US Prescribing Information
US Patient Medication Guide
IMPORTANT SAFETY INFORMATION ABOUT PROCENTRAŽ (DEXTROAMPHETAMINE SULFATE) CII
AMPHETAMINES HAVE A HIGH POTENTIAL FOR ABUSE AND MAY LEAD TO DRUG DEPENDENCE. MISUSE OF AMPHETAMINES MAY CAUSE SUDDEN DEATH AND SERIOUS CARDIOVASCULAR ADVERSE EVENTS.
Indications and Usage
ProCentraŽ (dextroamphetamine sulfate) is indicated for Attention Deficit Disorder with Hyperactivity as an integral part of a total treatment program that typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 years to 16 years) with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: Moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted.
Contraindications
ProCentraŽ is contraindicated in patients with advanced arteriosclerosis; symptomatic cardiovascular disease; moderate to severe hypertension; hyperthyroidism; known hypersensitivity or idiosyncrasy to the sympathomimetic amines; glaucoma; agitated states; patients with a history of drug abuse; and during, or within 14 days following the administration of monoamine oxidase inhibitors (MAOIs).
Warnings
Sudden death has been reported with stimulant treatment in patients with structural cardiac abnormalities or other serious heart problems. Stroke and myocardial infarction have also been reported in adults taking stimulant drugs. ProCentra should not be used in patients with known structural cardiac abnormalities; cardiomyopathy; serious heart rhythm problems; coronary artery disease; or other serious cardiac problems.
Use with caution in patients with hypertension and other cardiovascular conditions; psychosis; bipolar disorder; and with patients who have a history of seizures/EEG abnormalities.
Stimulants may cause new psychotic or manic symptoms such as hallucinations, delusional thinking or mania without a prior history of psychotic illness or mania. If such symptoms occur discontinuation of treatment may be appropriate.
Patients should be monitored at beginning of their treatment for appearance of, or worsening of, aggressive behavior or hostility. Growth should also be monitored during treatment, and if patients are not growing or gaining height or weight as expected, their treatment may need to be interrupted.
Stimulants may produce difficulties with accommodation and blurring of vision.
Precautions
The least amount feasible should be prescribed or dispensed at one time in order to minimize the possibility of overdosage. Amphetamines may impair the ability of the patient to engage in potentially hazardous activities such as operating machinery or vehicles; the patient should therefore be cautioned accordingly.
Adverse Reactions
The following adverse reactions have been reported with dextroamphetamine sulfate: Palpitations, tachycardia, elevated blood pressure, cardiomyopathy (associated with chronic amphetamine use), psychotic episodes at recommended doses (rare), overstimulation, restlessness, dizziness, insomnia, euphoria, dyskinesia, dysphoria, tremor, headache, exacerbation of motor and phonic tics and Tourette's syndrome, dryness of the mouth, unpleasant taste, diarrhea, constipation, anorexia, weight loss, urticaria, impotence, and changes in libido.
Drug Abuse and Dependence
Abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep EEG. Manifestations of chronic intoxication with amphetamines include severe dermatoses, marked insomnia, irritability, hyperactivity and personality changes. The most severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from schizophrenia. This is rare with oral amphetamines.
Please see Full Prescribing Information and Medication Guide for additional safety information.
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