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.
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.
Safety and effectiveness in pediatric patients below the age of 2 months have not been established (see WARNINGS).
No overall differences in safety or effectiveness have been observed between elderly and other adult patients.
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.
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.
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.
Store at 15°-25°C (59°-77°F). PROTECT FROM LIGHT.
RETAIN IN CARTON UNTIL TIME OF USE.
Bausch & Lomb Incorporated
Tampa, Florida 33637
©Bausch & Lomb Incorporated
Revised August 2007
| POLYMYXIN B SULFATE AND TRIMETHOPRIM |
polymyxin b sulfate and trimethoprim sulfate solution/ drops
|Labeler — Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC (831276758)|
|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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