DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLETS (MIXED SALTS OF A SINGLE ENTITY AMPHETAMINE PRODUCT) CII
5321
5323
5326
5327
Rx only

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

Inactive Ingredients: acacia, corn starch, lactose, magnesium stearate, sucrose, and FD&C Blue #1 as a color additive.

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 extraneuronal space.

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_½) for d-amphetamine was shorter than the t_½ of the l-isomer (9.77 to 11 hours vs. 11.5 to 13.8 hours). The PK parameters (C_max, AUC_0-inf) 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.

Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy.

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 ulener; 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.

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.

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.

The effectiveness of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets 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.

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

Agitated states.

Patients with a history of drug abuse.

During or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result).

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 naturaulic subgroups 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.

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.

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

The least amount of amphetamine feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets should be used with caution in patients who use other sympathomimetic drugs.

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.

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 spans. Patients should be given the opportunity to discuss the spans of the Medication Guide and to obtain answers to any questions they may have. The complete div of the Medication Guide is reprinted at the end of this document.

Acidifying agents

– Gastrointestinal acidifying agents (guanethidine, reserpine, glutamic acid HCl, ascorbic acid, fruit juices, etc.) lower absorption of amphetamines.

Urinary acidifying agents

– (ammonium chloride, sodium acid phosphate, etc.) increase the concentration of the ionized species of the amphetamine molecule, thereby increasing urinary excretion. Both groups of agents lower blood levels and efficacy of amphetamines.

Adrenergic blockers

– Adrenergic blockers are inhibited by amphetamines.

Alkalinizing agents

– Gastrointestinal alkalinizing agents (sodium bicarbonate, etc.) increase absorption of amphetamines. Coadministration of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets and gastrointestinal alkalizing agents, such as antacids, should be avoided. Urinary alkalinizing agents (acetazolamide, some thiazides) increase the concentration of the non-ionized species of the amphetamine molecule, thereby decreasing urinary excretion. Both groups of agents increase blood levels and therefore potentiate the actions of amphetamines.

Antidepressants, tricyclic

– Amphetamines may enhance the activity of tricyclic or sympathomimetic agents; d-amphetamine with desipramine or protriptyline and possibly other tricyclics cause striking and sustained increases in the concentration of d-amphetamine in the brain; cardiovascular effects can be potentiated.

MAO inhibitors

– MAOI antidepressants, as well as a metabolite of furazolidone, slow amphetamine metabolism. This slowing potentiates amphetamines, increasing their effect on the release of norepinephrine and other monoamines from adrenergic nerve endings; this can cause headaches and other signs of hypertensive crisis. A variety of neurological toxic effects and malignant hyperpyrexia can occur, sometimes with fatal results.

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 overdosage, amphetamine CNS stimulation is potentiated and fatal convulsions can occur.

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/m² body surface area basis.

Amphetamine, in the enantiomer ratio present in dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets (immediate-release)(d- to l- ratio of 3:1), was not clastogenic in the mouse bone marrow micronucleus test in vivo and was negative when tested in the E. coli component of the Ames test in vitro. d,l-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 vitro 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 l- 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/m² body surface area basis).

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 INDICATIONS.

Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets have 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, dizziness, insomnia, euphoria, dyskinesia, dysphoria, depression, tremor, headache, exacerbation of motor and phonic tics and Tourette’s syndrome, seizures, stroke.

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.

Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets are a Schedule II controlled substance.

Amphetamines have been extensively abused. Tolerance, extreme psychological dependence, and severe social disability have occurred. There are reports of patients who have increased the dosage to levels many times higher than recommended. Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG. Manifestations of chronic intoxication with amphetamines include severe dermatoses, marked insomnia, irritability, hyperactivity, and personality changes. The most severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from schizophrenia.

Individual patient response to amphetamines varies widely. Toxic symptoms may occur idiosyncratically at low doses.

Manifestations of acute overdosage with amphetamines include restlessness, tremor, hyperreflexia, rapid respiration, confusion, assaultiveness, hallucinations, panic states, hyperpyrexia and rhabdomyolysis.

