Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate

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Overview

What is Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate?

A single-entity amphetamine product combining the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d, 1-amphetamine aspartate monohydrate.

Inactive Ingredients

In addition, each tablet contains: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, povidone, and pregelatinized starch.

Colors

The 5 mg, 7.5 mg, and 10 mg tablets contain the color additive FD&C Blue #1 Aluminum Lake.

The 12.5 mg, 15 mg, 20 mg, and 30 mg tablets contain the color additive FD&C Yellow #6 Aluminum Lake.

What does Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate look like?

What are the available doses of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate?

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What should I talk to my health care provider before I take Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate?

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How should I use Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate?

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets are 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.

Special Diagnostic Considerations

Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of 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 child and not solely on the presence of the required number of DSM-IV characteristics.

Need for Comprehensive Treatment Program

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets are 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 children with this syndrome. Stimulants are not intended for use in the child who exhibits 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 child's symptoms.

Long-Term Use

The effectiveness of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets and for long-term use has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets for extended periods should periodically re evaluate the long-term usefulness of the drug for the individual patient.

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.

Where possible, drug administration should be interrupted occasionally to determine if there is a recurrence of behavioral symptoms sufficient to require continued therapy.

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.

What interacts with Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate?

Advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympathomimetic amines, glaucoma.

Agitated states.

Known hypersensitivity or idiosyncrasy to amphetamine. Patients with a history of drug abuse.

In patients known to be hypersensitive to amphetamine, or other components of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets . Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products [see

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 and.

What are the warnings of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate?

Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Patients apt to be exposed to direct sunlight or ultraviolet light should be advised that this reaction can occur with tetracycline drugs, and treatment should be discontinued at the first evidence of skin erythema.

Serious Cardiovascular Events

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 structural heart problems alone may carry an increased risk of sudden death, stimulant products generally should not be used in children or adolescents with known 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 [see

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

Hypertension and Other Cardiovascular Conditions

Stimulant medications cause a modest increase in average blood pressure (about 2 to 4 mmHg) and average heart rate (about 3 to 6 bpm) [see 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 preexisting hypertension, heart failure, recent myocardial infarction, or ventricular arrhythmia [see

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

Preexisting Psychosis

Administration of stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with preexisting psychotic disorder.

Bipolar Illness

Particular care should be taken in using stimulants to treat ADHD patients with comorbid bipolar disorder because of concern for possible induction of 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 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 3482 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 post marketing 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 sub groups of newly methylphenidate-treated and non-medication treated children over 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 will likely have this effect as well. Therefore, growth should be monitored during treatment with stimulants, and patients who are not growing or gaining 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 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 Tablets, used to treat ADHD are associated with peripheral vasculopathy, including Raynaud's phenomenon. Signs and symptoms are usually intermittent and mild; however, very rare sequelae include digital ulceration and/or soft tissue breakdown. Effects of peripheral vasculopathy, including Raynaud's phenomenon, were observed in post marketing reports at different times and at therapeutic doses in all age groups throughout the course of treatment. Signs and symptoms generally improve after reduction in dose or discontinuation of drug. Careful observation for digital changes is necessary during treatment with ADHD stimulants. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients.

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 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 The potential for a pharmacokinetic interaction exists with the coadministration of CYP2D6 inhibitors which may increase the risk with increased exposure to Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets . In these situations, consider an alternative non·serotonergic drug or an alternative drug that does not inhibit CYP2D6 [see

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 and Amphetamine Sulfate Tablets with MAOI drugs is contraindicated [see

Discontinue treatment with Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets 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 and Amphetamine Sulfate Tablets with other serotonergic drugs or CYP2D6 inhibitors is clinically warranted, initiate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets 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.

Difficulties with accommodation and blurring of vision have been reported with stimulant treatment.

What are the precautions of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate?

General

The least amount of amphetamine feasible should be prescribed or dispensed at one time in order to minimize the possibility of over dosage. Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets should be used with caution in patients who use other sympathomimetic drugs.

Tics

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.

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 amphetamine or dextroamphetamine and should counsel them in its appropriate use. A patient Medication Guide is available for Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets.

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]

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 HC1, ascorbic acid) and urinary acidifying agents (e.g., ammonium chloride, sodium acid phosphate, methenamine salts).

Adrenergic Blockers

Adrenergic blockers are inhibited by amphetamines.

Increase blood levels and potentiate the action of amphetamine. Co-administration of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets 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 Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets are CYP2D6 inhibitors may increase the exposure of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets compared to the use of the drug alone and increase the risk of serotonin syndrome. Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome particularly during Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets and initiation and after a dosage increase. If serotonin syndrome occurs, discontinue Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets and the CYP2D6 inhibitor [see Examples of CYP2D6 Inhibitors include paroxetine and fluoxetine (also serotonergic drugs), quinidine, ritonavir.

Serotonergic Drugs

The concomitant use of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets and serotonergic drugs increases the risk of serotonin syndrome. Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome, particularly during Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets and initiation or dosage increase. If serotonin syndrome occurs, discontinue Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets and the concomitant serotonergic drug(s) [see and Examples of serotonergic drugs include selective serotonin reuptake inhibitors (S SRI), 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 Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets and concomitantly or within 14 days after discontinuing MAOI [see and Examples of MAOIs include selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue.

Antihistamines

Amphetamines may counteract the sedative effect of antihistamines.

Antihypertensives

Amphetamines may antagonize the hypotensive effects of Antihypertensives.

Chlorpromazine

Chlorpromazine blocks dopamine and norepinephrine receptors, 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 receptors, thus inhibiting the central stimulant effects of amphetamines.

Lithium Carbonate

The anorectic and 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; coadministration of phenobarbital may produce a synergistic anticonvulsant action.

Phenytoin

Amphetamines may delay intestinal absorption of phenytoin; coadministration of phenytoin may produce a synergistic anticonvulsant action.

