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APO-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.
07% w/v) is administered by instillation into the affected eye. It is indicated for topical ophthalmic use only. 07% w/v has not been studied in pediatric patients, pregnant or nursing women and patients with hepatic impairment. Therefore, no specific dosage recommendations can be made for these patients.
Recommended Dose and Dosage Adjustment One drop of APO-BROMFENAC should be applied to the affected eye once daily beginning 1 day prior to cataract surgery, and continued on the day of surgery, and through the first 14 days of the postoperative period.
Missed Dose If a dose is missed, it should be applied as soon as possible. However, if it is almost time for the next dose, the missed dose should be skipped, and the regular dosing schedule should be resumed. Administration Instill one drop into the affected eye once daily beginning 1 day prior to surgery, continued on the day of surgery, and through the first 14 days of the postoperative period.
Discard any unused eye drops 28 days after opening. Use with Other Topical Ophthalmic Medications APO-BROMFENAC may be administered in conjunction with other topical ophthalmic medications such as alpha-agonists, beta-blockers, carbonic anhydrase inhibitors, cycloplegics, and mydriatics.
The medications should be administered at least 5 minutes apart. Contact Lens Wear APO-BROMFENAC should not be instilled while wearing contact lenses. If contact lenses use is recommended by the physician, they should be removed prior to instillation of APO-BROMFENAC and may be re-inserted 15 minutes following administration of APO-BROMFENAC.
PrAPO-BROMFENAC Product Monograph Page 10 of 26 The preservative in APO-BROMFENAC, benzalkonium chloride, may be absorbed by soft contact lenses. 07% w/v. If APO-BROMFENAC is accidentally ingested, drink fluids to dilute. For management of a suspected drug overdose, contact your regional poison control centre.
ACTION AND CLINICAL PHARMACOLOGY Mechanism of Action Bromfenac is a non-steroidal anti-inflammatory drug (NSAID) that has anti-inflammatory activity. The mechanism of action is thought to be due to the drug’s ability to block prostaglandin synthesis by inhibiting cyclooxygenase (COX) 1 and 2.
Prostaglandins have been shown in many animal models to be mediators of certain kinds of intraocular inflammation. In studies performed in animal eyes, prostaglandins have been shown to produce disruption of the blood-aqueous humor barrier, vasodilation, increased vascular permeability, leukocytosis, and increased intraocular pressure.
General There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other non-steroidal anti-inflammatory drugs (NSAIDs), including APO-BROMFENAC. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.
APO-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 APO-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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Pharmacodynamics In earlier studies the basic mechanism of action along with anti-inflammatory, anti-pyretic, and analgesic effects were examined using various in vitro and in vivo techniques. See DETAILED PHARMACOLOGY – Pharmacodynamics.
Pharmacokinetics Absorption Following ocular topical dosing, four times daily for 28 days in healthy human subjects, it was suggested that the bromfenac plasma concentration was very low (possibly ≤ 50ng/ml). 07% w/v is used as directed.
After oral administration, bromfenac has been shown to be absorbed into the systemic circulation. Distribution No human studies are available; however, studies in rabbits have shown that 14C-bromfenac is extensively distributed throughout the eye following a single topical administration.
See animal studies in DETAILED PHARMACOLOGY - Pharmacodynamics. PrAPO-BROMFENAC Product Monograph Page 11 of 26 Bromfenac shows high affinity for binding to mammalian plasma proteins. 8% of bromfenac was bound to proteins in human plasma.
In rabbits, Bromfenac is distributed to pigment rich ocular tissues, however, no biologically relevant binding to melanin was observed in vitro. See DETAILED PHARMACOLOGY - Protein Binding. Metabolism Although no studies have been conducted regarding the sites of metabolism for ophthalmic bromfenac, a study in human volunteers orally treated with radiolabelled 14C-bromfenac, suggested that, unchanged parent compound was the predominant component in plasma, and metabolites of bromfenac were predominant in urine.
Excretion Following oral administration of 14C-bromfenac to healthy human volunteers, the majority of radioactivity was detected in the urine, which accounted for approximately 82% of the dose, while fecal elimination represented approximately 13% of the dose.
, hepatic insufficiency). STORAGE AND STABILITY Store at 15°C - 25°C. Discard 28 days after opening. SPECIAL HANDLING INSTRUCTIONS To minimise the chance of contamination of the dropper tip and bromfenac solution, patients are advised to replace the bottle cap after use, and to avoid touching the eyelids, surrounding areas or other surfaces with the dropper tip of the bottle.
Patients are advised that a single bottle of APO-BROMFENAC is used to treat only one eye. 07% w/v topical ophthalmic solution. 07% w/v topical ophthalmic solution is supplied in a white opaque LDPE plastic bottle with a white translucent LDPE dropper and gray opaque HDPE plastic cap.
6 mL and 3 mL. 005%, and contains the following inactive ingredients: boric acid, EDTA […]
Patients may have to be monitored for occurrence of macular edema upon discontinuation of APO-BROMFENAC. PrAPO-BROMFENAC Product Monograph Page 5 of 26 Contact Lens Wear APO-BROMFENAC should not be instilled while wearing contact lenses.
Remove contact lenses prior to instillation of APO-BROMFENAC. The preservative in APO-BROMFENAC, benzalkonium chloride may be absorbed by soft contact lenses. Lenses may be reinserted 15 minutes after administration of APO-BROMFENAC.
Hematologic Bleeding With some NSAIDs, including APO-BROMFENAC, there exists the potential for increased bleeding time due to interference with platelet aggregation. 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 APO-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.
07% w/v in pregnant women. APO- 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 APO-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 APO-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 - PrAPO-BROMFENAC Product Monograph Page 6 of 26 Metabolism and Excretion. 07% w/v in pediatric patients have not been established. 07% w/v 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. 07% w/v 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 […]