Besivance

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Besivance

Medically reviewed

Marina Burgos

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Besivance

What is Besivance? Definition and Chemical Class

Property Description
Active Ingredient Besifloxacin
Form Ophthalmic Suspension (Sterile)
Pharmacological Class Fluoroquinolone Antibiotic (Quinolone Antimicrobial)
General Purpose Anti-infective agent (to kill bacteria)
Origin Synthetic

Besivance is a brand-name, prescription-only medicine containing the active ingredient Besifloxacin, a purely synthetic antibacterial agent used exclusively for topical ophthalmic administration. It is classified as a quinolone antimicrobial within the broader fluoroquinolone antibiotic family.

The substance Besifloxacin is recognized as a fourth-generation member of this class, distinguished by a unique molecular structure specifically designed for ocular use. This feature is associated with broad-spectrum activity against many common bacterial pathogens that affect the eye. This indicates that the medication is developed to effectively target a wide variety of harmful bacteria in localized infections.

Composition and Physical Form of Besifloxacin

This medication is formulated as a sterile ophthalmic suspension, which is its specific dosage form designed for direct application to the eye. The suspension contains the active ingredient, Besifloxacin, finely dispersed in a safe, aqueous vehicle.

As a single-component product, its therapeutic effect is derived from the sole pharmacological action of Besifloxacin. The physical properties of the suspension are intended to promote prolonged contact time on the ocular surface, an attribute often highlighted in its development, supporting its use for topical ophthalmic administration as specified for its clinical use.

General Function: How This Antibacterial Agent Works

The general purpose of Besivance is to act as a potent anti-infective agent to clear up infections by eliminating susceptible bacteria. This function relies on a powerful bactericidal action, which is the direct killing of the bacterial cells.

Besifloxacin achieves this goal by simultaneously targeting and inhibiting two critical enzymes within the bacterial cell: DNA gyrase and topoisomerase IV. The disruption of these enzymes, necessary for DNA replication and repair, prevents the bacteria from multiplying and subsequently leads to the elimination of the infectious organisms.

Regulatory References

  1. Besifloxacin Ophthalmic: MedlinePlus Drug Information
  2. DailyMed (NIH) - Besivance Label

What side effects are possible with Besivance?

Possible Side Effects and Safety Information

Besivance (besifloxacin ophthalmic suspension) is an antibacterial agent used for topical application to the eye. Safety information is primarily based on findings from clinical trials and regulatory guidance.

Adverse Reactions

The most frequently reported adverse reaction in clinical trials, occurring in approximately 2% of patients, was conjunctival redness (hyperemia).

Other commonly reported adverse events, occurring in approximately 1% to 2% of patients, included:

  • Blurred vision
  • Eye pain
  • Eye irritation
  • Eye pruritus (itching)
  • Headache

Warnings and Safety Restrictions

  1. Topical Use Only: Besivance is approved strictly for topical ophthalmic use. It is not for injection into the eye (e.g., subconjunctivally or directly into the anterior chamber).
  2. Hypersensitivity: Although systemic exposure is low, patients with a known history of hypersensitivity or allergic reaction to besifloxacin or other quinolone antibiotics should avoid its use.
  3. Super-infection Risk: As with other anti-infectives, prolonged use may lead to the overgrowth of non-susceptible organisms, including fungi. If a new infection or super-infection is suspected, the use of Besivance should be discontinued.
  4. Contact Lenses: Patients with signs or symptoms of bacterial conjunctivitis should not wear contact lenses during the course of therapy.
  5. Pediatric Use: Safety and effectiveness have been established for patients one year of age and older, but have not been established in infants below one year of age.

Overdose and Emergency Response

Overdose and when to seek help

The regulatory profile for Besivance overdose primarily addresses two distinct exposure scenarios: topical over-application and accidental oral ingestion, as overdosage via the intended topical route is stated to be unlikely to occur.

Exposure Scenario Mandated Emergency Action
Topical Over-application Flush the eye(s) immediately with warm tap water.
Accidental Oral Ingestion Contact a doctor, hospital emergency department, or regional poison control centre is required.

For topical over-application, no specific systemic symptoms are documented; however, immediate medical attention must be sought if persistent discomfort or irritation in the eye develops after flushing. Accidental oral ingestion carries an official classification of Acute Toxicity, and medical oversight is required immediately if severe manifestations occur, such as convulsions or loss of consciousness.

Authorities state that there is no specific antidote listed for besifloxacin overdose. In cases of severe accidental ingestion, supportive measures are required, including maintaining an open airway, and administering fluids or inducing vomiting is cautioned against if the person is unconscious or seizing. This structure reflects the mandatory actions prescribed by government health authorities based on the route of exposure.

Therapeutic Uses of Besivance

Besivance (besifloxacin) is a prescription ophthalmic medicine generally used in situations involving acute or disruptive symptom patterns, primarily relevant in situations involving a specific infectious condition of the eye. The application of this medicine is relevant in contexts where short-term symptomatic assistance and supportive relief are needed for conditions marked by increased physiological stress.

Addressing Acute Symptom Episodes

Besivance is used for conditions characterized by periods of heightened symptoms in the eye, such as those that appear suddenly and create noticeable functional strain. It is relevant for easing symptom clusters that include redness, irritation, and discharge. The use of this medicine may assist with maintaining a sense of stability and contributes to improved comfort during periods of heightened symptoms. “It helps patients cope more steadily with symptom fluctuations and supports general well-being during symptomatic phases.”

Support for Symptoms Related to Inflammatory or Irritative States

The medicine is applied across domains where additional symptomatic support is needed to address symptoms related to inflammatory or irritative states of the conjunctiva. These symptoms may interfere with daily functioning and include increased discomfort or tension. It offers symptomatic relief that helps patients cope more steadily and provides support that helps ease the overall symptom burden when symptoms become more noticeable.


Quick Fact: Relief for Ocular Discomfort The medicine is commonly used to help manage symptoms related to acute inflammation and eye discharge, symptoms that interfere with daily functioning.

Regulatory References

  1. DailyMed - NIH

Eligibility and Restrictions for Use

Eligibility for Besivance (Besifloxacin Ophthalmic Suspension)

Besivance is an ophthalmic anti-infective used for the treatment of bacterial conjunctivitis. Eligibility for this medicine is defined by specific patient populations, age restrictions, and health conditions, as outlined in official regulatory information.

Category Eligibility Status (Regulatory Basis)
Use is Allowed Patients 1 year of age and older who have bacterial conjunctivitis.
Contraindicated Use is Contraindicated in patients with a known hypersensitivity or allergic reaction to besifloxacin, other quinolone antibiotics, or any component of the formulation.
Age Restriction Safety and effectiveness have not been established in infants below one year of age. The medicine is safe for use in geriatric patients (elderly).
Pregnancy/Lactation In pregnancy, use is typically reserved only if the potential benefit justifies the potential risk, due to a lack of adequate human data. Caution should be exercised when administered to a nursing mother, as it is unknown if the drug is present in human milk.
Restrictions The suspension is for topical ophthalmic use only and must not be injected into the eye. Patients with bacterial conjunctivitis should not wear contact lenses during the course of the infection or treatment.

This medicine is strictly for use in the eye. The main official restriction on use is a prior allergic reaction to the drug or related compounds. The product is not recommended for children under the age of one because clinical studies establishing safety and effectiveness in that group are not complete.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official Regulatory Profile

This section summarizes the officially documented information regarding interactions between Besivance (besifloxacin ophthalmic suspension) and other medicines or products, based strictly on authoritative governmental regulatory documents (e.g., FDA, Health Canada).

Besivance is an antibacterial agent intended for topical use in the eye.

Due to the specific formulation and route of administration, the systemic exposure of the active ingredient, besifloxacin, following ocular application is documented to be very low. Consequently, regulatory documents from major health authorities indicate that systemic drug-drug interactions are generally not expected with this product.

Interacting Substances and Product Classes

Category Regulatory Status
Systemic Medicines Interactions are not expected. No specific drug-drug interaction studies were conducted or are required for systemic medicines.
Other Topical Ophthalmic Products No specific restrictions or timing-based rules for co-administration with other ophthalmic products are detailed in official interaction sections.

Regulatory Context:

Official labeling for Besivance does not list specific interacting medicinal products, drug classes, or timing-based constraints related to drug metabolism (such as CYP enzyme interactions). The official interaction profile is characterized by the absence of specific warnings or precautions concerning concomitant use with other systemic or ocular medicines. This stance is based on the limited systemic absorption of the active compound from the eye.

Mechanism of Action

Besivance (Besifloxacin) is a quinolone antibacterial agent that induces bacterial cell death (bactericidal activity) by disrupting core processes essential for maintaining the stability and function of the bacterial genome. The mechanism is rooted in the targeted inhibition of two distinct bacterial enzymes: DNA gyrase and topoisomerase IV. These enzymes are crucial for the unwinding, replication, transcription, and repair of bacterial DNA. By binding to the DNA-enzyme complexes, Besifloxacin prevents the completion of these vital functions, causing irreparable breaks and accumulating lethal damage in the bacterial DNA. This triggers an irreversible mechanistic cascade leading to the termination of all bacterial cellular activity. The strategy of dual enzyme inhibition also serves to modulate the pathways through which mutational resistance typically emerges, supporting the maintenance of antibacterial activity against susceptible organisms.

Dosage and Administration Information

Besivance (besifloxacin ophthalmic suspension) must be used strictly according to established administration protocols, and is for topical ophthalmic use only, meaning it should not be injected into the eye.

Dosing and Preparation

The required dosage is one drop instilled into the affected eye(s) 3 times a day (TID). This dosing schedule must be maintained for 7 days total. The intervals between doses must be separated by four to twelve hours.

Before administering each dose, the closed bottle must be inverted and shaken once to ensure the suspension is properly mixed. Care should be taken to avoid contaminating the applicator tip by not touching the eye, fingers, or any other surface.

Administration Component Standard Instruction
Route of Administration Topical Ophthalmic Use Only (Not for injection)
Dose and Frequency One drop in the affected eye(s) 3 times a day
Time Spacing Doses must be 4 to 12 hours apart
Total Duration Must be used for 7 days
Age Restriction Approved for patients 1 year of age and older

Contact Lens Use and Missed Doses

It is advised not to wear contact lenses if patients have signs or symptoms of the condition being treated, or at any time during the course of therapy with Besivance.

If a dose is missed, it should be applied as soon as the patient remembers. However, if it is almost time for the next scheduled dose, the patient must skip the missed dose and resume the regular dosing schedule. Two doses must not be used at one time to make up for a missed dose.

Recent Clinical Evidence

Besivance (besifloxacin ophthalmic suspension) 0.6% is a fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis in patients one year of age and older.

Efficacy in Clinical Trials

Clinical data from large, randomized, and double-masked trials have assessed the use of besifloxacin ophthalmic suspension in patients with acute bacterial conjunctivitis. These studies have evaluated the drug's effect when administered three times daily for five days, or twice daily for three days.

  • Clinical Resolution: The primary clinical endpoint in key trials was typically defined as the absence of both conjunctival discharge and bulbar conjunctival injection (redness) by a specific follow-up visit (e.g., Day 5 or Day 8). Studies demonstrated high rates of clinical resolution compared to the vehicle (inactive solution).
  • Microbial Eradication: Trials also measured microbial eradication, which is defined as the absence of all accepted ocular bacterial species that were present at baseline. The drug showed high eradication rates against common ocular pathogens, including Haemophilus influenzae, Staphylococcus aureus, and Streptococcus pneumoniae.

Activity Against Resistant Organisms

Besifloxacin demonstrates strong in vitro activity against many Gram-positive and Gram-negative organisms associated with ocular infections. This activity includes strains that are resistant to multiple drugs.

  • Resistant Strains: Studies have specifically focused on its activity against challenging pathogens like methicillin-resistant Staphylococcus aureus (MRSA) and ciprofloxacin-resistant strains of various bacteria, demonstrating low minimum inhibitory concentrations (MICs) against these isolates.

Safety Profile

The safety profile of besifloxacin ophthalmic suspension has been established in clinical trials involving approximately 1,000 patients aged 1 to 98 years. The medication is for topical ophthalmic use only and is not for injection into the eye.

Common Adverse Reactions (Approximate Incidence)
Conjunctival Redness approx 2%
Blurred Vision, Eye Pain, Eye Irritation, Eye Pruritus, Headache approx 1% - 2%

Safety and effectiveness in infants below one year of age have not been established.

Frequently Asked Questions (FAQ)

Common questions about Besivance (FAQ)

Q: How quickly can I expect to see an improvement in my pink eye symptoms after starting Besivance?

A: Official studies on Besivance evaluate the time it takes for the infection to completely clear, which is called clinical resolution. These trials demonstrated high rates of resolution by Day 5 or Day 8 of the study. The product information does not specify the exact time frame for initial symptomatic improvement, but the drug's mechanism of action is immediate upon contact with susceptible bacteria.

Q: Is it normal for Besivance to cause a temporary blurred vision or stinging right after I put the drops in?

A: Regulatory information indicates that blurred vision and eye irritation are reported adverse reactions, occurring in approximately 1% to 2% of patients in clinical trials. While the product label does not explicitly use the term 'stinging,' this sensation is typically covered under the category of 'eye irritation' or 'eye pain.' This sensation may be related to the drops themselves, as blurred vision and eye irritation are listed as common reported adverse reactions.

Q: Is a slight headache a common or expected side effect of Besivance?