Fatigue and depression usually follow the central stimulation.

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.

Consult with a Certified Poison Control Center for up to date guidance and advice. Management of acute amphetamine intoxication is largely symptomatic and includes gastric lavage, administration of activated charcoal, administration of a cathartic and sedation. Experience with hemodialysis or peritoneal dialysis is inadequate to permit recommendation in this regard. Acidification of the urine increases amphetamine excretion, but is believed to increase risk of acute renal failure if myoglobinuria is present. If acute, severe hypertension complicates amphetamine overdosage, administration of intravenous phentolamine has been suggested. However, a gradual drop in blood pressure will usually result when sufficient sedation has been achieved. Chlorpromazine antagonizes the central stimulant effects of amphetamines and can be used to treat amphetamine intoxication.

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.

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.

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.

Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets are available as:

5 mg: white to off-white, round, convex tablet, full and partial bisect, debossed “93” on one side, debossed “5321” on the other side in bottles of 100.

10 mg: white to off-white, round, convex tablet, full and partial bisect, debossed “93” on one side, debossed “5323” on the other side in bottles of 100.

20 mg: white to off-white, round, convex tablet, full and partial bisect, debossed “93” on one side, debossed “5326” on the other side in bottles of 100.

30 mg: white to off-white, round, convex tablet, full and partial bisect, debossed “93” on one side, debossed “5327” on the other side in bottles of 100.

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLETS (MIXED SALTS OF A SINGLE ENTITY AMPHETAMINE PRODUCT) CII

READ THE MEDICATION GUIDE THAT COMES WITH DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLETS BEFORE YOU OR YOUR CHILD STARTS TAKING THEM AND EACH TIME YOU GET A REFILL. THERE MAY BE NEW INFORMATION. THIS MEDICATION GUIDE DOES NOT TAKE THE PLACE OF TALKING TO YOUR DOCTOR ABOUT YOU OR YOUR CHILD’S TREATMENT WITH DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLETS.

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLETS?

THE FOLLOWING HAVE BEEN REPORTED WITH USE OF DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLETS AND OTHER STIMULANT MEDICINES.

1. HEART-RELATED PROBLEMS:

• sudden death in patients who have heart problems or heart defects
• stroke and heart attack in adults
• increased blood pressure and heart rate

TELL YOUR DOCTOR IF YOU OR YOUR CHILD HAVE ANY HEART PROBLEMS, HEART DEFECTS, HIGH BLOOD PRESSURE, OR A FAMILY HISTORY OF THESE PROBLEMS.

YOUR DOCTOR SHOULD CHECK YOU OR YOUR CHILD CAREFULLY FOR HEART PROBLEMS BEFORE STARTING DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLETS.

YOUR DOCTOR SHOULD CHECK YOUR OR YOUR CHILD’S BLOOD PRESSURE AND HEART RATE REGULARLY DURING TREATMENT WITH DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLETS.

CALL YOUR DOCTOR RIGHT AWAY IF YOU OR YOUR CHILD HAVE ANY SIGNS OF HEART PROBLEMS SUCH AS CHEST PAIN, SHORTNESS OF BREATH, OR FAINTING WHILE TAKING DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLETS.

2. MENTAL (PSYCHIATRIC) PROBLEMS:

ALL PATIENTS

• new or worse behavior and thought problems
• new or worse bipolar illness
• new or worse aggressive behavior or hostility

CHILDREN AND TEENAGERS

• new psychotic symptoms (such as hearing voices, believing things that are not true, are suspicious) or new manic symptoms

TELL YOUR DOCTOR ABOUT ANY MENTAL PROBLEMS YOU OR YOUR CHILD HAVE, OR ABOUT A FAMILY HISTORY OF SUICIDE, BIPOLAR ILLNESS, OR DEPRESSION.

Call your doctor right away if you or your child have any new or worsening mental symptoms or problems while taking dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets, especially seeing or hearing things that are not real, believing things that are not real, or are suspicious.

