Posted by Tom PharmD. on August 24, 1998 at 22:34:28:
In Reply to: Re: Ritalin report posted by Nancy on August 24, 1998 at 21:00:38:
he following was excerpted from the 42nd Edition of the Physicians' Desk ReferenceŽ*, on
the drug RitalinŽ:
"RITALIN-SRŽ methylphenidate hydrochloride USP sustained-release tablets."
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 are not yet available. Although a casual 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.
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. There have been
rare reports of Tourette's syndrome. Toxic psychosis has been reported. Although a definite casual 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.
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 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."
I hope this information helps.