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Ritalin advertisement Psychiatric Annals, November, 1975, pp. 80-82. Tested by time and experience in the treatment of MBD 1962 "...a considerable decrease of hyperactivity..." ~ Knobel, 1962 1974 "...an effective agent in the alleviation of the hyperkinetic disorder..." ~ Hoffman et al, 1974 Over a decade of controlled studies and clinical experience has shown the effectiveness of Ritalin in reducting the hyperactivity, distractibility, and disorganized behavior in the MBD child. By lessening the effects of motor and attentional disorders, Ritalin can help the MBD child to better focus his attention on meaningful stimuli and thus can often improve cognition and promote learning. And side effects -- insomnia and appetite loss -- with Ritalin have occurred less frequently than with dextroamphetamine. Indeed, Ritalin is currently a drug of choice in many MBD situations, and can prove to be an important element in many complete remedial programs for MBD. Therapy with Ritalin should be undertaken only after a medical diagnosis of MBD has been made. Drug treatment is not indicated for all children with MBD. Dosage should be periodically interrupted. Often, these interruptions reveal some "stabilization" in the child's behavior even without medication, permitting a reduction in dosage and eventual discontinuance of drug therapy. Ritalin® (methylphenidate) Only when medication is indicated. INDICATION ~ Minimal Brain Dysfunction in Children -- as adjunctive therapy to other remedial measures (psychological, educational, social) Special Diagnostic Considerations Specific etiology of Minimal Brain Dysfunction (MBD) is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources. Characteristics commonly reported include: chronic 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 of MBD 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 for all children with MBD. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is generally necessary. 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 child's symptoms. CONTRAINDICATIONS ~ Marked anxiety, tension, and agitation, since Ritalin may aggravate these symptoms. Also contraindicated in patients known to be hypersensitive to the drug and in patients with glaucoma. WARNINGS ~ Ritalin should not be used in children under six years, since safety and efficacy in this age group have not been established. Sufficient data on safety and efficacy of long-term use of Ritalin in children with minimal brain dysfunction are not yet available. Although a causal relationship has not been established, suppression of growth (i.e., weight gain, and/or height) has been reported with the long-term use of stimulants in children. Therefore, children requiring long-term therapy should be carefully monitored. Ritalin should not be used for severe depression of either exogenous or endogenous origin or for the prevention of normal fatigue states. Ritalin may lower the convulsive threshold in patients with or without prior seizures; with or without prior EEG abnormalities, even in absence of seizures. Safe concomitant use of anticonvulsants and Ritalin has not been established. If seizures occur, Ritalin should be discontinued. Use cautiously in patients with hypertension. Blood pressure should be monitored at appropriate intervals in all patients taking Ritalin, especially those with hypertension. Usage in Pregnancy Adequate animal reproduction studies to establish safe use of Ritalin during pregnancy have not been conducted. Therefore, until more information is available, Ritalin should not be prescribed for women of childbearing age unless, in the opinion of the physician, the potential benefits outweigh the possible risks. Drug Dependence: Ritalin should be given cautiously to emotionally unstable patients, such as those with a history of drug dependence or alcoholism, because such patients may increase dosage on their own initiative. Chronically abusive use can lead to marked tolerance and psychic dependence with varying degrees of abnormal behaviour. Frank psychotic episodes can occur, especially with parenteral abuse. Careful supervision is required during drug withdrawal, since severe depression as well as the effects of chronic