Little Ones Vitamin A And D
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Questions & Answers
Side Effects & Adverse Reactions
There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other nonsteroidal anti-inflammatory agents. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.
With some nonsteroidal anti-inflammatory drugs there exists the potential for increased bleeding time due to interference with thrombocyte aggregation. There have been reports that ocularly applied nonsteroidal anti-inflammatory drugs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery.
General: All topical nonsteroidal anti-inflammatory drugs (NSAIDs), including ketorolac tromethamine ophthalmic solution, may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDS and topical steroids may increase the potential for healing problems.
Use of topical NSAIDs may result in keratitis. In some susceptible patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration or corneal perforation. These events may be sight threatening. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs and should be closely monitored for corneal health.
Postmarketing experience with topical NSAIDs suggests that 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 may be at increased risk for corneal adverse events which may become sight threatening. Topical NSAIDs should be used with caution in these patients.
Postmarketing experience with topical NSAIDs also suggests that use more than 24 hours prior to surgery or use beyond 14 days post-surgery may increase patient risk for the occurrence and severity of corneal adverse events.
It is recommended that Ketorolac Ophthalmic Solution be used with caution in patients with known bleeding tendencies or who are receiving other medications, which may prolong bleeding time.
Information for Patients: Ketorolac Ophthalmic Solution should not be administered while wearing contact lenses.
Ketorolac tromethamine was neither carcinogenic in rats given up to 5 mg/kg/day orally for 24 months (156 times the maximum recommended human topical ophthalmic dose, on a mg/kg basis, assuming 100% absorption in humans and animals) nor in mice given 2 mg/kg/day orally for 18 months (62.5 times the maximum recommended human topical ophthalmic dose, on a mg/kg basis, assuming 100% absorption in humans and animals).
Ketorolac tromethamine was not mutagenic in vitro in the Ames assay or in forward mutation assays. Similarly, it did not result in an in vitro increase in unscheduled DNA synthesis or an in vivo increase in chromosome breakage in mice. However, ketorolac tromethamine did result in an increased incidence in chromosomal aberrations in Chinese hamster ovary cells.
Ketorolac tromethamine did not impair fertility when administered orally to male and female rats at doses up to 280 and 499 times the maximum recommended human topical ophthalmic dose, respectively, on a mg/kg basis, assuming 100% absorption in humans and animals.
Ketorolac tromethamine, administered during organogenesis, was not teratogenic in rabbits or rats at oral doses up to 112 times and 312 times the maximum recommended human topical ophthalmic dose, respectively, on a mg/kg basis assuming 100% absorption in humans and animals. When administered to rats after Day 17 of gestation at oral doses up to 46 times the maximum recommended human topical ophthalmic dose on a mg/kg basis, assuming 100% absorption in humans and animals, ketorolac tromethamine resulted in dystocia and increased pup mortality. There are no adequate and well-controlled studies in pregnant women. Ketorolac Ophthalmic Solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Because of the known effects of prostaglandin-inhibiting drugs on the fetal cardiovascular system (closure of the ductus arteriosus), the use of Ketorolac Ophthalmic Solution during late pregnancy should be avoided.
Nursing Mothers: Caution should be exercised when Ketorolac Ophthalmic Solution is administered to a nursing woman.
Pediatric Use: Safety and effectiveness of ketorolac tromethamine in pediatric patients below the age of 3 have not been established.
Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Ketorolac Tromethamine Ophthalmic Solution, 0.4% is indicated for the reduction of ocular pain and burning/stinging following corneal refractive surgery.
History
There is currently no drug history available for this drug.
Other Information
Ketorolac Tromethamine Ophthalmic Solution, 0.4% is a member of the pyrrolo-pyrrole group of nonsteroidal anti-inflammatory drugs (NSAIDS) for ophthalmic use.
Chemical Name: (±)-5-Benzoyl-2,3-dihydro-1H-pyrrolizine-l-carboxylic acid compound with 2-amino-2-(hydroxymethy1)-l,3-propanediol (1:1).
Contains: Active: ketorolac tromethamine 0.4%.
Inactives: edetate disodium 0.015%, octoxynol 40, sodium chloride and purified water. May contain hydrochloric acid and/or sodium hydroxide (to adjust the pH). Preservative: benzalkonium chloride 0.006%.
Ketorolac Tromethamine Ophthalmic Solution 0.4% is supplied as a sterile isotonic aqueous 0.4% solution, with a pH of approximately 7.4. Ketorolac Ophthalmic Solution is a racemic mixture of R-(+) and S-(-)-ketorolac tromethamine. Ketorolac tromethamine may exist in three crystal forms. All forms are equally soluble in water. The pKa of ketorolac is 3.5. This white to off-white crystalline substance discolors on prolonged exposure to light. The osmolality of Ketorolac Ophthalmic Solution is approximately 290 mOsml/kg.
Sources
Little Ones Vitamin A And D Manufacturers
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Kmart Corporation
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Little Ones Vitamin A And D | Akorn Inc.
The recommended dose of Ketorolac Tromethamine Ophthalmic Solution, 0.4% is one drop four times a day in the operated eye as needed for pain and burning/stinging for up to 4 days following corneal refractive surgery.
Ketorolac tromethamine ophthalmic solution has been safely administered in conjunction with other ophthalmic medications such as antibiotics, beta blockers, carbonic anhydrase inhibitors, cycloplegics, and mydriatics.
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