Methylphenidate precautions

List of precautions
Overview Children under 6 Depression Fatigue Carcinogenesis Mutagenesis Seizures Hypertension Visual disturbances Pregnancy Drug dependence

Overview
Patients with an element of agitation may react adversely; discontinue therapy if necessary. Periodic CBC, differential, and platelet counts are advised during prolonged therapy. Drug treatment is not indicated in all cases of this behavioral syndrome and should be considered only in light of the complete history and evaluation of the child. The decision to prescribe Methylphenidate should depend on the physician’s assessment of the chronicity and severity of the child’s symptoms and their appropriateness for his/her age. Prescription should not depend solely on the presence of one or more of the behavioral characteristics. When these symptoms are associated with acute stress reactions, treatment with Methylphenidate is usually not indicated. Long-term effects of Methylphenidate in children have not been well established. Return to top

Children under 6
Methylphenidate 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 Methylphenidate in children 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, patients requiring long-term therapy should be carefully monitored. Return to top

Depression
Methylphenidate should not be used for severe depression of either exogenous or endogenous origin. Clinical experience suggests that in psychotic children, administration of Methylphenidate may exacerbate symptoms of behavior disturbance and thought disorder. Return to top

Fatigue
Methylphenidate should not be used for the prevention or treatment of normal fatigue states. Return to top

Carcinogenesis
In a lifetime carcinogenicity study carried out in B6C3F1 mice, Methylphenidate caused an increase in hepatocellular adenomas and, in males only, an increase in hepatoblastomas, at a daily dose of approximately 60 mg/kg/day. This dose is approximately 30 times and 2.5 times the maximum recommended human dose on a mg/kg and mg/m2 basis, respectively. Hepatoblastoma is a relatively rare rodent malignant tumor type. There was no increase in total malignant hepatic tumors. The mouse strain used is sensitive to the development of hepatic tumors, and the significance of these results to humans is unknown. Methylphenidate did not cause any increases in tumors in a lifetime carcinogenicity study carried out in F344 rats; the highest dose used was approximately 45 mg/kg/day, which is approximately 22 times and 4 times the maximum recommended human dose on a mg/kg and mg/m2 basis, respectively. Return to top

Mutagenesis
Methylphenidate was not mutagenic in the in vitro Ames reverse mutation assay or in the in vitro mouse lymphoma cell forward mutation assay. Sister chromatid exchanges and chromosome aberrations were increased, indicative of a weak clastogenic response, in an in vitro assay in cultured Chinese Hamster Ovary (CHO) cells. The genotoxic potential of Methylphenidate has not been evaluated in an in vivo assay. Return to top

Seizures
There is some clinical evidence that Methylphenidate may lower the convulsive threshold in patients with prior history of seizures, with prior EEG abnormalities in absence of seizures, and, very rarely, in absence of history of seizures and no prior EEG evidence of seizures. Safe concomitant use of anticonvulsants and Methylphenidate has not been established. In the presence of seizures, the drug should be discontinued. Return to top

Hypertension
Use cautiously in patients with hypertension. Blood pressure should be monitored at appropriate intervals in all patients taking Methylphenidate, especially those with hypertension. Return to top

Visual disturbances
Symptoms of visual disturbances have been encountered in rare cases. Difficulties with accommodation and blurring of vision have been reported. Return to top

Pregnancy
Adequate animal reproduction studies to establish safe use of Methylphenidate during pregnancy have not been conducted. However, in a recently conducted study, Methylphenidate has been shown to have teratogenic effects in rabbits when given in doses of 200 mg/kg/day, which is approximately 167 times and 78 times the maximum recommended human dose on a mg/kg and a mg/m2 basis, respectively. In rats, teratogenic effects were not seen when the drug was given in doses of 75 mg/kg/day, which is approximately 62.5 and 13.5 times the maximum recommended human dose on a mg/kg and a mg/m2 basis, respectively. Therefore, until more information is available, Methylphenidate should not be prescribed for women of childbearing age unless, in the opinion of the physician, the potential benefits outweigh the possible risks. Return to top

Drug dependence
Methylphenidate 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 behavior. 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. Return to top