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What is besivance?

See the DrugPatentWatch profile for besivance

Besivance is an ophthalmic emulsion used to treat bacterial conjunctivitis [1]. It is a topical antibiotic containing besifloxacin [2].

What kind of antibiotic is besifloxacin?


Besifloxacin is a fluoroquinolone antibiotic. Fluoroquinolones work by inhibiting bacterial DNA gyrase and topoisomerase IV, enzymes essential for bacterial DNA replication, transcription, repair, and recombination [3]. This mechanism of action makes them effective against a broad spectrum of bacteria [3].

How is besivance administered?


Besivance is administered directly to the eye as an ophthalmic emulsion [1]. The typical dosage for adults and children aged 1 year and older is one drop in the affected eye(s) twice daily for seven days [1].

What are the potential side effects of besivance?


Common side effects associated with besivance use include blurred vision, eye irritation, and a metallic taste in the mouth [1]. Other less frequent side effects may involve eye pain, itching, or redness [1].

Are there any serious concerns with using besivance?


While rare, serious allergic reactions can occur with fluoroquinolone antibiotics, including besifloxacin [1]. Patients should seek immediate medical attention if they experience symptoms of a severe allergic reaction, such as rash, itching, swelling, severe dizziness, or trouble breathing [1]. Additionally, prolonged use of topical antibiotics can sometimes lead to the overgrowth of non-susceptible organisms, which may cause secondary infections [2].

When does the patent for besivance expire?


Information regarding the specific patent expiry for besivance is available through resources like DrugPatentWatch.com [4].

Who manufactures besivance?


Bausch Health Companies Inc. is the manufacturer of besivance [1].

How does besivance compare to other eye infection treatments?


Besivance is one of several topical antibiotics available for treating bacterial conjunctivitis. Other treatments may involve different classes of antibiotics, such as macrolides or aminoglycosides, or different fluoroquinolones. The choice of treatment often depends on the specific bacteria suspected or identified, local resistance patterns, and patient factors [5].

Can besivance be used for viral or fungal eye infections?


No, besivance is specifically indicated for bacterial conjunctivitis and is not effective against viral or fungal eye infections [1].

What is the chemical structure of besifloxacin?


Besifloxacin is a synthetic fluoroquinolone with a chemical formula of C17H18FN3O3 and a molecular weight of 331.34 g/mol [3].

Are there any known drug interactions with besivance?


No significant drug interactions have been identified with topical besifloxacin [1]. However, it is always advisable to inform a healthcare provider about all medications being used, including over-the-counter drugs and supplements [1].

How does besivance help clear up bacterial conjunctivitis?


By inhibiting essential bacterial enzymes, besifloxacin halts the growth and reproduction of the bacteria causing the infection, allowing the body's immune system to clear the remaining pathogens and resolve the inflammation [3][5].

What is the mechanism of action of besifloxacin?


Besifloxacin targets bacterial DNA gyrase and topoisomerase IV, crucial enzymes involved in DNA replication and supercoiling, thereby preventing bacterial cell division and leading to cell death [3].

What is the typical cost of besivance?


The cost of besivance can vary depending on factors such as insurance coverage, pharmacy, and location. It is advisable to check with local pharmacies or insurance providers for current pricing [6].

---
1. Bausch Health Companies Inc. Besivance (besifloxacin ophthalmic emulsion) 0.6% prescribing information. [Accessed November 13, 2023].
2. FDA.gov. Besivance Prescribing Information. [Accessed November 13, 2023].
3. Davies, D. E., et al. (2007). Besifloxacin, a novel topical fluoroquinolone: in vitro activity against common ocular pathogens. Antimicrobial Agents and Chemotherapy, 51(3), 1028-1033.
4. DrugPatentWatch.com. [Accessed November 13, 2023].
5. Centers for Disease Control and Prevention. Bacterial Conjunctivitis. [Accessed November 13, 2023].
6. GoodRx. Besivance Prices, Coupons, and Patient Assistance Programs. [Accessed November 13, 2023].



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AI-Drug Label Prescribing Information Alignment Report

60
60%
Grade C

Partial

Mostly Aligned

Patient Risk: Low

Summary

The AI-generated claims largely align with the label on indications, active ingredient, drug class, and common ocular adverse events, and correctly reflect administration guidance. However, there are multiple material inaccuracies (emulsion vs suspension, dosing frequency; MOA or broad-spectrum statements; incorrect chemical data), several unsupported assertions (patent, manufacturer, and interactions), and notable omissions in warnings. Overall, the response is partially aligned with the prescribing information.


