Regulatory Information
ZYFAS PHARMA PTE LTD
ZYFAS PHARMA PTE LTD
Therapeutic
Prescription Only
Formulation Information
TABLET
**DOSAGE & ADMINISTRATION:** Dosage should be individualized according to the needs and responses of the patient. In the treatment of ADHD, an attempt should be made to time administration to coincide with periods of greatest academic, behavioural and social stress. Rubifen should be started at a low dose with increments at weekly intervals. Daily doses above 60mg are not recommended. If symptoms do not improve after dose titration over a period of 1 month, Rubifen should be discontinued. If symptoms worsen or other adverse effects occur, the dosage should be reduced or, if necessary, the drug discontinued. If the effects of the drug wears off too early in the evening, disturbed behaviour and/or inability to go to sleep may recur. A small evening dose of the normal tablet or an afternoon dose of Rubifen may help to solve this problem. Rubifen should be discontinued periodically to assess the child's condition. Improvement may continue when the drug is temporarily or permanently discontinued. Drug treatment should not, and need not, be indefinite. It can usually be discontinued during or after puberty. However, ADHD may continue into adulthood and treatment with Rubifen may be beneficial to those after puberty. **Adults** Average dosage is 20 to 30mg daily (one tablet twice or three times a day). Some patients may require 40–60mg daily, while others, 10–15mg daily will be adequate. Patients who are unable to sleep if medication is taken late in the day should take the last dose before 6 p.m. **Children (6 years and over)** Start treatment with 5mg twice a day (before breakfast and lunch), increment gradually 5 to 10mg weekly if necessary. The total daily dosages should be administered in divided doses.
ORAL
Medical Information
**INDICATIONS** Attention-Deficit/Hyperactivity Disorder (ADHD, DSM-IV): ADHD was previously known as attention-deficit disorder or minimal brain dysfunction. Other terms used to describe this behavioral syndrome include hyperkinetic disorder, minimal brain damage, minimal cerebral dysfunction, minor cerebral dysfunction and psychoorganic syndrome of children. Rubifen is indicated as part of a comprehensive treatment programme which typically includes psychological, educational and social measures and is aimed at stabilizing children with a behavioural syndrome characterized by moderate to severe distractibility, short attention span, hyperactivity emotional lability and impulsivity. The diagnosis should be made according to DSM-IV criteria or the guidelines in ICD-10. Nonlocalising (soft) neurological signs, learning disability and abnormal EEG may or may not be present and a diagnosis of central nervous system dysfunction may or may not be warranted. Special Diagnostic Considerations for ADHD; The specific aetiology of this syndrome is unknown and there is no single diagnostic test. Proper diagnosis requires medical and neuropsychological, educational and social investigation. Characteristics commonly reported include history of short attention span, distractibility, emotional lability, impulsivity and moderate to severe hyperactivity, minor neurological signs and abnormal EEG. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of one or more of these characteristics. Drug treatment is not indicated in all children with this syndrome. Stimulants are not indicated in children with symptoms secondary to environmental factors (child abuse in particular) and/or primary psychiatric disorder, including psychosis. Appropriate educational placement is essential and psychosocial intervention is generally necessary. Where remedial measures alone prove insufficient, the decision to prescribe a stimulant must be based on rigorous assessment of the severity of the child's symptoms. Narcolepsy: Symptoms include daytime sleepiness, inappropriate sleep episodes and sudden loss of voluntary muscle tone.
**CONTRAINDICATIONS** Rubifen is contraindicated in patients with the following: - Anxiety and tension states - Agitation, - Tics - Tics in siblings - A family history or diagnosis of Tourette's syndrome. - Glaucoma - Hyperthyroidism - Cardiac arrhythmia - Severe angina pectoris - Treatment with monoamine oxidase inhibitors, and also within a minimum of 14 days following discontinuation of a monoaminase oxidase inhibitor (hypertensive crises may result). - Phaeochromocytoma - Known hypersensitivity to methylphenidate or to any component of the formulation.
N06BA04
methylphenidate
Manufacturer Information
ZYFAS PHARMA PTE. LTD.
LABORATORIOS RUBIO SA
Active Ingredients
Documents
Package Inserts
Rubifen PI (Clean proposed) 18.07.2022.pdf
Approved: July 18, 2022