OFLOXACIN 0.3% & KETOROLAC TROMETHAMINE 0.5% EYE DROP MANUFACTURERS SUPPLIERS - THIRD PARTY CONTRACT MANUFACTURING
COMPOSITION:OFLOXACIN 0.3% & KETOROLAC TROMETHAMINE 0.5%
Ofloxacin Ophthalmic Solution USP, 0.3% is a sterile ophthalmic solution. It is a fluorinated carboxyquinolone anti infective for topical ophthalmic use.Ofloxacin drops are an ophthalmic fluoroquinolone antibiotic. It stops or prevents bacterial infections of the eyeball by either killing susceptible bacteria or inhibiting their growth.
Ketorolac is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Ketorolac works by reducing hormones that cause inflammation and pain in the body.Ketorolac ophthalmic (for the eye) is used to relieve eye itching caused by seasonal allergies.Ketorolac ophthalmic is also used to reduce swelling, pain, and burning or stinging after cataract surgery or corneal refractive surgery.Ketorolac ophthalmic may also be used for other purposes not listed in this medication guide.
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.
Two drops of 0.5% ketorolac tromethamine ophthalmic solution instilled into the eyes of patients 12 hours and 1 hour prior to cataract extraction achieved a mean ketorolac concentration of 95 ng/mL in the aqueous humor of 8 of 9 eyes tested (range 40 to 170 ng/mL).
One drop of 0.5% ketorolac tromethamine ophthalmic solution was instilled into 1 eye and 1 drop of vehicle into the other eye TID in 26 healthy subjects. Five (5) of 26 subjects had detectable concentrations of ketorolac in their plasma (range 11 to 23 ng/mL) at Day 10 during topical ocular treatment. The range of concentrations following TID dosing of 0.5% ketorolac tromethamine ophthalmic solution are approximately 4 to 8% of the steady state mean minimum plasma concentration observed following four times daily oral administration of 10 mg ketorolac in humans (290 ± 70 ng/mL).