Iquix

Iquix

Iquix Recall

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Questions & Answers

Side Effects & Adverse Reactions

NOT FOR INJECTION.

IQUIX® solution should not be injected subconjunctivally, nor should it be introduced directly into the anterior chamber of the eye.

In patients receiving systemic quinolones, serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported, some following the first dose. 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 levofloxacin occurs, discontinue the drug. Serious acute hypersensitivity reactions may require immediate emergency treatment. Oxygen and airway management 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

IQUIX® solution is indicated for the treatment of corneal ulcer caused by susceptible strains of the following bacteria:

GRAM-POSITIVE BACTERIA: GRAM-NEGATIVE BACTERIA:
*
Efficacy for this organism was studied in fewer than 10 infections.
Corynebacterium species * Pseudomonas aeruginosa
Staphylococcus aureus Serratia marcescens*
Staphylococcus epidermidis
Streptococcus pneumoniae
Viridans group streptococci*

History

There is currently no drug history available for this drug.

Other Information

IQUIX® (levofloxacin ophthalmic solution) 1.5% is a sterile topical ophthalmic solution. Levofloxacin is a fluoroquinolone antibacterial active against a broad spectrum of Gram-positive and Gram-negative ocular pathogens. Levofloxacin is a fluorinated 4-quinolone containing a six-member (pyridobenzoxazine) ring from positions 1 to 8 of the basic ring structure. Levofloxacin is the pure(-)-(S)-enantiomer of the racemic drug substance, ofloxacin. It is more soluble in water at neutral pH than ofloxacin.

Chemical Structure

Chemical Name: (-)(S)-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 hemihydrate.

Levofloxacin (hemihydrate) is a yellowish-white crystalline powder.

Each mL of IQUIX® contains 15.36 mg of levofloxacin hemihydrate equivalent to 15 mg levofloxacin.

Contains

Active: Levofloxacin 1.5% (15 mg/mL); Inactives: glycerin and water. May also contain hydrochloric acid and/or sodium hydroxide to adjust pH to approximately 6.5. IQUIX® solution is isotonic with an osmolality of approximately 290 mOsm/kg.

Iquix Manufacturers


  • Vistakon Pharmaceuticals Llc
    Iquix (Levofloxacin) Solution [Vistakon Pharmaceuticals Llc]

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