Ofloxacin (Page 3 of 3)

DOSAGE AND ADMINISTRATION

The recommended dosage regimen for the treatment of bacterial conjunctivitis is:

Days 1 and 2 Instill one to two drops every two to four hours in the affected eye(s).
Days 3 through 7 Instill one to two drops four times daily.
The recommended dosage regimen for the treatment of bacterial corneal ulcer is:
Days 1 and 2 Instill one to two drops into the affected eye every 30 minutes, while awake.
Awaken at approximately four and six hours after retiring and instill one to two drops.
Days 3 through 7 to 9 Instill one to two drops hourly, while awake.
Days 7 to 9 through treatment completion Instill one to two drops, four times daily.

HOW SUPPLIED

Ofloxacin Ophthalmic Solution USP, 0.3% is supplied sterile in plastic dropper bottles of the following sizes:

  • 5 mL — NDC 68071-1607-5

STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

AKORN

Manufactured by: Akorn, Inc.
Lake Forest, IL 60045

LX00N Rev. 11/16

pdp
(click image for full-size original)

OFLOXACIN
ofloxacin solution/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68071-1607(NDC:17478-713)
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OFLOXACIN (OFLOXACIN) OFLOXACIN 3 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
HYDROCHLORIC ACID
SODIUM HYDROXIDE
WATER
BENZALKONIUM CHLORIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68071-1607-5 5 mL in 1 BOX None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076407 07/01/2008
Labeler — NuCare Pharmaceuticals, Inc. (010632300)
Establishment
Name Address ID/FEI Operations
NuCare Pharmaceuticals. Inc. 010632300 relabel (68071-1607)

Revised: 02/2021 NuCare Pharmaceuticals, Inc.

Page 3 of 3 1 2 3

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 © 2022. All Rights Reserved.