Besifloxacin

Besifloxacin
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]

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Overview

Besifloxacin is a quinolone antimicrobial that is FDA approved for the treatment of bacterial conjunctivitis. Common adverse reactions include conjunctival redness.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

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 catarrhalis*

Moraxella lacunata*

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.

Dosage

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.

DOSAGE FORMS AND STRENGTHS

7.5 mL bottle filled with 5 mL of besifloxacin ophthalmic suspension, 0.6%.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Besifloxacin in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Besifloxacin in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Besifloxacin in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Besifloxacin in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Besifloxacin in pediatric patients.

Contraindications

• None

Warnings

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.

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 .

Adverse Reactions

Clinical Trials Experience

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.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Besifloxacin in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Besifloxacin in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Besifloxacin during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Besifloxacin with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Besifloxacin with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Besifloxacin with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Besifloxacin with respect to specific gender populations.

Race

There is no FDA guidance on the use of Besifloxacin with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Besifloxacin in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Besifloxacin in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Besifloxacin in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Besifloxacin in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Besifloxacin in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Besifloxacin in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Besifloxacin in the drug label.

Pharmacology

There is limited information regarding Besifloxacin Pharmacology in the drug label.

Mechanism of Action

Structure

File:Besifloxacin01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Besifloxacin in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Besifloxacin in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Besifloxacin in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Besifloxacin in the drug label.

How Supplied

Storage

There is limited information regarding Besifloxacin Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Besifloxacin in the drug label.

Precautions with Alcohol

• Alcohol-Besifloxacin interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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