Besifloxacin

Generic name: besifloxacin ophthalmic
Brand name: Besivance
Dosage form: ophthalmic suspension (0.6%)
Drug class: Ophthalmic anti-infectives

Medically reviewed by  A Ras MD.

What is besifloxacin?

Besifloxacin is a prescription medicine that is used to treat eye infections.

Description

BESIVANCE® (besifloxacin ophthalmic suspension) 0.6% is a sterile ophthalmic suspension of besifloxacin formulated with DuraSite®† (polycarbophil, edetate disodium dihydrate, sodium chloride, sodium hydroxide, and water for injection). 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

Molecular Weight 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.

Before taking besifloxacin, tell your doctor:

• If you are allergic to besifloxacin; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take besifloxacin with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take besifloxacin?

• Tell all of your health care providers that you take besifloxacin. This includes your doctors, nurses, pharmacists, and dentists.
• Use care when driving or doing other tasks that call for clear eyesight.
• Do not use longer than you have been told. A second infection may happen.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using besifloxacin while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is besifloxacin best taken?

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

• 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.

What are the side effects of besifloxacin that I need to call my doctor about immediately?

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, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Change in eyesight, eye pain, or very bad eye irritation.

What are some other side effects of besifloxacin?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out besifloxacin?

• Store at room temperature. Do not freeze.
• Protect from light.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

• NDC 24208-446-05
• BAUSCH + LOMB
• Besivance®
• besifloxacin ophthalmic
• suspension, 0.6%
• Rx only
  Sterile
• FOR OPHTHALMIC
  USE ONLY.
• 5 mL
• 9553304
• AB44507

 

 

 

SRC: NLM .