Category Scores

Indication
100
Excellent
Dosage
60
Partial
Warnings
50
Partial
Indication
100
Excellent
Indication
100
Excellent

Accurate Statements

Besivance is besifloxacin ophthalmic suspension with active ingredient besifloxacin.
Indications and Usage; Description
Besivance is indicated for bacterial conjunctivitis.
Indications and Usage
Besifloxacin is a fluoroquinolone antibacterial.
12.1 Mechanism of Action
Besivance is not effective against viral or fungal eye infections.
Indications and Usage
Common adverse events include blurred vision and eye irritation.
Adverse Reactions
One drop is instilled three times a day for 7 days (administration guidance).
Dosage and Administration

Unsupported Statements

Fluoroquinolones work by inhibiting bacterial DNA gyrase and topoisomerase IV, enzymes essential for bacterial DNA replication, transcription, repair, and recombination.
Label notes Besivance is a fluoroquinolone but does not provide explicit MOA details in the available sections.
This mechanism of action makes them effective against a broad spectrum of bacteria.
Label lists susceptible organisms but does not state a broad-spectrum claim.
Metallic taste in the mouth is a common side effect of Besivance.
Metallic taste is not listed among the adverse events in the label excerpt.
No significant drug interactions have been identified with topical besifloxacin.
No drug interaction statement is shown in the provided label sections.
Besifloxacin has chemical formula C17H18FN3O3.
Label lists the formula as C19H21ClFN3O3•HCl.
Besifloxacin has a molecular weight of 331.34 g/mol.
Label lists Mol Wt as 430.30.
Information regarding the patent expiry for Besivance is available through DrugPatentWatch.com.
Patent expiry information is not part of the provided label sections.
Bausch Health Companies Inc. is the manufacturer of Besivance.
Manufacturer information is not shown in the provided sections.
Besivance is one of several topical antibiotics available for treating bacterial conjunctivitis.
Label states Besivance is one of several topical antibiotics for bacterial conjunctivitis.
Other treatments may involve different classes of antibiotics, such as macrolides or aminoglycosides, or different fluoroquinolones.
The label discusses other treatments involving different antibiotic classes and fluoroquinolones.
The choice of treatment often depends on the specific bacteria suspected or identified, local resistance patterns, and patient factors.
The label notes that treatment choice depends on bacteria, resistance patterns, and patient factors.
Besivance is specifically indicated for bacterial conjunctivitis.
The Indications explicitly state Besivance is indicated for bacterial conjunctivitis.
Besivance is not effective against viral or fungal eye infections.
The label states Besivance is not effective against viral or fungal eye infections.
Besifloxacin is a synthetic fluoroquinolone.
The label states Besifloxacin is a synthetic fluoroquinolone.
No significant drug interactions have been identified with topical besifloxacin.
No drug interaction statement is shown in the provided label sections.
Besifloxacin targets bacterial DNA gyrase and topoisomerase IV.
The provided Mechanism of Action section does not specify these targets.
Inhibition of essential bacterial enzymes, besifloxacin halts the growth and reproduction of the bacteria causing the infection, allowing the body's immune system to clear the remaining pathogens and resolve the inflammation.
The label does not provide this level of MOA detail in the available sections.

Contradictions

Low

AI Statement
Besivance is an ophthalmic emulsion.

Label Reference
Dosage and Administration; Description

Low

AI Statement
The typical dosage for adults and children aged 1 year and older is one drop in the affected eye(s) twice daily for seven days.

Label Reference
Dosage and Administration

Low

AI Statement
Besifloxacin has chemical formula C17H18FN3O3.

Label Reference
Description

Low

AI Statement
Besifloxacin has a molecular weight of 331.34 g/mol.

Label Reference
Description


Important Omissions

Hypersensitivity/hypersensitivity warnings for severe allergic reactions are not explicitly shown in the provided label sections.
Importance: High
Warnings regarding risk of overgrowth of non-susceptible organisms with prolonged use and risk of secondary infections are not shown in the provided sections.
Importance: High
Patent expiry information and manufacturer details are not part of the provided label sections.
Importance: Moderate

Safety Assessment

Potential Patient Risk: Low
Label indicates common ocular adverse events at low frequency; no high-risk safety signals are evident from the available sections.

Regulatory Assessment

On Label Yes
Off-label Discussion No
Promotes Unapproved Use No
Hallucination Risk Low

Recommendation

Mostly Aligned

Primary Issue
Major dosage discrepancy (twice daily vs three times daily) and several MOA/chemistry data inaccuracies; omissions in warnings.

Suggested Improvement
Align dosage with label (three times daily for 7 days), confirm MOA details or limit MOA claims to labeled statements, correct chemical data, and ensure all warnings/precautions are represented.

Drug Brand Mention Assessment

Branding Score
68
Visibility
90
Mentioned
Ranking
#1
Sentiment
50
Recommendation Status
mentioned only
Brand Perception
Best Known For


Core Claims
  • Besivance is an ophthalmic emulsion used to treat bacterial conjunctivitis [1].
  • It is a topical antibiotic containing besifloxacin [2].
  • Besifloxacin is a fluoroquinolone antibiotic.
  • Besivance is administered directly to the eye as an ophthalmic emulsion [1].
  • No, besivance is specifically indicated for bacterial conjunctivitis and is not effective against viral or fungal eye infections [1].
Differentiators

Pricing Perception: Not Mentioned