Rubifen Retard® 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 been shown to be insufficient on their own.
Treatment should be initiated and supervised by a specialist in child behavior disorders, a child and adolescent psychiatrist, or a psychiatrist.
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 made 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 generally 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, being easily distracted, emotional instability, impulsiveness, moderate to severe hyperactivity, minor neurological signs, and abnormal electroencephalogram (EEG). Learning ability may or may not be impaired.
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.
An appropriate educational placement is essential, and psychosocial intervention is often necessary. Where other measures have proven 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® must always be done in this way according to the authorized indication and the prescription and diagnostic guidelines.
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 absent-mindedness. Symptoms such as hyperactivity tend to decrease with increasing age, possibly due to adaptation, neurological development, and self-medication. Symptoms of inattention become more apparent and affect adults with ADHD to a greater extent. Diagnosis in adults should include a structured patient interview to determine current symptoms. The existence of ADHD in childhood is a requirement and must be determined retrospectively (by patient histories or, if these are not available, by appropriate and structured interviews). It is convenient to have the corroboration of a third person, and Rubifen Retard should not be started when verification of symptoms of ADHD in childhood is uncertain. The diagnosis cannot be made 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 (eg, social, academic, and/or occupational activity), affecting several aspects of the individual’s life.
HDPE bottles with child-resistant (PP) safety closure. It is marketed in:
