Strattera - Warnings & Precautions

(Page 3)

Orthostatic hypotension has been reported in subjects taking STRATTERA. In short-term, child-and adolescent-controlled trials, 1.8% (6/ 340) of STRATTERA-treated subjects experienced symptoms of postural hypotension compared with 0.5% (1/ 207) of placebo-treated subjects. STRATTERA should be used with caution in any condition that may predispose patients to hypotension. Effects on urine outflow from the bladder — In adult ADHD controlled trials, the rates of urinary retention (3%, 7/ 269) and urinary hesitation (3%, 7/ 269) were increased among atomoxetine subjects compared with placebo subjects (0%, 0/ 263). Two adult atomoxetine subjects and no placebo subjects discontinued from controlled clinical trials because of urinary retention. A complaint of urinary retention or urinary hesitancy should be considered potentially

related to atomoxetine.

Information for Patients

Patients should read Information for Patients before starting therapy with STRATTERA and when the prescription is renewed. Patients should consult a physician if they are taking or plan to take any prescription or over-the-counter medicines, dietary supplements, or herbal remedies. Patients should consult a physician if they are nursing, pregnant, or thinking of becoming pregnant while taking STRATTERA. Patients may take STRATTERA with or without food.

If patients miss a dose, they should take it as soon as possible, but should not take more than the prescribed total daily amount of STRATTERA in any 24-hour period. Patients should use caution when driving a car or operating hazardous machinery until they are reasonably certain that their performance is not affected by atomoxetine.

Laboratory Tests Routine laboratory tests are not required.

CYP2D6 metabolism — Poor metabolizers (PMs) of CYP2D6 have a 10-fold higher AUC and a 5-fold higher peak concentration to a given dose of STRATTERA compared with extensive metabolizers (EMs). Approximately 7% of a Caucasian population are PMs. Laboratory tests are available to identify CYP2D6 PMs. The blood levels in PMs are similar to those attained by taking strong inhibitors of CYP2D6. The higher blood levels in PMs lead to a higher rate of some adverse effects of STRATTERA (see ADVERSE REACTIONS).