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.
ADDERALL® CII Rx ONLY
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 monohydrate.
| 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 Monohydrate||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|
ADDERALL® is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy.
Attention Deficit Hyperactivity Disorder (ADHD)
A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD; DSM-IV®) implies the presence of 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 two 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 six 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 six 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; can't 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 not only of medical but of 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 child and not solely on the presence of the required number of DSM-IV® characteristics.
Need for Comprehensive Treatment Program
ADDERALL® is 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 children with this syndrome. Stimulants are not intended for use in the child who exhibits 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 physician's assessment of the chronicity and severity of the child's symptoms.
The effectiveness of ADDERALL® for long-term use has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use ADDERALL® for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
Media Articles Related to Adderall (Dextroamphetamine / Amphetamine / Dextroamphetamine / Amphetamine)
FDA Warns of Fake Version of ADHD Drug Adderall
Source: MedicineNet amphetamine and dextroamphetamine Specialty [2012.05.30]
Title: FDA Warns of Fake Version of ADHD Drug Adderall
Category: Health News
Created: 5/30/2012 10:05:00 AM
Last Editorial Review: 5/30/2012 12:00:00 AM
Published Studies Related to Adderall (Dextroamphetamine / Amphetamine / Dextroamphetamine / Amphetamine)
When we enhance cognition with Adderall, do we sacrifice creativity? A preliminary study. [2009.01]
CONCLUSION: The preliminary evidence is inconsistent with the hypothesis that Adderall has an overall negative effect on creativity. Its effects on divergent creative thought cannot be inferred with confidence from this study because of the ambiguity of null results. Its effects on convergent creative thought appear to be dependent on the baseline creativity of the individual. Those in the higher range of the normal distribution may be unaffected or impaired, whereas those in the lower range of the normal distribution experience enhancement.
Forecasting three-month outcomes in a laboratory school comparison of mixed amphetamine salts extended release (Adderall XR) and atomoxetine (Strattera) in school-aged children With ADHD. [2007.07]
CONCLUSION: This study suggests that relative advantages of MAS-XR seen in the first 3 weeks are likely to be maintained in subsequent weeks.
Efficacy and safety of mixed amphetamine salts extended release (adderall XR) in the management of oppositional defiant disorder with or without comorbid attention-deficit/hyperactivity disorder in school-aged children and adolescents: A 4-week, multicenter, randomized, double-blind, parallel-group, placebo-controlled, forced-dose-escalation study. [2006.03]
BACKGROUND: Oppositional defiant disorder (ODD)is associated with a high degree of impairment in social skills, family interaction, and academic functioning. Comorbid ODD is reportedly present in 40% to 70% of children and adolescents with attention-deficit/hyperactivity disorder (ADHD). OBJECTIVE: The goal of this study was to assess the efficacy and safety of mixed amphetamine salts extended release (MAS XR) for the treatment of ODD in children and adolescents aged 6 to 17 years... CONCLUSION: This study found that higher doses ofMAS XR (30 and 40 mg) were effective and well tolerated in the management of ODD in these school aged children and adolescents in the presence or absence of ADHD.
Efficacy and safety of mixed amphetamine salts extended release (Adderall XR) in the management of attention-deficit/hyperactivity disorder in adolescent patients: a 4-week, randomized, double-blind, placebo-controlled, parallel-group study. [2006.02]
BACKGROUND: The ability to recognize and diagnose attention-deficit/hyperactivity disorder (ADHD) has increased in recent years. The persistence of ADHD symptoms puts adolescents with ADHD at risk for long-term adverse psychosocial outcomes. OBJECTIVE: The primary goal of this study was to assess the efficacy and safety of mixed amphetamine salts extended release (MAS XR) in the management of adolescents with ADHD... CONCLUSIONS: The adolescents with ADHD treated with 10- to 40-mg/d MAS XR up to 4 weeks had significant improvements in ADHD symptoms compared with those who received placebo. Results of this study suggest that once-daily dosing with MAS XR up to 40 mg was effective and well tolerated for the management of ADHD in these adolescents.
A laboratory school comparison of mixed amphetamine salts extended release (Adderall XR) and atomoxetine (Strattera) in school-aged children with attention deficit/hyperactivity disorder. [2005.08]
Mixed amphetamine salts extended release (MAS XR; Adderall XR) and atomoxetine (Strattera) were compared in children 6 to 12 years old with attention deficit/hyperactivity disorder (ADHD) combined or hyperactive/impulsive type in a randomized, double-blind, multicenter, parallel-group, forced-dose-escalation laboratory school study...
Clinical Trials Related to Adderall (Dextroamphetamine / Amphetamine / Dextroamphetamine / Amphetamine)
Study of Adderall-XR for the Treatment of Adult Attention Deficit Hyperactivity Disorder and Cocaine Dependence [Recruiting]
The proposed protocol is a 3 group double-blind, placebo-controlled outpatient study of the
safety and efficacy of Adderall-XR (ER-MAS) in the treatment of comorbid ADHD and cocaine
dependence. Since this medication has independently shown promise in helping with ADHD and
cocaine abuse, we are proposing that it may be successful in the treatment of comorbid ADHD
and cocaine abuse. We plan to enroll 75 subjects in a 14-week trial. The primary objectives
of the study are to determine the efficacy of ER-MAS in promoting cocaine abstinence and
improvement in ADHD symptomology among cocaine-dependent patients with comorbid ADHD.
