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IT IS RECOMMENDED THAT THE LOWEST EFFECTIVE DOSE OF PROMETHAZINE BE USED IN PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER AND CONCOMITANT ADMINISTRATION OF OTHER DRUGS WITH RESPIRATORY DEPRESSANT EFFECTS BE AVOIDED.
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FDA is requiring a Boxed Warning for promethazine hydrochloride injection, USP products to better communicate the risks of severe tissue injury associated with administration of this drug.
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While the extent of this problem is unknown, numerous reports submitted to PA-PSRS and the United States Pharmacopeia-Institute for Safe Medication Practices (ISMP) Medication Errors Reporting Program (MERP); articles in professional literature; news of lawsuits in the media; and communications on various Internet listservs and message boards suggest that patient harm may be occurring more frequently than previously recognized.
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