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

NDC:50090-0598-0 10 mL in a BOTTLE, DROPPER

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

Trimethoprim sulfate and Polymyxin B sulfate

Label ImageLabel Image
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE
trimethoprim sulfate and polymyxin b sulfate solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-0598(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:50090-0598-0 1 BOTTLE, DROPPER in 1 CARTON contains a BOTTLE, DROPPER
1 10 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (50090-0598-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065006 12/17/1998
Labeler — A-S Medication Solutions (830016429)
Registrant — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-0598)

Revised: 11/2014 A-S Medication Solutions

Page 2 of 2 1 2

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.