Product Description.:
Alcon
Lodoxamide Tromethamine
Anti-allergy Agent
Action And Clinical Pharmacology: Lodoxamide, a mast cell stabilizer inhibits the in vivo type I immediate hypersensitivity reaction in animals and man.
In vitro studies have demonstrated the ability of lodoxamide to stabilize mast cells and prevent the antigen specific induced release of histamine. In addition, lodoxamide prevents the release of other mast cell inflammatory mediators (i.e., SRS-A, slow reacting substances of anaphylaxis also known as the peptido-leukotrienes) and appears to inhibit eosinophil chemotaxis. Lodoxamide inhibits histamine release in vitro by preventing the movement of calcium into the mast cell after stimulation.
Indications And Clinical Uses: Treatment of the ocular signs and symptoms associated with vernal keratoconjunctivitis, giant papillary conjunctivitis, and allergic/atopic conjunctivitis.
Contra-Indications: Hypersensitivity to any component of this product.
Precautions: General: As with all ophthalmic medications containing benzalkonium chloride, patients should be advised to remove their contact lenses to instill lodoxamide ophthalmic solution and wait at least 15 minutes before reinserting the lenses.
Pregnancy: Reproduction studies with lodoxamide administered orally to rats and rabbits have not shown any effect of the product on fertility or reproductive performance, or any evidence of embryotoxicity or pre- and postnatal toxicity. However, there are no adequate and well controlled studies in pregnant women. Since animal reproduction studies are not always predictive of human response, lodoxamide should be used during pregnancy only if clearly needed.
Lactation: It is not known whether lodoxamide is excreted in human milk. Caution should be exercised when it is given to a nursing mother.
Children: The safety and effectiveness of lodoxamide ophthalmic solution in children below the age of 4 years have not been established.
Adverse Reactions: Lodoxamide has been generally well tolerated. In controlled clinical studies the most common side effect reported was mild and transient discomfort upon instillation (8.7% of patients) expressed as burning, stinging, itching or tearing.
Symptoms And Treatment Of Overdose: Symptoms and Treatment: Overdosage in the use of topical ophthalmic preparations is a remote possibility. Discontinue medication when heavy or protracted use is suspected. tag_DosageDosage
Dosage And Administration: Adults and children is 1 or 2 drops in each eye 4 times a day at regular intervals.
Patients should be advised that the effect of lodoxamide therapy is dependent upon its administration at regular intervals, as directed.
The safety and effectiveness of lodoxamide ophthalmic solution in children below the age of 4 years have not been established.
Improvements in signs and symptoms in response to lodoxamide therapy (decreased discomfort, itching, foreign body sensation, photophobia, acute ocular pain, tearing, discharge, erythema/swelling, bulbar conjunctivae, limbus, epithelial disease, ptosis) are usually evident within a few days, but longer treatment for up to 4 weeks is sometimes required. Once symptomatic improvement has been established, therapy should be continued for as long as needed to sustain improvement.
Patients should be instructed to avoid contamination of the dropper tip.
Availability And Storage: Each mL of sterile isotonic solution contains: lodoxamide 0.1% (lodoxamide tromethamine 0.178%). Nonmedicinal ingredients: benzalkonium chloride 0.007% (as preservative), citric acid, edetate disodium, hydroxypropyl methylcellulose, mannitol, purified water, sodium citrate and tyloxapol. Natural plastic ophthalmic Drop-Tainer dispensers of 10 mL. Store at room temperature.