Propoxyphene

In cases of propoxyphene over dosage, amphetamine CNS stimulation is potentiated and fatal convulsions can occur.

Proton Pump Inhibitors

Time to maximum concentration (T) 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.

Veratrum Alkaloids

Amphetamines inhibit the hypotensive effect of Veratrum alkaloids.

Amphetamines can cause a significant elevation in plasma corticosteroid levels. This increase is greatest in the evening. Amphetamines may interfere with urinary steroid determinations.

No evidence of carcinogenicity was found in studies in which d,l-amphetamine (enantiomer ratio of 1:1) was administered to mice and rats in the diet for 2 years at doses of up to 30 mg/kg/day in male mice, 19 mg/kg/day in female mice, and 5 mg/kg/day in male and female rats. These doses are approximately 2.4, 1.5, and 0.8 times, respectively, the maximum recommended human dose of 30 mg/day [child] on a mg/m body surface area basis.

Amphetamine, in the enantiomer ratio present in Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets Sulfate and(immediate-release)(d- to 1- ratio of 3:1), was not clastogenic in the mouse bone marrow micronucleus test and was negative when tested in the E. coli component of the Ames test d, 1-Amphetamine (1:1 enantiomer ratio) has been reported to produce a positive response in the mouse bone marrow micronucleus test, an equivocal response in the Ames test, and negative responses in the in sister chromatid exchange and chromosomal aberration assays.

Amphetamine, in the enantiomer ratio present in Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (immediate-release)(d- to 1- ratio of 3:1), did not adversely affect fertility or early embryonic development in the rat at doses of up to 20 mg/kg/day (approximately 5 times the maximum recommended human dose of 30 mg/day on a mg/m body surface area basis).

Teratogenic Effects

Pregnancy Category C

Amphetamine, in the enantiomer ratio present in Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (d- to 1- ratio of 3:1), had no apparent effects on embryo fetal morphological development or survival when orally administered to pregnant rats and rabbits throughout the period of organogenesis at doses of up to 6 and 16 mg/kg/day, respectively. These doses are approximately 1.5 and 8 times, respectively, the maximum recommended human dose of 30 mg/day [child] on a mg/m body surface area basis. Fetal malformations and death have been reported in mice following parenteral administration of d-amphetamine doses of 50 mg/kg/day (approximately 6 times that of a human dose of 30 mg/day [child] on a mg/m basis) or greater to pregnant animals. Administration of these doses was also associated with severe maternal toxicity.

A number of studies in rodents indicate that prenatal or early postnatal exposure to amphetamine (d- or d,1-), at doses similar to those used clinically, can result in long-term neurochemical and behavioral alterations. Reported behavioral effects include learning and memory deficits, altered locomotor activity, and changes in sexual function.

There are no adequate and well-controlled studies in pregnant women. There has been one report of severe congenital bony deformity, tracheo-esophageal 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. Amphetamines 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.

Amphetamines are excreted in human milk Mothers taking amphetamines should be advised to refrain from nursing.

Long-term effects of amphetamines in children have not been well established. Amphetamines are not recommended for use in children under 3 years of age with Attention Deficit Hyperactivity Disorder described under

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets has not been studied in the geriatric population.

Instruct patients to call their physician immediately with any signs of unexplained wounds appearing on fingers or toes while taking Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets.

Instruct patients beginning treatment with Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets 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.
Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients.

What are the side effects of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate?

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, tics, aggression, anger, logorrhea, dermatillomania.

Eye Disorders

Vision blurred, mydriasis.

Gastrointestinal

Dryness of the mouth, unpleasant taste, diarrhea, constipation, 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.

Alopecia.

Musculoskeletal

Rhabdomyolysis.

What should I look out for while using Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate?

Advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympathomimetic amines, glaucoma.

Agitated states.

Known hypersensitivity or idiosyncrasy to amphetamine. Patients with a history of drug abuse.

In patients known to be hypersensitive to amphetamine, or other components of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets . Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products [see

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 and.

Serious Cardiovascular Events

Sudden Death and Preexisting 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 structural heart problems alone may carry an increased risk of sudden death, stimulant products generally should not be used in children or adolescents with known 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 [see

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

Hypertension and Other Cardiovascular Conditions

Stimulant medications cause a modest increase in average blood pressure (about 2 to 4 mmHg) and average heart rate (about 3 to 6 bpm) [see 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 preexisting hypertension, heart failure, recent myocardial infarction, or ventricular arrhythmia [see

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

Preexisting Psychosis

Administration of stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with preexisting psychotic disorder.

Bipolar Illness

Particular care should be taken in using stimulants to treat ADHD patients with comorbid bipolar disorder because of concern for possible induction of 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 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 3482 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 post marketing 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 sub groups of newly methylphenidate-treated and non-medication treated children over 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 will likely have this effect as well. Therefore, growth should be monitored during treatment with stimulants, and patients who are not growing or gaining 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 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 Tablets, used to treat ADHD are associated with peripheral vasculopathy, including Raynaud's phenomenon. Signs and symptoms are usually intermittent and mild; however, very rare sequelae include digital ulceration and/or soft tissue breakdown. Effects of peripheral vasculopathy, including Raynaud's phenomenon, were observed in post marketing reports at different times and at therapeutic doses in all age groups throughout the course of treatment. Signs and symptoms generally improve after reduction in dose or discontinuation of drug. Careful observation for digital changes is necessary during treatment with ADHD stimulants. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients.

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 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 The potential for a pharmacokinetic interaction exists with the coadministration of CYP2D6 inhibitors which may increase the risk with increased exposure to Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets . In these situations, consider an alternative non·serotonergic drug or an alternative drug that does not inhibit CYP2D6 [see

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 and Amphetamine Sulfate Tablets with MAOI drugs is contraindicated [see

Discontinue treatment with Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets 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 and Amphetamine Sulfate Tablets with other serotonergic drugs or CYP2D6 inhibitors is clinically warranted, initiate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets 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.

