Polymyxin B Sulfate and Trimethoprim (Page 2 of 2)

Nonteratogenic effects

The oral administration of trimethoprim to rats at a dose of 70 mg/kg/day commencing with the last third of gestation and continuing through parturition and lactation caused no deleterious effects on gestation or pup growth and survival.

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 polymyxin B sulfate and trimethoprim ophthalmic solution is administered to a nursing woman.

Pediatric use

Safety and effectiveness in pediatric patients below the age of 2 months have not been established (see WARNINGS).

Geriatric use

No overall differences in safety or effectiveness have been observed between elderly and other adult patients.

ADVERSE REACTIONS

The most frequent adverse reaction to polymyxin B sulfate and trimethoprim ophthalmic solution is local irritation consisting of increased redness, burning, stinging, and/or itching. This may occur on instillation, within 48 hours, or at any time with extended use. There are also multiple reports of hypersensitivity reactions consisting of lid edema, itching, increased redness, tearing, and/or circumocular rash. Photosensitivity has been reported in patients taking oral trimethoprim.

DOSAGE AND ADMINISTRATION

In mild to moderate infections, instill one drop in the affected eye(s) every three hours (maximum of 6 doses per day) for a period of 7 to 10 days.

HOW SUPPLIED

Polymyxin B Sulfate and Trimethoprim Ophthalmic Solution USP*, containing 10,000 polymyxin B units and 1 mg trimethoprim per mL, is supplied in a plastic bottle with a controlled drop tip in the following size:

10 mL — Prod. No. 31509

DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT.

*Does not meet USP packaging specification for light resistance.

STORAGE

Store at 15°-25°C (59°-77°F). PROTECT FROM LIGHT.

RETAIN IN CARTON UNTIL TIME OF USE.

Rx Only

MANUFACTURER INFORMATION

Bausch & Lomb Incorporated
Tampa, Florida 33637

©Bausch & Lomb Incorporated

Revised August 2007

9117800 (Folded)
9117900 (Flat)

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POLYMYXIN B SULFATE AND TRIMETHOPRIM
polymyxin b sulfate and trimethoprim sulfate solution/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49999-378(NDC:24208-315)
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POLYMYXIN B SULFATE (POLYMYXIN B) POLYMYXIN B 10000 [USP'U] in 1 mL
TRIMETHOPRIM SULFATE (TRIMETHOPRIM) TRIMETHOPRIM 1 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE
WATER
SODIUM CHLORIDE
SODIUM HYDROXIDE
SULFURIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49999-378-10 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
1 10 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (49999-378-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA064120 03/20/2012
Labeler — Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC (831276758)
Establishment
Name Address ID/FEI Operations
Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC 831276758 relabel

Revised: 06/2012 Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC

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