WHAT ARE DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLETS?

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLETS ARE A CENTRAL NERVOUS SYSTEM STIMULANT PRESCRIPTION MEDICINE. THEY ARE USED FOR THE TREATMENT OF ATTENTION-DEFICIT HYPERACTIVITY DISORDER (ADHD). DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLETS MAY HELP INCREASE ATTENTION AND DECREASE IMPULSIVENESS AND HYPERACTIVITY IN PATIENTS WITH ADHD.

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLETS SHOULD BE USED AS A PART OF A TOTAL TREATMENT PROGRAM FOR ADHD THAT MAY INCLUDE COUNSELING OR OTHER THERAPIES.

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLETS ARE ALSO USED IN THE TREATMENT OF A SLEEP DISORDER CALLED NARCOLEPSY.

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLETS ARE A FEDERALLY CONTROLLED SUBSTANCE (CII) BECAUSE THEY CAN BE ABUSED OR LEAD TO DEPENDENCE. KEEP DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLETS IN A SAFE PLACE TO PREVENT MISUSE AND ABUSE. SELLING OR GIVING AWAY DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLETS MAY HARM OTHERS AND IS AGAINST THE LAW.

Tell your doctor if you or your child have (or have a family history of) ever abused or been dependent on alcohol, prescription medicines or street drugs.

WHO SHOULD NOT TAKE DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLETS?

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLETS SHOULD NOT BE TAKEN IF YOU OR YOUR CHILD:

• have heart disease or hardening of the arteries
• have moderate to severe high blood pressure
• have hyperthyroidism
• have an eye problem called glaucoma
• are very anxious, tense, or agitated
• have a history of drug abuse
• are taking or have taken within the past 14 days an anti-depression medicine called a monoamine oxidase inhibitor or MAOI.
• are sensitive to, allergic to, or had a reaction to other stimulant medicines

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLETS ARE NOT RECOMMENDED FOR USE IN CHILDREN LESS THAN 3 YEARS OLD.

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLETS MAY NOT BE RIGHT FOR YOU OR YOUR CHILD. BEFORE STARTING DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLETS TELL YOUR OR YOUR CHILD’S DOCTOR ABOUT ALL HEALTH CONDITIONS (OR A FAMILY HISTORY OF) INCLUDING:

• heart problems, heart defects, high blood pressure
• mental problems including psychosis, mania, bipolar illness, or depression
• tics or Tourette’s syndrome
• liver or kidney problems
• thyroid problems
• seizures or have had an abnormal brain wave test (EEG)

TELL YOUR DOCTOR IF YOU OR YOUR CHILD ARE PREGNANT, PLANNING TO BECOME PREGNANT, OR BREASTFEEDING.

CAN DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLETS BE TAKEN WITH OTHER MEDICINES?

TELL YOUR DOCTOR ABOUT ALL OF THE MEDICINES THAT YOU OR YOUR CHILD TAKE INCLUDING PRESCRIPTION AND NONPRESCRIPTION MEDICINES, VITAMINS, AND HERBAL SUPPLEMENTS. DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLETS AND SOME MEDICINES MAY INTERACT WITH EACH OTHER AND CAUSE SERIOUS SIDE EFFECTS. SOMETIMES THE DOSES OF OTHER MEDICINES WILL NEED TO BE ADJUSTED WHILE TAKING DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLETS.

YOUR DOCTOR WILL DECIDE WHETHER DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLETS CAN BE TAKEN WITH OTHER MEDICINES.

ESPECIALLY TELL YOUR DOCTOR IF YOU OR YOUR CHILD TAKE:

• anti-depression medicines including MAOIs
• blood pressure medicines
• seizure medicines
• blood thinner medicines
• cold or allergy medicines that contain decongestants
• stomach acid medicines

KNOW THE MEDICINES THAT YOU OR YOUR CHILD TAKE. KEEP A LIST OF YOUR MEDICINES WITH YOU TO SHOW YOUR DOCTOR AND PHARMACIST.

