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Product: Concerta 30x 54mg
Each order unit contains: Concerta 30x 54mg
Active substance: Ritalin Methylphenidate
Manufacturer / Brand: Janssen-Cilag AG
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CONCERTA(Methylphenidate) 54mg , 100 Tabs*
Concerta (Methylphenidate) ranges as far back as the 1960s while over the course of time, the frequency with which it has been prescribed has increased substantially especially in the treatment of attention deficit hyperactivity disorder and attention deficit disorder. There was a 50% increase in the prescription of Methylphenidate in the United States between 2007 and 2012. Methylphenidate and Concerta are approved drugs by the Federal drug authority in the United States.
CONCERTA is 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].
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.
Uses and dosage :
Adults and Children:
Swallow whole with liquids. Take once daily in the AM. <6yrs: not established. Methylphenidate-naive: 6–12yrs: initially 18mg once daily, max 54mg/day; 13–17yrs: initially 18mg once daily, max 72mg daily or 2mg/kg/day (whichever is less). 18–65yrs: initially 18mg or 36mg/day; max 72mg/day. Switching from methylphenidate 5mg 2 or 3 times daily: initially Concerta 18mg once daily. Switching from methylphenidate 10mg 2 or 3 times daily: initially Concerta 36mg once daily. Switching from methylphenidate 15mg 2 or 3 times daily: initially Concerta 54mg once daily. Switching from methylphenidate 20mg 2 or 3 times per day : initially Concerta 72mg once daily. For all: may adjust in 18mg/day increments at 1-week intervals; max 54mg/day for children; max 72mg/day for adolescents and adults.
The following are discussed in more detail in other sections of the labeling:
Hypersensitivity to Methylphenidate
Monoamine Oxidase Inhibitors
Serious Cardiovascular Events
Psychiatric Adverse Events
Long-Term Suppression of Growth
Potential for Gastrointestinal Obstruction
The most common adverse reaction in double-blind clinical trials ( 5%) in pediatric patients (children and adolescents) was abdominal pain upper. The most common adverse reactions in double-blind clinical trials ( > 5%) in adult patients were decreased appetite, headache, dry mouth, nausea, insomnia, anxiety, dizziness, weight decreased, irritability, and hyperhidrosis.
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