Ofloxacin: Package Insert and Label Information (Page 2 of 2)
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 received.
Refer to WARNINGS for additional adverse reactions.
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.|
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].
Lake Forest, IL 60045
LX00N Rev. 11/16
| OFLOXACIN |
ofloxacin solution/ drops
|Labeler — NuCare Pharmaceuticals, Inc. (010632300)|
|NuCare Pharmaceuticals. Inc.||010632300||relabel (68071-1607)|
Revised: 02/2021 NuCare Pharmaceuticals, Inc.
DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.