DO NOT START ANY NEW MEDICINE WHILE TAKING DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLETS WITHOUT TALKING TO YOUR DOCTOR FIRST.

HOW SHOULD DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLETS BE TAKEN?

• Take dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets exactly as prescribed. Your doctor may adjust the dose until it is right for you or your child.
• Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets are usually taken two to three times a day. The first dose is usually taken when you first wake in the morning. One or two more doses may be taken during the day, 4 to 6 hours apart.
• Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets can be taken with or without food.
• From time to time, your doctor may stop dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablet treatment for a while to check ADHD symptoms.
• Your doctor may do regular checks of the blood, heart, and blood pressure while taking dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets. Children should have their height and weight checked often while taking dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablet treatment may be stopped if a problem is found during these check-ups.
• If you or your child take too many dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets or overdoses, call your doctor or poison control center right away, or get emergency treatment.

WHAT ARE POSSIBLE SIDE EFFECTS OF DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLETS?

SEE “WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLETS?” FOR INFORMATION ON REPORTED HEART AND MENTAL PROBLEMS.

OTHER SERIOUS SIDE EFFECTS INCLUDE:

• slowing of growth (height and weight) in children
• seizures, mainly in patients with a history of seizures
• eyesight changes or blurred vision

COMMON SIDE EFFECTS INCLUDE:

• headache
• stomach ache
• trouble sleeping
• decreased appetite
• nervousness
• dizziness

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLETS MAY AFFECT YOUR OR YOUR CHILD’S ABILITY TO DRIVE OR DO OTHER DANGEROUS ACTIVITIES.

TALK TO YOUR DOCTOR IF YOU OR YOUR CHILD HAVE SIDE EFFECTS THAT ARE BOTHERSOME OR DO NOT GO AWAY.

THIS IS NOT A COMPLETE LIST OF POSSIBLE SIDE EFFECTS. ASK YOUR DOCTOR OR PHARMACIST FOR MORE INFORMATION.

HOW SHOULD I STORE DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLETS?

• Store dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets in a safe place at room temperature, 20° to 25°C (68° to 77°F).
• Keep dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets and all medicines out of the reach of children.

GENERAL INFORMATION ABOUT DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLETS

MEDICINES ARE SOMETIMES PRESCRIBED FOR PURPOSES OTHER THAN THOSE LISTED IN A MEDICATION GUIDE. DO NOT USE DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLETS FOR A CONDITION FOR WHICH THEY WERE NOT PRESCRIBED. DO NOT GIVE DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLETS TO OTHER PEOPLE, EVEN IF THEY HAVE THE SAME CONDITION. IT MAY HARM THEM AND IT IS AGAINST THE LAW.

THIS MEDICATION GUIDE SUMMARIZES THE MOST IMPORTANT INFORMATION ABOUT DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLETS. IF YOU WOULD LIKE MORE INFORMATION, TALK WITH YOUR DOCTOR. YOU CAN ASK YOUR DOCTOR OR PHARMACIST FOR INFORMATION ABOUT DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLETS THAT WAS WRITTEN FOR HEALTHCARE PROFESSIONALS. FOR MORE INFORMATION, YOU MAY ALSO CONTACT TEVA PHARMACEUTICALS USA (THE MAKER OF DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLETS) AT 1-888-838-2872, MEDICAL AFFAIRS.

WHAT ARE THE INGREDIENTS IN DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE TABLETS?

ACTIVE INGREDIENTS: DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE; DEXTROAMPHETAMINE SULFATE, USP; AMPHETAMINE SULFATE, USP

INACTIVE INGREDIENTS: ACACIA, CORN STARCH, LACTOSE, MAGNESIUM STEARATE, SUCROSE, AND FD&C BLUE #1 AS A COLOR ADDITIVE

THIS MEDICATION GUIDE HAS BEEN APPROVED BY THE U.S. FOOD AND DRUG ADMINISTRATION.