Difficulties with accommodation and blurring of vision have been reported with stimulant treatment.

What might happen if I take too much Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate?

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.

How should I store and handle Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate?

StorageStore Pantoprazole Sodium Delayed-Release Tablets, USP at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [ ]. StorageStore Pantoprazole Sodium Delayed-Release Tablets, USP at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [ ]. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets are supplied as: 5 mg Tablets Bottles of 100 52343-160-01 7.5 mg Tablets Bottles of 100 52343-161-01 10 mg Tablets Bottles of 100 52343-162-01 12.5 mg Tablets Bottles of 100 52343-163-01 15 mg Tablets Bottles of 100 52343-164-01 20 mg Tablets Bottles of 100 52343-165-01 30 mg Tablets Bottles of 100 52343-166-01Dispense in a tight, light-resistant container as described in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Store Dispense with Medication Guide available at Distributed by: Acetris Health, LLC Saddle Brook, NJ 07663 Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810Issued: 10/2017Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets are supplied as: 5 mg Tablets Bottles of 100 52343-160-01 7.5 mg Tablets Bottles of 100 52343-161-01 10 mg Tablets Bottles of 100 52343-162-01 12.5 mg Tablets Bottles of 100 52343-163-01 15 mg Tablets Bottles of 100 52343-164-01 20 mg Tablets Bottles of 100 52343-165-01 30 mg Tablets Bottles of 100 52343-166-01Dispense in a tight, light-resistant container as described in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Store Dispense with Medication Guide available at Distributed by: Acetris Health, LLC Saddle Brook, NJ 07663 Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810Issued: 10/2017Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets are supplied as: 5 mg Tablets Bottles of 100 52343-160-01 7.5 mg Tablets Bottles of 100 52343-161-01 10 mg Tablets Bottles of 100 52343-162-01 12.5 mg Tablets Bottles of 100 52343-163-01 15 mg Tablets Bottles of 100 52343-164-01 20 mg Tablets Bottles of 100 52343-165-01 30 mg Tablets Bottles of 100 52343-166-01Dispense in a tight, light-resistant container as described in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Store Dispense with Medication Guide available at Distributed by: Acetris Health, LLC Saddle Brook, NJ 07663 Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810Issued: 10/2017Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets are supplied as: 5 mg Tablets Bottles of 100 52343-160-01 7.5 mg Tablets Bottles of 100 52343-161-01 10 mg Tablets Bottles of 100 52343-162-01 12.5 mg Tablets Bottles of 100 52343-163-01 15 mg Tablets Bottles of 100 52343-164-01 20 mg Tablets Bottles of 100 52343-165-01 30 mg Tablets Bottles of 100 52343-166-01Dispense in a tight, light-resistant container as described in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Store Dispense with Medication Guide available at Distributed by: Acetris Health, LLC Saddle Brook, NJ 07663 Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810Issued: 10/2017Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets are supplied as: 5 mg Tablets Bottles of 100 52343-160-01 7.5 mg Tablets Bottles of 100 52343-161-01 10 mg Tablets Bottles of 100 52343-162-01 12.5 mg Tablets Bottles of 100 52343-163-01 15 mg Tablets Bottles of 100 52343-164-01 20 mg Tablets Bottles of 100 52343-165-01 30 mg Tablets Bottles of 100 52343-166-01Dispense in a tight, light-resistant container as described in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Store Dispense with Medication Guide available at Distributed by: Acetris Health, LLC Saddle Brook, NJ 07663 Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810Issued: 10/2017Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets are supplied as: 5 mg Tablets Bottles of 100 52343-160-01 7.5 mg Tablets Bottles of 100 52343-161-01 10 mg Tablets Bottles of 100 52343-162-01 12.5 mg Tablets Bottles of 100 52343-163-01 15 mg Tablets Bottles of 100 52343-164-01 20 mg Tablets Bottles of 100 52343-165-01 30 mg Tablets Bottles of 100 52343-166-01Dispense in a tight, light-resistant container as described in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Store Dispense with Medication Guide available at Distributed by: Acetris Health, LLC Saddle Brook, NJ 07663 Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810Issued: 10/2017Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets are supplied as: 5 mg Tablets Bottles of 100 52343-160-01 7.5 mg Tablets Bottles of 100 52343-161-01 10 mg Tablets Bottles of 100 52343-162-01 12.5 mg Tablets Bottles of 100 52343-163-01 15 mg Tablets Bottles of 100 52343-164-01 20 mg Tablets Bottles of 100 52343-165-01 30 mg Tablets Bottles of 100 52343-166-01Dispense in a tight, light-resistant container as described in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Store Dispense with Medication Guide available at Distributed by: Acetris Health, LLC Saddle Brook, NJ 07663 Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810Issued: 10/2017Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets are supplied as: 5 mg Tablets Bottles of 100 52343-160-01 7.5 mg Tablets Bottles of 100 52343-161-01 10 mg Tablets Bottles of 100 52343-162-01 12.5 mg Tablets Bottles of 100 52343-163-01 15 mg Tablets Bottles of 100 52343-164-01 20 mg Tablets Bottles of 100 52343-165-01 30 mg Tablets Bottles of 100 52343-166-01Dispense in a tight, light-resistant container as described in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Store Dispense with Medication Guide available at Distributed by: Acetris Health, LLC Saddle Brook, NJ 07663 Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810Issued: 10/2017Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets are supplied as: 5 mg Tablets Bottles of 100 52343-160-01 7.5 mg Tablets Bottles of 100 52343-161-01 10 mg Tablets Bottles of 100 52343-162-01 12.5 mg Tablets Bottles of 100 52343-163-01 15 mg Tablets Bottles of 100 52343-164-01 20 mg Tablets Bottles of 100 52343-165-01 30 mg Tablets Bottles of 100 52343-166-01Dispense in a tight, light-resistant