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LEVOPHED™ NOREPINEPHRINE BITARTRATE, Ampul N+ U.S. Physician Prescribing Information Use in Specific Populations (norepinephrine bitartrate injection, USP)

Pregnancy

Animal reproduction studies have not been conducted with LEVOPHED. It is also not known whether LEVOPHED can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. LEVOPHED should be given to a pregnant woman only if clearly needed.


Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when LEVOPHED is administered to a nursing woman.


Pediatric Use

Safety and effectiveness in pediatric patients has not been established.


Geriatric Use

Clinical studies of LEVOPHED did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

LEVOPHED infusions should not be administered into the veins in the leg in elderly patients (see PRECAUTIONS, General).

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