GENOPTIC gentamicin 3mg/mL (as sulfate) eye drops

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

gentamicin sulfate, Quantity: 3 mg/mL (Equivalent: gentamicin, Qty 3 mg/mL)

Available from:

Abbvie Pty Ltd

Pharmaceutical form:

Eye Drops, solution

Composition:

Excipient Ingredients: polyvinyl alcohol; dibasic sodium phosphate heptahydrate; sodium chloride; disodium edetate; benzalkonium chloride; sodium hydroxide; purified water; hydrochloric acid

Administration route:

Ophthalmic

Units in package:

5mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

GENTOPIC eye drops are indicated in the topical treatment of infections of the external eye and its adnexa caused by susceptible bacteria. Such infections include conjunctivitis, keratitis, keratoconjunctivitis, corneal ulcers, blepharitis, blepharoconjunctivits, acute meibomianitis and dacryocystitis.

Product summary:

Visual Identification: Clear colourless solution; Container Type: Bottle; Container Material: LDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

1991-10-14

Patient Information leaflet

GENOPTIC
®
Gentamicin Sulfate Eye Drops- CMI Version 2.0
GENOPTIC
®
EYE DROPS
_ _
[gentamicin sulfate]
CONSUMER MEDICINE
INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
GENOPTIC
®
eye drops, (including
how to use the eye drops). It does
not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using GENOPTIC
®
eye drops against the benefits they
expect it will have for you.
If you have any concerns about
using/taking this medicine, ask
your doctor or pharmacist.
KEEP THIS LEAFLET WITH THE
MEDICINE. You may need to read
it again.
WHAT
GENOPTIC
®
EYE
DROPS ARE USED FOR
GENOPTIC
®
eye drops are used
for the treatment of infections of
the eye caused by bacteria. These
include conjunctivitis (an infection
of the transparent skin that covers
the inner surface of the eyelid and
the surface of the eye which
causes the eye to produce
discharge, to be itchy and to form
crusty eyelids); infection of the
cornea (the front layer of the
eyeball); corneal ulcers; infection
of the edges of the eyelids
including hair follicles and glands;
infection of the oil producing gland
that covers the inner surface of the
eyelid and infection of the tear sac.
_Mechanism of action: _
The active ingredient in
GENOPTIC
®
eye drops,
gentamicin sulfate, belongs to a
chemical group called the
aminoglycosides which have an
antibiotic activity against a wide
range of bacteria.
Your doctor may have prescribed
GENOPTIC
®
eye drops for another
reason. Ask your doctor if you
have any questions about why
GENOPTIC
®
eye drops have been
prescribed for you.
BEFORE YOU TAKE
GENOPTIC
®
EYE DROPS
_ _
_WHEN YOU MUST NOT USE IT _
Do not use GENOPTIC
®
eye
drops if:
1.
you have an allergy to
GENOPTIC
®
eye drops or
any of the ingredients listed at
the end of this leaflet.
Check with your doctor if:

you are pregnant or have
the intention of becoming
pregnant. Like some
medicines,

Summary of Product characteristics

GENOPTIC

Product Information Version 3
1
AUSTRALIAN PRODUCT INFORMATION – GENOPTIC
®
(GENTAMICIN SULFATE) EYE DROPS
1
NAME OF THE MEDICINE
Gentamicin sulfate.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each
mL
of
GENOTIC
®
eye
drops
contains
gentamicin
sulfate
(equivalent
to
3
mg
gentamicin).
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Eye drops, solution.
GENOPTIC
®
eye drops are a sterile, aqueous solution buffered to approximately pH
7.0 for
use in the eye.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
GENOPTIC

eye drops are indicated in the topical treatment of infections of the
external eye
and its adnexa caused by susceptible bacteria. Such infections include
conjunctivitis, keratitis,
keratoconjunctivitis, corneal ulcers, blepharitis,
blepharoconjunctivitis, acute meibomianitis
and dacryocystitis.
4.2
DOSE AND METHOD OF ADMINISTRATION
Instil one or two drops of GENOPTIC

eye drops into the affected eye(s) every four hours. In
severe infections, dosage may be increased to a maximum of 2 drops
once every hour.
In order to minimise systemic absorption of GENOPTIC

eye drops, apply pressure to the tear
duct immediately following administration of the drug.
4.3
CONTRAINDICATIONS
Hypersensitivity to gentamicin sulfate, benzalkonium chloride or any
of the other constituents.
GENOPTIC

Product Information Version 3
2
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
IDENTIFIED PRECAUTIONS
GENOPTIC

eye drops are not for injection. It should never be injected
subconjunctivally,
nor should it be introduced directly into the anterior chamber of the
eye.
Prolonged use of topical antibiotics may give rise to overgrowth of
nonsusceptible organisms,
such as fungi. Bacterial resistance to gentamicin may also develop.
Should this occur, or if
irritation or hypersensitivity to any component of the product
develops, or purulent discharge,
inflammation or pain becomes aggravated, discontinue use of the
preparation and institute
appropriate therapy.
Patien