RITALIN-SR® 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 causal relationship has not been established, suppression of growth (ie, 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; dizzines; 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 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.

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 parental abuse. Careful supervision is required during drug withdrawal, since severe depression as well as the effects of chronic over activity can be unmasked. Long-term follow-up may be required because of the patient's basic personality disturbances.

STIMULANT ANTIDEPRESSANT DRUGS
Depression may also be treated with drugs called psychostimulants. Use of such drugs is reserved for only two situations: (1) patients who have failed to respond to at least two other antidepressants and psychotherapy and who are seriously depressed, and (2) patients with serious and usually terminal medical illnesses such as cancer or AIDS who are depressed and too sick to take other kinds of antidepressants.The reason for these restrictions is that the stimulant drugs are addictive. They include amphetamines, sometimes called "speed" or "uppers," methylphenidate (Ritalin), and pemoline (Cylert). The drugs produce a short-term mood elevation even in people who are not depressed. College students take them to stay awake all night and finish term papers.In most people the effects of these stimulant drugs are short-lived and there is often a letdown or "crash" after they wear off. During this "crash" the patient can feel very depressed, sleepy, and sluggish. Furthermore, and very much unlike the other drugs discussed so far in this chapter, stimulant drugs have the potential to induce "tolerance." People who abuse amphetamines and other stimulants--usually in attempts to lose weight or stay awake for prolonged periods--often find that a dose that had worked for a while is suddenly ineffective and they need a higher dose. They then become "tolerant" to the higher dose and have to increase the dose again. Soon, the person is addicted to the drug. Stopping it suddenly leads to a severe withdrawal reaction characterized by bad depression and extreme fatigue. Suicides have been reported in people who suddenly stop taking amphetamines.Given all these problems, why even mention the stimulant drugs? Simply because they are the only drugs that work for some depressed patients. A very small group of usually chronically depressed patients seems to be resistant to every other treatment for depression. These people usually function at a fairly low level relative to their ability and they feel sad and blue all of the time. They complain of fatigue, low interest in life, and inability to concentrate. Many say they have been depressed since childhood.Another small group of patients with very serious medical problems also develops depression. Sometimes the medical problems they have make other antidepressant drugs unsafe, or the medical problems so magnify the side effects of the other antidepressants that the dying patient is made even more uncomfortable. Stimulant drugs may actually be the safest choice in this situation.For these two groups of patients stimulant drugs may be the only answer, even though the patient will probably become addicted. This is not to be taken lightly. The decision to place a patient on a stimulant drug for depression is serious and must be done only after all other efforts are declared either unsafe or ineffective. The patient must understand that he will probably become addicted to the medication and that he should never stop taking it abruptly.

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