Rx Drugs Info

dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine suflate (Dextroamphetamine Saccharate, Amphetamine Asparatate, Dextroamphetamine Sulfate and Amphetamine Sulfatetablet 
[BARR LABORATORIES, INC.]

(Three Medication Guides Attached)

Revised MARCH 2007

11001193

Rx only

AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE. ADMINISTRATION OF AMPHETAMINES FOR PROLONGED PERIODS OF TIME MAY LEAD TO DRUG DEPENDENCE AND MUST BE AVOIDED. PARTICULAR ATTENTION SHOULD BE PAID TO THE POSSIBILITY OF SUBJECTS OBTAINING AMPHETAMINES FOR NON-THERAPEUTIC USE OR DISTRIBUTION TO OTHERS, AND THE DRUGS SHOULD BE PRESCRIBED OR DISPENSED SPARINGLY.

MISUSE OF AMPHETAMINE MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS.

DESCRIPTION:

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.

EACH TABLET CONTAINS 5 mg 7.5 mg 10 mg 12.5 mg 15 mg 20 mg 30 mg
Dextroamphetamine Saccharate 1.25 mg 1.875 mg 2.5 mg 3.125 mg 3.75 mg 5 mg 7.5 mg
Amphetamine Aspartate 1.25 mg 1.875 mg 2.5 mg 3.125 mg 3.75 mg 5 mg 7.5 mg
Dextroamphetamine Sulfate USP 1.25 mg 1.875 mg 2.5 mg 3.125 mg 3.75 mg 5 mg 7.5 mg
Amphetamine Sulfate USP 1.25 mg 1.875 mg 2.5 mg 3.125 mg 3.75 mg 5 mg 7.5 mg
Total amphetamine base equivalence 3.13 mg 4.7 mg 6.3 mg 7.8 mg 9.4 mg 12.6 mg 18.8 mg

In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, compressible sugar, corn starch, magnesium stearate, microcrystalline cellulose and, saccharin sodium.

The 5, 7.5 and 10 mg also contain FD&C blue no.1 aluminum lake.

The 12.5, 15, 20 and 30 mg also contain FD&C yellow no. 6 aluminum lake.

CLINICAL PHARMACOLOGY:

Amphetamines are non-catecholamine sympathomimetic amines with CNS stimulant activity. Peripheral actions include elevation of systolic and diastolic blood pressures and weak bronchodilator and respiratory stimulant action.

There is neither specific evidence which clearly establishes the mechanism whereby amphetamine produces mental and behavioral effects in children, nor conclusive evidence regarding how these effects relate to the condition of the central nervous system.

Pharmacokinetics:

Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets contain d-amphetamine and 1-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 1-amphetamine. The mean elimination half-life (t½) for d-amphetamine was shorter than the t½ of the 1-isomer (9.77 to 11 hours vs. 11.5 to 13.8 hours). The PK parameters (Cmax, AUC0-inf) of d- and 1-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 has not been studied.

INDICATIONS:

Attention Deficit Disorder with Hyperactivity:

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets are  indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted.

In Narcolepsy

CONTRAINDICATIONS:

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).

WARNINGS:

Psychosis:

Clinical experience suggests that in psychotic children, administration of amphetamine may exacerbate symptoms of behavior disturbance and thought disorder.

Long-Term Suppression of Growth:

Data are inadequate to determine whether chronic administration of amphetamine may be associated with growth inhibition; therefore, growth should be monitored during treatment.

Sudden Death and Pre-existing Structural Cardiac Abnormalities:

Sudden death has been reported in association with amphetamine treatment at usual doses in children with structural cardiac abnormalities. Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets generally should not be used in children or adults with structural cardiac abnormalities.

Usage in Nursing Mothers:

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

PRECAUTIONS:

General:

The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage.

Hypertension:

Caution is to be exercised in prescribing amphetamines for patients with even mild hypertension. Blood pressure and pulse should be monitored at appropriate intervals in patients taking dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets, especially patients with hypertension.

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.

Drug Interactions:

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. 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:

Amphetamine may delay intestinal absorption of phenobarbital; co-administration of phenobarbital may produce a synergistic anticonvulsant action.

Phenytoin:

Amphetamines may delay intestinal absorption of phenytoin; co-administration 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.

