FDA label c905344e-2bfc-4a40-98c4-ff7320801212

CYLERT SHOULD NOT BE USED BY PATIENTS UNTIL THERE HAS BEEN A COMPLETE DISCUSSION OF THE RISKS AND BENEFITS OF CYLERT THERAPY AND WRITTEN INFORMED CONSENT HAS BEEN OBTAINED (SEE PATIENT INFORMATION/CONSENT FORM ). A SUPPLY OF PATIENT INFORMATION/ CONSENT FORMS AS PRINTED AT THE END OF THIS INSERT IS AVAILABLE, FREE OF CHARGE, BY CALLING (847) 937-7302. PERMISSION TO USE THE PATIENT INFORMATION/CONSENT FORM BY PHOTOCOPY REPRODUCTION IS HEREBY GRANTED BY ABBOTT LABORATORIES. Because of its association with life threatening hepatic failure, CYLERT should not ordinarily be considered as first line drug therapy for ADHD (see INDICATIONS AND USAGE). Because CYLERT provides an observable symptomatic benefit, patients who fail to show substantial clinical benefit within 3 weeks of completing dose titration, should be withdrawn from CYLERT therapy. Since CYLERT's marketing in 1975, 15 cases of acute hepatic failure have been reported to the FDA. While the absolute number of reported cases is not large, the rate of reporting ranges from 4 to 17 times the rate expected in the general population. This estimate may be conservative because of under reporting and because the long latency between initiation of CYLERT treatment and the occurrence of hepatic failure may limit recognition of the association. If only a portion of actual cases were recognized and reported, the risk could be substantially higher. Of the 15 cases reported as of December 1998, 12 resulted in death or liver transplantation, usually within four weeks of the onset of signs and symptoms of liver failure. The earliest onset of hepatic abnormalities occurred six months after initiation of CYLERT. Although some reports described dark urine and nonspecific prodromal symptoms (e.g., anorexia, malaise, and gastrointestinal symptoms), in other reports it was not clear if any prodromal symptoms preceded the onset of jaundice. Treatment with CYLERT should be initiated only in individuals without liver disease and with normal baseline liver function tests. It is not clear if baseline and periodic liver function testing are predictive of these instances of acute liver failure; however it is generally believed that early detection of drug-induced hepatic injury along with immediate withdrawal of the suspect drug enhances the likelihood for recovery. Accordingly, the following liver monitoring program is recommended: Serum ALT (SGPT) levels should be determined at baseline, and every two weeks thereafter. If CYLERT therapy is discontinued and then restarted, liver function test monitoring should be done at baseline and reinitiated at the frequency above. CYLERT should be discontinued if serum ALT (SGPT) is increased to a clinically significant level, or any increase ≥ 2 times the upper limit of normal, or if clinical signs and symptoms suggest liver failure (see PRECAUTIONS). The physician who elects to use CYLERT should obtain written informed consent from the patient prior to initiation of CYLERT therapy (see PATIENT INFORMATION/CONSENT FORM).

WARNINGS Decrements in the predicted growth (i.e., weight gain and/or height) rate have been reported with the long-term use of stimulants in children. Therefore, patients requiring long-term therapy should be carefully monitored.

ADVERSE REACTIONS The following are adverse reactions in decreasing order of severity within each category associated with CYLERT: Hepatic There have been reports of hepatic dysfunction, ranging from asymptomatic reversible increases in liver enzymes to hepatitis, jaundice and fatal hepatic failure, in patients taking CYLERT (see BOXED WARNING and PRECAUTIONS ). Hematopoietic There have been isolated reports of aplastic anemia. Central Nervous System The following CNS effects have been reported with the use of CYLERT: convulsive seizures; literature reports indicate that CYLERT may precipitate attacks of Gilles de la Tourette syndrome; hallucinations; dyskinetic movements of the tongue, lips, face and extremities; abnormal oculomotor function including nystagmus and oculogyric crisis; mild depression; dizziness; increased irritability; headache; and drowsiness. Insomnia is the most frequently reported side effect of CYLERT; it usually occurs early in therapy prior to an optimum therapeutic response. In the majority of cases it is transient in nature or responds to a reduction in dosage. Gastrointestinal Anorexia and weight loss may occur during the first weeks of therapy. In the majority of cases it is transient in nature; weight gain usually resumes within three to six months. Nausea and stomach ache have also been reported. Genitourinary A case of elevated acid phosphatase in association with prostatic enlargement has been reported in a 63 year old male who was treated with CYLERT for sleepiness. The acid phosphatase normalized with discontinuation of CYLERT and was again elevated with rechallenge. Miscellaneous Suppression of growth has been reported with the long-term use of stimulants in children. (See WARNINGS .) Skin rash has been reported with CYLERT. If adverse reactions are of a significant or protracted nature, dosage should be reduced or the drug discontinued.