Presentation and Status in Health Basket
| Presentation | Basket | Yarpa | Pharmasoft |
|---|---|---|---|
|
Eye Drops 1 x 5 ml |
|
35618 | 2948 |
Dosage
One drop should be applied to the affected eye twice daily (morning and evening) 1 day prior to surgery, the day of surgery, and 14 days post-surgery.
This medicinal product should be administered at least 5 minutes after instillation of other topical medications.
Indications
For the treatment of postoperative inflammation and prevention of ocular pain in adult patients undergoing cataract surgery.
Contra-Indications
Hypersensitivity to the active substance or to any of the inactive ingredients.
Special Precautions
Caution should be used when treating individuals who have previously exhibited sensitivities to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs, including bromfenac.
It is recommended to use this medicinal product with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time.
Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs, including bromfenac, and should be closely monitored for corneal health.
This medicinal product should not be administered while wearing contact lenses. The preservative, benzalkonium chloride, may be absorbed by soft contact lenses.
Side Effects
The following serious adverse reactions are known:
• Slow or delayed healing
• Potential for cross-sensitivity
• Increased bleeding time of ocular tissue
• Keratitis and corneal reaction
• Contact lens wear
See prescribing information for full details.
Drug interactions
There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs.
Pregnancy and Lactation
Pregnancy:
There are no adequate and well-controlled studies in pregnant women to inform any drug associated risks. Because of the known effects of prostaglandin biosynthesis-inhibiting drugs on the fetal cardiovascular system (closure of ductus arteriosus), the use of bromfenac during late pregnancy should be avoided.
Lactation:
There are no data on the presence of bromfenac in human milk, the effects on the breastfed infant, or the effects on milk production; however, systemic exposure to bromfenac from ocular administration is low. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for bromfenac and any potential adverse effects on the breast-fed child from bromfenac or from the underlying maternal condition.
