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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.
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ADDERALL SUMMARY
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 |
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| 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.
Long-Term Use
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.
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ADDERALL NEWS HIGHLIGHTS
Published Studies Related to Adderall (Dextroamphetamine / Amphetamine / Dextroamphetamine / Amphetamine)
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... The extended time course of action and greater therapeutic efficacy of MAS XR suggests that it is more effective than atomoxetine in children with ADHD.
Long-term tolerability and effectiveness of once-daily mixed amphetamine salts (Adderall XR) in children with ADHD. [2005.06]
CONCLUSIONS: In children with ADHD, once-daily 10 mg-30 mg MAS XR was well tolerated and significant behavioral improvements were consistently maintained during 24 months of treatment.
Clinical Trials Related to Adderall (Dextroamphetamine / Amphetamine / Dextroamphetamine / Amphetamine)
Randomized, Double-Blind, Placebo-Controlled Study of Mixed Amphetamine Salts (Adderall-XR) for the Treatment of Adult Attention Deficit Hyperactivity Disorder (ADHD) 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.
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
ADHD.
Analog Classroom Study Comparison of ADDERALL XR With STRATTERA in Children Aged 6-12 With ADHD [Completed]
A Within-Subject Cross-Over Comparison Between Immediate Release and Extended Release Adderall [Recruiting]
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.
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ADDERALL PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 16 ratings/reviews, Adderall has an overall score of 8.06. The effectiveness score is 8.62 and the side effect score is 7.50. 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 care giver of 15 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | ADD |
| Dosage & duration: | | 10 mg taken 2x a days mon - fri during school days for the period of 2 years |
| Other conditions: | | none |
| Other drugs taken: | | None | | |
Reported Results |
| Benefits: | | My daughter was unable to focus and concentrate during classes.
Her marks were terrible, she was failing many classes in spite of studying for hours on end (I can verify this as I studied with her) Her self esteem was very low due to this and the fact that she has a sister who consistently achieves high grades. She became depressed and frustrated by this situation.
After seeing a neurologist and doing many test she was diagnosed with ADD. We started her on Adderall and the results have been amazing. Now, she does minimal studying and her marks are EXCELLENT! She is able to focus and really pay attention in classes so the information is not only understood but retained. Her self esteem has soared and she is once again a happy little girl. |
| Side effects: | | We took her off the time released medication and switched is a regular so that it would not interfer with her sleep which it did in the beginning with the time released. |
| Comments: | | She takes 10 mg at 6:00 A.M. and another at 12:00 noon which lasts through homework. This is only on school days and we go off althought during summer and school holidays with not adverse effects |
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| | Adderall review by 46 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Considerably Effective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | attention deficit disorder |
| Dosage & duration: | | 20 mg once a day (I would cut in half) taken 10 mg twice a day for the period of 10 years |
| Other conditions: | | None |
| Other drugs taken: | | None | | |
Reported Results |
| Benefits: | | Adderall allowed me to start and FINISH projects. It also gave me energy. I am not a coffee drinker, so Adderall was like my “morning coffee.” It sometimes would give me a feeling of mild euphoria, which was nice. Certain tasks (like cleaning the house!) didn’t seem so difficult because I would not get distracted by other things. |
| Side effects: | | Adderall allowed me to start and FINISH projects. It also gave me energy. I am not a coffee drinker, so Adderall was like my “morning coffee.” It sometimes would give me a feeling of mild euphoria, which was nice. Certain tasks (like cleaning the house!) didn’t seem so difficult because I would not get distracted by other things. Also dry mouth. |
| Comments: | | I was put on the medication by my family doctor when I complained of my inability to finish projects. It was affecting every area of my life – work and relationships. Initially, I was prescribed Ritalin (but it gave me major tension headaches). I was then prescribed Adderall. It seemed to work right away with minimal side effects. |
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| | Adderall review by 35 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Marginally Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | ADHA |
| Dosage & duration: | | 20mg taken once daily for the period of 6 mths |
| Other conditions: | | Anxiety, depression |
| Other drugs taken: | | Wellbutin | | |
Reported Results |
| 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. |
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Page last updated: 2007-10-18
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