Drug/Laboratory Test Interactions:

Carcinogenesis/Mutagenesis:

Mutagenicity studies and long-term studies in animals to determine the carcinogenic potential of amphetamine, have not been performed.

Pregnancy:

Teratogenic Effects:

Pregnancy Category C:

Amphetamine has been shown to have embryotoxic and teratogenic effects when administered to A/Jax mice and C57BL mice in doses approximately 41 times the maximum human dose. Embryotoxic effects were not seen in New Zealand white rabbits given the drug in doses 7 times the human dose nor in rats given 12.5 times the maximum human dose. While there are no adequate and well-controlled studies in pregnant women, there has been one report of severe congenital bony deformity, tracheoesophageal fistula, and anal atresia (vater association) in a baby born to a woman who took dextroamphetamine sulfate with lovastatin during the first trimester of pregnancy. 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.

Pediatric Use:

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 Disorder with Hyperactivity described under INDICATIONS AND USAGE.

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.

Drug treatment is not indicated in all cases of Attention Deficit Disorder with Hyperactivity and should be considered only in light of the complete history and evaluation of the child. The decision to prescribe amphetamines should depend on the physician's assessment of the chronicity and severity of the child's symptoms and their appropriateness for his/her age. Prescription should not depend solely on the presence of one or more of the behavioral characteristics. When these symptoms are associated with acute stress reactions, treatment with amphetamines is usually not indicated.

ADVERSE REACTIONS:

Cardiovascular:

Palpitations, tachycardia, elevation of blood pressure, sudden death, myocardial infarction. There have been isolated reports of cardiomyopathy associated with chronic amphetamine use.

Central Nervous System:

Psychotic episodes at recommended doses (rare), 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 when amphetamines are used for other than the anorectic effect.

Allergic:

Urticaria.

Endocrine:

Impotence, changes in libido.

DRUG ABUSE AND DEPENDENCE:

Dextroamphetamine Sulfate is 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 many times 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. This is rare with oral amphetamines.

OVERDOSAGE:

Individual patient response to amphetamines varies widely. While toxic symptoms occasionally occur as an idiosyncrasy at doses as low as 2 mg, they are rare with doses of less than 15 mg; 30 mg can produce severe reactions, yet doses of 400 to 500 mg are not necessarily fatal.

In rats, the oral LD50 of dextroamphetamine sulfate is 96.8 mg/kg.

Symptoms:

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.

Treatment:

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.

DOSAGE AND ADMINISTRATION:

Regardless of indication, amphetamines should be administered at the lowest effective dosage and dosage should be individually adjusted. Late evening doses should be avoided because of the resulting insomnia.

Attention Deficit Disorder with Hyperactivity:

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.

HOW SUPPLIED:

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets is available as:

5 mg: Blue, oval, biconvex tablet with two partial bisects on one side debossed with stylized b over 971 and four partial bisects on the other side debossed with 5.

Available in bottles of:

50 Tablets NDC 0555-0971-10
100 Tablets NDC 0555-0971-02
500 Tablets NDC 0555-0971-04

7.5 mg: Blue, round, flat-faced, beveled-edge tablet debossed with stylized b over 775 on one side and two partial bisects and a full score on the other side debossed with 7│½.

Available in bottles of:

50 Tablets NDC 0555-0775-10
100 Tablets NDC 0555-0775-02
500 Tablets NDC 0555-0775-04

10 mg: Blue, oval, flat-faced, beveled-edge tablet with two partial bisects on one side debossed with stylized b over 972 and two partial bisects and a full score on the other side debossed with 1│0.

Available in bottles of:

50 Tablets NDC 0555-0972-10
100 Tablets NDC 0555-0972-02
500 Tablets NDC 0555-0972-04

12.5 mg: Peach, oval, biconvex tablet debossed with stylized b over 776 separated by a full score on one side and four partial bisects on the other side debossed with 12│½.

Available in bottles of:

50 Tablets NDC 0555-0776-10
100 Tablets NDC 0555-0776-02
500 Tablets NDC 0555-0776-04

15 mg: Peach, round, flat-faced, beveled-edge tablet debossed with stylized b over 777 on one side and two partial bisects and a full score on the other side debossed with 1│5.

