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Basic Drug Info
Drug Name:Dextroamphetamine Sulfate
Manufacturer:BARR LABORATORIES, INC.
Other Info:

BARR LABORATORIES, INC.omonaA, ..

10970Revised SEPTEMBER 2007BR 0952, 0953



Clinical Trials:


Indications and Usage

Dextroamphetamine sulfate tablets are indicated for:Narcolepsy.Attention Deficit Disorder with Hyperactivity, as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 to 16 years) with a 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.
Narcolepsy -- A condition characterized by recurrent episodes of daytime somnolence and lapses in consciousness (microsomnias) that may be associated with automatic behaviors and AMNESIA. CATAPLEXY; SLEEP PARALYSIS, and hypnagogic HALLUCINATIONS frequently accompany narcolepsy. The pathophysiology of this disorder includes sleep-onset rapid eye movement (REM) sleep, which normally follows stage III or IV sleep. (From Neurology 1998 Feb;50(2 Suppl 1):S2-S7)

Symptoms -- An indication that a person has a condition or disease. Some examples of symptoms are headache, fever, fatigue, nausea, vomiting, and pain.

Syndrome -- A symptom complex of unknown etiology, that is characteristic of a particular abnormality.

Functional disorder -- Disturbance, impairment or abnormality of function.

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).
Arteriosclerosis -- Thickening and loss of elasticity of the walls of ARTERIES of all sizes. There are many forms classified by the types of lesions and arteries involved, such as ATHEROSCLEROSIS with fatty lesions in the ARTERIAL INTIMA of medium and large muscular arteries.

Cardiovascular Diseases -- Pathological conditions involving the CARDIOVASCULAR SYSTEM including the HEART; the BLOOD VESSELS; or the PERICARDIUM.

Hypertensive disease -- Persistently high systemic arterial BLOOD PRESSURE. Based on multiple readings (BLOOD PRESSURE DETERMINATION), hypertension is currently defined as when SYSTOLIC PRESSURE is consistently greater than 140 mm Hg or when DIASTOLIC PRESSURE is consistently 90 mm Hg or more.

Hyperthyroidism -- Hypersecretion of THYROID HORMONES from the THYROID GLAND. Elevated levels of thyroid hormones increase BASAL METABOLIC RATE.

Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Glaucoma -- An ocular disease, occurring in many forms, having as its primary characteristics an unstable or a sustained increase in the intraocular pressure which the eye cannot withstand without damage to its structure or impairment of its function. The consequences of the increased pressure may be manifested in a variety of symptoms, depending upon type and severity, such as excavation of the optic disk, hardness of the eyeball, corneal anesthesia, reduced visual acuity, seeing of colored halos around lights, disturbed dark adaptation, visual field defects, and headaches. (Dictionary of Visual Science, 4th ed)

Hypertensive Crisis --

Warnings

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 serious heart problems alone carry an increased risk of sudden death, stimulant products generally should not be used in children or adolescents with known serious 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.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 CONTRAINDICATIONS).
Branded Drugs
The following US Branded drugs contain Dextroamphetamine Sulfate


DELCOBESE -- TEVA PHARMACEUTICALS USA INC

ADDERALL XR 10 -- SHIRE DEVELOPMENT INC

ADDERALL XR 15 -- SHIRE DEVELOPMENT INC

ADDERALL XR 20 -- SHIRE DEVELOPMENT INC

ADDERALL XR 25 -- SHIRE DEVELOPMENT INC

ADDERALL XR 30 -- SHIRE DEVELOPMENT INC

ADDERALL XR 5 -- SHIRE DEVELOPMENT INC

ADDERALL 10 -- DURAMED RESEARCH INC

ADDERALL 12.5 -- DURAMED RESEARCH INC

ADDERALL 15 -- DURAMED RESEARCH INC

ADDERALL 20 -- DURAMED RESEARCH INC

ADDERALL 30 -- DURAMED RESEARCH INC

ADDERALL 5 -- DURAMED RESEARCH INC

ADDERALL 7.5 -- DURAMED RESEARCH INC

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE -- BARR LABORATORIES INC

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE -- COREPHARMA LLC

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE -- MALLINCKRODT INC

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE -- MUTUAL PHARMACEUTICAL CO INC

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE -- SANDOZ INC

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE -- TEVA PHARMACEUTICALS USA

DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE -- WATSON LABORATORIES INC

DEXEDRINE -- SMITHKLINE BEECHAM CORP DBA GLAXOSMITHKLINE

DEXAMPEX -- TEVA PHARMACEUTICALS USA INC

DEXEDRINE -- GLAXOSMITHKLINE

DEXTROSTAT -- SHIRE DEVELOPMENT INC

FERNDEX -- FERNDALE LABORATORIES INC


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