Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets (Mixed salts of a single entity amphetamine product), for oral administration, are available as: 5 mg Dark blue, round, biconvex tablets, debossed “ E ” over “84” on one side and double-bisected on the other side and supplied as: NDC 0185-2098-01 bottles of 100 10 mg Dark blue, round, biconvex tablets, debossed “ E ” over “111” on one side and double-bisected on the other side and supplied as: NDC 0185-0842-01 bottles of 100 20 mg Dark orange, round, biconvex tablets, debossed “ E ” over “401” on one side and double-bisected on the other side and supplied as: NDC 0185-0853-01 bottles of 100 30 mg Dark orange, round, biconvex tablets, debossed “ E ” over “404” on one side and double-bisected on the other side and supplied as: NDC 0185-2099-01 bottles of 100 Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required. Protect from light and moisture. Keep tightly closed. Store at 20°C to 25°C (68°F to 77°F) (See USP Controlled Room Temperature). KEEP OUT OF THE REACH OF CHILDREN . Distributed by Sandoz Inc., Princeton, NJ 08540 1325A00 Revised: 04/2024; Mixed Salts of a Single Entity Amphetamine Product 5 mg x 100 Tablets - Label NDC 0185-0831-01 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of A Single Entity Amphetamine Product) 5 mg PHARMACIST: Please dispense with Medication Guide provided separately. Rx Only 100 Tablets Sandoz 5mgx100tabs; Mixed Salts of a Single Entity Amphetamine Product 5 mg x 100 Tablets - Label NDC 0185-2098-01 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of A Single Entity Amphetamine Product) 5 mg PHARMACIST: Please dispense with Medication Guide provided separately. Rx Only 100 Tablets Sandoz 5mg-label; Mixed Salts of a Single Entity Amphetamine Product 10 mg x 100 Tablets - Label NDC 0185-0842-01 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of A Single Entity Amphetamine Product) 10 mg PHARMACIST: Please dispense with Medication Guide provided separately. Rx Only 100 Tablets Sandoz 10mg-lbl; Mixed Salts of a Single Entity Amphetamine Product 20 mg x 100 Tablets - Label NDC 0185-0853-01 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of A Single Entity Amphetamine Product) 20 mg PHARMACIST: Please dispense with Medication Guide provided separately. Rx Only 100 Tablets Sandoz 20mg-lbl; Mixed Salts of a Single Entity Amphetamine Product 30 mg x 100 Tablets - Label NDC 0185-0864-01 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of A Single Entity Amphetamine Product) 30 mg PHARMACIST: Please dispense with Medication Guide provided separately. Rx Only 100 Tablets Sandoz 30mgx100tabs; PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 0185-2099-01 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of A Single Entity Amphetamine Product) 30 mg PHARMACIST: Please dispense with Medication Guide provided separately. Rx Only 100 Tablets Sandoz 30mg-lbl
- HOW SUPPLIED Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets (Mixed salts of a single entity amphetamine product), for oral administration, are available as: 5 mg Dark blue, round, biconvex tablets, debossed “ E ” over “84” on one side and double-bisected on the other side and supplied as: NDC 0185-2098-01 bottles of 100 10 mg Dark blue, round, biconvex tablets, debossed “ E ” over “111” on one side and double-bisected on the other side and supplied as: NDC 0185-0842-01 bottles of 100 20 mg Dark orange, round, biconvex tablets, debossed “ E ” over “401” on one side and double-bisected on the other side and supplied as: NDC 0185-0853-01 bottles of 100 30 mg Dark orange, round, biconvex tablets, debossed “ E ” over “404” on one side and double-bisected on the other side and supplied as: NDC 0185-2099-01 bottles of 100 Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required. Protect from light and moisture. Keep tightly closed. Store at 20°C to 25°C (68°F to 77°F) (See USP Controlled Room Temperature). KEEP OUT OF THE REACH OF CHILDREN . Distributed by Sandoz Inc., Princeton, NJ 08540 1325A00 Revised: 04/2024
- Mixed Salts of a Single Entity Amphetamine Product 5 mg x 100 Tablets - Label NDC 0185-0831-01 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of A Single Entity Amphetamine Product) 5 mg PHARMACIST: Please dispense with Medication Guide provided separately. Rx Only 100 Tablets Sandoz 5mgx100tabs
- Mixed Salts of a Single Entity Amphetamine Product 5 mg x 100 Tablets - Label NDC 0185-2098-01 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of A Single Entity Amphetamine Product) 5 mg PHARMACIST: Please dispense with Medication Guide provided separately. Rx Only 100 Tablets Sandoz 5mg-label
- Mixed Salts of a Single Entity Amphetamine Product 10 mg x 100 Tablets - Label NDC 0185-0842-01 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of A Single Entity Amphetamine Product) 10 mg PHARMACIST: Please dispense with Medication Guide provided separately. Rx Only 100 Tablets Sandoz 10mg-lbl
- Mixed Salts of a Single Entity Amphetamine Product 20 mg x 100 Tablets - Label NDC 0185-0853-01 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of A Single Entity Amphetamine Product) 20 mg PHARMACIST: Please dispense with Medication Guide provided separately. Rx Only 100 Tablets Sandoz 20mg-lbl
- Mixed Salts of a Single Entity Amphetamine Product 30 mg x 100 Tablets - Label NDC 0185-0864-01 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of A Single Entity Amphetamine Product) 30 mg PHARMACIST: Please dispense with Medication Guide provided separately. Rx Only 100 Tablets Sandoz 30mgx100tabs
- PACKAGE/LABEL PRINCIPAL DISPLAY PANEL NDC 0185-2099-01 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of A Single Entity Amphetamine Product) 30 mg PHARMACIST: Please dispense with Medication Guide provided separately. Rx Only 100 Tablets Sandoz 30mg-lbl
Overview
A single-entity amphetamine product combining the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d, l-amphetamine aspartate monohydrate. Each Tablet Contains 5 mg 10 mg 20 mg 30 mg Dextroamphetamine Saccharate 1.25 mg 2.5 mg 5 mg 7.5 mg Amphetamine Aspartate Monohydrate 1.25 mg 2.5 mg 5 mg 7.5 mg Dextroamphetamine Sulfate, USP 1.25 mg 2.5 mg 5 mg 7.5 mg Amphetamine Sulfate, USP 1.25 mg 2.5 mg 5 mg 7.5 mg Total Amphetamine Base Equivalence 3.13 mg 6.3 mg 12.6 mg 18.8 mg Inactive Ingredients: lactose monohydrate, pregelatinized starch (corn) and magnesium stearate. Color Additives: FD&C blue No. 1 aluminum lake (for 5 mg and 10 mg strengths) and FD&C yellow No. 6 aluminum lake (for 20 mg and 30 mg strengths).