overactivity can be unmasked. Long-term follow-up may be required because of the patient's basic personality disturbances. PRECAUTIONS ~ Patients with an element of agitation may react adversely; discontinue therapy if necessary. Periodic CBC, differential, and platelet counts are advised during prolonged therapy. ADVERSE REACTIONS ~ Nervousness and insomnia are the most common adverse reactions but are usually controlled by reducing dosage and omitting the drug in the afternoon or evening. Other reactions include hypersensitivity (including skin rash, urticaria, fever, arthralgia, exfoliative dermatitis, erythema multiforme with histopathological findings of necrotizing vasculitis, and thrombocytopenic purpura); anorexia; nausea; dizziness; palpitations; headache; dyskinesia; drowsiness; blood pressure and pulse changes, both up and down; tachycardia; angina; cardiac arrhythmia; abdominal pain; weight loss during prolonged therapy. Toxic psychosis has been reported. Although a definite causal relationship has not been established, the following have been reported in patients taking this drug: leukopenia and/or anemia; a few instances of scalp hair loss. In children, loss of appetite, abdominal pain, weight loss during prolonged therapy, insomnia, and tachycardia may occur more frequently; however, any of the other adverse reactions listed above may also occur. DOSAGE AND ADMINISTRATION ~ Children with Minimal Brain Dysfunction (6 years and over) Start with small doses (eg, 5 mg before breakfast and lunch) with gradual increments of 5 to 10 mg weekly. Daily dosage above 60 mg is not recommended. If improvement is not observed after appropriate dosage adjustment over a one-month period, the drug should be discontinued. If paradoxical aggravation of symptoms or other adverse effects occur, reduce dosage, or, if necessary, discontinue the drug. Ritalin should be periodically discontinued to assess the child's condition. Improvement may be sustained when the drug is either temporarily or permanently discontinued. Drug treatment should not and need not be indefinite and usually may be discontinued after puberty. HOW SUPPLIED ~ Tablets, 20 mg (peach, scored); bottles of 100 and 1000. Tablets, 10 mg (pale green, scored); bottles of 100, 500, 1000 and Accu-pak® blister units of 100. Tablets, 5 mg (pale yellow); bottles of 100, 500, and 1000. Consult complete product literature before prescribing. CIBA Pharmaceutical Company ~ Division of CIBA-GEIGY Corporation ~ Summit, New Jersey 07901 References: 1. Knobel M: Psychopharmacology for the hyperkinetic child, Arch Gen Psychiatry 6:198-202, 1962. 2. Hoffman SP, Engelhardt DM, Margolis RA, et al: Response to methylphenidate in low socio-economic hyperactive children, Arch Gen Psychiatry 30:354-359, 1974. 3. Sprague RL, Barnes KR, Werry JS: Methylphenidate and thioridazine: Learning, reaction time, activity, and classroom behavior in disturbed children. Am J Orthopsychiatry 40:615-628, 1970. 4. Knights RM, Hinton GG: The effects of methylphenidate (Ritalin) on the motor skills and behavior of children with learning problems. J Nerv Ment Dis 148:643-653, 1969. 5. Seger EY, Hallum G: Methylphenidate in children with minimal brain dysfunction: Effects on attention span, visual-motor skills, and behavior. Curr Ther Res 16:636-641, 1971. 6. Conners CK, Eisenberg L: The effects of methylphenidate on symptomatology and learning in disturbed children. Am J Psychiatry 120:458-464, 1963. 7. Creager RO, VanRiper C: The effect of methylphenidate on the verbal productivity of children with cerebral dysfunction. J Speech Hear Res 10:623-628, 1967. 8. Comly HH: Cerebral stimulants for children with learning disorders. J Learning Disabil 4:484-490, 1971. 9. Mackay MC, Beck L, Taylor R: Methylphenidate for adolescents with minimal brain dysfunction. NY State J Med 73:550-554, 1973. 10. Paine RS: Syndromes of "minimal cerebral damage." Pediatr Clin North Am 15:779-800, 1968. 11. Conners CK: Symposium: Behavior modification by drugs: II. Psychological effects of stimulant drugs in children with minimal brain dysfunction. Pediatrics 49:702-708, 1972. 12. Charlton MH: Symposium: Minimal brain dysfunction and the hyperkinetic child: Clinical aspects. NY State J Med 16:2058-2060, 1972. |