24 HR Methylphenidate Hydrochloride 27 MG Extended Release Oral Tablet
1 INDICATIONS AND USAGE Methylphenidate hydrochloride extended-release tablets are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents, and adults up to the age of 65 [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 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. Methylphenidate hydrochloride extended-release tablets are a CNS stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in children 6 years of age and older, adolescents, and adults up to the age of 65. ( 1 ) 1.1 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 presence of the required number of DSM-IV characteristics. 1.2 Need for Comprehensive Treatment Program Methylphenidate hydrochloride extended-release tablets are indicated as an integral part of a total treatment program for ADHD that may include other measures (psychological, educational, social). Drug treatment may not be indicated for all patients with ADHD. 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.
Mylan Pharmaceuticals Inc.
ROUND GREY M D27
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16 HOW SUPPLIED/STORAGE AND HANDLING Methylphenidate Hydrochloride Extended-Release Tablets, USP are available containing 18 mg, 27 mg, 36 mg or 54 mg of methylphenidate hydrochloride, USP. The 18 mg tablets are yellow, film-coated, round, unscored tablets imprinted with M over D18 in black ink on one side of the tablet and blank on the other side of the tablet. They are available as follows: NDC 0378-8155-77 bottles of 90 tablets NDC 0378-8155-01 bottles of 100 tablets The 27 mg tablets are gray, film-coated, round, unscored tablets imprinted with M over D27 in black ink on one side of the tablet and blank on the other side of the tablet. They are available as follows: NDC 0378-8156-77 bottles of 90 tablets NDC 0378-8156-01 bottles of 100 tablets The 36 mg tablets are white, film-coated, round, unscored tablets imprinted with M over D36 in black ink on one side of the tablet and blank on the other side of the tablet. They are available as follows: NDC 0378-8157-77 bottles of 90 tablets NDC 0378-8157-01 bottles of 100 tablets The 54 mg tablets are pink-orange, film-coated, round, unscored tablets imprinted with M over D54 in black ink on one side of the tablet and blank on the other side of the tablet. They are available as follows: NDC 0378-8158-77 bottles of 90 tablets NDC 0378-8158-01 bottles of 100 tablets Storage and Handling: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture and humidity. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.
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