besivance
Besivance (Besifloxacin Hydrochloride) is a quinolone antimicrobial.
Besifloxacin Hydrochloride · by Bausch and Lomb
Key facts
- Active ingredient
- Besifloxacin Hydrochloride
- Drug class
- Quinolone Antimicrobial
- Form
- Suspension
- Strength
- Besifloxacin Hydrochloride EQ 0.6% Base
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Bausch and Lomb
- FDA application
- NDA022308
What is Besivance?
From the FDA label:BESIVANCE ® (besifloxacin ophthalmic suspension) 0.6% is a sterile ophthalmic suspension of besifloxacin formulated with DuraSite ® † (polycarbophil, edetate disodium dihydrate, sodium chloride, sodium hydroxide, and water for injection). 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. C 19 H 21 ClFN 3 O 3 •HCl Molecular Weight 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); Inactives: polycarbophil, mannitol, poloxamer 407, sodium chloride, edetate disodium dihydrate, sodium hydroxide, and water for injection. Preservative: benzalkonium chloride 0.01% BESIVANCE is an isotonic suspension with an osmolality of approximately 290 mOsm/kg. Besifloxacin hydrochloride structural formula
How to use
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 )
Side effects
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 .
Warnings
Important safety information
Not for Injection into the Eye ( Error! Hyperlink reference not valid. ) Growth of Resistant Organisms with Prolonged Use ( Error! Hyperlink reference not valid. ) Avoidance of Contact Lenses: Patients should not wear contact lenses if they have signs or symptoms of bacterial conjunctivitis or during the course of therapy with BESIVANCE. ( 5.3 ) 5.1 Not for Injection into the Eye 5.2 Growth of Resistant Organisms with Prolonged Use As with other anti-infectives, prolonged use of BESIVANCE (besifloxacin ophthalmic suspension) 0.6% may result in overgrowth of non-susceptible organisms, including fungi. If super-infection occurs, discontinue use and institute alternative therapy. Whenever clinical judgment dictates, the patient should be examined with the aid of magnification, such as slit-lamp biomicroscopy, and, where appropriate, fluorescein staining. 5.3 Avoidance of Contact Lenses Patients should not wear contact lenses if they have signs or symptoms of bacterial conjunctivitis or during the course of therapy with BESIVANCE.
Who should not take Besivance
None. None. ( 4 )
Foods & drinks to be careful with
Well-established interactions for this medicine’s drug class, summarized from public health authorities. General information, not medical advice — always confirm with your pharmacist or the label.
Dairy, calcium, iron & antacids
Watch out for: milk and other dairy, calcium- or iron-fortified foods and supplements, and antacids.
Calcium, magnesium, and iron bind to these antibiotics in the gut and can stop them from being absorbed, making the medicine work less well.
What to do: Separate the antibiotic from dairy, supplements, and antacids by a couple of hours — take it at the interval the label or your pharmacist specifies.
Source: Tetracycline — MedlinePlus (U.S. National Library of Medicine) · Ciprofloxacin (a fluoroquinolone) — MedlinePlus (U.S. National Library of Medicine)
Drug class
Dosage forms
Suspension
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- Is there a coupon or discount for Besivance?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Besivance. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Besivance?
- Besivance is marketed by Bausch and Lomb. You can see Bausch and Lomb's full profile, rating, and other products on pharmaranks.
- Is Besivance a brand-name or generic drug?
- Besivance is a brand-name product with the active ingredient Besifloxacin Hydrochloride.
- Is Besivance available over the counter?
- No. Besivance is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Besivance come in?
- Besivance is currently marketed as suspension, per the FDA's National Drug Code Directory.
- What class of drug is Besivance?
- Besivance is classified as quinolone antimicrobial, per the FDA's Established Pharmacologic Class.
- Is Besivance FDA-registered?
- Besivance is on record with the U.S. FDA under application number NDA022308. You can verify this on its official FDA label.
- Is Besivance safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Besivance. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Besivance?
- Besivance's side effects are taken directly from its FDA label. From the label: 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.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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