Indication:
Ketorolac tromethamine is indicated for seasonal allergic
conjunctivitis and for pain and inflammation in ocular surgery. It is also
indicated for the treatment of postoperative inflammation in patients who have
undergone cataract extraction.
Dosage and Administration:For the treatment of relief of ocular itching due to
seasonal allergic conjunctivitis, one drop (0.25 mg) four times a day. For the
treatment of postoperative inflammation in patients who have undergone
cataract extraction, one drop should be applied to the affected eye(s) four times
daily beginning 24 hours after cataract surgery and continuing through the first
2 weeks of the postoperative period. It has been safely administered in
conjunction with other ophthalmic medications such as antibiotics, beta
blockers, carbonic anhydrase inhibitors, cycloplegics, and mydriatics.
Side Effects: Transient stinging and burning on instillation, allergic reactions,
corneal edema, iritis, ocular inflammation, ocular irritation, superficial keratitis
and superficial ocular infections. Corneal infiltrates, corneal ulcer, eye dryness,
headaches, and visual disturbance (blurry vision).
Contraindications: Contraindicated in patients with previously demonstrated
hypersensitivity to any of the ingredients in the formulation.
Warning: There is the potential for cross‐sensitivity to acetylsalicylic acid,
phenylacetic acid derivatives, and other nonsteroidal anti‐inflammatory agents.
Therefore, caution should be used when treating individuals who have
previously exhibited sensitivities to these drugs. With some nonsteroidal anti‐
inflammatory drugs, there exists the potential for increased bleeding time due to
interference with thrombocyte aggregation. There have been reports that
ocularly applied nonsteroidal anti‐inflammatory drugs may cause increased
bleeding of ocular tissues in conjunction with ocular surgery.
Precaution: All topical nonsteroidal anti‐inflammatory drugs (NSAIDs) may
slow or delay healing. Topical corticosteroids are also known to slow or delay
healing. Concomitant use of topical NSAIDS and topical steroids may increase the
potential for healing problems. Use of topical NSAIDs may result in keratitis. In
some susceptible patients, continued use of topical NSAIDs may result in
epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration or
corneal perforation. These events may be sight threatening. Patients with
evidence of corneal epithelial breakdown should immediately discontinue use of
topical NSAIDs and should be closely monitored for corneal health.
High Risk Group: Pregnancy Category C: There is no adequate and well‐
controlled studies in pregnant women. The drug should be used during
pregnancy only if the potential benefit justifies the potential risk to the fetus. The
use of drug during late pregnancy should be avoided. Nursing Mothers: Caution
should be exercised when ophthalmic solution is administered to a nursing
woman. Pediatric Use: Safety and efficacy in pediatric patients below the age of 3
have not been established. Geriatric Use: No overall differences in safety or
effectiveness have been observed between elderly and younger patients.
Drug Interactions: No information available.
Pharmaceutical Precautions: Store in a cool and dry place, away from light.
Keep out of reach of children.
Commercial Pack: Xidolac® 0.5% Eye Drops: Plastic dropper bottle containing
5 ml of sterile solution. Each ml contains Ketorolac Tromethamine USP 5 mg.
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