Transcription of Reference ID: 3416347 - Food and Drug Administration
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Reference ID: 3416347 - Food and Drug Administration
HIGHLIGHTS OF PRESCRIBING INFORMATION Increase in Blood Pressure: Monitor blood pressure and pulse These highlights do not include all the information needed to at appropriate intervals. Use with caution in patients for use adderall XR safely and effectively. See full whom blood pressure increases may be problematic. ( ). prescribing information for adderall XR. Psychiatric Adverse Events: Stimulants may cause treatment- adderall XR (mixed salts of a single-entity emergent psychotic or manic symptoms in patients with no amphetamine product) dextroamphetamine sulfate, prior history, or exacerbation of symptoms in patients with dextroamphetamine saccharate, amphetamine aspartate pre-existing psychosis. Evaluate for bipolar disorder prior to monohydrate, amphetamine sulfate capsules, CII stimulant use. Monitor for aggressive behavior. ( ). Initial Approval: 2001 Long-term Suppression of Growth: Monitor height and weight at appropriate intervals. ( ). WARNING: POTENTIAL FOR ABUSE.
ADDERALL XR capsules may be taken whole, or the capsule may be opened and the entire contents sprinkled on applesauce. If the patient is using the sprinkle administration method, the sprinkled applesauce should be consumed immediately; it should not be stored. Patients should take the applesauce with sprinkled beads in its entirety without chewing.
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