose Management Consider the possibility of multiple drug ingestion. The pharmacokinetic profile of Dextroamphetamine sulfate should be considered when treating patients with overdose. D-amphetamine is not dialyzable.
Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdose management recommendations.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Amphetamines are noncatecholamine, sympathomimetic amines with CNS stimulant activity. Peripheral actions include elevations of systolic and diastolic blood pressures and weak bronchodilator and respiratory stimulant action. There is neither specific evidence that clearly establishes the mechanism whereby amphetamines produce mental and behavioral effects in children, nor conclusive evidence regarding how these effects relate to the condition of the central nervous system.
Dextroamphetamine sulfate extended-release capsules are formulated to release the active drug substance in vivo in a more gradual fashion than the standard formulation, as demonstrated by blood levels. The formulation has not been shown superior in effectiveness over the same dosage of the standard, noncontrolled-release formulations given in divided doses. Pharmacokinetics The pharmacokinetics of the tablet and extended-release capsule were compared in 12 healthy subjects.
The extent of bioavailability of the extended-release capsule was similar compared to the immediate-release tablet. Following administration of three 5-mg tablets, average maximal dextroamphetamine plasma concentrations (C max ) of 36.6 ng/mL were achieved at approximately 3 hours. Following administration of one 15-mg extended-release capsule, maximal dextroamphetamine plasma concentrations were obtained approximately 8 hours after dosing.
The average C max was 23.5 ng/mL. The average plasma T 1/2 was similar for both the tablet and extended-release capsule and was approximately 12 hours. In 12 healthy subjects, the rate and extent of dextroamphetamine absorption were similar following administration of the extended-release capsule formulation in the fed (58 gm to 75 gm fat) and fasted state.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Dextroamphetamine Sulfate Extended-Release Capsules are available as follows: 5 mg - Capsules with a light brown opaque cap and body are printed with and 0303 on both cap and body in black ink and contain 5 mg of dextroamphetamine sulfate, USP. Capsules are supplied in bottles of 90 (NDC 45963-303-09). 10 mg - Capsules with a light brown opaque cap and light orange transparent body are printed with and 0304 on both cap and body in black ink and contain 10 mg of dextroamphetamine sulfate, USP.
Capsules are supplied in bottles of 90 (NDC 45963-304-09). 15 mg - Capsules with a light brown opaque cap and light orange transparent body are printed with and 0305 on both cap and body in black ink and contain 15 mg of dextroamphetamine sulfate, USP. Capsules are supplied in bottles of 90 (NDC 45963-305-09).
Store at controlled room temperature between 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. Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev.
C 4/2026 1 2 3
📋 Description ▾
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 extended-release 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 5 mg capsule, with a light brown opaque cap and body, contains 5 mg of dextroamphetamine sulfate, USP. The 5 mg capsule is printed with and 0303 on both cap and body in black ink. Each 10 mg capsule, with a light brown opaque cap and light orange transparent body, contains 10 mg of dextroamphetamine sulfate, USP.
The 10 mg capsule is printed with and 0304 on both cap and body in black ink. Each 15 mg capsule, with a light brown opaque cap and light orange transparent body, contains 15 mg of dextroamphetamine sulfate, USP. The 15 mg capsule is printed with and 0305 on both cap and body in black ink.
Inactive ingredients: ethylcellulose dispersion type B (which contains, ethylcellulose, medium chain triglycerides, oleic acid, ammonium hydroxide and water), hydroxypropyl cellulose, hypromellose 2910, polyethylene glycol 400 & 8000, purified water, sugar spheres (which contain sucrose and corn starch), and talc. The capsule shells of the 5 mg, 10 mg and 15 mg contain carboxymethylcellulose, gelatin, iron oxide black, iron oxide red, iron oxide yellow, silicon dioxide, sodium lauryl sulfate, titanium dioxide. In addition, the 10 mg and 15 mg capsule shell contains D&C yellow # 10, FD&C red # 40.
The capsule shells are imprinted with black ink which contains: ammonium hydroxide, black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac, and strong ammonia solution. 1 2 3 4
💬 Information for Patients ▾
Information for Patients Advise the patient to read the FDA-approved patient labeling (Medication Guide). Abuse, Misuse, and Addiction Educate patients and their families about the risks of abuse, misuse, and addiction of dextroamphetamine sulfate extended-release, which can lead to overdose and death, and proper disposal of any unused drug [see Warnings, Drug Abuse and Dependence, Overdosage] . Advise patients to store dextroamphetamine sulfate extended-release in a safe place, preferably locked, and instruct patients to not give dextroamphetamine sulfate extended-release to anyone else.