container as described in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Store Dispense with Medication Guide available at Distributed by: Acetris Health, LLC Saddle Brook, NJ 07663 Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810Issued: 10/2017Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets are supplied as: 5 mg Tablets Bottles of 100 52343-160-01 7.5 mg Tablets Bottles of 100 52343-161-01 10 mg Tablets Bottles of 100 52343-162-01 12.5 mg Tablets Bottles of 100 52343-163-01 15 mg Tablets Bottles of 100 52343-164-01 20 mg Tablets Bottles of 100 52343-165-01 30 mg Tablets Bottles of 100 52343-166-01Dispense in a tight, light-resistant container as described in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Store Dispense with Medication Guide available at Distributed by: Acetris Health, LLC Saddle Brook, NJ 07663 Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810Issued: 10/2017Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets are supplied as: 5 mg Tablets Bottles of 100 52343-160-01 7.5 mg Tablets Bottles of 100 52343-161-01 10 mg Tablets Bottles of 100 52343-162-01 12.5 mg Tablets Bottles of 100 52343-163-01 15 mg Tablets Bottles of 100 52343-164-01 20 mg Tablets Bottles of 100 52343-165-01 30 mg Tablets Bottles of 100 52343-166-01Dispense in a tight, light-resistant container as described in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Store Dispense with Medication Guide available at Distributed by: Acetris Health, LLC Saddle Brook, NJ 07663 Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810Issued: 10/2017Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets are supplied as: 5 mg Tablets Bottles of 100 52343-160-01 7.5 mg Tablets Bottles of 100 52343-161-01 10 mg Tablets Bottles of 100 52343-162-01 12.5 mg Tablets Bottles of 100 52343-163-01 15 mg Tablets Bottles of 100 52343-164-01 20 mg Tablets Bottles of 100 52343-165-01 30 mg Tablets Bottles of 100 52343-166-01Dispense in a tight, light-resistant container as described in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Store Dispense with Medication Guide available at Distributed by: Acetris Health, LLC Saddle Brook, NJ 07663 Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810Issued: 10/2017Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets are supplied as: 5 mg Tablets Bottles of 100 52343-160-01 7.5 mg Tablets Bottles of 100 52343-161-01 10 mg Tablets Bottles of 100 52343-162-01 12.5 mg Tablets Bottles of 100 52343-163-01 15 mg Tablets Bottles of 100 52343-164-01 20 mg Tablets Bottles of 100 52343-165-01 30 mg Tablets Bottles of 100 52343-166-01Dispense in a tight, light-resistant container as described in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Store Dispense with Medication Guide available at Distributed by: Acetris Health, LLC Saddle Brook, NJ 07663 Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810Issued: 10/2017Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets are supplied as: 5 mg Tablets Bottles of 100 52343-160-01 7.5 mg Tablets Bottles of 100 52343-161-01 10 mg Tablets Bottles of 100 52343-162-01 12.5 mg Tablets Bottles of 100 52343-163-01 15 mg Tablets Bottles of 100 52343-164-01 20 mg Tablets Bottles of 100 52343-165-01 30 mg Tablets Bottles of 100 52343-166-01Dispense in a tight, light-resistant container as described in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Store Dispense with Medication Guide available at Distributed by: Acetris Health, LLC Saddle Brook, NJ 07663 Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810Issued: 10/2017Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets are supplied as: 5 mg Tablets Bottles of 100 52343-160-01 7.5 mg Tablets Bottles of 100 52343-161-01 10 mg Tablets Bottles of 100 52343-162-01 12.5 mg Tablets Bottles of 100 52343-163-01 15 mg Tablets Bottles of 100 52343-164-01 20 mg Tablets Bottles of 100 52343-165-01 30 mg Tablets Bottles of 100 52343-166-01Dispense in a tight, light-resistant container as described in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Store Dispense with Medication Guide available at Distributed by: Acetris Health, LLC Saddle Brook, NJ 07663 Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810Issued: 10/2017Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets are supplied as: 5 mg Tablets Bottles of 100 52343-160-01 7.5 mg Tablets Bottles of 100 52343-161-01 10 mg Tablets Bottles of 100 52343-162-01 12.5 mg Tablets Bottles of 100 52343-163-01 15 mg Tablets Bottles of 100 52343-164-01 20 mg Tablets Bottles of 100 52343-165-01 30 mg Tablets Bottles of 100 52343-166-01Dispense in a tight, light-resistant container as described in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Store Dispense with Medication Guide available at Distributed by: Acetris Health, LLC Saddle Brook, NJ 07663 Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810Issued: 10/2017Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets are supplied as: 5 mg Tablets Bottles of 100 52343-160-01 7.5 mg Tablets Bottles of 100 52343-161-01 10 mg Tablets Bottles of 100 52343-162-01 12.5 mg Tablets Bottles of 100 52343-163-01 15 mg Tablets Bottles of 100 52343-164-01 20 mg Tablets Bottles of 100 52343-165-01 30 mg Tablets Bottles of 100 52343-166-01Dispense in a tight, light-resistant container as described in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Store Dispense with Medication Guide available at Distributed by: Acetris Health, LLC Saddle Brook, NJ 07663 Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810Issued: 10/2017Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets are supplied as: 5 mg Tablets Bottles of 100 52343-160-01 7.5 mg Tablets Bottles of 100 52343-161-01 10 mg Tablets Bottles of 100 52343-162-01 12.5 mg Tablets Bottles of 100 52343-163-01 15 mg Tablets Bottles of 100 52343-164-01 20 mg Tablets Bottles of 100 52343-165-01 30 mg Tablets Bottles of 100 52343-166-01Dispense in a tight, light-resistant container as described in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Store Dispense with Medication Guide available at Distributed by: Acetris Health, LLC Saddle Brook, NJ 07663 Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810Issued: 10/2017Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets