Rubifen is indicated as part of a comprehensive treatment program for attention deficit/hyperactivity disorder (ADHD) in children from 6 years of age and adults when other measures have proven to be insufficient alone.
Treatment should be initiated and supervised by a specialist in childhood behavioral disorders, a child and adolescent psychiatrist, or a psychiatrist.
Special diagnostic considerations for ADHD in children.
The diagnosis should be made according to DMS criteria or ICD guidelines and should be based on a complete history and evaluation of the patient. The diagnosis cannot be based solely on the presence of one or more symptoms.
The specific etiology of this syndrome is unknown and there is no single diagnostic test. For an adequate diagnosis, it is necessary to resort to clinical and specialized psychology, and to social and educational resources.
A comprehensive treatment program typically includes psychological, educational, and social measures, as well as pharmacotherapy, and is intended to stabilize children suffering from a behavioral syndrome characterized by symptoms that may include a chronic history of difficulty paying attention, easily distractible, unsteady emotional, impulsivity, moderate to severe hyperactivity, minor neurological signs and abnormal electroencephalogram (EEG). Learning ability may or may not be affected.
Treatment with Rubifen Retard® is not indicated for all children with ADHD and the decision to use the drug must be based on a very complete evaluation of the severity and chronicity of the child’s symptoms in relation to her age.
Appropriate educational placement is essential and psychosocial intervention is often necessary. When other measures have been insufficient on their own, the decision to prescribe a stimulant should be based on a rigorous assessment of the severity of the child’s symptoms. The use of Rubifen Retard® should always be done in this way according to the authorized indication and prescription and diagnostic guidelines.
Special Diagnostic Considerations for ADHD in Adults
The diagnosis should be made according to DMS criteria or ICD guidelines and should be based on a complete history and evaluation of the patient.
The specific etiology of this syndrome is unknown and there is no single diagnostic test.
Adults with ADHD exhibit symptom patterns characterized by restlessness, impatience, and distractibility. Symptoms such as hyperactivity tend to decrease with age, possibly due to adaptation, neurological development, and self-medication. Symptoms of inattention become more evident and affect adults with ADHD to a greater extent. Diagnosis in adults should include a structured interview with the patient to determine current symptoms. The existence of ADHD in childhood is a requirement and must be determined retrospectively (through patient medical records or, if these are not available, through appropriate and structured interviews). It is advisable to have corroboration from a third person, and Rubifen Retard should not be started when the verification of ADHD symptoms in childhood is uncertain. The diagnosis cannot be based solely on the presence of one or more symptoms. The decision to use a stimulant in adults should be based on a rigorous evaluation, and the diagnosis should include moderate or severe functional impairment in at least 2 domains (e.g., social, academic, and/or work activity), affecting several aspects of the life of the individual.
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