Composition :
1 ml of the solution contains:
Ketorolac Tromethamine IP 0.4% w/v + Hydroxypropylmethyl Cellulose IP 0.25% w/v + Benzalkonium Chloride IP 0.02% v/v

Indications :
The treatment of inflammation following cataract surgery with lubrication.
The temporary relief of ocular itching due to seasonal allergic conjunctivitis.

Dosage and Administration :
One drop of Ketrol LS should be applied to the affected eyes four times a day for relief of ocular itching due to seasonal allergic conjunctivitis.
For the treatment of postoperative inflammation in patients who have undergone cataract extraction, one drop of Ketrol LS should be applied to the affected eye four times daily beginning 24 hours after cataract surgery and continuing through the first 2 weeks of the postoperative period.

Contraindications :
Hypersensitivity to any of preparation ingredient.

Warning and Precautions :
Delayed healing
Cross-sensitivity or hypersensitivity
Increased bleeding time due to interference with thrombocyte aggregation
Corneal effects including keratitis

Adverse Effects :
Allergic reactions to the ingredients.

CLINICAL PHARMACOLOGY :
Mechanism of Action :
Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug which, when administered systemically, has demonstrated analgesic, anti-inflammatory, and anti-pyretic activity. The mechanism of its action is thought to be due to its ability to inhibit prostaglandin biosynthesis.

USE IN SPECIFIC POPULATIONS :
Pregnancy Teratogenic Effects :
Pregnancy Category C Ketorolac tromethamine, administered during organogenesis, was not teratogenic in rabbits and rats at oral doses of 3.6 mg/kg/day and 10 mg/kg/day, respectively. These doses are approximately 100 times and 250 times higher respectively than the maximum recommended human topical ophthalmic daily dose to affected eyes on an mg/kg basis. Additionally, when administered to rats after Day 17 of gestation at oral doses up to 1.5 mg/kg/day (approximately 40 times the typical human topical ophthalmic daily dose), ketorolac tromethamine resulted in dystocia and increased pup mortality. There are no adequate and well-controlled studies in pregnant women. Ketrol LS solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nonteratogenic Effects :
Because of the known effects of prostaglandin-inhibiting drugs on the fetal cardiovascular system (closure of the ductus arteriosus), the use of solution during late pregnancy should be avoided.
Nursing Mothers :
Because many drugs are excreted in human milk, caution should be exercised when drug is administered to a nursing woman.
Paediatric Use :
Safety and efficacy in paediatric patients below the age of 2 have not been established.
Geriatric Use :
No overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients.

Packaging :
5 ml round low density polyethylene bottle with a dispensing plug and white polypropylene screw cap containing 5 ml solution.

Storage Conditions :
In dry place protected from light at a temperature below 25°С. Do not freeze. After instillation the vial should be tightly closed. Keep out of reach of children.

Shelf Life :
15 months after opening the vial it is suitable for use within 1 month.
Do not use after the expiration date stated on the package