Xirom 0.09%5 ml

Xirom 0.09% 5 ml ophthalmic solution is a topical nonsteroidal anti-inflammatory drug (NSAID) formulated for use in the eye. Its evidence-based uses are as follows:

Established / FDA-approved use

• Treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. This is the primary, well-established indication for Xirom 0.09% 5 ml ophthalmic solution and is supported by controlled clinical trials.

Guideline-supported / commonly extended use

• Some ophthalmologists use Xirom 0.09% 5 ml ophthalmic solution off-label for control of postoperative inflammation following other anterior segment surgeries (e.g. corneal or refractive procedures), based on its NSAID mechanism, although this is not a formally FDA-approved indication and should only be done under specialist supervision.

Xirom 0.09% 5 ml ophthalmic solution is for topical use in the eye only and is not intended for injection, oral, or systemic use.

Each formulation of Xirom 0.09% 5 ml ophthalmic solution contains Xirom 0.09% 5 ml as the active ingredient, at a strength (commonly 0.07% or 0.09% w/v depending on the specific branded product) determined by the prescribing physician and product availability.

Inactive ingredients typically include a preservative (e.g. benzalkonium chloride), tonicity and buffering agents (such as boric acid, sodium borate, and edetate disodium), and purified water. The exact inactive-ingredient composition may vary slightly by manufacturer/brand.

Xirom 0.09% 5 ml is a topical, nonsteroidal anti-inflammatory drug (NSAID) formulated as a sterile ophthalmic solution (eye drops). It belongs to the phenylacetic acid class of NSAIDs and is used to reduce ocular inflammation and pain, most commonly following cataract surgery.

Xirom 0.09% 5 ml ophthalmic solution works by inhibiting the cyclooxygenase (COX) enzymes involved in the production of prostaglandins — key inflammatory mediators responsible for postoperative pain, redness, and swelling in the eye.

Xirom 0.09% 5 ml ophthalmic solution is intended for use strictly in the eye and must not be injected or taken orally.

Ophthalmic Nonsteroidal Anti-Inflammatory Drug (NSAID) — Xirom 0.09% 5 ml belongs to this class of topical anti-inflammatory eye preparations.

Xirom 0.09% 5 ml is a nonsteroidal anti-inflammatory drug (NSAID) that works by non-selectively and reversibly inhibiting the cyclooxygenase (COX-1 and COX-2) enzymes, which are responsible for converting arachidonic acid into prostaglandins and other prostanoids.

By blocking prostaglandin synthesis in ocular tissue, Xirom 0.09% 5 ml ophthalmic solution reduces the inflammatory cascade that produces pain, redness, photophobia, and vascular permeability associated with intraocular surgery. Unlike corticosteroids, Xirom 0.09% 5 ml ophthalmic solution does not raise intraocular pressure and does not appear to impair wound healing to the same degree, though it can still delay healing in some patients (see Precautions and Warnings).

Following topical ocular administration, systemic absorption of Xirom 0.09% 5 ml is minimal, and plasma concentrations are generally very low or undetectable, limiting the potential for systemic NSAID-type adverse effects.

• For topical ophthalmic (eye) use only. Xirom 0.09% 5 ml ophthalmic solution must never be injected or swallowed.
• Wash hands before use. Avoid letting the dropper tip touch the eye, eyelid, fingers, or any other surface, to prevent contamination.
• Tilt the head back, gently pull down the lower eyelid to form a small pocket, and instill one drop as directed.
• Close the eye gently for 1–2 minutes after instillation; avoid blinking rapidly. Applying gentle pressure at the inner corner of the eye (nasolacrimal occlusion) can reduce systemic absorption.
• Remove contact lenses before instilling Xirom 0.09% 5 ml ophthalmic solution; lenses may be reinserted after a period as advised by the physician (the product contains a preservative that can be absorbed by soft contact lenses).
• If more than one topical ophthalmic medicine is being used, wait at least 5 minutes between different products.
• Use Xirom 0.09% 5 ml ophthalmic solution for the full course prescribed, even if the eye feels better, unless your physician instructs otherwise.

Other topical ophthalmic NSAIDs or corticosteroids: Concurrent use of Xirom 0.09% 5 ml ophthalmic solution with other topical NSAIDs may increase the risk of corneal healing problems; use of Xirom 0.09% 5 ml ophthalmic solution together with topical corticosteroids may also increase the potential for delayed healing. Such combinations should only be used under close ophthalmologist supervision.

Systemic anticoagulants and antiplatelet agents (e.g. warfarin, heparin, aspirin, clopidogrel): Xirom 0.09% 5 ml ophthalmic solution can interfere with platelet aggregation; patients on these agents, or with known bleeding tendencies, may have an increased risk of ocular bleeding (including hyphema) during ocular surgery when using Xirom 0.09% 5 ml ophthalmic solution — see Precautions and Warnings.

Because systemic absorption of Xirom 0.09% 5 ml ophthalmic solution after topical ocular use is minimal, clinically significant systemic drug interactions (e.g. with oral medications) are not expected, but patients should inform their physician of all medicines and eye drops they are using.