A: Yes, regulatory documents indicate that headache is a reported adverse reaction. In clinical trials, headache occurred in approximately 1% to 2% of patients. This incidence means it is one of the more common side effects reported by patients using Besivance.

Q: Can Besivance interact with other eye drops, like lubricating tears or glaucoma medication?

A: Due to the low systemic absorption of Besivance from the eye, systemic drug-drug interactions are generally not expected. While official documents do not list specific timing restrictions for other ophthalmic products, patient information commonly advises that different eye drops should be separated by at least five minutes.

Q: Are there any known drug interactions between Besivance and oral antibiotics or medications?

A: Official regulatory documents indicate that systemic drug-drug interactions are not expected with Besivance. This is because the active ingredient, besifloxacin, has very limited absorption into the body when applied as eye drops. Therefore, the official labeling does not list specific interacting systemic medications or oral antibiotics.

Q: Can Besivance be used in both eyes, even if only one eye seems to be infected?

A: The official dosing instructions specify that one drop should be instilled into the 'affected eye(s).' Decisions on treating both eyes should be determined by a healthcare provider.

Q: Can Besivance treat eye infections caused by viruses or fungi?

A: No. Besivance contains an antibacterial agent, besifloxacin, and is indicated specifically for the treatment of bacterial conjunctivitis. Official patient guidance confirms that the medication will not work for eye infections caused by viruses, fungi, or other non-bacterial pathogens.

Q: Could Besivance eye drops cause a metallic or bad taste in the mouth?

A: This side effect is not listed among the most common adverse reactions in the official Besivance product labeling. A metallic taste is a known, though uncommon, effect of some ophthalmic products that drain into the throat.

Q: Is eye redness a normal side effect of the drop itself, or is it a sign the infection is getting worse?

A: Conjunctival redness is the most frequently reported adverse reaction in clinical trials, occurring in approximately 2% of patients. While it is a known side effect of the drop itself, it is also a primary symptom of the bacterial infection. If eye redness or any symptom worsens after starting therapy, this information should be shared with a healthcare provider.

Q: Why does the Besivance bottle need to be shaken or inverted before each use?

A: Besivance is formulated as an ophthalmic suspension, meaning the active drug ingredient is finely dispersed in a liquid vehicle. The official instructions require the closed bottle to be inverted and shaken once before each use to ensure the active ingredient is properly mixed and evenly distributed in the drop you administer.

Q: What happens if I accidentally touch the tip of the Besivance dropper to my eye?

A: Official patient instructions strongly emphasize the importance of avoiding contamination by not touching the dropper tip to the eye, fingers, or any other surface. If contamination is suspected, information regarding the safe continued use of the bottle should be sought from a healthcare professional.

Q: Can I use Besivance if I am pregnant or breastfeeding?

A: For pregnancy, the official label advises that the medication should generally be used only if the potential benefit justifies the potential risk, as human data is limited. For nursing mothers, caution should be exercised because it is unknown if the drug passes into human milk. Any use of Besivance during pregnancy or while breastfeeding requires a review of the potential benefits and risks.

Q: Does Besivance cause issues with sun exposure or light sensitivity (photophobia)?

A: Light sensitivity, or photophobia, is not listed as a common adverse reaction in the summary of safety data for Besivance. While some antibiotics in the same class (fluoroquinolones) have been associated with sensitivity to sunlight, Besivance is generally not reported to cause this side effect.

Q: Are there any ingredients in Besivance that people with common allergies should be cautious of?

A: Patients with a known hypersensitivity to the active ingredient, besifloxacin, or to other antibiotics in the quinolone class, are advised to avoid its use. Allergies to the inactive ingredients or preservatives in the suspension are a known contraindication for some patients.

Q: How soon after my symptoms clear up can I stop using Besivance?

A: Official instructions emphasize the importance of completing the entire course of therapy as directed by the prescriber. Stopping treatment prematurely, even if symptoms improve, may risk the return of the infection and may contribute to antibiotic resistance.

How should Besivance be stored and disposed of?

Storage Conditions and Container Rules

Besivance (besifloxacin ophthalmic suspension) must be stored at controlled room temperature, maintained between 15 C and 25 C (59 F and 77 F). The product must be kept in its original container and the container must remain tightly closed when not in use.

It is mandatory to not freeze the suspension and to store it away from excessive heat and moisture.

Stability and Child Safety

For stability purposes, any unused portion of the suspension must be discarded 30 days after the container is first opened. The medicine must be stored out of the sight and reach of children.

Official Disposal Instructions

Unused or expired Besivance should be disposed of using a local drug take-back program. If a take-back program is unavailable, the medicine should be mixed with an undesirable substance, placed in a sealed container, and discarded in the household trash.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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