Besivance 6 mg/mL
Besifloxacin · SUSPENSION · Bausch & Lomb Incorporated
Besivance is a suspension containing besifloxacin at 6 mg/mL, taken ophthalmic. Manufactured by Bausch & Lomb Incorporated.
Key Facts
- Brand Name
- Besivance
- Generic Name
- Besifloxacin
- NDC Code (Product)
24208-446- Manufacturer
- Bausch & Lomb Incorporated
- Strength
- 6 mg/mL
- Dosage Form
- SUSPENSION
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- NDA022308
- Drug Class
- Quinolone Antimicrobial [EPC]
- Marketing Start
- 05/28/2009
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE 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. BESIVANCE ® (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*, Staphy…
Dosage & Administration
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 )
Contraindications
4 CONTRAINDICATIONS None. None. ( 4 )
Adverse Reactions
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 BESIVANCE 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 BESIVANCE 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 BESIVANCE 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 .
Frequently Asked Questions
What is Besivance used for?
Besivance contains Besifloxacin. It is a suspension taken ophthalmic. Consult your doctor for specific uses.
Is Besivance a controlled substance?
Besivance is not classified as a controlled substance by the DEA.
What is the generic name for Besivance?
The generic name for Besivance is Besifloxacin. There are no other listed brand versions of Besifloxacin.
What is the NDC code for Besivance 6 mg/mL?
The NDC (National Drug Code) for Besivance 6 mg/mL is 24208-446, listed by Bausch & Lomb Incorporated.
Other Besivance Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)