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Amphetamine aspartate 5 MG Amphetamine Sulfate 5 MG Dextroamphetamine saccharate 5 MG Dextroamphetamine Sulfate 5 MG Oral Tablet

INDICATIONS & USAGE Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets 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 ยฎ ) 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; โ€œon the go;โ€ 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 ยฎ characteristics. Need for Comprehensive Treatment Program Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets 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 dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets 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 reยญevaluate the long-term usefulness of the drug for the individual patient.

Lannett Company, Inc.


1 year ago OVAL ORANGE 2 0 e 505 Amphetamine aspartate 5 MG  Amphetamine Sulfate 5 MG  Dextroamphetamine saccharate 5 MG  Dextroamphetamine Sulfate 5 MG Oral Tablet

OVAL ORANGE 2 0 e 505

1 year ago OVAL ORANGE 2 0 e 505 Amphetamine aspartate 5 MG  Amphetamine Sulfate 5 MG  Dextroamphetamine saccharate 5 MG  Dextroamphetamine Sulfate 5 MG Oral Tablet

2 0 e 505 OVAL ORANGE

HOW SUPPLIED

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE tablets are supplied as follows: 5 mg: A blue, oval, flat-faced, beveled-edge tablet debossed with โ€œeโ€ over โ€œ500โ€ separated by a full score on one side and a full score on the other side debossed with 5 โ”‚ . 100 Tablets NDC 0527-1500-37 500 Tablets NDC 0527-1500-41 7.5 mg: A blue, oval, flat-faced, beveled-edge tablet debossed with โ€œeโ€ over โ€œ501โ€ separated by a full score on one side and two partial bisects and a full score on the other side debossed with 7 โ”‚ 1/2. 100 Tablets NDC 0527-1501-37 500 Tablets NDC 0527-1501-41 10 mg: A blue, flat-faced, beveled-edge tablet debossed with โ€œeโ€ over โ€œ502โ€ separated by a full score on one side and two partial bisects and a full score on the other side debossed with 1 โ”‚ 0. 100 Tablets NDC 0527-1502-37 500 Tablets NDC 0527-1502-41 12.5 mg: A peach, oval biconvex tablet debossed with โ€œeโ€ over โ€œ503โ€ separated by a full score on one side and four partial bisects on the other side debossed with 12 1/2. 100 Tablets NDC 0527-1503-37 500 Tablets NDC 0527-1503-41 15 mg: A peach, oval, flat-faced, beveled-edge tablet debossed with โ€œeโ€ over โ€œ504โ€ separated by a full score on one side and two partial bisects and a full score on the other side debossed with 1 โ”‚ 5. 100 Tablets NDC 0527-1504-37 500 Tablets NDC 0527-1504-41 20 mg: A peach, oval, flat-faced, beveled-edge tablet with two partial bisects on one side debossed with โ€œeโ€ over โ€œ505โ€ and two partial bisects and a full score on the other side debossed with 2 โ”‚ 0. 100 Tablets NDC 0527-1505-37 500 Tablets NDC 0527-1505-41 30 mg: A peach, oval, biconvex tablet with two partial bisects on one side debossed with โ€œeโ€ over โ€œ506โ€ and two partial bisects and a full score on the other side debossed with 3 โ”‚ 0. 100 Tablets NDC 0527-1506-37 500 Tablets NDC 0527-1506-41 Dispense in a tight, light-resistant container. Store at 20ยฐ to 25ยฐC (68ยฐ to 77ยฐF) [See USP Controlled Room Temperature]. Distributed by: Lannett Company, Inc. Philadelphia, PA 19136 Rev. 09/22 IN0535


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