are supplied as: 5 mg Tablets Bottles of 100 52343-160-01 7.5 mg Tablets Bottles of 100 52343-161-01 10 mg Tablets Bottles of 100 52343-162-01 12.5 mg Tablets Bottles of 100 52343-163-01 15 mg Tablets Bottles of 100 52343-164-01 20 mg Tablets Bottles of 100 52343-165-01 30 mg Tablets Bottles of 100 52343-166-01Dispense in a tight, light-resistant container as described in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Store Dispense with Medication Guide available at Distributed by: Acetris Health, LLC Saddle Brook, NJ 07663 Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810Issued: 10/2017Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets are supplied as: 5 mg Tablets Bottles of 100 52343-160-01 7.5 mg Tablets Bottles of 100 52343-161-01 10 mg Tablets Bottles of 100 52343-162-01 12.5 mg Tablets Bottles of 100 52343-163-01 15 mg Tablets Bottles of 100 52343-164-01 20 mg Tablets Bottles of 100 52343-165-01 30 mg Tablets Bottles of 100 52343-166-01Dispense in a tight, light-resistant container as described in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Store Dispense with Medication Guide available at Distributed by: Acetris Health, LLC Saddle Brook, NJ 07663 Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810Issued: 10/2017Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets are supplied as: 5 mg Tablets Bottles of 100 52343-160-01 7.5 mg Tablets Bottles of 100 52343-161-01 10 mg Tablets Bottles of 100 52343-162-01 12.5 mg Tablets Bottles of 100 52343-163-01 15 mg Tablets Bottles of 100 52343-164-01 20 mg Tablets Bottles of 100 52343-165-01 30 mg Tablets Bottles of 100 52343-166-01Dispense in a tight, light-resistant container as described in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Store Dispense with Medication Guide available at Distributed by: Acetris Health, LLC Saddle Brook, NJ 07663 Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810Issued: 10/2017Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets are supplied as: 5 mg Tablets Bottles of 100 52343-160-01 7.5 mg Tablets Bottles of 100 52343-161-01 10 mg Tablets Bottles of 100 52343-162-01 12.5 mg Tablets Bottles of 100 52343-163-01 15 mg Tablets Bottles of 100 52343-164-01 20 mg Tablets Bottles of 100 52343-165-01 30 mg Tablets Bottles of 100 52343-166-01Dispense in a tight, light-resistant container as described in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Store Dispense with Medication Guide available at Distributed by: Acetris Health, LLC Saddle Brook, NJ 07663 Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810Issued: 10/2017Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets are supplied as: 5 mg Tablets Bottles of 100 52343-160-01 7.5 mg Tablets Bottles of 100 52343-161-01 10 mg Tablets Bottles of 100 52343-162-01 12.5 mg Tablets Bottles of 100 52343-163-01 15 mg Tablets Bottles of 100 52343-164-01 20 mg Tablets Bottles of 100 52343-165-01 30 mg Tablets Bottles of 100 52343-166-01Dispense in a tight, light-resistant container as described in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Store Dispense with Medication Guide available at Distributed by: Acetris Health, LLC Saddle Brook, NJ 07663 Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810Issued: 10/2017Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets are supplied as: 5 mg Tablets Bottles of 100 52343-160-01 7.5 mg Tablets Bottles of 100 52343-161-01 10 mg Tablets Bottles of 100 52343-162-01 12.5 mg Tablets Bottles of 100 52343-163-01 15 mg Tablets Bottles of 100 52343-164-01 20 mg Tablets Bottles of 100 52343-165-01 30 mg Tablets Bottles of 100 52343-166-01Dispense in a tight, light-resistant container as described in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Store Dispense with Medication Guide available at Distributed by: Acetris Health, LLC Saddle Brook, NJ 07663 Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810Issued: 10/2017Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets are supplied as: 5 mg Tablets Bottles of 100 52343-160-01 7.5 mg Tablets Bottles of 100 52343-161-01 10 mg Tablets Bottles of 100 52343-162-01 12.5 mg Tablets Bottles of 100 52343-163-01 15 mg Tablets Bottles of 100 52343-164-01 20 mg Tablets Bottles of 100 52343-165-01 30 mg Tablets Bottles of 100 52343-166-01Dispense in a tight, light-resistant container as described in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Store Dispense with Medication Guide available at Distributed by: Acetris Health, LLC Saddle Brook, NJ 07663 Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810Issued: 10/2017Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets are supplied as: 5 mg Tablets Bottles of 100 52343-160-01 7.5 mg Tablets Bottles of 100 52343-161-01 10 mg Tablets Bottles of 100 52343-162-01 12.5 mg Tablets Bottles of 100 52343-163-01 15 mg Tablets Bottles of 100 52343-164-01 20 mg Tablets Bottles of 100 52343-165-01 30 mg Tablets Bottles of 100 52343-166-01Dispense in a tight, light-resistant container as described in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Store Dispense with Medication Guide available at Distributed by: Acetris Health, LLC Saddle Brook, NJ 07663 Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810Issued: 10/2017Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets are supplied as: 5 mg Tablets Bottles of 100 52343-160-01 7.5 mg Tablets Bottles of 100 52343-161-01 10 mg Tablets Bottles of 100 52343-162-01 12.5 mg Tablets Bottles of 100 52343-163-01 15 mg Tablets Bottles of 100 52343-164-01 20 mg Tablets Bottles of 100 52343-165-01 30 mg Tablets Bottles of 100 52343-166-01Dispense in a tight, light-resistant container as described in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Store Dispense with Medication Guide available at Distributed by: Acetris Health, LLC Saddle Brook, NJ 07663 Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810Issued: 10/2017Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets are supplied as: 5 mg Tablets Bottles of 100 52343-160-01 7.5 mg Tablets Bottles of 100 52343-161-01 10 mg Tablets Bottles of 100 52343-162-01 12.5 mg Tablets Bottles of 100 52343-163-01 15 mg Tablets Bottles of 100 52343-164-01 20 mg Tablets Bottles of 100 52343-165-01 30 mg Tablets Bottles of 100 