Most adverse effects of Xirom 0.09% 5 ml ophthalmic solution are local, mild, and transient. Reported adverse reactions include:

• Eye irritation, eye pain, or abnormal sensation in the eye
• Conjunctival hyperemia (redness)
• Itching (pruritus) of the eye
• Photophobia (light sensitivity)
• Blurred vision
• Headache
• Iritis

Less common but more serious effects — corneal thinning, erosion, or perforation, and increased ocular bleeding — are discussed in detail under Precautions and Warnings, as they represent important class warnings for ophthalmic NSAIDs such as Xirom 0.09% 5 ml ophthalmic solution.

Pregnancy: There are no adequate and well-controlled studies of Xirom 0.09% 5 ml ophthalmic solution in pregnant women. As with other NSAIDs, use during the third trimester of pregnancy should generally be avoided because of the potential for premature closure of the fetal ductus arteriosus. Xirom 0.09% 5 ml ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, and only under the direct advice of a physician.

Lactation: It is not known whether Xirom 0.09% 5 ml is excreted in human breast milk following topical ocular administration. Because many drugs are excreted in human milk, caution should be exercised and a physician consulted before using Xirom 0.09% 5 ml ophthalmic solution while breastfeeding.

Corneal effects

Use of topical NSAIDs, including Xirom 0.09% 5 ml ophthalmic solution, may cause keratitis. In some susceptible patients, continued use can lead to corneal 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 discontinue Xirom 0.09% 5 ml ophthalmic solution immediately and be closely monitored.

Postmarketing experience with topical NSAIDs, including Xirom 0.09% 5 ml ophthalmic solution, 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, and those using topical NSAIDs for longer than the recommended duration or concomitantly with topical corticosteroids, may be at increased risk for corneal adverse events.

Increased bleeding risk

Xirom 0.09% 5 ml ophthalmic solution, like other topical NSAIDs, may interfere with platelet aggregation and cause increased bleeding of ocular tissues, including hyphema, in conjunction with ocular surgery. Caution is advised in patients with known bleeding tendencies or who are taking other medications that may prolong bleeding time.

Delayed healing

Xirom 0.09% 5 ml ophthalmic solution, like other NSAIDs, may slow or delay healing of ocular tissue. Concomitant use of topical corticosteroids with Xirom 0.09% 5 ml ophthalmic solution may increase this risk.

Contact lens use

Contact lenses should be removed prior to instillation of Xirom 0.09% 5 ml ophthalmic solution; the preservative in the solution may be absorbed by soft contact lenses.

Not for injection

Xirom 0.09% 5 ml ophthalmic solution is for topical ophthalmic use only and must not be injected into the eye or used systemically.

Cross-sensitivity

There is a potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs. Caution should be used when treating patients who have previously exhibited sensitivity to these drugs.

Topical ocular overdose of Xirom 0.09% 5 ml ophthalmic solution is unlikely to cause serious systemic toxicity because systemic absorption after ophthalmic use is minimal. If excess solution is instilled, the eye may be flushed with lukewarm water.

If Xirom 0.09% 5 ml ophthalmic solution is accidentally swallowed, drink fluids to dilute and seek immediate medical attention or contact a poison control center / emergency services. Do not attempt any specific home treatment beyond this without medical guidance.

Store at room temperature (15°C to 25°C / 59°F to 77°F). Protect from light. Do not freeze. Keep the bottle tightly closed when not in use, and keep out of reach of children.

Pediatric patients

Safety and effectiveness of Xirom 0.09% 5 ml ophthalmic solution in pediatric patients have not been established.

Geriatric patients

No overall differences in safety or effectiveness of Xirom 0.09% 5 ml ophthalmic solution have been observed between elderly and younger adult patients; no dose adjustment is required based on age alone.

Renal and hepatic impairment

Specific studies in patients with renal or hepatic impairment have not been conducted; however, because systemic absorption of Xirom 0.09% 5 ml ophthalmic solution after topical ocular use is minimal, dose adjustment is not generally expected to be necessary. Physician judgment should still guide use in such patients.

Xirom 0.09% 5 ml ophthalmic solution is typically used for approximately 2 weeks (14 days) around the time of cataract surgery — beginning 1 day before surgery (for once-daily formulations) or the day after surgery (for twice-daily formulations) and continuing through the first 14 postoperative days — unless the prescribing physician directs a different duration. Treatment should not be continued beyond the period recommended by the physician, given the risk of corneal adverse effects with prolonged use.

Nonsteroidal Anti-Inflammatory Drug (NSAID) — phenylacetic acid derivative; ophthalmic anti-inflammatory / anti-inflammatory eye drop. Xirom 0.09% 5 ml belongs to this drug class.

Xirom 0.09% 5 ml exerts its effect by reversibly inhibiting the cyclooxygenase (COX-1 and COX-2) enzymes, which reduces the synthesis of prostaglandins in ocular tissue. Because prostaglandins are key mediators of inflammation, pain, vasodilation, and increased vascular permeability, this inhibition by Xirom 0.09% 5 ml ophthalmic solution reduces postoperative ocular inflammation, pain, and photophobia without the intraocular-pressure-raising effects associated with corticosteroids.

C

The safety and effectiveness of Xirom 0.09% 5 ml ophthalmic solution have not been established in pediatric patients. It should be used in children only if a physician determines that the potential benefit outweighs the potential risk, and under close medical supervision, since dedicated pediatric clinical trial data are lacking.