Besifloxacin hydrochloride

What is Besifloxacin hydrochloride?

• Besifloxacin hydrochloride (Besivance) is a quinolone antimicrobial used for the treatment of bacterial conjunctivitis.

Besifloxacin

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What are the uses of this medicine?

• Besifloxacin hydrochloride (Besivance) is used for the treatment of bacterial conjunctivitis caused by susceptible isolates of the following bacteria:
• CDC coryneform group G
• Corynebacterium pseudodiphtheriticum*
• Corynebacterium striatum*
• Haemophilus influenzae
• Moraxella lacunata*
• Staphylococcus aureus
• Staphylococcus epidermidis
• Staphylococcus hominis*
• Staphylococcus lugdunensis*
• Streptococcus mitis group
• Streptococcus oralis
• Streptococcus pneumoniae
• Streptococcus salivarius*

How does this medicine work?

• Besifloxacin is a fluoroquinolone antibacterial.
• Besifloxacin is an 8-chloro fluoroquinolone with a N-1 cyclopropyl group.
• The compound has activity against Gram-positive and Gram-negative bacteria due to the inhibition of both bacterial DNA gyrase and topoisomerase IV.
• DNA gyrase is an essential enzyme required for replication, transcription and repair of bacterial DNA.
• Topoisomerase IV is an essential enzyme required for partitioning of the chromosomal DNA during bacterial cell division.
• Besifloxacin is bactericidal with minimum bactericidal concentrations (MBCs) generally within one dilution of the minimum inhibitory concentrations (MICs).

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• No formal drug interaction studies have been conducted with Besivance.

Is this medicine FDA approved?

• The eye drop was approved by the United States Food and Drug Administration (FDA) on May 29, 2009.

How should this medicine be used?

Recommended dosage:

• Instill one drop in the affected eye(s) 3 times a day, four to twelve hours apart for 7 days.

Administration:

• Patients should be advised to thoroughly wash hands prior to using Besivance.
• Patients should be instructed to invert closed bottle (upside down) and shake once before each use. Remove cap with bottle still in the inverted position. Tilt head back, and with bottle inverted, gently squeeze bottle to instill one drop into the affected eye(s).
• Patients should be advised not to wear contact lenses if they have signs or symptoms of bacterial conjunctivitis or during the course of therapy with Besivance™.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As 7.5 mL size bottle filled with 5 mL of besifloxacin ophthalmic suspension, 0.6%

This medicine is available in fallowing brand namesː

• Besivance

What side effects can this medication cause?

The most common side effects of this medicine include:

• conjunctival redness

What special precautions should I follow?

• 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.
• 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.
• Patients should not wear contact lenses if they have signs or symptoms of bacterial conjunctivitis or during the course of therapy with Besivance.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• 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.
• Pregnancy Category C.

Can this medicine be used in children?

• The safety and effectiveness of Besivance™ in infants below one year of age have not been established.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• BESIFLOXACIN

Inactive ingredients:

• BENZALKONIUM CHLORIDE
• POLYCARBOPHIL
• MANNITOL
• POLOXAMER 407
• SODIUM CHLORIDE
• EDETATE DISODIUM
• SODIUM HYDROXIDE
• WATER

Who manufactures and distributes this medicine?

Manufactured by:

• Bausch & Lomb Incorporated
• Tampa, Florida 33637
• ©Bausch & Lomb Incorporated

• Besivance™ is a trademark of Bausch & Lomb Incorporated

What should I know about storage and disposal of this medication?

• Store at 15°- 25°C (59° - 77°F).
• Protect from Light.
• Invert closed bottle and shake once before use.

• Dailymed label info on Besifloxacin hydrochloride
• FDA Besifloxacin hydrochloride

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