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Dextroamphetamine Sulfate 5 MG Extended Release Oral Capsule

INDICATIONS AND USAGE Dextroamphetamine sulfate extended-release capsules are indicated in: Narcolepsy Attention Deficit Disorder with Hyperactivity As an integral part of a total treatment program that typically includes other measures (psychological, educational, social) for patients (ages 6 years to 16 years) with this syndrome. A diagnosis of attention deficit hyperactivity disorder (ADHD; DSM-IV) implies the presence of the 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 2 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 6 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 6 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 of medical and 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 patient and not solely on the presences of the required number of DSM-IV characteristics. Need for Comprehensive Treatment Program Dextroamphetamine sulfate extended-release capsules 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 patients with this syndrome. Stimulants are not intended for use in patients who exhibit 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 patient’s symptoms.

SpecGx LLC


3 years ago CAPSULE WHITE M 8960 5 mg Dextroamphetamine Sulfate 5 MG Extended Release Oral Capsule

CAPSULE WHITE M 8960 5 mg

3 years ago CAPSULE WHITE M 8960 5 mg Dextroamphetamine Sulfate 5 MG Extended Release Oral Capsule

M 8960 5 mg CAPSULE WHITE

HOW SUPPLIED

DEXTROAMPHETAMINE SULFATE Extended-Release capsules Each capsule, with white opaque cap and white opaque body, contains

DEXTROAMPHETAMINE SULFATE. The 5 mg capsule is imprinted with an ® on the cap and is imprinted 8960 5 mg on the body in black. The 10 mg capsule is imprinted with an ® on the cap and is imprinted 8961 10 mg on the body in blue. The 15 mg capsule is imprinted with an ® on the cap and is imprinted 8962 15 mg on the body in pink. 5 mg Bottles of 100……………….NDC 0406-8960-01 10 mg Bottles of 100……………….NDC 0406-8961-01 15 mg Bottles of 100……………….NDC 0406-8962-01 Store at controlled room temperature between 20° to 25°C (68° to 77°F) [see USP]. Dispense in a tight, light-resistant container with a child-resistant closure. Mallinckrodt, the “M” brand mark, the Mallinckrodt Pharmaceuticals logo and are trademarks of a Mallinckrodt company. © 2023 Mallinckrodt. SpecGx LLC Webster Groves, MO 63119 USA Rev 10/2023 Mallinckrodt™ Pharmaceuticals Boxed M Boxed M Boxed M Boxed M


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