Patient Medication Information: uses, side effects, how to take - Besivance
ABOUT THIS MEDICATION
What the medication is used for:
BESIVANCE™ is an eye drop that is used to treat bacterial conjunctivitis (a type of eye infection). Antibacterial drugs like BESIVANCE™ treat only bacterial infections. They do not treat viral infections such as the common cold. Although you may feel better early in treatment, BESIVANCE™ should be used exactly as directed. Misuse or overuse of BESIVANCE™ could lead to the growth of bacteria that will not be killed by BESIVANCE™ (resistance). This means that BESIVANCE™ may not work for you in the future. Do not share your medicine.
What it does:
BESIVANCE™ kills certain bacteria (“germs”) that cause infection of the eye.
When it should not be used:
BESIVANCE™ should not be used if you are allergic to besifloxacin, other quinolones or any of the ingredients in this drug (See What the nonmedicinal ingredients are).
What the medicinal ingredient is:
BESIVANCE™ contains besifloxacin which belongs to a group of medicines called fluoroquinolones.
What the nonmedicinal ingredients are:
Benzalkonium chloride, edetate disodium dihydrate, mannitol, poloxamer 407, polycarbophil, sodium chloride, sodium hydroxide, and water for injection.
What dosage forms it comes in:
BESIVANCE™ is a sterile ophthalmic suspension (a liquid). It is supplied in a bottle with a dropper tip and cap. The bottle contains 5 mL of BESIVANCE™ suspension.
WARNINGS AND PRECAUTIONS
BEFORE you use BESIVANCE™, talk to your doctor or pharmacist if:
You wear contact lenses. You should not wear
contact lenses if you have bacterial conjunctivitis or if you are using BESIVANCE™
You are pregnant or plan on becoming pregnant
- You are breastfeeding or planning to breastfeed
- You are allergic to any medications
INTERACTIONS WITH THIS MEDICATION
Drug interactions were not studied with this drug and are not expected.
PROPER USE OF THIS MEDICATION
Before using BESIVANCE™, thoroughly wash hands.
Take care to avoid contaminating the applicator tip with material from the eye, fingers or other sources.
Invert closed bottle (turn 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).
Usual dose:
Instill one drop in the affected eye(s) 3 times a day for 7 days.
Although it is common to feel better early in the course of the therapy, this medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may:
- 1. Decrease the effectiveness of the immediate treatment
- 2. Increase the likelihood that bacteria will develop resistance and will not be treatable by BESIVANCE™ or any other antibacterial drugs in the future.
Overdose:
No information is available on overdosage of BESIVANCE™. A topical overdose of BESIVANCE™ may be flushed from the eye(s) with warm tap water
In case of accidental oral ingestion, contact your doctor, hospital emergency department, or regional poison control centre.
Missed Dose:
If a dose of this medication has been missed, it should be taken as soon as possible. However, if it is almost time for the next dose, skip the missed dose and go back to the regular dosing schedule. Do not double doses.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
Besifloxacin ophthalmic suspension, 0.6% Page 27 of 27 Discontinue use immediately and contact your doctor at the first sign of an allergic reaction, such as symptoms of swollen eyes, face, and throat, difficultly in breathing, rash and itching.
Like all medicines, BESIVANCE™ can have unwanted effects. The most common side effects in patients treated with BESIVANCE™ are:
- Blurred vision
- Discharge from the eyes
- Eye pain
- Itching in the eye
- Eye irritation
This is not a complete list of side effects. For any unexpected effects while taking BESIVANCE ™, contact your doctor or pharmacist.
HOW TO STORE IT
Store BESIVANCE™ at 15º - 25ºC (room temperature). Protect from light.
Keep out of reach of children.
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free to 1-866-234-2345
Complete Canada Vigilance Reporting Form and:
-Fax toll-free to 1-866-678-6789, or -Mail to: Canada Vigilance Program
Health Canada Postal Locator 0701C Ottawa, ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
MORE INFORMATION
This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Bausch & Lomb Incorporated, at:
1-800-686-7720 (English)
1-800-686-0002 (French)