ACULAR ketorolac trometamol 5mg/mL eye drop bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

ketorolac trometamol, Quantity: 5 mg/mL

Available from:

Abbvie Pty Ltd

Pharmaceutical form:

Eye Drops, solution

Composition:

Excipient Ingredients: sodium chloride; disodium edetate; benzalkonium chloride; octoxinol 40; sodium hydroxide; hydrochloric acid; purified water

Administration route:

Ophthalmic

Units in package:

3mL, 10mL, 5mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Acular eye drops are indicated for the short term (2-4 weeks) relief of symptoms of seasonal allergic conjunctivitis. Acular eye drops are also indicated for the short term (2-4 weeks) prophylaxis and reduction in inflammation in patients undergoing cataract extraction.

Product summary:

Visual Identification: Clear, colourless to pale yellow, aqueous solution, practically free from particulate matter.; Container Type: Bottle; Container Material: LDPE; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1998-06-23

Patient Information leaflet

ACULAR
®
CMIv5-PIv4
Page 1 of 3
ACULAR
® EYE DROPS
(KETOROLAC TROMETAMOL) 5 MG/ML EYE DROPS
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about ACULAR
®
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 ACULAR
®
eye
drops against the benefits they expect
it will have for you.
If you have any concerns about using
this medicine, ask your doctor or
pharmacist.
KEEP THIS LEAFLET WITH THE MEDICINE
.
YOU MAY NEED TO READ IT AGAIN.
WHAT ACULAR
® EYE DROPS
ARE
USED FOR
These eyedrops contain the drug
ketorolac trometamol and are used to
treat itchy eyes occurring in the
condition called seasonal allergic
conjunctivitis. They are also used for
the relief of swelling and redness
after cataract surgery.
Ketorolac trometamol works by
decreasing prostaglandin E
2
levels in
the eye. Prostaglandins are normally
produced by the body and are
thought to be associated with pain,
itching and inflammation.
ACULAR
®
eye drops are only
available with a doctor’s
prescription from pharmacies.
Ask your doctor if you have
any questions about why
ACULAR
®
eye drops have
been prescribed for you.
BEFORE YOU USE ACULAR
® EYE
DROPS
_WHEN YOU MUST NOT USE IT _
Do not use ACULAR
®
eye drops if:
•
You have an allergy to ketorolac
trometamol or to any of the
ingredients listed at the end of
this leaflet
•
You have ever had an allergic
reaction to aspirin or certain types
of medicines used for arthritis or
pain relief (non steroidal anti-
inflammatory drugs)
•
The seal around the cap is
broken
•
The bottle/packaging shows
signs of tampering
•
The product does not look quite
right
•
The expiry date on the bottle has
passed.
If you use this medicine after the
expiry date has passed, it may not
work effectively.
Do not put the eye drops into your
eye(s) while you are wearing soft
c

Summary of Product characteristics

ACULAR
®
PIv4-CCDSv4
1
AUSTRALIAN PRODUCT INFORMATION
ACULAR
® (KETOROLAC TROMETAMOL) EYE DROPS
1
NAME OF THE MEDICINE
Ketorolac trometamol
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACULAR

contains ketorolac trometamol 5 mg/mL.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
ACULAR

eye drops is a clear, colourless to pale yellow, sterile, isotonic
aqueous solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ACULAR

eye drops are indicated for the short term (2-4 weeks) relief of
symptoms of
seasonal allergic conjunctivitis.
ACULAR

eye drops are also indicated for the short term (2-4 weeks)
prophylaxis and
reduction in inflammation in patients undergoing cataract extraction.
4.2
DOSE AND METHOD OF ADMINISTRATION
SEASONAL ALLERGIC CONJUNCTIVITIS
The recommended dose of ACULAR

eye drops for the relief of symptoms of seasonal
allergic conjunctivitis is one drop (0.25 mg) instilled in the eye
four times daily. Treatment
may be continued for up to four weeks.
POST-OPERATIVE INFLAMMATION
The recommended dose of ACULAR

eye drops for the prophylaxis and treatment of
inflammation in patients who have undergone cataract extraction is one
to two drops (0.25-
0.5 mg) four times daily, starting 24 hours before surgery and
continuing for 2-4 weeks.
4.3
CONTRAINDICATIONS
ACULAR

eye drops are contraindicated in patients hypersensitive to any of the
components of the medication.
The potential exists for cross sensitivity to acetylsalicylic acid,
phenylacetic acid derivatives
and other nonsteroidal anti-inflammatory medicines. ACULAR

eye drops are
contraindicated in patients who have previously exhibited
sensitivities to these drugs.
ACULAR
®
PIv4-CCDSv4
2
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
PATIENTS WITH BLEEDING TENDENCIES
With some nonsteroidal anti-inflammatory drugs a potential exists for
increased bleeding
time due to interference with thrombocyte aggregation. There have been
reports that ocularly
applied nonsteroidal anti-inflammat