Amphetamine aspartate 7.5 MG Amphetamine Sulfate 7.5 MG Dextroamphetamine saccharate 7.5 MG Dextroamphetamine Sulfate 7.5 MG Oral Tablet
INDICATIONS AND USAGE Mixed Salts of a Single Entity Amphetamine Product 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 Mixed Salts of a Single Entity Amphetamine Product 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 Mixed Salts of a Single Entity Amphetamine Product for long-term use has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use Mixed Salts of a Single Entity Amphetamine Product for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
Eon Labs, Inc.
ROUND ORANGE E 404
E 404 ROUND ORANGE
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HOW SUPPLIED Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product), for oral administration, are available as: 5 mg: Dark blue, round, flat face, bevel edge tablets, debossed “ E †over “84†on one side and double-bisected on the other side and supplied as: NDC 0185-0084-01 bottles of 100 10 mg: Dark blue, round, biconvex tablets, debossed “ E †over “111†on one side and double-bisected on the other side and supplied as: NDC 0185-0111-01 bottles of 100 20 mg: Dark orange, round, biconvex tablets, debossed “ E †over “401†on one side and double-bisected on the other side and supplied as: NDC 0185-0401-01 bottles of 100 30 mg: Dark orange, round, flat faced tablets, debossed “ E †over “404†on one side and double-bisected on the other side and supplied as: NDC 0185-0404-01 bottles of 100 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense contents in a tight, light-resistant container as defined in the USP with a child-resistant closure, as required. Protect from light and moisture. Keep tightly closed. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.
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