Ketorolac Other names: Ketorolac trometamol

All non-steroidal anti-inflammatory drugs (NSAIDs) may slow down or delay wound healing. Concomitant use of NSAIDs and topical steroids can increase the potential for healing problems.

Concomitant use of ketorolac and topical corticosteroids should be exercised with caution in patients susceptible to corneal epithelial breakdown.

It is recommended that ketorolac be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time.

Topical NSAIDs should be used with caution in patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g. dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time, as they may be at increased risk for corneal adverse events which may become sight threatening.

There are no adequate data from the use of eye drops containing ketorolac in pregnant women. Studies in animals have shown reproductive toxicity. Inhibition of prostaglandin synthesis may negatively affect pregnancy and/or embryonal/foetal development and/or postnatal development. Although a very low systemic exposure is expected after the use of ketorolac eye drops, ketorolac is not recommended during pregnancy.

Ketorolac should not be used during breast-feeding. Ketorolac is excreted in human milk after systemic administration.

Fertility

There are no adequate data from the use of ketorolac on fertility in humans.

Transient blurring of vision may occur on instillation of eye drops. Do not drive or use hazardous machinery unless vision is clear.

The most frequent adverse events reported with the use of ketorolac are transient stinging and burning on instillation.

The frequency of adverse reactions documented during clinical trials of ketorolac trometamol and through post-marketing experience is given below and is defined as follows:

Very Common (≥1/10); Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Very Rare (<1/10,000); Not Known (cannot be estimated from available data).

^* Occasional post marketing reports of corneal damage including corneal thinning, corneal erosion, epithelial breakdown and corneal perforation have been received. These occurred mainly in patients using concomitant topical corticosteroids and/or with predisposing co-morbidity.
^** There have been post-marketing reports of bronchospasm or exacerbation of asthma, in patients, who have either a known hypersensitivity to aspirin/non-steroidal anti-inflammatory drugs or a past medical history of asthma, associated with the use of ketorolac which may be contributory.

None of the typical adverse reactions reported with the systemic non-steroidal anti-inflammatory agents (including ketorolac trometamol) have been observed at the doses used in topical ophthalmic therapy.