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Basic Drug Info
Drug Name:Dextroamphetamine Sulfate
Manufacturer:ETHEX Corporation
Other Info:

Attention Deficit Disorder with Hyperactivity:Not recommended for pediatric patients under 3 years of age.In pediatric patients from 3 to 5 years of age, start with 2.5 mg daily, by tablet; daily dosage may be raised in increments of 2.5 mg at weekly intervals until optimal response is obtained.In pediatric patients 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.



Clinical Trials:


Indications and Usage

Dextroamphetamine sulfate tablets are indicated in:1.

Narcolepsy.2.

Attention Deficit Disorder with Hyperactivity: As an integral part of a total treatment program that typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 years 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 2 --

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

Serious Cardiovascular EventsSudden Death in Patients with Pre-existing Structural Cardiac Abnormalities or Other Serious Heart Problems:Children and AdolescentsSudden 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 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.AdultsSudden 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).Hypertension and Other Cardiovascular ConditionsStimulant medications cause a modest increase in average blood pressure (about 2 to 4 mmHg) and average heart rate (about 3 to 6 bpm), 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 pre-existing hypertension, heart failure, recent myocardial infarction, or ventricular arrhythmia (see CONTRAINDICATIONS).Assessing Cardiovascular Status in Patients Being Treated with Stimulant MedicationsChildren, 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 EventsPre-Existing PsychosisAdministration of stimulants may exacerbate symptoms of behavior disturbance and thought disorder in patients with a pre-existing psychotic disorder.Bipolar IllnessParticular 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 SymptomsTreatment 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 3,482 exposed to methylphenidate or amphetamine for several weeks at usual doses) of stimulant-treated patients compared to 0 in placebo-treated patients.AggressionAggressive behavior or hostility is often observed in children and adolescents with ADHD, and has been reported in clinical trials and the postmarketing 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 GrowthCareful 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 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 likely have this effect as well.

Therefore, growth should be monitored during treatment with stimulants, and patients who are not growing or gaining height or weight as expected may need to have their treatment interrupted.SeizuresThere 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.Visual DisturbanceDifficulties with accommodation and blurring of vision have been reported with stimulant treatment.
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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