Available in bottles of:

50 Tablets NDC 0555-0777-10
100 Tablets NDC 0555-0777-02
500 Tablets NDC 0555-0777-04

20 mg: Peach, oval, flat-faced, beveled-edge tablet with two partial bisects on one side debossed with stylized b over 973 and two partial bisects and a full score on the other side debossed with 2│0.

Available in bottles of:

50 Tablets NDC 0555-0973-10
100 Tablets NDC 0555-0973-02
500 Tablets NDC 0555-0973-04

30 mg: Peach, oval, biconvex tablet with two partial bisects on one side debossed with stylized b over 974 and two partial bisects and a full score on the other side debossed with 3│0.

Available in bottles of:

50 Tablets NDC 0555-0974-10
100 Tablets NDC 0555-0974-02
500 Tablets NDC 0555-0974-04

Dispense with a child-resistant closure in a tight, light-resistant container.

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

MEDICATION GUIDE

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS

Rx only

Read the Medication Guide that comes with Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets before you or your child starts taking it 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:

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:

A ll Patients

Children and Teenagers

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

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets is a central nervous system stimulant prescription medicine. It is 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 is a federally controlled substance (CII) because it 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:

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets is 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:

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 takes 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:

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?

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:

Common side effects include:

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?

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 it was 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 about Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, please contact Barr Laboratories, Inc. at 1-800-BARRLAB(227-7522).

What are the ingredients in Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets?

Active Ingredient: dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, USP, amphetamine sulfate, USP

Inactive Ingredients: lactitol, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate, and other ingredients.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

MANUFACTURED BY
BARR LABORATORIES, INC.
POMONA, NY 10970

Revised MARCH 2007 / BR-0971, 0775, 0972, 0776, 0777, 0973, 0974


Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Suflate (Dextroamphetamine Saccharate, Amphetamine Asparatate, Dextroamphetamine Sulfate and Amphetamine Sulfate)
PRODUCT INFO
Product Code 0555-0971 Dosage Form TABLET
Route Of Administration ORAL DEA Schedule CII
INGREDIENTS
Name (Active Moiety) Type Strength
Dextroamphetamine Saccharate (Dextroamphetamine) Active 1.25 MILLIGRAM  In 1 TABLET
Amphetamine Aspartate (Amphetamine) Active 1.25 MILLIGRAM  In 1 TABLET
Dextroamphetamine Sulfate (Dextroamphetamine) Active 1.25 MILLIGRAM  In 1 TABLET
Amphetamine Sulfate (Amphetamine) Active 1.25 MILLIGRAM  In 1 TABLET
colloidal silicon dioxide Inactive  
compressible sugar Inactive  
corn starch Inactive  
magnesium stearate Inactive  
microcrystalline cellulose Inactive  
saccharin sodium Inactive  
FDC blue no. 1 aluminum lake Inactive  
IMPRINT INFORMATION
Characteristic Appearance Characteristic Appearance
Color BLUE (BLUE) Score 4
Shape OVAL (OVAL) Symbol true
Imprint Code b/971;5 Coating false
Size 8mm
PACKAGING
# NDC Package Description Multilevel Packaging
1 0555-0971-10 50 TABLET In 1 BOTTLE None
2 0555-0971-02 100 TABLET In 1 BOTTLE None
3 0555-0971-04 500 TABLET In 1 BOTTLE None

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Suflate (Dextroamphetamine Saccharate, Amphetamine Asparatate, Dextroamphetamine Sulfate and Amphetamine Sulfate)
PRODUCT INFO
Product Code 0555-0775 Dosage Form TABLET
Route Of Administration ORAL DEA Schedule CII
INGREDIENTS
Name (Active Moiety) Type Strength
Dextroamphetamine Saccharate (Dextroamphetamine) Active 1.875 MILLIGRAM  In 1 TABLET
Amphetamine Aspartate (Amphetamine) Active 1.875 MILLIGRAM  In 1 TABLET
Dextroamphetamine Sulfate (Dextroamphetamine) Active 1.875 MILLIGRAM  In 1 TABLET
Amphetamine Sulfate (Amphetamine) Active 1.875 MILLIGRAM  In 1 TABLET
colloidal silicon dioxide Inactive  
compressible sugar Inactive  
corn starch Inactive  
magnesium stearate Inactive  
microcrystalline cellulose Inactive  
saccharin sodium Inactive  
FDC blue no. 1 aluminum lake Inactive  
IMPRINT INFORMATION
Characteristic Appearance Characteristic Appearance
Color BLUE (BLUE) Score 4
Shape ROUND (ROUND) Symbol true
Imprint Code b/775;7l1/2 Coating false
Size 8mm
PACKAGING
# NDC Package Description Multilevel Packaging
1 0555-0775-04 500 TABLET In 1 BOTTLE None
2 0555-0775-02 100 TABLET In 1 BOTTLE None
3 0555-0775-10 50 TABLET In 1 BOTTLE None

