IMPORTANT RISK INFORMATION
DRUG ABUSE AND DEPENDENCE
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 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.
- Methylphenidate hydrochloride oral solution is contraindicated in patients:
- with marked anxiety, tension, or agitation
- with a known hypersensitivity to the drug
- with glaucoma
- with motor tics or a family history or diagnosis of Tourette’s syndrome
- being treated with a monoamine oxidase inhibitor (MAOI) or within 14 days of discontinuation of MAOI
WARNINGS AND PRECAUTIONS
- Sudden death has been reported in association with CNS stimulant treatment at usual doses in children and adolescents with structural cardiac abnormalities or other serious heart problems. Sudden death, stroke, and myocardial infarction have been reported in adults taking stimulants at usual doses for ADHD.
- Stimulants cause a modest increase in average blood pressure and average heart rate, and individuals may have larger increases.
- Use of stimulants may cause treatment-emergent psychotic or manic symptoms in patients with no prior history, or exacerbation of symptoms in patients with preexisting psychiatric illness, including bipolar or pre-existing psychosis. Clinical evaluation for Bipolar Disorder is recommended prior to stimulant use. Monitor for aggressive behavior.
- Stimulants may lower the convulsive threshold.
- Peripheral vasculopathy including Raynaud’s phenomenon are associated with stimulant use.
- Consistently medicated children may exhibit a temporarily slowed growth rate.
- Difficulties with accommodation and blurring of vision have been reported with stimulant treatment.
- Hematologic monitoring: Periodic CBC, differential, and platelet counts are advised during prolonged therapy.
- Long-term effects of Methylphenidate HCl Oral Solution in children have not been well established.
- Serious adverse events include sudden death, stroke, myocardial infarction, slowing of growth, seizures, and changes in vision, peripheral vasculopathy, including Raynaud’s phenomenon, hypersensitivity, tachycardia, angina, cardiac arrhythmia, Tourette’s syndrome, and toxic psychosis.
- The most common adverse reactions are nervousness, insomnia, loss of appetite, abdominal pain, and weight loss during prolonged therapy.
USE IN SPECIFIC POPULATIONS
- Animal studies have shown teratogenic effects in rabbits. 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.
- Safety and efficacy in children under six years of age has not been established.
Colorless, grape flavored liquid
10 mg/5 mL
For additional information on Methylphenidate hydrochloride oral solution 10 mg/5 mL, call Customer Service at 1.800.325.8888 or Medical Information at 1.800.778.7898.
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