BOX 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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SUMMARY
Dextroamphetamine sulfate, USP is the dextro isomer of the compound d,l -amphetamine sulfate, a sympathomimetic amine of the amphetamine group.
Dextroamphetamine Sulfate Extended-Release Capsules are indicated in:
Narcolepsy
Attention Deficit Disorder with Hyperactivity
As an integral part of a total treatment program that typically includes other measures (psychological, educational, social) for patients (ages 6 years to 16 years) with this syndrome. A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV) implies the presence of the 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 2 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 6 of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; 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 6 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; cant wait turn; intrusive. The Combined Type requires both inattentive and hyperactive-impulsive criteria to be met.
Special Diagnostic Considerations
Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use of medical and 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 patient and not solely on the presences of the required number of DSM-IV characteristics.
Need for Comprehensive Treatment Program
Dextroamphetamine sulfate extended-release capsules 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 patients with this syndrome. Stimulants are not intended for use in patients who exhibit 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 physicians assessment of the chronicity and severity of the patients symptoms.
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NEWS HIGHLIGHTS
Published Studies Related to Dextroamphetamine
A randomized, placebo-controlled trial of sustained-release dextroamphetamine for treatment of methamphetamine addiction. [2011.02] Sixty treatment-seeking individuals with methamphetamine (MA) dependence entered a randomized, placebo-controlled, double-blind clinical trial of oral dextroamphetamine (d-AMP) as a replacement therapy for MA dependence. The subjects took 60 mg sustained-release d-AMP for 8 weeks, during which time they received eight 50-min sessions of individual psychotherapy...
Minocycline attenuates subjective rewarding effects of dextroamphetamine in humans. [2011.01] RATIONALE: Minocycline, a tetracycline antibiotic, interacts with brain glutamate and dopamine neurotransmission. In preclinical studies, minocycline attenuated amphetamine-induced acute dopamine release and subsequent behavioral sensitization. The goal of this study was to determine minocycline's effects on the acute physiological, behavioral, and subjective responses to dextroamphetamine (DAMP) in healthy volunteers... CONCLUSIONS: These findings warrant further studies examining the potential use of minocycline for stimulant addiction.
A randomized, placebo-controlled trial of sustained-release dextroamphetamine for
treatment of methamphetamine addiction. [2011] Sixty treatment-seeking individuals with methamphetamine (MA) dependence entered
a randomized, placebo-controlled, double-blind clinical trial of oral
dextroamphetamine (d-AMP) as a replacement therapy for MA dependence. The
subjects took 60 mg sustained-release d-AMP for 8 weeks, during which time they
received eight 50-min sessions of individual psychotherapy...
Double-blind study of dextroamphetamine versus caffeine augmentation for treatment-resistant obsessive-compulsive disorder. [2009.11] CONCLUSIONS: Larger, double-blind, placebo-controlled trials of both d-amphetamine and caffeine augmentation are needed in OCD subjects inadequately responsive to adequate doses of an SSRI or SNRI. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00363298. Copyright 2009 Physicians Postgraduate Press, Inc.
Sustaining executive functions during sleep deprivation: A comparison of caffeine, dextroamphetamine, and modafinil. [2009.02.01] OBJECTIVES: Stimulant medications appear effective at restoring simple alertness and psychomotor vigilance in sleep deprived individuals, but it is not clear whether these medications are effective at restoring higher order complex cognitive capacities such as planning, sequencing, and decision making... CONCLUSIONS: Although comparisons across tasks cannot be made due to the different times of administration, within-task comparisons suggest that, at the doses tested here, each stimulant may produce differential advantages depending on the cognitive demands of the task.
Clinical Trials Related to Dextroamphetamine
Dextroamphetamine and tDCS to Improve the Fluency [Recruiting]
The proposed study aims to evaluate safety and efficacy of combined dextroamphetamine
(Dexedrine) and transcranial direct current stimulation with melodic intonation therapy for
treatment of aphasia after stroke. The target population is patients with chronic speech
deficits due to a left hemisphere non-hemorrhagic stroke. Findings from this proposed
project will help in the design of future larger studies. The safety phase will use
cross-over, placebo controlled and single-blinded design. 10 participants with post stroke
chronic non-fluent aphasia will undergo two experiments. To study the safety and effect of
combined dextroamphetamine, tDCS and MIT therapy the study will use a parallel-groups,
randomized, sham and placebo controlled, and double-blinded design in which 48 participants
with post stroke chronic non-fluent aphasia will be randomly assigned to receive either 1)
dextroamphetamine therapy with active stimulation, 2) placebo medication with active
stimulation, 3) dextroamphetamine therapy with sham stimulation or 4) placebo medication
with sham stimulation for the same duration.
