Ritalin-page2

How Supplied

• 5 mg: round, yellow, uncoated, unscored, (debossed 531 and MD)
• 10 mg: round, pale blue/green, uncoated, scored (debossed 530 and MD)
• 20 mg: round, orange, uncoated, scored, (debossed 532 and MD)
• Extended-release tablets, 20 mg: round, white, uncoated, unscored, (debossed 562 and MD)

Possible Side Effects

• 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 multiform 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

• instances of abnormal liver function, ranging from transaminase elevation to hepatic coma
• isolated cases of cerebral arteritis and /or occlusion
• leukopenia and / or anemia
• transient depressed mood
• a few instances of scalp hair loss

• loss of appetite
• abdominal pain
• weight loss during prolonged therapy
• insomnia
• tachycardia may occur more frequently; however, any of the other adverse reactions listed above may also occur.

Drug Interactions

Warnings

     Methylphenidate should not be used in children under six years, since safety and effecency of long term use of methylphenidate hydrochloride 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.  Methylphenidate should not be used for severe depression of either exogenous or endogenous origin.  Clinical experience suggests that in psychotic children, administraition of methylphenidate may exacerbate symptoms of behavior disturbance and thought disorder.

     Methylphenidals should not be used for the prevention or treatment of normal fatigue states.  There is some clinical evidence that methylphenidate may lower the convulsive threshold in patients with prior history of seizures, with prior EEG abnormalities in absense 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. &nsp;In the presence of seizures, the drug should be discontinued.  Use cautiously in patients with hypertension.  Blood pressure should be monitored at apropriate intervals in all patients taking methylphenidate, especially those with hypertension.  Symptoms of visual disturbances have been encountered in rare cases.  Difficulties with accommodation and blurring of vision have been reported.

Use In Pregancy

     Adequate animal reproduction studies to establish safe use of methylphenidate during pregnancy have not been conducted.  Therefore, until more information is available, methylphenidate hydrochloride should not be prescribed for women of childbearing age unless, in the opinion of teh physician, the potential benefits outweigh the possible risks.

Drug Dependance

     Methylphenidate hydrochloride 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 dependance 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 ups 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 C.C. 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.