Besivance

Mechanism of Action

Bactericidal

Inhibits DNA-gyrase (a topoisomerase) in susceptible organisms, which in turn inhibits cell division.

Pharmacokinetics

Half-life: 7 hr

Do not use this medication while you are wearing contact lenses. Besifloxacin ophthalmic may contain a preservative that can be absorbed by soft contact lenses. Wait at least 15 minutes after using the medication before putting your contact lenses in.

You should not wear contact lenses while you still have active symptoms of the eye infection you are treating.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• drainage or crusting of your eye;

• severe eye irritation after using the eye drops;

• feeling like there is something in your eye;

• severe eye redness or swelling; or

• fever, or any signs of a new infection.

Less serious side effects may include:

• eye redness or pain;

• itchy or irritated eyes;

• headache; or

• blurred vision.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Absorption

Bioavailability

After topical application of besifloxacin 0.6% ophthalmic suspension to each eye 3 times daily for 16 doses, maximum plasma concentrations of the drug were <1.3 ng/mL.1

Distribution

Extent

Penetrates into conjunctiva and aqueous humor;2 maximum concentrations reported are 62.8 and 1.7 mcg/mL, respectively.2

Elimination

Half-life

Average elimination half-life of systemically absorbed drug estimated to be 7 hours.1

If your eye infection does not improve, or if it becomes worse, check with your doctor.

Stop using this medicine and check with your doctor right away if you have a rash, itching, or red or swollen skin around the eye or eyelid. These may be symptoms of an allergic reaction.

Do not wear contact lenses while you are using this medicine to avoid further eye irritation.

Use Besivance as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• To gain the most benefit, do not miss doses.
• Use as you have been told, even if your signs get better.
• For the eye only.
• Wash your hands before and after use.
• Do not touch the container tip to the eye, lid, or other skin.
• Turn container upside down and shake once before each use.
• Tilt your head back and drop drug into the eye.
• After use, keep your eyes closed. Put pressure on the inside corner of the eye. Do this for 1 to 2 minutes. This keeps the drug in your eye.
• Put the cap back on after you are done using your dose.
• Avoid wearing contacts unless told to wear them by your doctor.
• Do not put contacts back in if eyes are irritated or infected.

What do I do if I miss a dose?

• Use a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not use 2 doses at the same time or extra doses.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Change in eyesight, eye pain, or very bad eye irritation.

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.

Besivance (besifloxacin ophthalmic suspension) 0.6%, is a sterile ophthalmic suspension of besifloxacin formulated with DuraSite®† (polycarbophil, edetate disodium dihydrate and sodium chloride). Each mL of Besivance contains 6.63 mg besifloxacin hydrochloride equivalent to 6 mg besifloxacin base. It is an 8-chloro fluoroquinolone anti-infective for topical ophthalmic use.

C19H21ClFN3O3•HCl

Mol Wt 430.30

Chemical Name: (+)-7-[(3R)-3-aminohexahydro-1H-azepin-1-yl]-8-chloro-1- cyclopropyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid hydrochloride.

Besifloxacin hydrochloride is a white to pale yellowish-white powder.

Each mL contains:

Active: besifloxacin 0.6% (6 mg/mL);

Inactives: polycarbophil, mannitol, poloxamer 407, sodium chloride, edetate disodium dihydrate, sodium hydroxide and water for injection.

Preservative: benzalkonium chloride 0.01%

Besivance is an isotonic suspension with an osmolality of approximately 290 mOsm/kg.

Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of Besivance is not likely to cause life-threatening symptoms.