Amphetamine aspartate 3.125 MG Amphetamine Sulfate 3.125 MG Dextroamphetamine saccharate 3.125 MG Dextroamphetamine Sulfate 3.125 MG Oral 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 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 re-evaluate the long-term usefulness of the drug for the individual patient.
Mylan Pharmaceuticals Inc.
ROUND ORANGE M A12
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HOW SUPPLIED Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets contain dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, USP and amphetamine sulfate, USP. The 5 mg tablets contain 1.25 mg of dextroamphetamine saccharate, 1.25 mg of amphetamine aspartate monohydrate (equivalent to 1.17 mg of amphetamine aspartate anhydrous), 1.25 mg of dextroamphetamine sulfate, USP and 1.25 mg of amphetamine sulfate, USP. The 5 mg tablets are light blue, round, tablets debossed with M over A5 on one side of the tablet and a quadrisect on the other side. They are available as follows: NDC 0378-4541-01 bottles of 100 tablets The 7.5 mg tablets contain 1.875 mg of dextroamphetamine saccharate, 1.875 mg of amphetamine aspartate monohydrate (equivalent to 1.755 mg of amphetamine aspartate anhydrous), 1.875 mg of dextroamphetamine sulfate, USP and 1.875 mg of amphetamine sulfate, USP. The 7.5 mg tablets are blue, round, tablets debossed with M over A7 on one side of the tablet and a quadrisect on the other side. NDC 0378-4542-01 bottles of 100 tablets The 10 mg tablets contain 2.5 mg of dextroamphetamine saccharate, 2.5 mg of amphetamine aspartate monohydrate (equivalent to 2.34 mg of amphetamine aspartate anhydrous), 2.5 mg of dextroamphetamine sulfate, USP and 2.5 mg of amphetamine sulfate, USP. The 10 mg tablets are dark blue, round, tablets debossed with M over A10 on one side of the tablet and a quadrisect on the other side. NDC 0378-4543-01 bottles of 100 tablets The 12.5 mg tablets contain 3.125 mg of dextroamphetamine saccharate, 3.125 mg of amphetamine aspartate monohydrate (equivalent to 2.925 mg of amphetamine aspartate anhydrous), 3.125 mg of dextroamphetamine sulfate, USP and 3.125 mg of amphetamine sulfate, USP. The 12.5 mg tablets are peach, round, tablets debossed with M over A12 on one side of the tablet and a quadrisect on the other side. NDC 0378-4544-01 bottles of 100 tablets The 15 mg tablets contain 3.75 mg of dextroamphetamine saccharate, 3.75 mg of amphetamine aspartate monohydrate (equivalent to 3.51 mg of amphetamine aspartate anhydrous), 3.75 mg of dextroamphetamine sulfate, USP and 3.75 mg of amphetamine sulfate, USP. The 15 mg tablets are peach, round, tablets debossed with M over A15 on one side of the tablet and a quadrisect on the other side. NDC 0378-4545-01 bottles of 100 tablets The 20 mg tablets contain 5 mg of dextroamphetamine saccharate, 5 mg of amphetamine aspartate monohydrate (equivalent to 4.6 mg of amphetamine aspartate anhydrous), 5 mg of dextroamphetamine sulfate, USP and 5 mg of amphetamine sulfate, USP. The 20 mg tablets are peach, round, tablets debossed with M over A20 on one side of the tablet and a quadrisect on the other side. NDC 0378-4546-01 bottles of 100 tablets The 30 mg tablets contain 7.5 mg of dextroamphetamine saccharate, 7.5 mg of amphetamine aspartate monohydrate (equivalent to 7.03 mg of amphetamine aspartate anhydrous), 7.5 mg of dextroamphetamine sulfate, USP and 7.5 mg of amphetamine sulfate, USP. The 30 mg tablets are peach, round, tablets debossed with M over A30 on one side of the tablet and a quadrisect on the other side. NDC 0378-4547-01 bottles of 100 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription. * The brands listed are trademarks of their respective owners.
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