1 INDICATIONS AND USAGE Dexmethylphenidate HCl extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older. The effectiveness of dexmethylphenidate HCl extended-release capsules in the treatment of ADHD in patients aged 6 years and older was established in 2 placebo-controlled studies in patients meeting DSM-IV criteria for ADHD [ see Clinical Studies ( 14 ) ] . 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 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; â€śon the goâ€ť; excessive talking; blurting answers; canâ€™t wait turn; intrusive. The Combined Types 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 Dexmethylphenidate HCl 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 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 physicianâ€™s assessment of the chronicity and severity of the childâ€™s symptoms. Long-Term Use The effectiveness of dexmethylphenidate HCl extended-release capsules for long-term use, i.e., for more than 7 weeks, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use dexmethylphenidate HCl extended-release capsules for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient [ see Dosage and Administration ( 2.3 ) ]. Dexmethylphenidate HCl extended-release capsules are a CNS stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older. ( 1 )
lannett company, inc.
16 HOW SUPPLIED/STORAGE AND HANDLING 5 mg extended-release capsules (NDC 0527-8106-37) are blue (imprinted 106), capsule-shaped and supplied in bottles of 100 10 mg extended-release capsules (NDC 0527-8107-37) are clear containing white to off-white beads (imprinted 107), capsule-shaped and supplied in bottles of 100 15 mg extended-release capsules (NDC 0527-8108-37) are light green (imprinted 108), capsule-shaped and supplied in bottles of 100 20 mg extended-release capsules (NDC 0527-8109-37) are white (imprinted 109), capsule-shaped and supplied in bottles of 100 25 mg extended-release capsules (NDC 0527-8110-37) are blue and white (imprinted 110), capsule-shaped and supplied in bottles of 100 30 mg extended-release capsules (NDC 0527-8111-37) are clear and white containing white to off-white beads (imprinted 111), capsule-shaped and supplied in bottles of 100 35 mg extended-release capsules (NDC 0527-8112-37) are blue and clear containing white to off-white beads (imprinted 112), capsule-shaped and supplied in bottles of 100 40 mg extended-release capsules (NDC 0527-8113-37) are light green and white (imprinted 113), capsule-shaped and supplied in bottles of 100 Store at 25Â°C (77Â°F); excursions permitted between 15Â° to 30Â°C (59Â° to 86Â°F). [See USP Controlled Room Temperature.] Dispense in tight container (USP).
torrent pharmaceuticals limited
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