Xirom

Xirom

Manufacturer:

Aristopharma

Distributor:

KTZ
Full Prescribing Info
Contents
Bromfenac.
Description
Each eye drops contains bromfenac sodium equivalent to bromfenac 0.9 mg and 0.01% sodium perborate as preservative.
Action
Pharmacology: Bromfenac is a nonsteroidal anti-inflammatory drug (NSAID) that has anti-inflammatory potency higher than diclofenac. The mechanism of its action is thought to be due to its ability to block prostaglandin synthesis by inhibiting cyclooxygenase 1 and 2.
Indications/Uses
Treatment of postoperative inflammation and pain in patients who have undergone cataract extraction, prevention of miosis in cataract surgery, treatment of pseudophakic cystoid macular edema (CME), treatment of external or anterior ocular Inflammatory diseases eg, blepharitis, conjunctivitis and scleritis.
Dosage/Direction for Use
Postoperative Inflammation in Patients who have Undergone Cataract Extraction: 1 drop 2 times daily beginning 24 hrs after cataract surgery and continuing through the first 2 weeks of the postoperative period.
Prevention of Miosis in Cataract Surgery: Beginning 1 hr prior to surgery, instill bromfenac every 30 min.
Pseudophakic Cystoid Macular Edema (CME): 1 drop 2 times daily for 3 months.
Other Indications: 1 drop 2 times daily.
Contraindications
Hypersensitivity to any ingredient in the formulation of Xirom.
Special Precautions
Use of topical NSAIDs in patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (eg, 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.
It is recommended that Xirom eye drops should be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time. Xirom eye drops should not be administered while wearing contact lenses.
Use in children: Safety and efficacy in pediatric patients have not been established.
Use in pregnancy: Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in lactation: Caution should be exercised when Xirom eye drops is administered to a nursing woman.
Use In Pregnancy & Lactation
Use in pregnancy: Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Use in lactation: Caution should be exercised when Xirom eye drops is administered to a nursing woman.
Adverse Reactions
The most commonly reported adverse experiences include abnormal sensation in eye, conjunctival hyperemia, eye irritation (including burning/stinging), eye pain, eye pruritus, eye redness, headache and iritis.
Drug Interactions
Not known.
Storage
Store below 30°C. Protect from light.
Not to be used 1 month after opening.
ATC Classification
S01BC11 - bromfenac ; Belongs to the class of non-steroidal antiinflammatory agents. Used in the treatment of inflammation of the eye.
Presentation/Packing
Eye drops 0.9% x 5 mL, 10 mL.
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