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Suflate (Dextroamphetamine Saccharate, Amphetamine Asparatate, Dextroamphetamine Sulfate and Amphetamine Sulfate)
PRODUCT INFO
Product Code 0555-0972 Dosage Form TABLET
Route Of Administration ORAL DEA Schedule CII
INGREDIENTS
Name (Active Moiety) Type Strength
Dextroamphetamine Saccharate (Dextroamphetamine) Active 2.5 MILLIGRAM  In 1 TABLET
Amphetamine Aspartate (Amphetamine) Active 2.5 MILLIGRAM  In 1 TABLET
Dextroamphetamine Sulfate (Dextroamphetamine) Active 2.5 MILLIGRAM  In 1 TABLET
Amphetamine Sulfate (Amphetamine) Active 2.5 MILLIGRAM  In 1 TABLET
colloidal silicon dioxide Inactive  
compressible sugar Inactive  
corn starch Inactive  
magnesium stearate Inactive  
microcrystalline cellulose Inactive  
saccharin sodium Inactive  
FDC blue no. 1 aluminum lake Inactive  
IMPRINT INFORMATION
Characteristic Appearance Characteristic Appearance
Color BLUE (BLUE) Score 4
Shape OVAL (OVAL) Symbol true
Imprint Code b/972;1/0 Coating false
Size 10mm
PACKAGING
# NDC Package Description Multilevel Packaging
1 0555-0972-04 500 TABLET In 1 BOTTLE None
2 0555-0972-02 100 TABLET In 1 BOTTLE None
3 0555-0972-10 50 TABLET In 1 BOTTLE None

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Suflate (Dextroamphetamine Saccharate, Amphetamine Asparatate, Dextroamphetamine Sulfate and Amphetamine Sulfate)
PRODUCT INFO
Product Code 0555-0776 Dosage Form TABLET
Route Of Administration ORAL DEA Schedule CII
INGREDIENTS
Name (Active Moiety) Type Strength
Dextroamphetamine Saccharate (Dextroamphetamine) Active 3.125 MILLIGRAM  In 1 TABLET
Amphetamine Aspartate (Amphetamine) Active 3.125 MILLIGRAM  In 1 TABLET
Dextroamphetamine Sulfate (Dextroamphetamine) Active 3.125 MILLIGRAM  In 1 TABLET
Amphetamine Sulfate (Amphetamine) Active 3.125 MILLIGRAM  In 1 TABLET
colloidal silicon dioxide Inactive  
compressible sugar Inactive  
corn starch Inactive  
magnesium stearate Inactive  
microcrystalline cellulose Inactive  
saccharin sodium Inactive  
FDC yellow no. 6 aluminum lake Inactive  
IMPRINT INFORMATION
Characteristic Appearance Characteristic Appearance
Color ORANGE (ORANGE) Score 4
Shape OVAL (OVAL) Symbol true
Imprint Code b/776;12;1/2 Coating false
Size 9mm
PACKAGING
# NDC Package Description Multilevel Packaging
1 0555-0776-04 500 TABLET In 1 BOTTLE None
2 0555-0776-02 100 TABLET In 1 BOTTLE None
3 0555-0776-10 50 TABLET In 1 BOTTLE None

