Proparacaine Hydrochloride Solution/ Drops

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Proparacaine Hydrochloride Solution/ Drops Recall

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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.

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Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

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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

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History

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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.

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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.

No Recall
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.

No Recall
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.

No Recall
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

No Recall
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.

No Recall
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.

No Recall
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

No Recall