KETOROLIN Eye drops

COMPOSITION:
Sterile ophthalmic solution containing ketorolac tromethamine 0.5% (w/v).

Description

PROPERTIES:
KETOROLIN eye drops contain ketorolac tromethamine which is a nonsteroidal anti-inflammatory agent showing analgesic and anti-inflammatory activity. Ketorolac tromethamine inhibits biosynthesis of prostaglandins which are mediators of certain kinds of intraocular inflammation. Prostaglandins have been shown to produce disruption of the blood-aqueous humor barrier, vasodilatation, increased vascular permeability, leukocytosis and increased intraocular pressure. Prostaglandins also appear to play a role in the miotic response produced during ocular surgery by constricting the iris sphincter independently of cholinergic mechanisms. KETOROLIN has proven to be safe preparation and devoid from steroid-like side effects.

INDICATIONS:
 Temporary relief of ocular itching due to seasonal allergic conjunctivitis.
 Postoperative inflammation in patients who have undergone cataract extraction.

DOSAGE:
Ocular itching due to seasonal allergic conjunctivitis: 1 drop 4 times daily.
Postoperative inflammation in patients who have undergone cataract extraction:
1 drop should be applied to the affected eye(s) 4 times daily beginning 24 hours after surgery and continuing through the first 2 weeks of the postoperative period.

SIDE EFFECTS:
The most frequent side effect is a transient stinging and burning, rarely allergic reactions, corneal oedema, iritis, ocular inflammation, ocular irritation, superficial keratitis, superficial ocular infections, corneal infiltrates, corneal ulcer, eye dryness, headaches, visual disturbance.

CONTRAINDICATIONS:
Hypersensitivity to any component of the drops.

PRECAUTIONS:
 Caution should be exercised when treating patients who have previously exhibited sensitivity to aspirin and other NSAIDs.
 Should be used with caution in patients with bleeding tendencies or who are receiving other medications which may prolong bleeding time.
 All topical NSAIDs may slow or delay healing.
 Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems.
 Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs and should be closely monitored for corneal health.
 Topical NSAIDs should be used with caution in case of patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases, rheumatoid arthritis or repeated ocular surgeries within a short period of time.
 Should not be administered while wearing contact lenses.
 Safety and efficacy in pediatric patients below the age of 3 have not been established.

PREGNANCY & LACTATION:
 Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
 Caution should be exercised when administered during lactation.

PACKING:
A carton box containing plastic dropper of 10 or 15 ml and an inner leaflet.

STORAGE:
Keep at temperature (15-30c).
Keep out of reach of children.

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