Rx only

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: denatured alcohol, ammonium hydroxide, ethylcellulose, gelatin, hydroxypropyl cellulose, hypromellose, medium chain triglycerides, oleic acid, polyethylene glycol and sugar spheres (which contain sucrose and corn starch).

The capsule shells of the 5 mg, 10 mg and 15 mg contain black iron oxide, red iron oxide, silicon dioxide, sodium lauryl sulfate, talc, titanium dioxide and yellow iron oxide. In addition, the 10 mg and 15 mg capsule shell contains FD&C Red #40 and D&C Yellow #10.

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.

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.

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.

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].

Abuse, Misuse, and Addiction

Amphetamines 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. Amphetamines can be diverted for non-medical use into illicit channels or distribution [see Drug Abuse and Dependence]. Misuse and abuse of CNS stimulants, including Amphetamines 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 Amphetamines, 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 Amphetamines to anyone else. Throughout Amphetamines 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 Amphetamines 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

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, 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.

Peripheral Vasculopathy, including Raynaud’s phenomenon

Stimulants, including dextroamphetamine sulfate extended-release, used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; however, sequelae have included digital ulceration and/or soft tissue breakdown. Effects of peripheral vasculopathy, including Raynaud’s phenomenon, were observed in post-marketing reports and at therapeutic dosages in all age groups throughout the course of treatment. Signs and symptoms generally improve after dosage reduction or discontinuation of the CNS stimulant. Careful observation for digital changes is necessary during Amphetamines treatment. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for Dextroamphetamine sulfate-treated patients who develop signs or symptoms of peripheral vasculopathy.

Serotonin Syndrome

Serotonin syndrome, a potentially life-threatening reaction, may occur when amphetamines are used in combination with other drugs that affect the serotonergic neurotransmitter systems such as monoamine oxidase inhibitors (MAOIs), selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John’s Wort [see Drug Interactions]. Amphetamines and amphetamine derivatives are known to be metabolized, to some degree, by cytochrome P450 2D6 (CYP2D6) and display minor inhibition of CYP2D6 metabolism [see Clinical Pharmacology]. The potential for a pharmacokinetic interaction exists with the coadministration of CYP2D6 inhibitors which may increase the risk with increased exposure to dextroamphetamine sulfate extended-release. In these situations, consider an alternative non-serotonergic drug or an alternative drug that does not inhibit CYP2D6 [see Drug Interactions].

Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).

Concomitant use of dextroamphetamine sulfate extended-release with MAOI drugs is contraindicated [see Contraindications].

Discontinue treatment with dextroamphetamine sulfate extended-release and any concomitant serotonergic agents immediately if the above symptoms occur, and initiate supportive symptomatic treatment. If concomitant use of dextroamphetamine sulfate extended-release with other serotonergic drugs or CYP2D6 inhibitors is clinically warranted, initiate dextroamphetamine sulfate extended-release with lower doses, monitor patients for the emergence of serotonin syndrome during drug initiation or titration, and inform patients of the increased risk for serotonin syndrome.

Motor and Verbal Tics, and Worsening of Tourette’s Syndrome

CNS stimulants, including amphetamine sulfate, have been associated with the onset or exacerbation of motor and verbal tics. Worsening of Tourette’s syndrome has also been reported. Before initiating amphetamines sulfate, assess the family history and clinically evaluate patients for tics or Tourette’s syndrome. Regularly monitor patients for the emergence or worsening of tics or Tourette’s syndrome with Amphetamines sulfate, and discontinue treatment if clinically appropriate.

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 EVENTS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.

Controlled Substance

Dextroamphetamine sulfate is a Schedule II controlled substance.

Abuse

Dextroamphetamine sulfate has a high potential for abuse and misuse which can lead to the development of a substance use disorder, including addiction [see Warnings]. Dextroamphetamine sulfate can be diverted for non-medical use into illicit channels or distribution.

Abuse is the intentional non-therapeutic use of a drug, even once, to achieve a desired psychological or physiological effect. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence.

Misuse and abuse of amphetamine may cause increased heart rate, respiratory rate, or blood pressure; sweating; dilated pupils; hyperactivity; restlessness; insomnia; decreased appetite; loss of coordination; tremors; flushed skin; vomiting; and/or abdominal pain. Anxiety, psychosis, hostility, aggression, and suicidal or homicidal ideation have also been observed with CNS stimulants abuse and/or misuse. Misuse and abuse of CNS stimulants, including Dextroamphetamine 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.

Dependence

Physical Dependence

Dextroamphetamine sulfate may produce physical dependence. Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug.

Withdrawal signs and symptoms after abrupt discontinuation or dose reduction following prolonged use of CNS stimulants including Dextroamphetamine sulfate include dysphoric mood; depression; fatigue; vivid, unpleasant dreams; insomnia or hypersomnia; increased appetite; and psychomotor retardation or agitation.

Tolerance

Dextroamphetamine sulfate may produce tolerance. Tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose).

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 Amphetamines, 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.

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° and 25°C (68° and 77°F) [see USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP.

Dispense with Medication Guide available at: www.tevausa.com/medguides

Manufactured For:

Teva Pharmaceuticals

Parsippany, NJ 07054

Rev. D 5/2024

Dispense with Medication Guide available at: www.tevausa.com/medguides

This Medication Guide has been approved by the U.S. Food and Drug Administration.                                                                                           Rev. D 5/2024

NDC 45963-303-09

Dextroamphetamine Sulfate Extended-Release Capsules 5 mg   CII

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only

90 Capsules

NDC 45963-304-09

Dextroamphetamine Sulfate Extended-Release Capsules 10 mg   CII

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only

90 Capsules

NDC 45963-305-09

Dextroamphetamine Sulfate Extended-Release Capsules 15 mg   CII

PHARMACIST: Dispense the accompanying Medication Guide to each patient.

Rx only

90 Capsules