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Ritalin advertisement, 1973. American Journal of Diseases of Children, Vol. 125, No. 5. Monday's child is fair of face, Tuesday's child is full of grace, Wednesday's child is full of woe... -- first three lines of anonymous nursery rhyme Managing Wednesday's Child... the child with MBD "Wednesday's child is full of woe" ~ It need not be this way for the MBD child. He can learn and adjust if given a helping hand. Without help the MBD child may be a slow reader, can find writing difficult, and arithmetic hard to grasp. He may be excitable, and his actions can be disruptive. The result can seriously hamper his educational and social development. But, properly diagnosed and treated, MBD -- Minimal Brain Dysfunction -- can be brought under control so that the afflicted child can develop normally. And Ritalin can play an important part in the total rehabilitation program of the MBD child, which includes remedial measures at home and at school. It's currently the drug of choice in many MBD situations.(1) Ritalin is well tolerated. It can help control the excessive motor activity of the MBD child and ameliorate behavioral and learning problems. Of course, Ritalin is not indicated for childhood personality and behavioral disorders not associated with MBD. Reference 1. Charlton, M.H.: NY State J Med 16:2058 (Aug 15) 1972. Ritalin® hydrochloride (methylphenidate hydrochloride) TABLETS 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. Drug Interactions Ritalin may decrease the hypotensive effect of guanethidine. Use cautiously with pressor agents and MAO inhibitors. Ritalin may inhibit the metabolism of coumarin anticoagulants, anticonvulsants (phenobarbital, diphenylhydantoin, primidone), phenylbutazone, and tricyclic antidepressants (imipramine, desipramine). Downward dosage adjustments of these drugs may be required when given concomitantly with Ritalin. 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 Ritalin® (methylphenidate) only when medication is indicated CIBA |