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Besifloxacin: Drug information

Besifloxacin: Drug information
(For additional information see "Besifloxacin: Patient drug information" and see "Besifloxacin: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Besivance
Brand Names: Canada
  • Besivance
Pharmacologic Category
  • Antibiotic, Fluoroquinolone;
  • Antibiotic, Ophthalmic
Dosing: Adult
Bacterial conjunctivitis

Bacterial conjunctivitis: Ophthalmic: Instill 1 drop into affected eye(s) 3 times daily (4 to 12 hours apart) for 7 days.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling. However, dosage adjustment unlikely due to low systemic absorption.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Besifloxacin: Pediatric drug information")

Bacterial conjunctivitis

Bacterial conjunctivitis: Children and Adolescents: Ophthalmic: Instill 1 drop into affected eye(s) 3 times daily (4 to 12 hours apart) for 7 days

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely due to low systemic absorption.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely due to low systemic absorption.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency not always defined.

1% to 2%:

Central nervous system: Headache

Ophthalmic: Conjunctival erythema (2%), blurred vision, eye irritation, eye pain, eye pruritus

Contraindications

There are no contraindications listed in the manufacturer's labeling.

Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to besifloxacin, any component of the formulation, or other quinolones.

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity reactions: Severe hypersensitivity reactions, including anaphylaxis, have occurred with systemic quinolone therapy. The spectrum of these reactions can vary widely; reactions may present as typical allergic symptoms (eg, itching, urticaria, rash, edema) after a single dose, or may manifest as severe idiosyncratic dermatologic (eg, Stevens-Johnson, toxic epidermal necrolysis), vascular (eg, vasculitis), pulmonary (eg, pneumonitis), renal (eg, nephritis), hepatic (eg, hepatic failure or necrosis), and/or hematologic (eg, anemia, cytopenias) events, usually after multiple doses. Prompt discontinuation of drug should occur if skin rash or other symptoms arise.

• Superinfection: Prolonged use may result in fungal or bacterial superinfection. Discontinue use and initiate alternative therapy if superinfection occurs.

Special populations:

• Contact lens wearers: Contact lenses should not be worn during treatment of ophthalmic infections.

Dosage form specific issues:

• Ophthalmic solution: For topical ophthalmic use only. Do not inject ophthalmic solution subconjunctivally or introduce directly into the anterior chamber of the eye.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Suspension, Ophthalmic:

Besivance: 0.6% (5 mL) [contains benzalkonium chloride, edetate (edta) disodium dihydrate]

Generic Equivalent Available: US

No

Pricing: US

Suspension (Besivance Ophthalmic)

0.6% (per mL): $54.39

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Suspension, Ophthalmic:

Besivance: 0.6% (2 mL, 5 mL) [contains benzalkonium chloride, edetate (edta) disodium dihydrate]

Administration: Adult

Ophthalmic: For topical ophthalmic use only. Wash hands before and after instillation. Invert bottle while closed and shake once prior to each administration. Avoid contaminating the applicator tip with affected eye(s), fingers, or other sources.

Administration: Pediatric

Ophthalmic: For topical ophthalmic use only. Wash hands before and after instillation. Invert bottle while closed and shake bottle once prior to each administration. Avoid contaminating the applicator tip with affected eye(s), fingers, or other sources.

Use: Labeled Indications

Bacterial conjunctivitis: Treatment of bacterial conjunctivitis caused by susceptible isolates of the following bacteria: Aerococcus viridans, CDC coryneform group G, Haemophilus influenzae, Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus mitis group, Streptococcus oralis, Streptococcus pneumoniae, Corynebacterium pseudodiphtheriticum, Corynebacterium striatum, Moraxella lacunata, Moraxella catarrhalis, Pseudomonas aeruginosa, Staphylococcus hominis, Staphylococcus lugdunensis, Staphylococcus warneri, Streptococcus salivarius.

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

Systemic concentrations of besifloxacin following ophthalmic administration are low. If ophthalmic agents are needed during pregnancy, the minimum effective dose should be used in combination with punctal occlusion for 3 to 5 minutes after application to decrease potential exposure to the fetus (Samples 1988).

Breastfeeding Considerations

It is not known if besifloxacin is present in breast milk. According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.

Mechanism of Action

Inhibits both DNA gyrase and topoisomerase IV. DNA gyrase is an essential bacterial enzyme required for DNA replication, transcription, and repair. Topoisomerase IV is an essential bacterial enzyme required for decatenation during cell division. Inhibition effect is bactericidal.

Pharmacokinetics (Adult Data Unless Noted)

Half-life elimination: ~7 hours

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Besivance;
  • (AR) Argentina: Besivance;
  • (BD) Bangladesh: Besibac | Besiflox | Besiven | Florobex;
  • (BR) Brazil: Besivance;
  • (CO) Colombia: Besivance;
  • (GB) United Kingdom: Besivance;
  • (IN) India: Basi | Besibact | Besitop | Besivance;
  • (KR) Korea, Republic of: Besivance;
  • (LB) Lebanon: Besivance;
  • (MX) Mexico: Besivance;
  • (MY) Malaysia: Besivance;
  • (PH) Philippines: Besivance;
  • (QA) Qatar: Besivance;
  • (SG) Singapore: Besivance;
  • (TH) Thailand: Besivance;
  • (TR) Turkey: Besivance;
  • (TW) Taiwan: Besivance;
  • (ZA) South Africa: Besivance
  1. Besivance (besifloxacin) [prescribing information]. Tampa, FL: Bausch & Lomb Inc; February 2022.
  2. Besivance (besifloxacin) [product monograph]. Laval, QC, Canada: Valent Canada; February 2018.
  3. Cambau E, Matrat S, Pan XS, et al, “Target Specificity of the New Fluoroquinolone Besifloxacin in Streptococcus pneumoniae, Staphylococcus aureus and Escherichia coli,” J Antimicrob Chemother, 2009, 63(3):443-50. [PubMed 19147516]
  4. Karpecki P, DePaolis M, Hunter JA, et al, “Besifloxacin Ophthalmic Suspension 0.6% in Patients With Bacterial Conjunctivitis: A Multicenter, Prospective, Randomized, Double-Masked, Vehicle-Controlled, 5-Day Efficacy and Safety Study,” Clin Ther, 2009, 31(3):514-26. [PubMed 19393842]
  5. Samples JR, Meyer SM. Use of ophthalmic medications in pregnant and nursing women. Am J Ophthalmol. 1988;106(5):616-623. [PubMed 2903673]
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