Pulmozyme

Pulmozyme

Pulmozyme Recall

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Questions & Answers

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

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

Besivance® (besifloxacin ophthalmic suspension) 0.6%, is indicated for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following bacteria:

Aerococcus viridans*

CDC coryneform group G

Corynebacterium pseudodiphtheriticum*

Corynebacterium striatum*

Haemophilus influenzae

Moraxella catarrhalis*

Moraxella lacunata*

Pseudomonas aeruginosa

Staphylococcus aureus

Staphylococcus epidermidis

Staphylococcus hominis*

Staphylococcus lugdunensis*

Staphylococcus warneri*

Streptococcus mitis group

Streptococcus oralis

Streptococcus pneumoniae

Streptococcus salivarius*

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

History

There is currently no drug history available for this drug.

Other Information

Besivance (besifloxacin ophthalmic suspension) 0.6%, is a sterile ophthalmic suspension of besifloxacin formulated with DuraSite®* (polycarbophil, edetate disodium dihydrate and sodium chloride). Each mL of Besivance contains 6.63 mg besifloxacin hydrochloride equivalent to 6 mg besifloxacin base. It is an 8-chloro fluoroquinolone anti-infective for topical ophthalmic use.

Besifloxacin hydrochloride structural formula

C19H21ClFN3O3•HCl

Mol Wt 430.30

Chemical Name:(+)-7-[(3R)-3-aminohexahydro-1H-azepin-1-yl]-8-chloro-1- cyclopropyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid hydrochloride.

Besifloxacin hydrochloride is a white to pale yellowish-white powder.

Each mL Contains:

Active: besifloxacin 0.6% (6 mg/mL);

Preservative: benzalkonium chloride 0.01%

Inactives: polycarbophil, mannitol, poloxamer 407, sodium chloride, edetate disodium dihydrate, sodium hydroxide and water for injection.

Besivance is an isotonic suspension with an osmolality of approximately 290 mOsm/kg.

Pulmozyme Manufacturers


  • Genentech, Inc.
    Pulmozyme (Dornase Alfa) Solution [Genentech, Inc.]

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