Risks to Patients with Serious Cardiac Disease Advise patients that there are potential risks to patients with serious cardiac disease, including sudden death, with dextroamphetamine sulfate extended-release use. Instruct patients to contact a healthcare provider immediately if they develop symptoms such as exertional chest pain, unexplained syncope, or other symptoms suggestive of cardiac disease [see Warnings] . Increased Blood Pressure and Heart Rate Instruct patients that dextroamphetamine sulfate extended-release can elevate blood pressure and heart rate [see Warnings] .
Psychiatric Adverse Reactions Advise patients that dextroamphetamine sulfate extended-release, at recommended doses, can cause psychotic or manic symptoms, even in patients without prior history of psychotic symptoms or mania [see Warnings] . Long-Term Suppression of Growth in Pediatric Patients Advise patients that dextroamphetamine sulfate extended-release may cause slowing of growth and weight loss in pediatric patients [see Warnings] . Circulation problems in fingers and toes [Peripheral vasculopathy, including Raynaud’s phenomenon] Instruct patients beginning treatment with dextroamphetamine sulfate extended-release 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 extended-release. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients [see Warnings] .
Motor and Verbal Tics, and Worsening of Tourette’s Syndrome Advise patients that motor and verbal tics and worsening of Tourette’s Syndrome may occur during treatment with dextroamphetamine sulfate extended-release. Instruct the patients to notify their healthcare provider if emergence or worsening of tics or Tourette’s syndrome occurs [see Warnings] .
💬 Medication Guide ▾
MEDICATION GUIDE Dextroamphetamine Sulfate (dex'' troe am fet' a meen sul' fate) Extended-Release Capsules, CII What is the most important information I should know about dextroamphetamine sulfate extended-release capsules? Dextroamphetamine sulfate extended-release capsules may cause serious side effects, including : Abuse, misuse, and addiction. Dextroamphetamine sulfate extended-release capsules has a high chance for abuse and misuse and may lead to substance use problems, including addiction.
Misuse and abuse of Dextroamphetamine sulfate extended-release capsules, other amphetamine containing medicines, and methylphenidate containing medicines, can lead to overdose and death. The risk of overdose and death is increased with higher doses of Dextroamphetamine sulfate extended-release capsules or when it is used in ways that are not approved, such as snorting or injection. Your healthcare provider should check you or your child’s risk for abuse, misuse, and addiction before starting treatment with Dextroamphetamine sulfate extended-release capsules and will monitor you or your child during treatment.
Dextroamphetamine sulfate extended-release capsules may lead to physical dependence after prolonged use, even if taken as directed by your healthcare provider. Do not give Dextroamphetamine sulfate extended-release capsules to anyone else. See “What are Dextroamphetamine sulfate extended-release capsules?” for more information.
Keep Dextroamphetamine sulfate extended-release capsules in a safe place and properly dispose of any unused medicine. See “How should I store Dextroamphetamine sulfate extended-release capsules?” for more information. Tell your healthcare provider if you or your child have ever abused or been dependent on alcohol, prescription medicines, or street drugs.
Risks for people with serious heart disease. Sudden death has happened in people who have heart defects or other serious heart disease. Your healthcare provider should check you or your child carefully for heart problems before starting dextroamphetamine sulfate extended-release capsules.
Tell your healthcare provider if you or your child have any heart problems, heart disease, or heart defects. Call your healthcare provider right away or go to the nearest hospital emergency room right away if you or your child have any signs of heart problems such as chest pain, shortness of breath, or fainting during treatment with dextroamphetamine sulfate extended-release capsules. Increased blood pressure and heart rate.
Your healthcare provider should check you or your child’s blood pressure and heart rate regularly during treatment with Dextroamphetamine sulfate extended-release capsules. Mental (psychiatric) problems, including: new or worse behavior or thought problems new or worse bipolar illness new psychotic symptoms (such as hearing voices, or seeing or believing things that are not real) or new manic symptoms Tell your healthcare provider about any mental problems you or your child have, or about a family history of suicide, bipolar illness, or depression.
Call your healthcare provider right away if you or your child have any new or worsening mental symptoms or problems during treatment with dextroamphetamine sulfate extended-release capsules, especially hearing voices, seeing or believing things that are not real, or new manic symptoms. What are dextroamphetamine sulfate extended-release capsules ? Dextroamphetamine sulfate extended-release capsules are a central nervous system (CNS) stimulant prescription medicine used for the treatment of: a sleep disorder called narcolepsy.
Attention-Deficit Hyperactivity Disorder (ADHD) in children 6 to 17 years of age. Dextroamphetamine sulfate extended-release capsules may help increase attention and decrease impulsiveness and hyperactivity in people with ADHD. Dextroamphetamine sulfate extended-release capsules is not recommended for use in children under 6 years of age with ADHD.
Dextroamphetamine sulfate extended-re…