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]

63187-193-10
(click image for full-size original)
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE
trimethoprim sulfate and polymyxin b sulfate solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63187-193(NDC:17478-703)
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Trimethoprim sulfate (Trimethoprim) Trimethoprim 1 mg in 1 mL
Polymyxin B sulfate (Polymyxin B) Polymyxin B 10000 [USP’U] in 1 mL
Inactive Ingredients
Ingredient Name Strength
benzalkonium chloride
sodium chloride
sulfuric acid
sodium hydroxide
water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63187-193-10 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
1 10 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (63187-193-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065006 12/17/1998
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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