Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3286
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Dextroamphetamine Sulfate (Tablet)
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| dailymed-instance:dosage |
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. Narcolepsy:Usual dose is 5 mg to 60 mg per day in divided doses, depending on the individual patient response. Narcolepsy seldom occurs in pediatric pateints under 12 years of age; however, when it does, dextroamphetamine sulfate tablets 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 an 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. 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.
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| dailymed-instance:clinicalP... |
Amphetamines are non-catecholamine, sympathomimetic amines with CNS stimulant activity. Peripheral actions include elevations of systolic and diastolic blood pressures and weak bronchodilator and respiratory stimulant action. There is neither specific evidence that clearly establishes the mechanism whereby amphetamines produce mental and behavioral effects in children, nor conclusive evidence regarding how these effects relate to the condition of the central nervous system.<br/>Pharmacokinetics: The pharmacokinetics of the tablet and sustained-release capsule were compared in 12 healthy subjects. the extent of bioavailability of the sustained-release capsule was similar compared to the immediate-release tablet. Following administration of three 5 mg tablets, average maximal dextroamphetamine plasma concentrations (C) of 36.6 ng/mL were achieved at approximately 3 hours. Following administration of one 15 mg sustained-release capsule, maximal dextroamphetamine plasma concentrations were obtained approximately 8 hours after dosing. The average Cwas 23.5 ng/mL. The average plasma Twas similar for both the tablet and sustained-release capsule and was approximately 12 hours. In 12 healthy subjects, the rate and extent of dextroamphetamine absorption were similar following administration of the sustained-release capsule formulation in the fed (58 to 75 gm fat) and fasted state.
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| dailymed-instance:supply |
Dextroamphetamine sulfate tablets, USP, 5 mg are round, flat-face, bevel edge, orange mottled tablets, debossed "ETHEX" and "311" on one side and bisect on the other side, packaged as follows: NDC 58177-311-04 bottle of 100 tabletsNDC 58177-311-09 bottle of 1000 tablets Dextroamphetamine sulfate tablets, USP, 10 mg are round, flat-face, bevel edge, orange mottled tablets, debossed "ETHEX" and "312" on one side and double-scored on the other side, packaged as follows: NDC 58177-312-04 bottle of 100 tabletsNDC 58177-312-09 bottle of 1000 tablets Dispense in a tight container as defined in the USP.Store at 68��to 77��F (20��to 25��C). [see USP Controlled Room Temperature.] DEA Order Form Required. Manufactured byKV Pharmaceutical Co. forETHEX CorporationSt. Louis, MO 63044 P5557-1 12/07
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| dailymed-instance:boxedWarn... |
WARNING: 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 AMPHETAMINES MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS.
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| dailymed-instance:inactiveI... |
dailymed-ingredient:D&C_Yellow_No._10,
dailymed-ingredient:FD&C_Blue_No._2,
dailymed-ingredient:FD&C_Red_No._40,
dailymed-ingredient:hydrated_alumina,
dailymed-ingredient:magnesium_stearate,
dailymed-ingredient:mannitol,
dailymed-ingredient:microcrystalline_cellulose,
dailymed-ingredient:povidone,
dailymed-ingredient:starch,
dailymed-ingredient:stearic_acid
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| dailymed-instance:genericMe... |
dextroamphetamine sulfate
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| dailymed-instance:fullName |
Dextroamphetamine Sulfate (Tablet)
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| dailymed-instance:adverseRe... |
Cardiovascular:Palpitations, tachycardia, elevation of blood pressure. 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, tremor, headache, exacerbation of motor and phonic tics and Tourette's syndrome. Gastrointestinal:Dryness of the mouth, unpleasant taste, diarrhea, constipation, other gastrointestinal disturbances. Anorexia and weight loss may occur as undesirable effects. Allergic:Urticaria. Endocrine:Impotence, changes in libido.
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| dailymed-instance:indicatio... |
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.
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| dailymed-instance:name |
Dextroamphetamine Sulfate
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