52343-166-01Dispense in a tight, light-resistant container as described in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Store Dispense with Medication Guide available at Distributed by: Acetris Health, LLC Saddle Brook, NJ 07663 Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810Issued: 10/2017Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets are supplied as: 5 mg Tablets Bottles of 100 52343-160-01 7.5 mg Tablets Bottles of 100 52343-161-01 10 mg Tablets Bottles of 100 52343-162-01 12.5 mg Tablets Bottles of 100 52343-163-01 15 mg Tablets Bottles of 100 52343-164-01 20 mg Tablets Bottles of 100 52343-165-01 30 mg Tablets Bottles of 100 52343-166-01Dispense in a tight, light-resistant container as described in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Store Dispense with Medication Guide available at Distributed by: Acetris Health, LLC Saddle Brook, NJ 07663 Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810Issued: 10/2017Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets are supplied as: 5 mg Tablets Bottles of 100 52343-160-01 7.5 mg Tablets Bottles of 100 52343-161-01 10 mg Tablets Bottles of 100 52343-162-01 12.5 mg Tablets Bottles of 100 52343-163-01 15 mg Tablets Bottles of 100 52343-164-01 20 mg Tablets Bottles of 100 52343-165-01 30 mg Tablets Bottles of 100 52343-166-01Dispense in a tight, light-resistant container as described in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Store Dispense with Medication Guide available at Distributed by: Acetris Health, LLC Saddle Brook, NJ 07663 Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810Issued: 10/2017Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets are supplied as: 5 mg Tablets Bottles of 100 52343-160-01 7.5 mg Tablets Bottles of 100 52343-161-01 10 mg Tablets Bottles of 100 52343-162-01 12.5 mg Tablets Bottles of 100 52343-163-01 15 mg Tablets Bottles of 100 52343-164-01 20 mg Tablets Bottles of 100 52343-165-01 30 mg Tablets Bottles of 100 52343-166-01Dispense in a tight, light-resistant container as described in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Store Dispense with Medication Guide available at Distributed by: Acetris Health, LLC Saddle Brook, NJ 07663 Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810Issued: 10/2017Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets are supplied as: 5 mg Tablets Bottles of 100 52343-160-01 7.5 mg Tablets Bottles of 100 52343-161-01 10 mg Tablets Bottles of 100 52343-162-01 12.5 mg Tablets Bottles of 100 52343-163-01 15 mg Tablets Bottles of 100 52343-164-01 20 mg Tablets Bottles of 100 52343-165-01 30 mg Tablets Bottles of 100 52343-166-01Dispense in a tight, light-resistant container as described in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Store Dispense with Medication Guide available at Distributed by: Acetris Health, LLC Saddle Brook, NJ 07663 Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810Issued: 10/2017Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets are supplied as: 5 mg Tablets Bottles of 100 52343-160-01 7.5 mg Tablets Bottles of 100 52343-161-01 10 mg Tablets Bottles of 100 52343-162-01 12.5 mg Tablets Bottles of 100 52343-163-01 15 mg Tablets Bottles of 100 52343-164-01 20 mg Tablets Bottles of 100 52343-165-01 30 mg Tablets Bottles of 100 52343-166-01Dispense in a tight, light-resistant container as described in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Store Dispense with Medication Guide available at Distributed by: Acetris Health, LLC Saddle Brook, NJ 07663 Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810Issued: 10/2017Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets are supplied as: 5 mg Tablets Bottles of 100 52343-160-01 7.5 mg Tablets Bottles of 100 52343-161-01 10 mg Tablets Bottles of 100 52343-162-01 12.5 mg Tablets Bottles of 100 52343-163-01 15 mg Tablets Bottles of 100 52343-164-01 20 mg Tablets Bottles of 100 52343-165-01 30 mg Tablets Bottles of 100 52343-166-01Dispense in a tight, light-resistant container as described in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Store Dispense with Medication Guide available at Distributed by: Acetris Health, LLC Saddle Brook, NJ 07663 Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810Issued: 10/2017Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets are supplied as: 5 mg Tablets Bottles of 100 52343-160-01 7.5 mg Tablets Bottles of 100 52343-161-01 10 mg Tablets Bottles of 100 52343-162-01 12.5 mg Tablets Bottles of 100 52343-163-01 15 mg Tablets Bottles of 100 52343-164-01 20 mg Tablets Bottles of 100 52343-165-01 30 mg Tablets Bottles of 100 52343-166-01Dispense in a tight, light-resistant container as described in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Store Dispense with Medication Guide available at Distributed by: Acetris Health, LLC Saddle Brook, NJ 07663 Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810Issued: 10/2017Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets are supplied as: 5 mg Tablets Bottles of 100 52343-160-01 7.5 mg Tablets Bottles of 100 52343-161-01 10 mg Tablets Bottles of 100 52343-162-01 12.5 mg Tablets Bottles of 100 52343-163-01 15 mg Tablets Bottles of 100 52343-164-01 20 mg Tablets Bottles of 100 52343-165-01 30 mg Tablets Bottles of 100 52343-166-01Dispense in a tight, light-resistant container as described in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Store Dispense with Medication Guide available at Distributed by: Acetris Health, LLC Saddle Brook, NJ 07663 Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810Issued: 10/2017Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets are supplied as: 5 mg Tablets Bottles of 100 52343-160-01 7.5 mg Tablets Bottles of 100 52343-161-01 10 mg Tablets Bottles of 100 52343-162-01 12.5 mg Tablets Bottles of 100 52343-163-01 15 mg Tablets Bottles of 100 52343-164-01 20 mg Tablets Bottles of 100 52343-165-01 30 mg Tablets Bottles of 100 52343-166-01Dispense in a tight, light-resistant container as described in the USP.KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Store Dispense with Medication Guide available at Distributed by: Acetris Health, LLC Saddle Brook, NJ 07663 Manufactured by: Aurolife Pharma LLC Dayton, NJ 08810Issued: 10/2017

