Adderall XR (Dextroamphetamine Saccharate / Amphetamine Aspartate Monohydrate / Dextroamphetamine Sulfate / Amphetamine Sulfate) - Summary

ADDERALL XR SUMMARY

ADDERALL XR^® CAPSULES CII Rx Only

ADDERALL XR® is a once daily extended-release, single-entity amphetamine product. ADDERALL XR® combines the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine sac-charate and d,l-amphetamine aspartate monohydrate. The ADDERALL XR® capsule contains two types of drug-containing beads designed to give a double-pulsed delivery of amphetamines, which prolongs the release of amphetamine from ADDERALL XR® compared to the conventional ADDERALL® (immediate-release) tablet formulation.

ADDERALL XR® is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

The efficacy of ADDERALL XR® in the treatment of ADHD was established on the basis of two controlled trials in children aged 6 to 12, and one controlled trial in adults who met DSM-IV criteria for ADHD (see CLINICAL PHARMACOLOGY), along with extrapolation from the known efficacy of ADDERALL®, the immediate-release formulation of this substance.

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 XR® 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 XR® for long-term use, i.e., for more than 3 weeks in children and 4 weeks in adults, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use ADDERALL XR® for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.

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NEWS HIGHLIGHTS

Published Studies Related to Adderall XR (Dextroamphetamine / Amphetamine / Dextroamphetamine / Amphetamine)

Effects of oral methamphetamine on cocaine use: A randomized, double-blind, placebo-controlled trial. [2008.12.04]
BACKGROUND: No medication is currently approved for the treatment of cocaine dependence, but several preclinical and clinical reports suggest agonist-like medications, e.g., amphetamine analogues, may be a productive strategy for medication development. OBJECTIVE: This current proof-of-concept study sought to evaluate the safety, tolerability, and effectiveness of methamphetamine as a candidate treatment for cocaine dependence... CONCLUSIONS: SR methamphetamine significantly reduced cocaine use and craving. Additional research is warranted to develop and evaluate agonist-like medications that may effectively treat cocaine dependence.

Evaluation of subjective effects of aripiprazole and methamphetamine in methamphetamine-dependent volunteers. [2008.12]
A variety of neuropharmacological strategies are being pursued in the search for an effective treatment for methamphetamine (Meth) addiction. In this study, we investigated the safety and potential efficacy of aripiprazole, an antipsychotic agent acting on both dopamine and serotonin systems... Further research with lower doses of aripiprazole, possibly using study designs aimed at evaluating efficacy for relapse prevention, are needed before ruling out aripiprazole as a treatment for Meth dependence.

Attention-deficit/hyperactivity disorder-specific quality of life with triple-bead mixed amphetamine salts (SPD465) in adults: Results of a randomized, double-blind, placebo-controlled study. [2008.11.04]
CONCLUSIONS: Adults with ADHD showed significantly improved QOL for both ADHD-specific and global measures with triple-bead MAS in comparison to placebo, based on AIM-A scores. Treatment-emergent adverse events were mostly mild to moderate in intensity and were consistent with amphetamine treatment. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00150579. (c) Copyright 2008 Physicians Postgraduate Press, Inc.

Naltrexone for the treatment of amphetamine dependence: a randomized, placebo-controlled trial. [2008.11]
CONCLUSIONS: This trial demonstrated the efficacy of naltrexone in reducing amphetamine use in amphetamine-dependent individuals.

Restoration of risk-propensity during sleep deprivation: caffeine, dextroamphetamine, and modafinil. [2008.09]
INTRODUCTION: Sleep deprivation alters risk-related judgments, decision-making, and behavioral control. Stimulant medications are used to restore cognitive performance, but their effects on risk-taking and judgment in sleep-deprived subjects have not been explored... CONCLUSIONS: Stimulant medications, particularly dextroamphetamine, sustained risk-related attitudes and behavior during continuous wakefulness. The extent to which stimulants restore other aspects of judgment during sleep loss remains to be determined.

