البلد: سنغافورة
اللغة: الإنجليزية
المصدر: HSA (Health Sciences Authority)
Methylphenidate 46.71mg eqv Methylphenidate HCl
JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD
N06BA04
54mg
TABLET, FILM COATED
Methylphenidate 46.71mg eqv Methylphenidate HCl 54mg
ORAL
Prescription Only
JANSSEN-CILAG MANUFACTURING, LLC
ACTIVE
2002-10-11
1 PRODUCT NAME CONCERTA ® (methylphenidate hydrochloride) DOSAGE FORMS AND STRENGTHS Extended-release tablets: 18 MG TABLET Capsule-shaped yellow tablet with “alza 18” printed on one side in black ink. Each tablet contains 18 mg of methylphenidate hydrochloride. 27 MG TABLET Capsule-shaped gray tablet with “alza 27” printed on one side in black ink. Each tablet contains 27 mg of methylphenidate hydrochloride. 36 MG TABLET Capsule-shaped white tablet with “alza 36” printed on one side in black ink. Each tablet contains 36 mg of methylphenidate hydrochloride. 54 MG TABLET Capsule-shaped brownish-red tablet with “alza 54” printed on one side in black ink. Each tablet contains 54 mg of methylphenidate hydrochloride. For excipients, see _List of Excipients_. CLINICAL INFORMATION INDICATIONS CONCERTA ® is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). The efficacy of CONCERTA ® in the treatment of ADHD was established in controlled trials of children and adolescents aged 6 to 17 and adults aged 18 to 65 who met DSM-IV criteria for 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, eg, in social, academic, or occupational functioning, and be present in two or more settings, eg, 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 followi اقرأ الوثيقة كاملة
1 PRODUCT NAME CONCERTA ® (methylphenidate hydrochloride) DOSAGE FORMS AND STRENGTHS Extended-release tablets: 18 MG TABLET Capsule-shaped yellow tablet with “alza 18” printed on one side in black ink. Each tablet contains 18 mg of methylphenidate hydrochloride. 27 MG TABLET Capsule-shaped gray tablet with “alza 27” printed on one side in black ink. Each tablet contains 27 mg of methylphenidate hydrochloride. 36 MG TABLET Capsule-shaped white tablet with “alza 36” printed on one side in black ink. Each tablet contains 36 mg of methylphenidate hydrochloride. 54 MG TABLET Capsule-shaped brownish-red tablet with “alza 54” printed on one side in black ink. Each tablet contains 54 mg of methylphenidate hydrochloride. For excipients, see _List of Excipients_. CLINICAL INFORMATION INDICATIONS CONCERTA ® is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). The efficacy of CONCERTA ® in the treatment of ADHD was established in controlled trials of children and adolescents aged 6 to 17 and adults aged 18 to 65 who met DSM-IV criteria for ADHD. CONCERTA ® should be used as a part of a comprehensive treatment program where remedial measures alone prove insufficient. A comprehensive treatment program for the treatment of ADHD may include other measures (psychological, educational, social) for patients with this disorder. Diagnosis must be made according to the current DSM criteria or ICD guidelines. CONCERTA ® treatment is not indicated in all patients with ADHD and the decision to use the drug must be based on a very thorough assessment of the severity of the patient’s symptoms. Stimulants are not intended for use in the patient 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. Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use of medica اقرأ الوثيقة كاملة