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AURO-BROMFENAC is a brand name for Bromfenac, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS................................................................................................... 3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
General There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other non-steroidal anti-inflammatory drugs (NSAIDs), including Auro-Bromfenac. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.
Auro-Bromfenac contains sodium sulfite, which may cause allergic type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low.
Sulfite sensitivity is seen more frequently in asthmatic than in non- asthmatic people. Ophthalmologic Corneal Effects and keratitis 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, including Auro-Bromfenac, and should be closely monitored for corneal health. , 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. Post-marketing 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.
Delayed Healing All topical NSAIDs may slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems. 07% w/v, a flare-up of the inflammatory response, in the form of macular edema, due to the cataract operation may occur.
Patients may have to be monitored for occurrence of macular edema upon discontinuation of Auro-Bromfenac. Contact Lens Wear Auro-Bromfenac should not be instilled while wearing contact lenses. Remove contact lenses Page 5 of 23 prior to instillation of Auro-Bromfenac.
The preservative in Auro-Bromfenac, benzalkonium chloride may be absorbed by soft contact lenses. Lenses may be reinserted 15 minutes after administration of Auro-Bromfenac. Hematologic Bleeding With some NSAIDs, including Auro-Bromfenac, there exists the potential for increased bleeding time due to interference with platelet aggregation.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Bromfenac in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
There have been reports that ocularly applied NSAIDs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery. It is recommended that Auro-Bromfenac ophthalmic solution be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time.
Carcinogenesis and Mutagenesis Carcinogenicity and mutagenicity have not been studied in humans; see TOXICOLOGY.
Special Populations Pregnant Women:
There are no studies with bromfenac ophthalmic solution in pregnant women. Auro-Bromfenac should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Because of the known effects of prostaglandin biosynthesis-inhibiting drugs on the fetal cardiovascular system (closure of ductus arteriosus), the use of Auro-Bromfenac during late pregnancy should be avoided.
Studies in rats and rabbits produced no clear treatment-related malformations in reproduction studies at doses up to 90 times (for rats) and 150 times (for rabbits) the recommended human ophthalmic dose [RHOD], there was however, embryo-fetal lethality and maternal toxicity.
See TOXICOLOGY - Reproduction and Development. Nursing Women Auro-Bromfenac should not be administered to a nursing woman unless the potential benefit justifies the potential risk to the fetus. No specific studies have been performed to evaluate bromfenac sodium levels in the milk of lactating women associated with topical administration.
However, bromfenac is excreted in milk of lactating female rats. See Animal Pharmacokinetics - Metabolism and Excretion. Pediatrics (< 18 years of age) The safety and effectiveness of bromfenac ophthalmic solution in pediatric patients have not been established.
Page 6 of 23 Geriatrics (> 70 years of age):
No overall differences in safety and effectiveness have been observed with bromfenac ophthalmic solution between elderly and younger patients. ADVERSE REACTIONS Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Two multi-centre, randomized, double-masked, parallel-group and placebo (vehicle)-controlled, phase 3 studies of identical design (S00124 ER and S00124 WR) evaluated the efficacy and safety of bromfenac ophthalmic solution as compared with vehicle in the treatment of ocular inflammation and pain associated with cataract surgery.
The safety analyses were conducted on the Safety population, which included all randomized subjects undergoing cataract surgery who received at least 1 dose of investigational product (IP). In the pooled studies, a total of 416 patients were randomized with 212 receiving bromfenac ophthalmic solution alone and 204 receiving […]