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Clinical Trials Related to Adderall XR (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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PATIENT REVIEWS / RATINGS / COMMENTS

Adderall XR review by 54 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		Adult ADD
Dosage & duration:		20 mg. taken 1 x day for the period of 2004 to present
Other conditions:		asthma, allergies
Other drugs taken:		flovent, flonase, albuteral inhaler
		Reported Results
Benefits:		In a very short period of time, there was a mental clarity that I had never experienced. I felt a calm and order to my life and work. I was truly able to focus on important things that I needed to do and did so efficiently, which was something I was never able to do. Menopause exacerbated the extreme mental fuzziness that I had already been experiencing with 4 children and a more than full time job. This drug has truly changed my life for the better!
Side effects:		I did not experience any side effects that were negative. I could hear better and think in a focused way within a short amount of time (30-45 minutes after taking the drug)
Comments:		I take a 30 mg. pill shortly after waking and within an hour, the fog that I chronically have had all of my life just lifts!

Adderall XR review by 16 year old male patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Severe Side Effects
		Treatment Info
Condition / reason:		ADD management
Dosage & duration:		25 MG taken daily for the period of 5 months
Other conditions:		None
Other drugs taken:		Prozac 3 months after being on adderall
		Reported Results
Benefits:		This does actually help calm you down and help you concentrate. My grades went upby a lot. I was calm and was doing much better on it (much better reffering to the ADD treatment) but there are so many negative side effects. In a way I regret ever taking it.
Side effects:		I developed an anorexia, I stopped eating and lost so much weight. I'm about 5ft. 6 now and weigh about 130 LBS. which is really skinny for my age and height. If I wouldn't have stopped I would be skin and bones. I got to a point where I lost color and I'm now way too skinny. Another side effect that I developed is insomnia. I have a VERY hard time sleeping. I can't fall asleep until about 1:00 and that's every night. It's horrible. Another side effect that's very serious, is development of depression. I had to go on anti-depressants because of the drug about 3 months after using adderall. It depresses you so much. After school I'd get home and be so depressed. I'd cry and just feel so misserable. I was seriously depressed. A fact that everyone should understand about adderall is that it's in a way a wattered down version of meth. The side effects are the same but not as severe. But it's still bad. It will mess up your teeth by giving you a VERY dry mouth, your weight and most of all your brain chemistry. I went from ADD to depression to now ADHD. I'm going back on stimulant drugs like adderall when school starts. I don't know how it'll work out because I now have a tolerance to it. And I'm getting new treatment. I don't know what'll happen or anything. But I just wantto get through school. Anyone that will be perscribbed to this should research on it and get the facts. Research for a long time. Not just one article reading. Get as much info as possible. The side effects are so severe that you should really know what you're exposing yourself to. They're all horrible. Especially the addiction that you get to it. I'm addicted to it and can't stop craving it. I feel like I need it so bad. It's been months and still I want it extremely bad. Be careful what choice you make. It gets the job done. Hut will screw up your life. This is just my experience. It may be different for you but still do your research.
Comments:		I was on 20 MGS for a while then went up to 40 then more and went back down to 25.

Adderall XR review by 17 year old male patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Extremely Severe Side Effects
		Treatment Info
Condition / reason:		ADHD
Dosage & duration:		70mg taken once daily for the period of 3 years
Other conditions:		none
Other drugs taken:		effexor
		Reported Results
Benefits:		i cant list very many benefits because my expierience was so bad that i would rather have been dead than have been forced to have taken this pill every day for 3 to 4 years
Side effects:		i was severly depressed and had a lot of suicide attempts and i thought everyone hated me. i always wanted to be dead and nobody listened to me, they just upped the dosage and with the higher dosage the worse it got
Comments:		it sucked. sure i didnt have ADHD but i also felt as though i lost my soul in the proccess. i became so depressed i actually began to feel like a shell