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Description
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 sacrate and d,l-amphetamine aspartate monohydrate. The ADDERALL XR capsule contains two types of drug-containing beads designed to provide a double-pulsed delivery of amphetamines, which prolongs the amphetamine release of ADDERALL XR compared to the conventional ADDERALL (immediate-release) tablet formulation. Buy Adderall XR | Buy Adderall XR Netherlands and Belgium
Each capsule contains: 5 mg 10 mg 15 mg 20 mg 25 mg 30 mg
Dextroamphetamine Saccharate 1.25mg 2.5mg 3.75mg 5.0mg 6.25mg 7.5mg
Amphetamine Aspartate Monohydrate 1.25 mg 2.5 mg 3.75 mg 5.0 mg 6.25 mg 7.5 mg
Dextroamphetamine Sulfate USP 1.25mg 2.5mg 3.75mg 5.0mg 6.25mg 7.5mg
Amphetamine Sulfate USP 1.25 mg 2.5 mg 3.75 mg 5.0 mg 6.25 mg 7.5 mg
Total amphetamine base equivalence 3.1 mg 6.3mg 9.4 mg 12.5mg 15.6 mg 18.8 mg
Inactive ingredients and colors
The inactive ingredients in ADDERALL XR capsules are: gelatin capsules, hydroxypropyl methylcellulose, methacrylic acid copolymer, opadry beige, sugar spheres, talc, and triethyl citrate. Gelatin capsules contain edible inks, kosher gelatin, and titanium dioxide. The 5 mg, 10 mg and 15 mg capsules also contain FD&C Blue #2. The 20 mg, 25 mg, and 30 mg capsules also contain red iron oxide and yellow iron oxide.
Clues
ADDERALL XR™ is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
The effectiveness of ADDERALL XR™ in the treatment of ADHD was established based on two
trials in children aged 6 to 12 years and one controlled trial in adults who met DSM-IV criteria for ADHD (see
CLINICAL PHARMACOLOGY), along with extrapolation of the known efficacy of ADDERALL®
formulation of this substance immediately.
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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 home. The symptoms may not be better accounted for by another mental disorder. For the inattentive type, at least six of the following symptoms must have lasted for 4 months: lack of attention to detail/careless mistakes; lack of sustained attention; bad listener; failure to perform tasks; bad organization; avoids tasks that require sustained mental effort; lose 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 the seat; inappropriate running/climbing; difficulties with quiet activities; "on the road;" excessive talking; answers blur; can not wait; Pushy. The combined type requires both inattentive and hyperactive impulsive criteria to be met.
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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 compromised. Diagnosis should be based on a complete history and evaluation of the child and not just 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
treatment program for ADHD that may include other measures (psychological, educational, social) for patients
with this syndrome. Drug treatment cannot be indicated for all children with this syndrome. Stimulants are not
intended for use in the child presenting with symptoms secondary to environmental and/or other primary factors
psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial
intervention is often helpful. When remedial measures alone are insufficient, the decision is to prescribe stimulants
medication will depend on 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, ie
children and 4 weeks in adults, has not been systematically evaluated in controlled trials. Therefore the
physician who chooses to use ADDERALL XR™ for extended periods of time should periodically re-evaluate for long-term use
usefulness of the drug for the individual patient.
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