Drug: Besivance

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. 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.

Source: http://www.rxlist.com

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in one clinical trial of a drug cannot be directly compared with the rates in the clinical trials of the same or another drug and may not reflect the rates observed in 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. Read the Besivance (besifloxacin ophthalmic suspension) Side Effects Center for a complete guide to possible side effectsLearn More »

Source: http://www.rxlist.com

Invert closed bottle and shake once before use. Instill one drop in the affected eye(s) 3 times a day, four to twelve hours apart for 7 days.

Source: http://www.rxlist.com

No information provided. Last reviewed on RxList: 10/26/2012
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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 lacunata*
Moraxella catarrhalis*
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.

Source: http://www.rxlist.com

None Last reviewed on RxList: 10/26/2012
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

No information provided.

Source: http://www.rxlist.com

Dosage Forms And Strengths 7.5 mL bottle filled with 5 mL of besifloxacin ophthalmic suspension, 0.6%. Storage And Handling Besivance® (besifloxacin) Ophthalmic Suspension 0.6%, is supplied as a sterile ophthalmic suspension in a white low density polyethylene (LDPE) bottle with a controlled dropper tip and tan polypropylene cap. Tamper evidence is provided with a shrink band around the cap and neck area of the package. 5 mL in 7.5 mL bottle NDC 24208-446-05 Storage Store at 15°- 25°C (59° - 77°F). Protect from Light. Invert closed bottle and shake once before use. Manufactured by: Bausch & Lomb Incorporated Tampa, Florida 33637. Revised: 9/2012 Last reviewed on RxList: 10/26/2012
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

Topical Ophthalmic Use Only NOT FOR INJECTION INTO THE EYE. Besivance® is for topical ophthalmic use only, and should not be injected subconjunctivally, nor should it be introduced directly into the anterior chamber of the eye. 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. 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®. Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals to determine the carcinogenic potential of besifloxacin have not been performed. No in vitro mutagenic activity of besifloxacin was observed in an Ames test (up to 3.33 mcg/plate) on bacterial tester strains Salmonella typhimurium TA98, TA100, TA1535, TA1537 and Escherichia coli WP2uvrA. However, it was mutagenic in S. typhimurium strain TA102 and E. coli strain WP2(pKM101). Positive responses in these strains have been observed with other quinolones and are likely related to topoisomerase inhibition. Besifloxacin induced chromosomal aberrations in CHO cells in vitro and it was positive in an in vivo mouse micronucleus assay at oral doses ≥ 1500 mg/kg. Besifloxacin did not induce unscheduled DNA synthesis in hepatocytes cultured from rats given the test compound up to 2,000 mg/ kg by the oral route. In a fertility and early embryonic development study in rats, besifloxacin did not impair the fertility of male or female rats at oral doses of up to 500 mg/kg/day. This is over 10,000 times higher than the recommended total daily human ophthalmic dose. Use In Specific Populations Pregnancy Pregnancy Category C Oral doses of besifloxacin up to 1000 mg/kg/day were not associated with visceral or skeletal malformations in rat pups in a study of embryo-fetal development, although this dose was associated with maternal toxicity (reduced body weight gain and food consumption) and maternal mortality. Increased post-implantation loss, decreased fetal body weights, and decreased fetal ossification were also observed. At this dose, the mean Cmax in the rat dams was approximately 20 mcg/mL, > 45,000 times the mean plasma concentrations measured in humans. The No Observed Adverse Effect Level (NOAEL) for this embryo-fetal development study was 100 mg/kg/day (Cmax, 5 mcg/mL, > 11,000 times the mean plasma concentrations measured in humans). In a prenatal and postnatal development study in rats, the NOAELs for both fetal and maternal toxicity were also 100 mg/kg/day. At 1000 mg/kg/day, the pups weighed significantly less than controls and had a reduced neonatal survival rate. Attainment of developmental landmarks and sexual maturation were delayed, although surviving pups from this dose group that were reared to maturity did not demonstrate deficits in behavior, including activity, learning and memory, and their reproductive capacity appeared normal. Since there are no adequate and well-controlled studies in pregnant women, Besivance® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nursing Mothers Besifloxacin has not been measured in human milk, although it can be presumed to be excreted in human milk. Caution should be exercised when Besivance® is administered to a nursing mother. Pediatric Use The safety and effectiveness of Besivance® in infants below one year of age have not been established. The efficacy of Besivance® in treating bacterial conjunctivitis in pediatric patients one year or older has been demonstrated in controlled clinical trials [see Clinical Studies]. There is no evidence that the ophthalmic administration of quinolones has any effect on weight bearing joints, even though systemic administration of some quinolones has been shown to cause arthropathy in immature animals. Geriatric Use No overall differences in safety and effectiveness have been observed between elderly and younger patients. Last reviewed on RxList: 10/26/2012
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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