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What is CONCERTA (methylphenidate)?
CONCERTA (methylphenidate) is a central nervous system stimulant. It affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control.
Concerta extended-release tablets are used to treat attention deficit hyperactivity disorder (ADHD) in adults and children 6 years of age and older.
Concerta may also be used for purposes not listed in this medication guide.
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
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.
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.
Need For Comprehensive Treatment Program
CONCERTA is 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.
SIDE EFFECTS of CONCERTA (Methylphenidate)
The following are discussed in more detail in other sections of the labeling:
- Drug Dependence
- Hypersensitivity to Methylphenidate
- Monoamine Oxidase Inhibitors
- Serious Cardiovascular Events
- Psychiatric Adverse Events
- Long-Term Suppression of Growth
- Visual Disturbance
- Potential for Gastrointestinal Obstruction
- Hematologic Monitoring
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.
The most common adverse reactions associated with discontinuation ( ≥ 1%) from either pediatric or adult clinical trials were anxiety, irritability, insomnia, and blood pressure increased.
DOSAGE AND ADMINISTRATION of CONCERTA (Methylphenidate)
General Dosing Information
CONCERTA (methylphenidate) should be administered orally once daily in the morning with or without food.
CONCERTA (methylphenidate) must be swallowed whole with the aid of liquids, and must not be chewed, divided, or crushed .
Patients New To Methylphenidate
The recommended starting dose of CONCERTA® for patients who are not currently taking methylphenidate or stimulants other than methylphenidate is 18 mg once daily for children and adolescents and 18 or 36 mg once daily for adults
Patients Currently Using Methylphenidate
The recommended dose of CONCERTA® for patients who are currently taking methylphenidate twice daily or three times daily at doses of 10 to 60 mg/day is provided in Table 2. Dosing recommendations are based on current dose regimen and clinical judgment. Conversion dosage should not exceed 72 mg daily.
Other methylphenidate regimens: Clinical judgment should be used when selecting the starting dose.
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