Sequential Tranylcypromine (TC), TC + Dextroamphetamine and TC + Triiodothyronine for Refractory Depression [Terminated]
This pilot study will assess the efficacy of several sequential pharmacological treatments
for patients with Refractory Depression.
Comparing the Efficacy of Methylphenidate, Dextroamphetamine and Placebo in Children Diagnosed With ADHD [Completed]
The study compares the efficacy of methylphenidate, dextroamphetamine and placebo on
neuropsychological functioning and behavioral symptoms in 36 children diagnosed with ADHD
within a double-blind cross-over design over six weeks. The assessment of ADHD followed
formalized guidelines and a diagnosis of ADHD was based on DSM-IV criteria. A
neuropsychological testbattery and four behavioral questionnaires were selected as efficacy
variables. The neuropsychological testbattery includes Qb-test (visual attention, inhibitory
control, motor activity), Score (auditory attention), Stroop Test (processing speed,
inhibitory control) and Grooved Pegboard (motor speed). The participants were tested once on
each type of medication. The four questionnaires are: a)Side-Effects Rating Scale (completed
by a parent at the end of each of the six weeks), b)Self-Report Questionnaire (completed by
the child at the end of each of the six weeks), c)Parent and Teacher Questionnaire(completed
by a parent and a teacher Monday till Friday through every week), Test Performance
Questionnaire (completed by the child immediately after each of the three test sessions).
Main hypothesis: A trial including both dextroamphetamine(Dex) and methylphenidate(Met) will
provide better results than a trial including only Met. a)Met and Dex are efficient as
treatment for ADHD compared to placebo, albeit Dex has moderately better effect compared to
Met. b)At an individual level some of the participants will show positive response to one
type of stimulants and no response, mixed response or adverse response to the other type of
stimulant. c)Neuropsychological tests and behavioral questionnaires are moderately in
agreement but also add unique information in the assessment of the effect of stimulants.
d)Qb-test is sensitive and valid as a measure of the effect of stimulants.
Dextro-Amphetamine Versus Caffeine in Treatment-resistant OCD [Completed]
The study hypothesis is that dextro-amphetamine (d-amphetamine) will be safe and effective
when used to augment treatment for OCD, and that tolerance (loss of therapeutic effect) to
the medication will not develop over a period of several weeks.
Pilot Study Examining Effect for Dextroamphetamine to Treat Cocaine Dependence Plus Attention-deficit Hyperactivity Disorder (ADHD) [Terminated]
Dextroamphetamine is commonly used to treat ADHD, and recent evidence suggests that this
medication may decrease drug use in individuals dependent on cocaine. Thus, the present
pilot study will determine the ability of dextroamphetamine to treat individuals with both
cocaine dependence and ADHD.
Reports of Suspected Dextroamphetamine Side Effects
Aggression (6),
Coordination Abnormal (5),
Feeling Abnormal (5),
Completed Suicide (4),
Nausea (4),
Muscular Weakness (4),
Ataxia (4),
Gait Disturbance (4),
Dyskinesia (3),
Somnolence (3), more >>
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 3 ratings/reviews, Dextroamphetamine has an overall score of 8.33. The effectiveness score is 9.33 and the side effect score is 7.33. The scores are on ten point scale: 10 - best, 1 - worst.
