Trimethoprim Sulfate and Polymyxin B Sulfate (Page 2 of 2)
ADVERSE REACTIONS
The most frequent adverse reaction to Trimethoprim Sulfate and Polymxin B Sulfate 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
Adults: 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.
Pediatric Use: Clinical studies have shown Trimethoprim and Polymyxin B Sulfate Ophthalmic Solution to be safe and effective for use in pediatric patients over two months of age. The dosage regimen is the same as for adults.
HOW SUPPLIED
Trimethoprim Sulfate and Polymyxin B Sulfate Ophthalmic Solution is supplied as a sterile solution in plastic dropper bottles in the following size: 10 mL in a 10 mL bottle NDC 63187-193-10
STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light.
WARNING – KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
Akorn
Manufactured by: Akorn, Inc.
Lake Forest, IL 60045
ATP00N
Rev. 10/08
Relabeled by: Proficient Rx LP
Thousand Oaks, CA 91320
Principal Display Panel Text for Container Label:
NDC 63187-193-10
Trimethoprim Sulfate
and Polymyxin B
Sulfate Ophthalmic
Solution
10 mL
For the eye
Sterile
Rx only [Akorn Logo]
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE trimethoprim sulfate and polymyxin b sulfate solution | |||||||||||||||||
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Labeler — Proficient Rx LP (079196022) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Proficient Rx LP | 079196022 | REPACK (63187-193), RELABEL (63187-193) |
Revised: 01/2021 Proficient Rx LP
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