ACULAR 0,5% Ophthalmic Solution

SCHEDULING STATUS
Schedule 4

PROPRIETARY NAME
(and dosage form):

ACULAR 0,5% Ophthalmic Solution

COMPOSITION
ACULAR 0,5% Ophthalmic Solution contains:
Ketorolac tromethamine 5 mg/mL
Preservatives:
Benzalkonium chloride 0,01% m/v
Disodium edetate 0,1% m/v

PHARMACOLOGICAL CLASSIFICATION
A 15.4 Ophthalmic preparations. Other.

PHARMACOLOGICAL ACTION
ACULAR 0,5% (ketorolac tromethamine) is a non-steroidal anti-inflammatory agent demonstrating analgesic and anti-inflammatory activity. It is believed to inhibit the cyclo-oxygenase enzyme essential for biosynthesis of prostaglandins. ACULAR 0,5% has been shown to reduce prostaglandin levels in the aqueous humour after topical ophthalmic administration.
Ketorolac tromethamine given systemically does not cause pupil constriction. Results from clinical studies indicate that ACULAR 0,5% has no significant effect on intraocular pressure.

INDICATIONS
ACULAR 0,5% is indicated for the relief of inflammation following ocular surgery.

CONTRA-INDICATIONS
ACULAR 0,5% is contra-indicated in patients hypersensitive to any component of the medicine. The potential exists for cross-sensitivity to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs.
ACULAR 0,5% is contra-indicated in individuals who have previously exhibited sensitivities to the components.
Safety and effectiveness in children have not been established.
Safety of use in pregnant women has not been established.
ACULAR 0,5% is not recommended for nursing mothers. Ketorolac tromethamine is secreted in human milk after systemic administration.
ACULAR 0,5% should not be used while wearing soft contact lenses.

WARNINGS
As the possibility of adverse effects on the corneal permeability and danger of disruption of the corneal epithelium with prolonged or repeated usage of benzalkonium chloride preserved preparations cannot be excluded, regular ophthalmological examination is required.
Caution should be exercised in the use of benzalkonium chloride preserved topical medication over an extended period in patients with extensive ocular surface disease.
It is recommended that ACULAR 0,5% be used with caution in patients with known bleeding tendencies or who are receiving other medication which may prolong bleeding time and in patients with known history of peptic ulceration.
In common with other anti-inflammatory drugs, ACULAR 0,5% may mask the usual signs of infection. ACULAR 0,5% may cause transient blurring on instillation. Do not drive or use hazardous machinery unless vision is clear.

DOSAGE AND DIRECTIONS FOR USE
One drop instilled into the eye three times daily starting 24 hours before surgery and continuing post-operatively.

SIDE EFFECTS AND SPECIAL PRECAUTIONS
The most frequent side effects reported with the use of ACULAR 0,5% are stinging and burning on instillation.
Blurring and/or diminished vision have been reported with the use of ACULAR 0,5%.
None of the typical adverse reactions reported with the systemic non-steroidal anti-inflammatory agents have been observed at the doses used in topical ophthalmic therapy.
The use of ACULAR 0,5% while wearing soft (hydrophilic) contact lenses is not recommended.
Drug interactions:
ACULAR 0,5% has been safely administered with systemic and ophthalmic medications such as antibiotics, sedatives, beta blockers, carbonic anhydrase inhibitors, miotics, mydriatics, cycloplegics and corticosteroids.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
In the event of topical overdose, wash the eye with water.
Treatment is symptomatic and supportive.

IDENTIFICATION
ACULAR 0,5% is a clear, colourless to slight yellow sterile ophthalmic solution.

PRESENTATION
ACULAR 0,5% is supplied in sterile dropper bottles containing 5 mL solution.

STORAGE INSTRUCTIONS
Store below 25°C. Do not use more than 30 days after opening.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER
29/15.4/0265

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION
Allergan Pharmaceuticals (Pty) Ltd
30 New Road (entrance off Bavaria Road)
Randjespark Ext 11, Midrand, 1682
Johannesburg, Gauteng
SOUTH AFRICA

DATE OF PUBLICATION OF THIS PACKAGE INSERT
27 November 1995

Updated on this site: August 2012
Source: Pharmaceutical Industry