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.

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