Download IMPORTANT PRESCRIBING INFORMATION Injection 50 mg/5 mL

May 2015
IMPORTANT PRESCRIBING INFORMATION
Injection 50 mg/5 mL and 100 mg/10 mL
Dear Health Care Provider:
The purpose of this letter is to announce changes to the Vazculep (phenylephrine hydrochloride)
Injection 50 mg/5 mL and 100 mg/10 mL labeling. Vazculep is indicated for the treatment of clinically
important hypotension resulting from vasodilation in the setting of anesthesia. The labeling revision was
-ups involving
undertaken in response to reports of medication errors
Bloxiverz (neostigmine methylsulfate) Injection and Vazculep (phenylephrine hydrochloride)
Injection.
According to some of the medication error reports, Vazculep 50 mg/5 mL and Bloxiverz 10 mg/10
mL were inadvertently substituted for one another due to similarities in packaging and labeling; however,
due to secondary checking of the preparation, no patient received the wrong drug. Both products utilized
similar colors on their vial labels and carton labeling. To minimize the risk for wrong drug errors
Pharmaceuticals has revised the vial label and carton labeling for Vazculep 50 mg/5 mL by changing a
red box containing the product strength to a gold box, and adding yellow highlighting to the pharmacy
bulk package statement. This is intended to further differentiate Vazculep
Bloxiverz
To enhance safe use of Vazculep
bulk packag
also added to the 100 mg/10 ml strength as well.
Figure 2: Vial Labels
Figure 1: Cartons:
Original 50mg/5mL Carton
Revised 50mg/5mL Carton
Original 50mg/5mL Vial Label
Revised 50mg/5mL Vial Label
In one
-miss where the Vazculep 50 mg/5 mL pharmacy bulk package
was confused with Bloxiverz in the operating room (OR) setting. We remind health care providers that
the Vazculep 50 mg/5 mL and 100 mg/10 mL pharmacy bulk packages should be stored and used
ONLY in the pharmacy to mitigate the potential for serious adverse events. See section 2.5 of the
attached Vazculep prescribing information for directions for dispensing from the pharmacy bulk vial.
t Pharmaceuticals intends to implement this change with our next printing. However, we recognize
there is current inventory in pharmacies and warehouses that still retain the previous labeling. Thus, we
Before
have enclosed with this letter alert stickers that
Use.” These stickers should be applied on the top flap of the cartons of your current stock of Vazculep™
50 mg/5 mL so as to not obscure other important drug information. These stickers can also be applied to
shelving or bins where Vazculep™ and Bloxiverz® are stored as needed to further alert users. Additional
stickers can be obtained free of charge by calling toll free 1-844-827-5007 or via email to
[email protected].
Recommended Actions to Prevent Medication Errors
• Double check the name and strength of your product before preparation and administration.
• Use provided alert stickers on all Vazculep™ 50 mg/5 mL vial cartons currently in stock.
• Use provided alert stickers on shelving and bins where Vazculep™ and Bloxiverz® are stored.
• Contact Éclat Pharmaceuticals to receive additional alert stickers as needed until newly labelled
stock is received.
Reporting Adverse Events
Heath care providers and patients are encouraged to report adverse events in patients taking Vazculep™
to Éclat Pharmaceuticals at 1-877-622-2320. You are encouraged to report side effects of Vazculep™
and Bloxiverz® to the FDA MedWatch program. Visit www.fda.gov/medwatch, or call 1-800-FDA1088.
Please note that this letter is not intended as a complete description of the risk profile for Vazculep™.
Please refer to the enclosed full prescribing information for a complete discussion of the risks associated
with Vazculep™.
For additional information, please call Éclat Pharmaceuticals at 1-844-827-5007 or visit
www.vazculep.com.
Sincerely,
Heather R. Kruchowski
Director, Quality Operations
Enclosures: Vazculep™ Full Prescribing Information
Alert stickers