FDA records indicate that there are no current recalls for this drug.
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Questions & Answers
Side Effects & Adverse Reactions
NOT FOR INJECTION.
Ofloxacin ophthalmic solution should not be injected subconjunctivally, nor should it be introduced directly into the anterior chamber of the eye.
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions, some following the first dose, have been reported in patients receiving systemic quinolones, including ofloxacin. Some reactions were accompanied by cardiovascular collapse, loss of consciousness, angioedema (including laryngeal, pharyngeal or facial edema), airway obstruction, dyspnea, urticaria, and itching. A rare occurrence of Stevens-Johnson syndrome, which progressed to toxic epidermal necrolysis, has been reported in a patient who was receiving topical ophthalmic ofloxacin. If an allergic reaction to ofloxacin occurs, discontinue the drug. Serious acute hypersensitivity reactions may require immediate emergency treatment. Oxygen and airway management, including intubation should be administered as clinically indicated.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Ofloxacin ophthalmic solution is indicated for the treatment of infections caused by susceptible strains of the following bacteria in the conditions listed below:
CONJUNCTIVITIS:
Gram-positive bacteria: | Gram-negative bacteria: |
Staphylococcus aureus | Enterobacter cloacae |
Staphylococcus epidermidis | Haemophilus influenzae |
Streptococcus pneumoniae | Proteus mirabilis Pseudomonas aeruginosa |
CORNEAL ULCERS:
*Efficacy for this organism was studied in fewer than 10 infections | ||
Gram-positive bacteria: | Gram-negative bacteria: | Anaerobic species: |
Staphylococcus aureus | Pseudomonas aeruginosa | Propionibacterium acnes |
Staphylococcus epidermidis | Serratia marcescens* | |
Streptococcus pneumoniae |
History
There is currently no drug history available for this drug.
Other Information
Ofloxacin Ophthalmic Solution USP, 0.3% is a sterile ophthalmic solution. It is a fluorinated carboxyquinolone anti-infective for topical ophthalmic use.
Chemical Name: (±)-9-Fluoro-2, 3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido [1,2,3-de]-1,4 benzoxazine-6-carboxylic acid.
Contains: Active: ofloxacin 0.3% (3 mg/mL);
Preservative: benzalkonium chloride (0.005%);
Inactives: sodium chloride and water for injection. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH.
Ofloxacin Ophthalmic Solution USP, 0.3% is unbuffered and formulated with a pH of 6.4 (range - 6.0 to 6.8). It has an osmolality of 300 mOsm/kg. Ofloxacin is a fluorinated 4-quinolone which differs from other fluorinated 4-quinolones in that there is a six member (pyridobenzoxazine) ring from positions 1 to 8 of the basic ring structure.
Sources
Proparacaine Hydrochloride Solution/ Drops Manufacturers
- Henry Schein Inc.
Proparacaine Hydrochloride Solution/ Drops | Henry Schein Inc.
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. - Mwi
Proparacaine Hydrochloride Solution/ Drops | Mwi
Deep anesthesia as in cataract extraction:
Instill 1 drop to the eye every 5 to 10 minutes for 5 to 7 doses.Removal of sutures:
Instill 1 or 2 drops to the eye 2 or 3 minutes before removal of stitches.Removal of foreign bodies:
Instill 1 or 2 drops to the eye prior to operating.Tonometry:
Instill 1 or 2 drops to the eye immediately before measurement. - Akorn, Inc.
Proparacaine Hydrochloride Solution/ Drops | Akorn, Inc.
Deep anesthesia as in cataract extraction:
Instill 1 drop to the eye every 5 to 10 minutes for 5 to 7 doses.Removal of sutures:
Instill 1 or 2 drops to the eye 2 or 3 minutes before removal of stitches.Removal of foreign bodies:
Instill 1 or 2 drops to the eye prior to operating.Tonometry:
Instill 1 or 2 drops to the eye immediately before measurement. - H.j. Harkins Company, Inc.
Proparacaine Hydrochloride Solution/ Drops | H.j. Harkins Company, Inc.
Deep anesthesia as in cataract extraction:
Instill 1 drop every 5 to 10 minutes for 5 to 7 doses.
Removal of sutures:
Instill 1 or 2 drops 2 or 3 minutes before removal of stitches.
Removal of foreign bodies:
Instill 1 or 2 drops prior to operating.
Tonometry:
Instill 1 or 2 drops immediately before measurement
FOR OPHTHALMIC USE ONLY
- A-s Medication Solutions Llc
Proparacaine Hydrochloride Solution/ Drops | A-s Medication Solutions Llc
Deep anesthesia as in cataract extraction:
Instill 1 drop to the eye every 5 to 10 minutes for 5 to 7 doses.Removal of sutures:
Instill 1 or 2 drops to the eye 2 or 3 minutes before removal of stitches.Removal of foreign bodies:
Instill 1 or 2 drops to the eye prior to operating.Tonometry:
Instill 1 or 2 drops to the eye immediately before measurement. - Bausch & Lomb Incorporated
Proparacaine Hydrochloride Solution/ Drops | Bluepoint Laboratories
Carefully consider the potential benefits and risks of diclofenac sodium delayed-release tablets and other treatment options before deciding to use diclofenac sodium delayed-release tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS).
After observing the response to initial therapy with diclofenac sodium delayed-release tablets, the dose and frequency should be adjusted to suit an individual patient’s needs.
For the relief of osteoarthritis, the recommended dosage is 100 to 150 mg/day in divided doses (50 mg b.i.d. or t.i.d., or 75 mg b.i.d.).
For the relief of rheumatoid arthritis, the recommended dosage is 150 to 200 mg/day in divided doses (50 mg t.i.d. or q.i.d., or 75 mg b.i.d.).
For the relief of ankylosing spondylitis, the recommended dosage is 100 to 125 mg/day, administered as 25 mg q.i.d., with an extra 25 mg dose at bedtime if necessary.
Different formulations of diclofenac (diclofenac sodium enteric-coated tablets; diclofenac sodium extended-release tablets; diclofenac potassium immediate-release tablets) are not necessarily bioequivalent even if the milligram strength is the same.
- Preferred Pharmaceuticals, Inc.
Proparacaine Hydrochloride Solution/ Drops | Preferred Pharmaceuticals, Inc.
Deep anesthesia as in cataract extraction:
Instill 1 drop every 5 to 10 minutes for 5 to 7 doses.
Removal of sutures:
Instill 1 or 2 drops 2 or 3 minutes before removal of stitches.
Removal of foreign bodies:
Instill 1 or 2 drops prior to operating.
Tonometry:
Instill 1 or 2 drops immediately before measurement
FOR OPHTHALMIC USE ONLY
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