DESCRIPATION:
Ketorocin-LS Eye Drops is a member of the pyrrolo-pyrrole group of non-steroidal anti-inflammatory drugs ( NSAIDS ) for ophthalmic use.
COMPOSITION:
Label Claim: Each mL Contains :
- Ketorolac Tromethamine IP â¦â¦â¦â¦â¦4 mg
- Stabilized Oxychloro complex â¦â¦â¦0.05 mg (As preservative)
- Water for injections IPâ¦â¦.â¦â¦â¦â¦â¦â¦.q.s.
PACKAGING
Primary packing - 5ml White Poly bottles White caps &Nozzles.
Secondary Packing - Labels, Cartons, Shrink Pack & Shipper box.
SHELF LIFE:
24 months from the date of manufacturing.
STORAGE:
Keep in a cool & dark place. Below 25ºC.Do not allow to Freeze.
AVAILABILITY:
5ml of solution in White poly bottles with white caps & nozzles in properly sealed.
CLINICAL PHARMACOLOGY :
Mechanism of Action:
Ketorocin-LS Eye Drops 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. Ketorolac tromethamine given systemically does not cause pupil constriction.
Pharmacokinetics:
One drop (0.05 mL) of 0.5% Ketorocin-LS Eye Drops was instilled into one eye and one drop of vehicle into the other eye TID in 26 normal subjects. Only 5 of 26 subjects had a detectable amount of ketorolac in their plasma (range 10.7 to 22 5 ng/mL) at day 10 during topical ocular treatment.
Clinical Studies:
In two double-masked, multi-centered, parallel-group studies, 313 patients who had undergone photorefractive keratectomy received Ketorocin-LS Eye Drops or its vehicle QID for up to 4 days. Significant differences favored Ketorocin-LS Eye Drops for the reduction of ocular pain and burning/stinging following photorefractive keratectomy surgery.
Results from clinical studies indicate that ketorolac tromethamine has no significant effect upon intraocular pressure.
Ketorocin-LS Eye Drops 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. Ketorolac tromethamine given systemically does not cause pupil constriction.
INDICATIONS AND USAGE:
Ketorocin-LS Eye Drops is indicated for the relief of ocular itching due to seasonal allergic conjunctivitis. It is also indicated for the prophylaxis and relief of post operative ocular inflammation.
CONTRAINDICATIONS:
Ketorocin-LS Eye Drops is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formulations.
WARNINGS:
There is the potential for cross-sensitivity to acetylsalicylic acid derivatives and other non-steroidal anti-inflammatory agents. Therefore, caution should be used when treating individuals who have previously exhibited sensitiveness to these drugs. With some non-steroidal anti-inflammatory drugs there exists the potential for increased bleeding time due to interference with thrombocyte aggregation . There have been reports that ocularly applied non â steroidal antiinflammatory drugs may cause increased bleeding of ocular tissue (including hyphemas) in conjunction with ocular surgery.
DOSAGE AND ADMINISTRATION:
The recommended dose of Ketorocin-LS Eye Drops is one drop four times a day . Ketorocin-LS Eye Drops has been safely administered in conjunction with other ophthalmic medications as anti biotics, beta blockers, carbonic anhydrase inhibitors, cyclopegics and mydriatics.
SUPPLY:
Ketorocin-LS Eye Drops is supplied in one Opeque Polethylene Bottle packed with printed labeled in a unit carton and, Such 25 Carton Packed in a Shrink Sleeves.Such 12 shrinks packed in a shipper.