Indications & Usage
Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets (Mixed salts of a single entity amphetamine product) is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy. Attention Deficit Hyperactivity Disorder (ADHD) 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 two 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 six 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 six 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.
Dosage & Administration
Regardless of indication, amphetamines should be administered at the lowest effective dosage, and dosage should be individually adjusted according to the therapeutic needs and response of the patient. Late evening doses should be avoided because of the resulting insomnia. Attention Deficit Hyperactivity Disorder Not recommended for children under 3 years of age. In children 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 optimal response is obtained. In children 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. Give first dose on awakening; additional doses (1 or 2) at intervals of 4 to 6 hours. Prior to treating patients with dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate 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 before initiating dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate (see WARNINGS ). Narcolepsy Usual dose 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 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 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 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.
Warnings & Precautions
WARNINGS Abuse, Misuse, and Addiction Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate has a high potential for abuse and misuse. The use of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate exposes individuals to the risks of abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate can be diverted for non-medical use into illicit channels or distribution (see DRUG ABUSE and DEPENDENCE: Abuse ). Misuse and abuse of CNS stimulants, including dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate, can result in overdose and death (see OVERDOSAGE ), and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate, 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 saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate to anyone else. Throughout dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate 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 were treated with CNS stimulant treatment at the recommended ADHD dosages. Avoid dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate 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). Some patients may have larger increases. Monitor all dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate-treated patients for potential tachycardia and hypertension. Psychiatric Adverse Reactions Exacerbation of Preexisting 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 Disorder 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, consider discontinuing dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate. Long-Term Suppression of Growth in Pediatric Patients CNS stimulants have been associated with weight loss and slowing of growth rate in pediatric patients. Closely monitor growth (weight and height) in dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate-treated pediatric patients treated with CNS stimulants. Pediatric patients who are not growing or gaining 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 seizure, 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 saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate, used to treat ADHD are associated with peripheral vasculopathy, including Raynaud’s phenomenon. Signs and symptoms are usually intermittent and mild; however, sequelae include digital ulceration and/or soft tissue breakdown. Effects of peripheral vasculopathy, including Raynaud’s phenomenon, were observed in postmarketing reports and at the therapeutic dosage of CNS stimulants in all age groups throughout the course of treatment. Signs and symptoms generally improved after dosage reduction or discontinuation of the CNS stimulant. Careful observation for digital changes is necessary during dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate treatment. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine 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 ). The co-administration with cytochrome P450 (CYP2D6) inhibitors increase the risk with increased exposure to dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, amphetamine sulfate. 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 saccharate, amphetamine aspartate, dextroamphetamine sulfate, amphetamine sulfate with MAOI drugs is contraindicated (see CONTRAINDICATIONS ). Discontinue treatment with dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, amphetamine sulfate and any concomitant serotonergic agents immediately if the above symptoms occur, and initiate supportive symptomatic treatment. If concomitant use of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, amphetamine sulfate with other serotonergic drugs or CYP2D6 inhibitors is clinically warranted, initiate dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, amphetamine sulfate 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 dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine 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 dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate, and discontinue treatment if clinically appropriate.
Boxed Warning
ABUSE, MISUSE, AND ADDICTION Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate 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 dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate, can result in overdose and death (see OVERDOSAGE ), and this risk is increased with higher doses or unapproved methods of administration, such as snorting or injection. Before prescribing dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate, 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 saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate 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 ).
Contraindications
In patients known to be hypersensitive to amphetamine, or other components of mixed salts of a single entity amphetamine product. 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 ).
Adverse Reactions
Cardiovascular Palpitations, tachycardia, elevation of blood pressure, sudden death, myocardial infarction. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use. Central Nervous System Psychotic episodes at recommended doses, overstimulation, restlessness, irritability, euphoria, dyskinesia, dysphoria, depression, tremor, motor and verbal tics, aggression, anger, logorrhea, dermatillomania. Eye Disorders Vision blurred, mydriasis. 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, rash, hypersensitivity reactions including angioedema and anaphylaxis. Serious skin rashes, including Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported. Endocrine Impotence, changes in libido, frequent or prolonged erections. Skin Alopecia. Musculoskeletal Rhabdomyolysis. To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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