Medi-first Sinus Decongestant

Medi-first Sinus Decongestant

Medi-first Sinus Decongestant Recall

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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:

Gram-positive bacteria:
Gram-negative bacteria:
     Staphylococcus aureus
     Pseudomonas aeruginosa
     Staphylococcus epidermidis
     Serratia marcescens*
     Streptococcus pneumoniae
Anaerobic species:

     Propionibacterium acnes

* Efficacy for this organism was studied in fewer than 10 infections

History

There is currently no drug history available for this drug.

Other Information

Ofloxacin ophthalmic solution 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 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.

Structure

Image

Medi-first Sinus Decongestant Manufacturers


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