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Pharmacodynamics

Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. The mode of therapeutic action in Attention Deficit Hyperactivity Disorder (ADHD) is not known. Amphetamines are thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extra neuronal space.

Pharmacokinetics

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets contain d-amphetamine and l-amphetamine salts in the ratio of 3:1. Following administration of a single dose 10 or 30 mg of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets to healthy volunteers under fasted conditions, peak plasma concentrations occurred approximately 3 hours post-dose for both d-amphetamine and l- amphetamine. The mean elimination half-life (t) for d-amphetamine was shorter than the tof the 1- isomer (9.77 to 11 hours vs. 11.5 to 13.8 hours). The PK parameters (C, AUC) of d-and l - amphetamine increased approximately three-fold from 10 mg to 30 mg indicating dose-proportional pharmacokinetics.

The effect of food on the bioavailability of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets has not been studied.

Amphetamine is reported to be oxidized at the 4 position of the benzene ring to form 4- hydroxyamphetamine, or on the side chain α or β carbons to form alpha-hydroxy-amphetamine or norephedrine, respectively. Norephedrine and 4-hydroxy-amphetamine are both active and each is subsequently oxidized to form 4-hydroxy-norephedrine. Alpha-hydroxy-amphetamine undergoes deamination to form phenyl acetone, which ultimately forms benzoic acid and its glucuronide and the glycine conjugate hippuric acid. Although the enzymes involved in amphetamine metabolism have not been clearly defined, CYP2D6 is known to be involved with formation of 4-hydroxy-amphetamine. Since CYP2D6 is genetically polymorphic, population variations in amphetamine metabolism are a possibility.

Amphetamine is known to inhibit monoamine oxidase, whereas the ability of amphetamine and its metabolites to inhibit various P450 isozymes and other enzymes has not been adequately elucidated. experiments with human microsomes indicate minor inhibition of CYP2D6 by amphetamine and minor inhibition of CYP1A2, 2D6, and 3A4 by one or more metabolites. However, due to the probability of auto-inhibition and the lack of information on the concentration of these metabolites relative to concentrations, no predications regarding the potential for amphetamine or its metabolites to inhibit the metabolism of other drugs by CYP isozymes can be made.

With normal urine pHs approximately half of an administered dose of amphetamine is recoverable in urine as derivatives of alpha-hydroxy-amphetamine and approximately another 30% to 40% of the dose is recoverable in urine as amphetamine itself. Since amphetamine has a pKa of 9.9, urinary recovery of amphetamine is highly dependent on pH and urine flow rates. Alkaline urine pHs result in less ionization and reduced renal elimination, and acidic pHs and high flow rates result in increased renal elimination with clearances greater than glomerular filtration rates, indicating the involvement of active secretion. Urinary recovery of amphetamine has been reported to range from 1% to 75%, depending on urinary pH, with the remaining fraction of the dose hepatically metabolized. Consequently, both hepatic and renal dysfunction have the potential to inhibit the elimination of amphetamine and result in prolonged exposures. In addition, drugs that affect urinary pH are known to alter the elimination of amphetamine, and any decrease in amphetamine's metabolism that might occur due to drug interactions or genetic polymorphisms is more likely to be clinically significant when renal elimination is decreased [see

Non-Clinical Toxicology

Advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympathomimetic amines, glaucoma.

Agitated states.

Known hypersensitivity or idiosyncrasy to amphetamine. Patients with a history of drug abuse.

In patients known to be hypersensitive to amphetamine, or other components of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets . Hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products [see

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 and.

Serious Cardiovascular Events

Sudden Death and Preexisting 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 structural heart problems alone may carry an increased risk of sudden death, stimulant products generally should not be used in children or adolescents with known 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 [see

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

Hypertension and Other Cardiovascular Conditions

Stimulant medications cause a modest increase in average blood pressure (about 2 to 4 mmHg) and average heart rate (about 3 to 6 bpm) [see 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 preexisting hypertension, heart failure, recent myocardial infarction, or ventricular arrhythmia [see

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

Preexisting Psychosis

Administration of stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with preexisting psychotic disorder.

Bipolar Illness

Particular care should be taken in using stimulants to treat ADHD patients with comorbid bipolar disorder because of concern for possible induction of 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 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 3482 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 post marketing 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 sub groups of newly methylphenidate-treated and non-medication treated children over 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 will likely have this effect as well. Therefore, growth should be monitored during treatment with stimulants, and patients who are not growing or gaining 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 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 Tablets, used to treat ADHD are associated with peripheral vasculopathy, including Raynaud's phenomenon. Signs and symptoms are usually intermittent and mild; however, very rare sequelae include digital ulceration and/or soft tissue breakdown. Effects of peripheral vasculopathy, including Raynaud's phenomenon, were observed in post marketing reports at different times and at therapeutic doses in all age groups throughout the course of treatment. Signs and symptoms generally improve after reduction in dose or discontinuation of drug. Careful observation for digital changes is necessary during treatment with ADHD stimulants. Further clinical evaluation (e.g., rheumatology referral) may be appropriate for certain patients.

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 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 The potential for a pharmacokinetic interaction exists with the coadministration of CYP2D6 inhibitors which may increase the risk with increased exposure to Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets . In these situations, consider an alternative non·serotonergic drug or an alternative drug that does not inhibit CYP2D6 [see

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 and Amphetamine Sulfate Tablets with MAOI drugs is contraindicated [see

Discontinue treatment with Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets 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 and Amphetamine Sulfate Tablets with other serotonergic drugs or CYP2D6 inhibitors is clinically warranted, initiate Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets 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.