Adderall XR and Processing Speed in Multiple Sclerosis (MS) [Not yet recruiting]
Cognitive impairment, or problems with thinking and memory, is common in multiple sclerosis
(MS) and can occur independently of physical disability. It is the most common reason, along
with physical fatigue, for MS patients to stop working. The most frequent complaint is
problems with multi-tasking or thinking quickly, which corresponds to impairment in the
cognitive domain of processing speed. Currently there is treatment available to prevent
relapses and physical disability but there are no medications that have been shown to treat
cognitive impairment. Amphetamines have been beneficial for selective attention and
processing speed in attention deficit hyperactivity disorder (ADHD) and traumatic brain
injury. This is study will determine whether Adderall XR improves objective measures of
processing speed and attention in MS patients impaired in this cognitive domain, by
comparing two doses of Adderall XR (5 and 10mg) to placebo before and after the medication
is administered. The results of this study will help provide data to design a larger study
to determine if Adderall XR, and potentially other amphetamine drugs, will help treat
cognitive impairment in MS patients.
Free Treatment for Cocaine Dependence: A Placebo-Controlled Study of Mixed Amphetamine Salts (Adderall-XR) and Topiramate for the Treatment of Cocaine Dependence [Recruiting]
The proposed protocol is a double-blind, placebo-controlled outpatient study of the safety
and efficacy of Adderall-XR (ER-MAS) and topiramate in the treatment of cocaine dependence.
Since both of these medications have independently shown promise in helping with cocaine
abuse we are proposing that together they may be even more successful in the treatment of
cocaine abuse. We plan to enroll 120 subjects in a 14-week trial. The primary objective of
the study is to determine the efficacy of ER-MAS and topiramate in promoting cocaine
abstinence among cocaine-dependent patients. This study includes free treatment for cocaine
dependence that includes medication.
NRP104, Adderall XR or Placebo in Children Aged 6-12 Years With ADHD [Completed]
The purpose of this study is to assess, in a controlled environment, the efficacy and safety
of NRP104 and Adderall XR compared to placebo in treatment of children, aged 6-12, with
Analog Classroom Study Comparison of ADDERALL XR With STRATTERA in Children Aged 6-12 With ADHD [Completed]
PATIENT REVIEWS / RATINGS / COMMENTS
Based on a total of 23 ratings/reviews, Adderall has an overall score of 8.26. The effectiveness score is 8.87 and the side effect score is 7.39. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
Adderall review by 52 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Highly Effective|
|Side effects:|| || No Side Effects|
|Condition / reason:|| || Adult ADD|
|Dosage & duration:|| || 7.5 mg taken 2 times per day for the period of 2 years-still taking it|
|Other conditions:|| || depression|
|Other drugs taken:|| || Zoloft|
|Benefits:|| || Adderall greatly improved my focus and concentration. Before my diagnosis of adult ADD, I had a very difficult time focusing and staying on task. I also experienced "hyper-focusing", which prevented me from getting things done at work in a timely manner. It has also helped improved my memory.|
|Side effects:|| || I didn't notice any side effects from Adderall. However, it is metabolized very quickly and only stays effective for about 3 to 4 hours. Forgetting to take the second dose around 1:00pm makes for a confusing afternoon, until I remember to take it.|
|Comments:|| || My prescriber and I went through about 3 different medications before Adderall, and those did have unpleasant side effects such as sweaty palms (all the time), dizziness, and heart palpitations. Once I found that Adderall didn't cause side effects for me, we gradually increased the dosage from 5 mg to 10mg and then back down to 7.5 mg which works best for me.|
Adderall review by 39 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Considerably Effective|
|Side effects:|| || Mild Side Effects|
|Condition / reason:|| || ADHD|
|Dosage & duration:|| || 15 mg, 3x/day taken every day for the period of 1 year|
|Other conditions:|| || I've had insomnia when I take this drug too late in the day.|
|Other drugs taken:|| || Lorazapem (occasionally)|
|Benefits:|| || Ability to focus, not become so disoriented. Able to think more clearly.|
|Side effects:|| || Hard to fall asleep if taken too late in the day. Affects my skin somewhat (more blemishes, seems to age my skin somewhat)|
|Comments:|| || I take 3 Adderall per day. 1 1/2 pill in the morning, and 1 1/2 in the the afternoon. Each pill is 15 mg. I break one in half to divide between morning and afternoon. I see my doctor once every 3 months to discuss how it's working. I started out on 5mg, 2x/day, but I developed a tolerance to it over time and went from 5 mg/2x day, to 10mg/2x day to 15mg 2x/day to 15mg 3/day. |
Adderall review by 35 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Marginally Effective|
|Side effects:|| || Mild Side Effects|
|Condition / reason:|| || ADHA|
|Dosage & duration:|| || 20mg taken once daily for the period of 6 mths|
|Other conditions:|| || Anxiety, depression|
|Other drugs taken:|| || Wellbutin|
|Benefits:|| || This medication helped me marginally to focus better and was somewhat more energetic. |
|Side effects:|| || I did not had much side effects, had some dry mouth at times but was manageable.|
|Comments:|| || I started with low dose with 5 mg dialy, gradually increased upto 20 mg. Did not hv satisfactory results but my psychiatrist did not feel comfortable to increase the dose due to serious drug abuse potential though I absolutely hv never tried as illicit drugs including the most commonly used MJ and alcohol.|
Page last updated: 2012-05-30