| Dextroamphetamine review by 36 year old male patient | | Rating |
Overall rating: | | |
Effectiveness: | | Highly Effective |
Side effects: | | Mild Side Effects | | Treatment Info |
Condition / reason: | | ADD and Depression |
Dosage & duration: | | 60m (dosage frequency: 1 pid) for the period of one month |
Other conditions: | | anxiety |
Other drugs taken: | | Cymbalta | | Reported Results |
Benefits: | | Clear headed, Able to complete projects without procastination, 100% help with short-term memory, lessened depression and anxiety, no more obsessive eating, weight loss... |
Side effects: | | Dry mouth (which is great because I now drink a lot of water instead of sodas because the sodas don't quinch my thirst) |
Comments: | | I have been on antidepression meds for 15 years, but my depression persisted regardless of the treatment. I used to sleep 12-16 hours per day and was always tired and fatigued when awake. I was diagnosed with sleep apnea 5 years ago, but even sleeping with CPAP did not help with my daytime fatigue. After seeing MANY family practitioners, I finally broke down and INVESTED in a very well educated Psychiatrist who diagnoed me with ADD since childhood. His decision to prescribe Vyvanse was brilliant! I feel better than ever and am totally clear headed and able to consentrate. For the first time in as long as I can remember, I can think normally! No more racing thoughts in my head, and my depression and anxiety has all but vanashed! I do still take an antidepressive, but I am CERTAIN that the Vyvanse gave the antidepression meds the ability to work. I can FINALLY sleep a normal 7 to 9 hours and still be awake and alert throughout my 12-hour work days. I was worried that the Vyvanse would elevate my anxiety level, but the opposite occured! My anxiety is all but absent, and I no longer have the need to continue with my anti-anxiety meds! There is NO SUBSTITUTE for a Doctor who is a specialist in mental health. Spend the money and see! A good Psychiatrist will spend HOURS with you before making a diagnosis, and if Adult ADD is what you have, then give Vyvanse a try. It worked GREAT for me and my live has turned around for the better. It is the best remedy that I have found in 15 years! You MUST take it when you awaken for your day, because it takes about 12-15 hours to get out of your system. If you take it later in the day - you will experaince insomnia. Ask your SPECIALIST about Vyvanse... |
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| Dextroamphetamine review by 27 year old male patient | | Rating |
Overall rating: | | |
Effectiveness: | | Highly Effective |
Side effects: | | Moderate Side Effects | | Treatment Info |
Condition / reason: | | ADD |
Dosage & duration: | | 10mg taken 4 times daily for the period of 2 months |
Other conditions: | | Depression |
Other drugs taken: | | Lexapro | | Reported Results |
Benefits: | | Smoother more gradual onset and effect than Adderall. Effective at controlling ADD symptoms previously controlled by Adderall however this drug seems more natural and transparent. Less tension and anxiety. Less "druggy" unnatural feelings and thoughts. |
Side effects: | | Dexerine IR tablets need to be taken more often than adderall and also wear off more abruptly. Generic tablets are not high quality and somewhat expensive due to the need for a large quantity of tablets. |
Comments: | | Switched from Adderall to Dexedrine to compare the effects. Dexedrine is simply dextroamphetamine while Adderall is a mixture of Amphetamine salts. This might explain the increased effectiveness of the Dexedrine contrary to popular belief. I found it important to take several relatively low doses frequently to achieve a balanced effect. |
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| Dextroamphetamine review by 27 year old male patient | | Rating |
Overall rating: | | |
Effectiveness: | | Highly Effective |
Side effects: | | Moderate Side Effects | | Treatment Info |
Condition / reason: | | ADD |
Dosage & duration: | | 10mg taken 4 times daily for the period of 2 months |
Other conditions: | | Depression |
Other drugs taken: | | Lexapro | | Reported Results |
Benefits: | | Smoother more gradual onset and effect than Adderall. Effective at controlling ADD symptoms previously controlled by Adderall however this drug seems more natural and transparent. Less tension and anxiety. Less "druggy" unnatural feelings and thoughts. |
Side effects: | | Dexerine IR tablets need to be taken more often than adderall and also wear off more abruptly. Generic tablets are not high quality and somewhat expensive due to the need for a large quantity of tablets. |
Comments: | | Switched from Adderall to Dexedrine to compare the effects. Dexedrine is simply dextroamphetamine while Adderall is a mixture of Amphetamine salts. This might explain the increased effectiveness of the Dexedrine contrary to popular belief. I found it important to take several relatively low doses frequently to achieve a balanced effect. |
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Page last updated: 2013-02-10
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