Ofloxacin Solution

Ofloxacin Solution

Ofloxacin Solution Recall

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Questions & Answers

Side Effects & Adverse Reactions

NOT FOR OPHTHALMIC USE.

NOT FOR INJECTION.

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. If an allergic reaction to ofloxacin is suspected, stop 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 otic solution 0.3% is indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in the specific conditions listed below

Otitis Externa in adults and pediatric patients, 6 months and older, due to Escherichia coli, Pseudomonas aeruginosa and Staphylococcus aureus.
Chronic Suppurative Otitis Media in patients 12 years and older with perforated tympanic membranes due to Proteus mirabilis, Pseudomonas aeruginosa and Staphylococcus aureus.
Acute Otitis Media in pediatric patients one year and older with tympanostomy tubes due to Haemophilus influenzae, Moraxella catarrhalis, Pseudomonas aeruginosa, Staphylococcus aureus and Streptococcus pneumoniae.

History

There is currently no drug history available for this drug.

Other Information

Ofloxacin Otic Solution 0.3% is a sterile aqueous anti-infective (anti-bacterial) solution for otic use. Chemically, ofloxacin has three condensed 6-membered rings made up of a fluorinated carboxyquinolone with a benzoxazine ring. The chemical name of ofloxacin is: (±)-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. The empirical formula of ofloxacin is C18H20FN3O4 and its molecular weight is 361.38. The structural formula is:

Structural Formula

Ofloxacin otic solution contains 0.3% (3mg/mL) ofloxacin with benzalkonium chloride (0.0025%), sodium chloride (0.9%), and purified water, USP. Hydrochloric acid and/or sodium hydroxide may be added to adjust the pH 6.5±0.5.

Ofloxacin Solution Manufacturers


  • Proficient Rx Lp
    Ofloxacin Solution [Proficient Rx Lp]
  • Direct Rx
    Ofloxacin Solution [Direct Rx]
  • Lake Erie Medical Dba Quality Care Products Llc
    Ofloxacin Solution [Lake Erie Medical Dba Quality Care Products Llc]
  • Rising Pharmaceuticals, Inc.
    Ofloxacin Solution [Rising Pharmaceuticals, Inc.]
  • Pack Pharmaceuticals, Llc
    Ofloxacin Solution [Pack Pharmaceuticals, Llc]
  • Pharmaforce, Inc.
    Ofloxacin Solution [Pharmaforce, Inc.]
  • Falcon Pharmaceuticals, Ltd.
    Ofloxacin Solution [Falcon Pharmaceuticals, Ltd.]
  • Falcon Pharmaceuticals, Ltd.
    Ofloxacin Solution [Falcon Pharmaceuticals, Ltd.]
  • H.j. Harkins Company, Inc.
    Ofloxacin Solution [H.j. Harkins Company, Inc.]
  • Rebel Distributors Corp
    Ofloxacin Solution [Rebel Distributors Corp]
  • Bausch & Lomb Incorporated
    Ofloxacin Solution [Bausch & Lomb Incorporated]
  • Remedyrepack Inc.
    Ofloxacin Solution [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Ofloxacin Solution [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Ofloxacin Solution [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Ofloxacin Solution [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Ofloxacin Solution [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Ofloxacin Solution [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Ofloxacin Solution [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Ofloxacin Solution [Remedyrepack Inc. ]
  • Remedyrepack Inc.
    Ofloxacin Solution [Remedyrepack Inc. ]
  • Clinical Solutions Wholesale
    Ofloxacin Solution [Clinical Solutions Wholesale]
  • Aidarex Pharmaceuticals Llc
    Ofloxacin Solution [Aidarex Pharmaceuticals Llc]

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