Besivance

DRUG DESCRIPTION

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.

Besivance™
  (besifloxacin) Structural Formula Illustration

C19H21CIFN3O3•HCI
Mol Wt 430.30

Chemical Name: (+)-7-[(3R)-3-aminohexahydro-1 H-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);

Preservative: benzalkonium chloride 0.01%

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

Besivance™ (besifloxacin ophthalmic suspension) is an isotonic suspension with an osmolality of approximately 290 mOsm/kg.

What are the possible side effects of besifloxacin ophthalmic (Besivance)?

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...

Read All Potential Side Effects and See Pictures of Besivance »

What are the precautions when taking besifloxacin ophthalmic suspension (Besivance)?

Before using besifloxacin, tell your doctor or pharmacist if you are allergic to it; or to other quinolone antibiotics (such as ciprofloxacin, norfloxacin); or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like benzalkonium chloride), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other eye problems.

After you apply this drug, your vision may become temporarily blurred. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

During pregnancy, this medication should be used only when clearly...

Read All Potential Precautions of Besivance »


Besivance Consumer (continued)

SIDE EFFECTS: Temporary eye redness/itching/pain or temporary blurred vision may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat/eye/eyelid), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using besifloxacin, tell your doctor or pharmacist if you are allergic to it; or to other quinolone antibiotics (such as ciprofloxacin, norfloxacin); or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like benzalkonium chloride), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other eye problems.

After you apply this drug, your vision may become temporarily blurred. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this medication passes into breast milk. Consult your doctor before breast-feeding.


Besivance Patient Information Including Side Effects

Brand Names: Besivance

Generic Name: besifloxacin ophthalmic (Pronunciation: BE si FLOX a sin)

  • What is besifloxacin ophthalmic (Besivance)?
  • What are the possible side effects of besifloxacin ophthalmic (Besivance)?
  • What is the most important information I should know about besifloxacin ophthalmic (Besivance)?
  • What should I discuss with my healthcare provider before using besifloxacin ophthalmic (Besivance)?
  • How should I use besifloxacin ophthalmic (Besivance)?
  • What happens if I miss a dose (Besivance)?
  • What happens if I overdose (Besivance)?
  • What should I avoid while using besifloxacin ophthalmic (Besivance)?
  • What other drugs will affect besifloxacin ophthalmic (Besivance)?
  • Where can I get more information?

What is besifloxacin ophthalmic (Besivance)?

Besifloxacin is in a group of antibiotics called fluoroquinolones (flor-o-KWIN-o-lones). Besifloxacin fights bacteria in the body.

Besifloxacin ophthalmic (for the eyes) is used to treat bacterial infections of the eyes.

Besifloxacin ophthalmic may also be used for other purposes not listed in this medication guide.

What are the possible side effects of besifloxacin ophthalmic (Besivance)?

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.

What is the most important information I should know about besifloxacin ophthalmic (Besivance)?

You should not use this medication if you are allergic to besifloxacin.

Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Serious side effects of besifloxacin ophthalmic may include eye drainage or crusting, severe eye irritation, feeling like there is something in your eye, eye redness or swelling, fever, or any signs of new infection.

Keep using this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.

Do not use this medication while you are wearing contact lenses. This medication may contain a preservative that can be absorbed by soft contact lenses. Wait at least 15 minutes after using besifloxacin ophthalmic 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.

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