Ofloxacin (Page 3 of 3)

ADVERSE REACTIONS

Ophthalmic Use: The most frequently reported drug-related adverse reaction was transient ocular burning or discomfort. Other reported reactions include stinging, redness, itching, chemical conjunctivitis/keratitis, ocular/periocular/facial edema, foreign body sensation, photophobia, blurred vision, tearing, dryness, and eye pain. Rare reports of dizziness and nausea have been reported.

To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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 throughtreatment completion Instill one to two drops, four times daily.

HOW SUPPLIED

Ofloxacin Ophthalmic Solution 0.3% is supplied sterile in a labeled translucent LDPE bottle with insert cap assembly comprising of tan colored HDPE screw cap over a LDPE nozzle with tamper-evident LDPE dust cover sealing the bottle cap.

5 mL in 5 mL bottle NDC 55545-1003-1

10 mL in 10 mL bottle NDC 55545-1003-2

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

Rx Only

Manufactured by:

FDC Limited,

B-8, MIDC Industrial Area,

Waluj, Aurangabad — 431 136,

Maharashtra, India

Manufactured for:

Rising Pharmaceuticals, Inc Allendale, NJ 07401

Issued: 11/2017

INSTRUCTIONS FOR USE

Please follow these instructions carefully when using Ofloxacin Ophthalmic Solution.

Use Ofloxacin ophthalmic solution as prescribed by your doctor.

1. If you use other topically applied ophthalmic medications, they should be administered at least 10 minutes before or after the use of Ofloxacin ophthalmic solution.

2. Wash hands before each use.

3. Before using the medication for the first time, be sure the dust cover seal is unbroken.

4. Refer (I-VI)

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5. OPHTHALMIC MEDICATIONS, IF HANDLED IMPROPERLY, CAN BECOME CONTAMINATED BY COMMON BACTERIA KNOWN TO CAUSE EYE INFECTIONS. SERIOUS DAMAGE TO THE EYE AND SUBSEQUENT LOSS OF VISION MAY RESULT FROM USING CONTAMINATED OPHTHALMIC MEDICATIONS. IF YOU THINK YOUR MEDICATION MAY BE CONTAMINATED, OR IF YOU DEVELOP AN EYE INFECTION, CONTACT YOUR DOCTOR IMMEDIATELY CONCERNING CONTINUED USE OF THIS BOTTLE.

6. Repeat (V) and (VI) with the other eye if instructed to do by your doctor.

7. The insert tip is designed to provide a premeasured drop; therefore, do NOT enlarge the hole of the insert tip.

8. After you have used all doses, there will be some Ofloxacin Ophthalmic Solution left in the bottle. You should not be concerned since an extra amount of Ofloxacin Ophthalmic Solution has been added and you will get the full amount of Ofloxacin Ophthalmic Solution that your doctor prescribed. Do not attempt to remove excess medicine from the bottle.

WARNING: KEEP OUT OF REACH OF CHILDREN.

IF YOU HAVE ANY QUESTIONS ABOUT THE USE OF OFLOXACIN OPHTHALMIC SOLUTION, PLEASE CONSULT YOUR DOCTOR.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Ofloxacin Ophthalmic Solution 0.3% 5 mL Container

FDC Limited NDC 55545-1003-1

Ofloxacin Ophthalmic Solution 0.3% 10 mL Container

FDC Limited NDC 55545-1003-2

Ophthalmic Solution USP

Rx Only 0.3%

Active: Ofloxacin USP 0.3%

Preservative: Benzalkonium Chloride (0.005%)

Usual Dosage: See package insert.

FOR TOPICAL OPHTHALMIC USE ONLY

Retain in carton until contents are used. Protect from light.

Carton
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OFLOXACIN ofloxacin solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55545-1003
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
BENZALKONIUM CHLORIDE 0.05 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55545-1003-2 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
1 10 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (55545-1003-2)
2 NDC:55545-1003-1 1 BOTTLE, PLASTIC in 1 CARTON contains a BOTTLE, PLASTIC
2 5 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (55545-1003-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078559 12/15/2014
Labeler — FDC Limited (650441301)
Registrant — FDC Limited (650078413)
Establishment
Name Address ID/FEI Operations
FDC Limited 862267994 analysis (55545-1003), manufacture (55545-1003)

Revised: 11/2017 FDC Limited

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