EXOCIN DROPS

Country: South Africa

Language: English

Source: South African Health Products Regulatory Authority (SAHPRA)

Available from:

Abbvie (Pty) Ltd

Dosage:

See ingredients

Pharmaceutical form:

DROPS

Composition:

EACH 1 ml SOLUTION CONTAINS OFLOXACINE 3 mg

Authorization status:

Registered

Authorization date:

1994-09-08

Patient Information leaflet

AbbVie (Pty) Ltd
Exocin
®
Ofloxacin 3,0 mg/ml
Ophthalmic Solution
1.3.2 Patient Information Leaflet
Page 1 of 6
PATIENT INFORMATION LEAFLET
SCHEDULING STATUS
Schedule 4
PROPRIETARY NAME, STRENGTH AND PHARMACEUTICAL FORM
EXOCIN
®
OFLOXACIN 3,0 mg/ml, ophthalmic solution
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING EXOCIN
®

Keep this leaflet. You may need to read it again.

If you have further questions, please ask your doctor or your
pharmacist.

EXOCIN
®
has been prescribed for you personally and you should not share your
medicine
with other people. It may harm them, even if their symptoms are the
same as yours.
1.
WHAT EXOCIN
®
CONTAINS

The active substance is ofloxacin.

The other ingredients are benzalkonium chloride 0,005 % m/v, sodium
chloride and purified
water.
2.
WHAT EXOCIN
®
IS USED FOR
EXOCIN
®
is an eye drop used to treat external eye infections such as some
types of
conjunctivitis. EXOCIN
®
belongs to a group of medicines called 4-quinolone antibacterial
agents.
3.
BEFORE YOU USE EXOCIN
®
DO NOT USE EXOCIN
®
:

If you are hypersensitive (allergic) to ofloxacin, benzalkonium
chloride, or sodium chloride;

If you are pregnant or breastfeeding.
Safety and effectiveness in infants below the age of one year have not
been established.
TAKE SPECIAL CARE WITH EXOCIN
®
:

If you have a defect or ulceration of the surface of the eye;

If you are sensitive to other quinolone antibacterial agents.
Long term use may result in a new bacterial infection which does not
respond to EXOCIN
®
.
AbbVie (Pty) Ltd
Exocin
®
Ofloxacin 3,0 mg/ml
Ophthalmic Solution
1.3.2 Patient Information Leaflet
Page 2 of 6
PREGNANCY AND BREASTFEEDING
If you are pregnant or breastfeeding your baby, please consult your
doctor, pharmacist or other
healthcare professional for advice before using EXOCIN
®
.
This medicine should not be used during pregnancy or breastfeeding.
DRIVING AND USING MACHINERY
On instillation of the eye drops, your vision may be briefly blurred.
Do not drive or op

Summary of Product characteristics

AbbVie (Pty) Ltd
Exocin
®
Ofloxacin 3,0 mg/ml
Ophthalmic Solution
1.3.1.1 Professional Information
Page 1 of 8
SCHEDULING STATUS
Schedule 4
PROPRIETARY NAME AND DOSAGE FORM
EXOCIN
®
Ophthalmic Solution (Eye Drops)
COMPOSITION
EXOCIN
®
Ophthalmic Solution contains:
Ofloxacin 3,0 mg/ml
Preservative: Benzalkonium chloride 0,005 % m/v
Other ingredients are sodium chloride and purified water.
PHARMACOLOGICAL CLASSIFICATION
A. 15.1 Ophthalmic preparations with antibiotics.
PHARMACOLOGICAL ACTION
PHARMACODYNAMIC PROPERTIES
Ofloxacin is a synthetic fluorinated 4-quinolone antibacterial agent
with activity against a broad
spectrum of Gram-negative, and to a lesser degree, Gram-positive
organisms.
Ofloxacin is bacteriocidal at concentrations equal to or slightly
greater than inhibitory
concentrations.
The primary mechanism of action is through inhibition of bacterial
DNA gyrase, the enzyme
responsible for maintaining the structure of DNA.
Ofloxacin possesses an additional bacteriocidal mechanism, which is
not dependent on
protein or RNA synthesis. It is bacteriocidal in both replicating and
non-replicating stages of
bacterial growth.
Cross-resistance has been observed between ofloxacin and other
fluoroquinolones.
AbbVie (Pty) Ltd
Exocin
®
Ofloxacin 3,0 mg/ml
Ophthalmic Solution
1.3.1.1 Professional Information
Page 2 of 8
The safety and effectiveness of ofloxacin in treating ophthalmologic
infections due to the
following microorganisms have not been established in adequate and
well-controlled clinical
trials:
Aerobes, Gram-Positive
_Enterococcus faecalis_
_Streptococcus mitis_
_Listeria monocytogenes_
_Staphylococcus simulans_
_Staphylococcus capitis_
_Staphylococcus hominus_
_Streptococcus pyogenes_
Aerobes, Gram-Negative
_Acinetobacter calcoaceticus var. anitratum_
_Klebsiella pneumonia_
_Acinetobacter calcoaceticus var. wolffii_
_Moraxella (branhameila) catarrhalis_
_Citrobacter diversus_
_Moraxella lacunata_
_Citrobacter freundii_
_Morganella morganii_
_Enterobacter aerogenes_
_Neisseria gonorrhoeae_
_Enterobacter