Difficulties with accommodation and blurring of vision have been reported with stimulant treatment.

General

The least amount of amphetamine feasible should be prescribed or dispensed at one time in order to minimize the possibility of over dosage. Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets should be used with caution in patients who use other sympathomimetic drugs.

Tics

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.

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 amphetamine or dextroamphetamine and should counsel them in its appropriate use. A patient Medication Guide is available for Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets.

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]

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 HC1, ascorbic acid) and urinary acidifying agents (e.g., ammonium chloride, sodium acid phosphate, methenamine salts).

Adrenergic Blockers

Adrenergic blockers are inhibited by amphetamines.

Increase blood levels and potentiate the action of amphetamine. Co-administration of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets 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 Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets are CYP2D6 inhibitors may increase the exposure of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets compared to the use of the drug alone and increase the risk of serotonin syndrome. Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome particularly during Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets and initiation and after a dosage increase. If serotonin syndrome occurs, discontinue Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets and the CYP2D6 inhibitor [see Examples of CYP2D6 Inhibitors include paroxetine and fluoxetine (also serotonergic drugs), quinidine, ritonavir.

Serotonergic Drugs

The concomitant use of Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets and serotonergic drugs increases the risk of serotonin syndrome. Initiate with lower doses and monitor patients for signs and symptoms of serotonin syndrome, particularly during Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets and initiation or dosage increase. If serotonin syndrome occurs, discontinue Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets and the concomitant serotonergic drug(s) [see and Examples of serotonergic drugs include selective serotonin reuptake inhibitors (S SRI), 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 Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets and concomitantly or within 14 days after discontinuing MAOI [see and Examples of MAOIs include selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue.

Antihistamines

Amphetamines may counteract the sedative effect of antihistamines.

Antihypertensives

Amphetamines may antagonize the hypotensive effects of Antihypertensives.

Chlorpromazine

Chlorpromazine blocks dopamine and norepinephrine receptors, 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 receptors, thus inhibiting the central stimulant effects of amphetamines.

Lithium Carbonate

The anorectic and 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; coadministration of phenobarbital may produce a synergistic anticonvulsant action.

Phenytoin

Amphetamines may delay intestinal absorption of phenytoin; coadministration of phenytoin may produce a synergistic anticonvulsant action.

Propoxyphene

In cases of propoxyphene over dosage, amphetamine CNS stimulation is potentiated and fatal convulsions can occur.

Proton Pump Inhibitors

Time to maximum concentration (T) 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.

Veratrum Alkaloids

Amphetamines inhibit the hypotensive effect of Veratrum alkaloids.

Amphetamines can cause a significant elevation in plasma corticosteroid levels. This increase is greatest in the evening. Amphetamines may interfere with urinary steroid determinations.

No evidence of carcinogenicity was found in studies in which d,l-amphetamine (enantiomer ratio of 1:1) was administered to mice and rats in the diet for 2 years at doses of up to 30 mg/kg/day in male mice, 19 mg/kg/day in female mice, and 5 mg/kg/day in male and female rats. These doses are approximately 2.4, 1.5, and 0.8 times, respectively, the maximum recommended human dose of 30 mg/day [child] on a mg/m body surface area basis.

Amphetamine, in the enantiomer ratio present in Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets Sulfate and(immediate-release)(d- to 1- ratio of 3:1), was not clastogenic in the mouse bone marrow micronucleus test and was negative when tested in the E. coli component of the Ames test d, 1-Amphetamine (1:1 enantiomer ratio) has been reported to produce a positive response in the mouse bone marrow micronucleus test, an equivocal response in the Ames test, and negative responses in the in sister chromatid exchange and chromosomal aberration assays.

Amphetamine, in the enantiomer ratio present in Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (immediate-release)(d- to 1- ratio of 3:1), did not adversely affect fertility or early embryonic development in the rat at doses of up to 20 mg/kg/day (approximately 5 times the maximum recommended human dose of 30 mg/day on a mg/m body surface area basis).

Teratogenic Effects

Pregnancy Category C

Amphetamine, in the enantiomer ratio present in Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (d- to 1- ratio of 3:1), had no apparent effects on embryo fetal morphological development or survival when orally administered to pregnant rats and rabbits throughout the period of organogenesis at doses of up to 6 and 16 mg/kg/day, respectively. These doses are approximately 1.5 and 8 times, respectively, the maximum recommended human dose of 30 mg/day [child] on a mg/m body surface area basis. Fetal malformations and death have been reported in mice following parenteral administration of d-amphetamine doses of 50 mg/kg/day (approximately 6 times that of a human dose of 30 mg/day [child] on a mg/m basis) or greater to pregnant animals. Administration of these doses was also associated with severe maternal toxicity.

A number of studies in rodents indicate that prenatal or early postnatal exposure to amphetamine (d- or d,1-), at doses similar to those used clinically, can result in long-term neurochemical and behavioral alterations. Reported behavioral effects include learning and memory deficits, altered locomotor activity, and changes in sexual function.

There are no adequate and well-controlled studies in pregnant women. There has been one report of severe congenital bony deformity, tracheo-esophageal 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. Amphetamines 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.

Amphetamines are excreted in human milk Mothers taking amphetamines should be advised to refrain from nursing.

Long-term effects of amphetamines in children have not been well established. Amphetamines are not recommended for use in children under 3 years of age with Attention Deficit Hyperactivity Disorder described under

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets has not been studied in the geriatric population.

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, tics, aggression, anger, logorrhea, dermatillomania.

Eye Disorders

Vision blurred, mydriasis.

Gastrointestinal

Dryness of the mouth, unpleasant taste, diarrhea, constipation, 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.

Alopecia.

Musculoskeletal

Rhabdomyolysis.

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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