ACULAR (ketorolac tromethamine)

There are 0 contraindications.

There are 0 severe contraindications.

There are 7 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Corneal degeneration
Corneal erosion
Diabetes mellitus
Dry eye
Hemophilia
Increased risk of bleeding due to coagulation disorder
Rheumatoid arthritis

There are 8 severe adverse reactions.

More Frequent	Less Frequent
None.	Keratitis

Rare/Very Rare
Asthma exacerbation Bronchospastic pulmonary disease Corneal erosion Corneal ulcer Impaired wound healing Ocular hemorrhage Perforation of cornea

There are 17 less severe adverse reactions.

More Frequent	Less Frequent
Blurred vision Conjunctival hemorrhage Conjunctival hyperemia Headache disorder Infiltrate of cornea Ocular hypertension Ocular pain	Contact dermatitis Ocular irritation Ocular itching Ocular redness Skin rash

Rare/Very Rare
Corneal dystrophy Corneal edema Dry eye Eyelid edema Iritis

Reproduction studies in rabbits and rats receiving oral ketorolac tromethamine dosages up to 109 and 303 times the maximum recommended human topical ophthalmic dosage of ketorolac tromethamine 0.5% (on a mg/kg basis), respectively, have not revealed evidence of harm to the fetus. However, oral dosages exceeding 45 times the maximum recommended human topical ophthalmic dosage of ketorolac tromethamine 0.5%

(on a mg/kg basis) in rats produced dystocia and was associated with an increased neonatal death rate. There are no adequate and controlled studies to date using ophthalmic ketorolac tromethamine in pregnant women, and the drug should be used during pregnancy only when the potential benefits justify the possible risk to the fetus. Ketorolac tromethamine ophthalmic solution should not be used during late pregnancy, since inhibitors of prostaglandin synthesis may have adverse effects on the fetal cardiovascular system (e.g., premature closure of the ductus arteriosus).

Because ketorolac is distributed into milk following systemic administration (see Pharmacokinetics: Distribution, in Ketorolac 28:08.04.92), the ophthalmic solution should be used with caution in nursing women.

No enhanced Geriatric Use information available for this drug.