Besivance

Besivance is an FDA-registered drug product whose active ingredient is BESIFLOXACIN. It is labelled by Sportpharm LLC taken by ophthalmic and marketed as a human prescription drug product. Identifiers on file: NDC 85766-260, application NDA022308, label effective 20260728. It is one of 2 FDA drug label records sharing the active ingredient BESIFLOXACIN. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing BESIFLOXACIN are most often described in connection with: besifloxacin ophthalmic, treatment bacterial, conjunctivitis caused, susceptible isolates, following bacteria, aerococcus viridans, cdc coryneform, group corynebacterium. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

1 INDICATIONS AND USAGE 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. Besifloxacin ophthalmic suspension 0.6% is a quinolone antimicrobial 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. ( 1 )

2 DOSAGE AND ADMINISTRATION Invert closed bottle and shake once before use. Instill one drop in the affected eye(s) 3 times a day, 4 to 12 hours apart for 7 days. Instill one drop in the affected eye(s) 3 times a day, 4 to 12 hours apart for 7 days. ( 2 )

4 CONTRAINDICATIONS None. None. ( 4 )

6 ADVERSE REACTIONS Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The data described below reflect exposure to besifloxacin ophthalmic suspension in approximately 1,000 patients between 1 and 98 years old with clinical signs and symptoms of bacterial conjunctivitis. The most frequently reported ocular adverse reaction was conjunctival redness, reported in approximately 2% of patients. Other adverse reactions reported in patients receiving besifloxacin ophthalmic suspension occurring in approximately 1-2% of patients included: blurred vision, eye pain, eye irritation, eye pruritus and headache. The most common adverse reaction reported in 2% of patients treated with besifloxacin ophthalmic suspension was conjunctival redness. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

FDA lists 2 drug label records with BESIFLOXACIN as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

What is Besivance used for?
1 INDICATIONS AND USAGE 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 …

Who makes Besivance?
Sportpharm LLC is the labeler of record for Besivance. 2 FDA label records share the active ingredient BESIFLOXACIN, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Besivance come in?
administered by ophthalmic. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Besivance prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing BESIFLOXACIN?
Yes. 2 FDA drug label records list BESIFLOXACIN as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Besivance been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.