POLYMYXIN B (Page 2 of 2)

ADVERSE REACTIONS

See WARNING box.

Nephrotoxic reactions: Albuminuria, cylinduria, azotemia, and rising blood levels without any increase in dosage.

Neurotoxic reactions: Facial flushing, dizziness progressing to ataxia, drowsiness, peripheral paresthesias (circumoral and stocking glove), apnea due to concurrent use of curariform muscle relaxants, other neurotoxic drugs or inadvertent overdosage, and signs of meningeal irritation with intrathecal administration, e.g., fever, headache, stiff neck and increased cell count and protein cerebrospinal fluid.

Other reactions occasionally reported: Drug fever, urticarial rash, pain (severe) at intramuscular injection sites, and thrombophlebitis at intravenous injection sites.

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DOSAGE AND ADMINISTRATION

PARENTERAL:

Intravenous. Dissolve 500,000 polymyxin B units in 300 to 500 mL solutions for parenteral 5% Dextrose Injection for continuous drip.

Adults and children. 15,000 to 25,000 units/kg body weight/day in individuals with normal kidney function. This amount should be reduced from 15,000 units/kg downward for individuals with kidney impairment. Infusions may be given every 12 hours; however, the total daily dose must not exceed 25,000 units/kg/day.

Infants. Infants with normal kidney function may receive up to 40,000 units/kg/day without adverse effects.

Intramuscular. Not recommended routinely because of severe pain at injection sites, particularly in infants and children. Dissolve 500,000 Polymyxin B units in 2 mL sterile water for injection or sodium chloride injection or procaine hydrochloride injection 1%.

Adults and children. 25,000 to 30,000 units/kg/day. This should be reduced in the presence of renal impairment. The dosage may be divided and given at either 4 or 6 hour intervals.

Infants. Infants with normal kidney function may receive up to 40,000 units/kg/day without adverse effects.

Note: Doses as high as 45,000 units/kg/day have been used in limited clinical studies in treating prematures and newborn infants for sepsis caused by P. aeruginosa.

Intrathecal . A treatment of choice for P. aeruginosa meningitis.

Dissolve 500,000 polymyxin B units in 10 mL sodium chloride injection, USP for 50,000 units per mL dosage unit.

Adults and children over 2 years of age.

Dosage is 50,000 units once daily intrathecally for 3 to 4 days, then 50,000 units once every other day for at least 2 weeks after cultures of the cerebrospinal fluid are negative and sugar content has returned to normal.

Children under 2 years of age. 20,000 units once daily, intrathecally for 3 to 4 days or 25,000 units once every other day. Continue with a dose of 25,000 units once every other day for at least 2 weeks after cultures of the cerebrospinal fluid are negative and sugar content has returned to normal.

IN THE INTEREST OF SAFETY, SOLUTIONS OF PARENTERAL USE SHOULD BE STORED UNDER REFRIGERATION, AND ANY UNUSED PORTIONS SHOULD BE DISCARDED AFTER 72 HOURS.

TOPICAL:

Ophthalmic. Dissolve 500,000 polymyxin B units in 20 to 50 mL sterile water for injection or sodium chloride injection USP for a 10,000 to 25,000 units per mL concentration.

For the treatment of P. aeruginosa infections of the eye, a concentration of 0.1 percent to 0.25 percent (10,000 units to 25,000 units per mL) is administered 1 to 3 drops every hour, increasing the intervals as response indicates.

Subconjunctival injection of up to 100,000 units/day may be used for the treatment of P. aeruginosa infections of the cornea and conjunctiva.

Note: Avoid total systemic and ophthalmic instillation over 25,000 units/kg/day.

HOW SUPPLIED

Polymyxin B for injection, USP, 500,000 polymyxin B units per vial is supplied as follows.

Product
Code
Unit of Sale Strength Each
PRX320110 NDC 63323-321-12
Unit of 10
500,000 units per vial NDC 63323-321-02

Storage recommendations:

Before reconstitution: Store at 20° to 25° C (68° to 77° F) (See USP controlled Room Temperature)

Protect from light. Retain in carton until time of use.

After reconstitution: Product must be stored under refrigeration, between 2° to 8°C (36° to 46°F) and any unused portion should be discarded after 72 hours.

This container closure is not made with natural rubber latex.

PREMIERProRx® is a registered trademark of Premier Healthcare Alliance, L.P., used under license.

Manufactured by:
Fresenius Kabi
Lake Zurich, IL 60047

www.fresenius-kabi.com/us
451688
Issued: February 2021

Fresenius Kabi Logo

PRINCIPAL DISPLAY PANEL – VIAL LABEL

NDC 63323-321-02 PRX320110

Polymyxin B
for injection, USP
500,000 units per vial

Each vial contains Polymyxin B
Sulfate equivalent to 500,000
polymyxin B units.

Sterile
Lyophilized Rx only

PRINCIPAL DISPLAY PANEL – VIAL LABEL
(click image for full-size original)

PRINCIPAL DISPLAY PANEL – Vial Tray

NDC 63323-321-12 PRX320110

Polymyxin B
for injection, USP
500,000 units per vial

Each vial contains Polymyxin B Sulfate equivalent
to 500,000 polymyxin B units.

Sterile
Lyophilized
Rx only 10 Sterile Vials

PRINCIPAL DISPLAY PANEL – Vial Tray
(click image for full-size original)
POLYMYXIN B
polymyxin b sulfate injection, powder, lyophilized, for solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63323-321
Route of Administration INTRAVENOUS, INTRAMUSCULAR, INTRATHECAL, OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B 500000 [USP’U]
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63323-321-12 10 VIAL in 1 TRAY contains a VIAL (63323-321-02)
1 NDC:63323-321-02 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL This package is contained within the TRAY (63323-321-12)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065372 11/17/2009
Labeler — Fresenius Kabi USA, LLC (608775388)
Establishment
Name Address ID/FEI Operations
Fresenius Kabi USA, LLC 023648251 MANUFACTURE (63323-321), ANALYSIS (63323-321)

Revised: 05/2021 Fresenius Kabi USA, LLC

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