dextroamphetamine saccharate amphetamine aspartate monohydrate dextroamphetamine sulfate and amphetamine sulfate tablet
INDICATIONS AND USAGE Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets are 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 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets 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 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 Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets and for long-term use has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use Dextroamphetamine Saccharate, Amphetamine Aspartate , Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.
aurolife pharma, llc
ROUND BLUE U27
U27 ROUND BLUE
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HOW SUPPLIED Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate tablets are supplied as: 5 mg Tablets - Light blue to blue colored, mottled, round, flat-faced, beveled edge tablets debossed with ‘U25’ on one side and quadrisect on other side. Bottles of 50 13107-068-50 Bottles of 100 13107-068-01 Bottles of 250 13107-068-25 Bottles of 500 13107-068-05 Bottles of 1000 13107-068-99 7.5 mg Tablets - Light blue to blue colored, mottled, round, convex tablets debossed with ‘U26’ on one side and quadrisect on other side. Bottles of 50 13107-069-50 Bottles of 100 13107-069-01 Bottles of 250 13107-069-25 Bottles of 500 13107-069-05 Bottles of 1000 13107-069-99 10 mg Tablets - Light blue to blue colored, mottled, round, convex tablets debossed with ‘U27’ on one side and quadrisect on other side. Bottles of 50 13107-070-50 Bottles of 100 13107-070-01 Bottles of 250 13107-070-25 Bottles of 500 13107-070-05 Bottles of 1000 13107-070-99 12.5 mg Tablets - Light orange to orange colored, mottled, round, flat-faced, beveled edge tablets debossed with ‘U28’ on one side and quadrisect on other side. Bottles of 50 13107-071-50 Bottles of 100 13107-071-01 Bottles of 250 13107-071-25 Bottles of 500 13107-071-05 Bottles of 1000 13107-071-99 15 mg Tablets - Light orange to orange colored, mottled, round, convex tablets debossed with ‘U29’ on one side and quadrisect on other side. Bottles of 50 13107-072-50 Bottles of 100 13107-072-01 Bottles of 250 13107-072-25 Bottles of 500 13107-072-05 Bottles of 1000 13107-072-99 20 mg Tablets - Light orange to orange colored, mottled, round, convex tablets debossed with ‘U30’ on one side and quadrisect on other side. Bottles of 50 13107-073-50 Bottles of 100 13107-073-01 Bottles of 250 13107-073-25 Bottles of 500 13107-073-05 Bottles of 1000 13107-073-99 30 mg Tablets - are light orange to orange colored, mottled, round, flat-faced, beveled edge tablets debossed with ‘U31’ on one side and quadrisect on other side. Bottles of 50 13107-074-50 Bottles of 100 13107-074-01 Bottles of 250 13107-074-25 Bottles of 500 13107-074-05 Bottles of 1000 13107-074-99 Dispense in a tight, light-resistant container as described in the USP. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense with Medication Guide available at www.aurobindousa.com/medication-guides Distributed by: Aurobindo Pharma USA, Inc 279 Princeton-Hightstown Road East Windsor, NJ-08520 Revised: 06/2024
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