OPTIMYXIN OPHTHALMIC OINTMENT

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

POLYMYXIN B (POLYMYXIN B SULFATE); BACITRACIN (BACITRACIN ZINC)

Available from:

EURO-PHARM INTERNATIONAL CANADA INC

ATC code:

S01AA30

INN (International Name):

COMBINATIONS OF DIFFERENT ANTIBIOTICS

Dosage:

10000UNIT; 500UNIT

Pharmaceutical form:

OINTMENT

Composition:

POLYMYXIN B (POLYMYXIN B SULFATE) 10000UNIT; BACITRACIN (BACITRACIN ZINC) 500UNIT

Administration route:

OPHTHALMIC

Units in package:

1X3.5G

Prescription type:

OTC

Therapeutic area:

ANTIBACTERIALS

Product summary:

Active ingredient group (AIG) number: 0205854001; AHFS:

Authorization status:

APPROVED

Authorization date:

2019-11-05

Summary of Product characteristics

_Optimyxin Ophthalmic Ointment _
_ _
_Page 1 of 6 _
PRESCRIBING INFORMATION
OPTIMYXIN
®
OPHTHALMIC OINTMENT
BACITRACIN ZINC AND POLYMYXIN B SULFATE OPHTHALMIC OINTMENT USP
ANTIBIOTIC
Sandoz Canada Inc.
Date of Revision: November 29, 2017
145 Jules-Léger
Boucherville, QC, Canada
J4B 7K8
Control number: 209550
_Optimyxin Ophthalmic Ointment _
_ _
_Page 2 of 6 _
OPTIMYXIN OPHTHALMIC OINTMENT
(BACITRACIN ZINC AND POLYMYXIN B SULFATE OPHTHALMIC OINTMENT USP)
INDICATIONS
For treatment of superficial ocular infections involving the
conjunctiva and/or cornea
caused by organisms susceptible to polymyxin B and bacitracin zinc.
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
Optimyxin Opthalmic Ointment and other antibacterial drugs, Optimyxin
Opthalmic
Ointment should be used only to treat infections that are proven or
strongly suspected to be
caused by bacteria.
CONTRAINDICATIONS
Hypersensitivity to any of the components.
Patients who have glaucoma, should not use this product except under
the advice and
supervision of a physician.
WARNINGS AND PRECAUTIONS
Ophthalmic ointments may retard corneal healing.
If the symptoms do not start to clear in 48 hours, discontinue use and
medical
consultation is indicated.
The overuse of this product may increase redness of the eye.
Patients who experience eye pain, changes in vision, continued redness
or irritation of the
eye, or if the condition worsens or persists should consult a
physician.
The vision may be blurred for a few minutes after using the product.
Patient should not
drive or operate machinery until vision returns.
GERIATRICS
: No specific information is available regarding the use of Optimyxin
Ophthalmic Ointment in the elderly; however, the maximum dosage should
be reduced in
cases where a decrease in renal function may exist.
PREGNANCY:
The clinical benefit of treatment to the patient must be balanced
against any
possible, but unknown hazards to the fetus. Do not use unless advised
by your doctor.
SUSCEPTIBILITY/RESISTANCE
_Optim