Proparacaine Hydrochloride Solution/ Drops

Proparacaine Hydrochloride Solution/ Drops

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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 aureusEnterobacter cloacae
Staphylococcus epidermidisHaemophilus influenzae
Streptococcus pneumoniaeProteus 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 aureusPseudomonas aeruginosaPropionibacterium acnes
Staphylococcus epidermidisSerratia 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.

structural formula

Proparacaine Hydrochloride Solution/ Drops Manufacturers


  • Henry Schein Inc.
    Proparacaine Hydrochloride Solution/ Drops [Henry Schein Inc.]
  • Mwi
    Proparacaine Hydrochloride Solution/ Drops [Mwi]
  • Akorn, Inc.
    Proparacaine Hydrochloride Solution/ Drops [Akorn, Inc.]
  • H.j. Harkins Company, Inc.
    Proparacaine Hydrochloride Solution/ Drops [H.j. Harkins Company, Inc.]
  • A-s Medication Solutions Llc
    Proparacaine Hydrochloride Solution/ Drops [A-s Medication Solutions Llc]
  • Bausch & Lomb Incorporated
    Proparacaine Hydrochloride Solution/ Drops [Bausch & Lomb Incorporated]
  • Preferred Pharmaceuticals, Inc.
    Proparacaine Hydrochloride Solution/ Drops [Preferred Pharmaceuticals, Inc.]

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