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Suflate (Dextroamphetamine Saccharate, Amphetamine Asparatate, Dextroamphetamine Sulfate and Amphetamine Sulfate)
PRODUCT INFO
Product Code 0555-0777 Dosage Form TABLET
Route Of Administration ORAL DEA Schedule CII
INGREDIENTS
Name (Active Moiety) Type Strength
Dextroamphetamine Saccharate (Dextroamphetamine) Active 3.75 MILLIGRAM  In 1 TABLET
Amphetamine Aspartate (Amphetamine) Active 3.75 MILLIGRAM  In 1 TABLET
Dextroamphetamine Sulfate (Dextroamphetamine) Active 3.75 MILLIGRAM  In 1 TABLET
Amphetamine Sulfate (Amphetamine) Active 3.75 MILLIGRAM  In 1 TABLET
colloidal silicon dioxide Inactive  
compressible sugar Inactive  
corn starch Inactive  
magnesium stearate Inactive  
microcrystalline cellulose Inactive  
saccharin sodium Inactive  
FDC yellow no. 6 aluminum lake Inactive  
IMPRINT INFORMATION
Characteristic Appearance Characteristic Appearance
Color ORANGE (ORANGE) Score 4
Shape ROUND (ROUND) Symbol true
Imprint Code b/777;1l5 Coating false
Size 8mm
PACKAGING
# NDC Package Description Multilevel Packaging
1 0555-0777-04 500 TABLET In 1 BOTTLE None
2 0555-0777-02 100 TABLET In 1 BOTTLE None
3 0555-0777-10 50 TABLET In 1 BOTTLE None

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Suflate (Dextroamphetamine Saccharate, Amphetamine Asparatate, Dextroamphetamine Sulfate and Amphetamine Sulfate)
PRODUCT INFO
Product Code 0555-0973 Dosage Form TABLET
Route Of Administration ORAL DEA Schedule CII
INGREDIENTS
Name (Active Moiety) Type Strength
Dextroamphetamine Saccharate (Dextroamphetamine) Active 5 MILLIGRAM  In 1 TABLET
Amphetamine Aspartate (Amphetamine) Active 5 MILLIGRAM  In 1 TABLET
Dextroamphetamine Sulfate (Dextroamphetamine) Active 5 MILLIGRAM  In 1 TABLET
Amphetamine Sulfate (Amphetamine) Active 5 MILLIGRAM  In 1 TABLET
colloidal silicon dioxide Inactive  
compressible sugar Inactive  
corn starch Inactive  
magnesium stearate Inactive  
microcrystalline cellulose Inactive  
saccharin sodium Inactive  
FDC yellow no. 6 aluminum lake Inactive  
IMPRINT INFORMATION
Characteristic Appearance Characteristic Appearance
Color ORANGE (ORANGE) Score 4
Shape OVAL (OVAL) Symbol true
Imprint Code b/973;2/0 Coating false
Size 10mm
PACKAGING
# NDC Package Description Multilevel Packaging
1 0555-0973-04 500 TABLET In 1 BOTTLE None
2 0555-0973-02 100 TABLET In 1 BOTTLE None
3 0555-0973-10 50 TABLET In 1 BOTTLE None

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Suflate (Dextroamphetamine Saccharate, Amphetamine Asparatate, Dextroamphetamine Sulfate and Amphetamine Sulfate)
PRODUCT INFO
Product Code 0555-0974 Dosage Form TABLET
Route Of Administration ORAL DEA Schedule CII
INGREDIENTS
Name (Active Moiety) Type Strength
Dextroamphetamine Saccharate (Dextroamphetamine) Active 7.5 MILLIGRAM  In 1 TABLET
Amphetamine Aspartate (Amphetamine) Active 7.5 MILLIGRAM  In 1 TABLET
Dextroamphetamine Sulfate (Dextroamphetamine) Active 7.5 MILLIGRAM  In 1 TABLET
Amphetamine Sulfate (Amphetamine) Active 7.5 MILLIGRAM  In 1 TABLET
colloidal silicon dioxide Inactive  
compressible sugar Inactive  
corn starch Inactive  
magnesium stearate Inactive  
microcrystalline cellulose Inactive  
saccharin sodium Inactive  
FDC yellow no. 6 aluminum lake Inactive  
IMPRINT INFORMATION
Characteristic Appearance Characteristic Appearance
Color ORANGE (ORANGE) Score 4
Shape OVAL (OVAL) Symbol true
Imprint Code b/974;3/0 Coating false
Size 12mm
PACKAGING
# NDC Package Description Multilevel Packaging
1 0555-0974-04 500 TABLET In 1 BOTTLE None
2 0555-0974-02 100 TABLET In 1 BOTTLE None
3 0555-0974-10 50 TABLET In 1 BOTTLE None

Revised: 08/2007BARR LABORATORIES, INC.

Data are from FDA and U.S. National Library of Medicine.