Alomide (Lodoxamide tromethamine) ® (lodoxamide tromethamine ophthalmic solution) 0.1% is a sterile ophthalmic solution containing the mast cell stabilizer lodoxamide tromethamine for topical administration to the eyes. Lodoxamide tromethamine is a white, crystalline, water-soluble powder with a molecular weight of 553.91. The chemical structure is presented below:

N,N'-(2-chloro-5-cyano-m-phenylene)dioxamic acid tromethamine salt

Molecular Formula: CHONCl

Lodoxamide tromethamine is a mast cell stabilizer that inhibits the Type I immediate hypersensitivity reaction. Lodoxamide therapy inhibits the increases in cutaneous vascular permeability that are associated with reagin or IgE and antigen-mediated reactions.

Lodoxamide has no intrinsic vasoconstrictor, antihistaminic, cyclooxygenase inhibition, or other anti-inflammatory activity.

The disposition of C-lodoxamide was studied in six healthy adult volunteers receiving a 3 mg (50 μCi) oral dose of lodoxamide. Urinary excretion was the major route of elimination. The elimination half-life of C-lodoxamide was 8.5 hours in urine. In a study conducted in twelve healthy adult volunteers, topical administration of Alomide (Lodoxamide tromethamine) ® (lodoxamide tromethamine ophthalmic solution) 0.1%, one drop in each eye four times per day for ten days, did not result in any measurable lodoxamide plasma levels at a detection limit of 2.5 ng/mL.

Alomide (Lodoxamide tromethamine) ® (lodoxamide tromethamine ophthalmic solution) 0.1% is indicated in the treatment of the ocular disorders referred to by the terms vernal keratoconjunctivitis, vernal conjunctivitis, and vernal keratitis.

Hypersensitivity to any component of this product.

FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION. As with all ophthalmic preparations containing benzalkonium chloride, patients should be instructed not to wear soft contact lenses during treatment with Alomide (Lodoxamide tromethamine) ® Ophthalmic Solution. Do not touch the dropper tip to any surface, as this may contaminate the solution.

During clinical studies of Alomide (Lodoxamide tromethamine) ® (lodoxamide tromethamine ophthalmic solution) 0.1%, the most frequently reported ocular adverse experiences were transient burning, stinging, or discomfort upon instillation, which occurred in approximately 15% of the subjects. Other ocular events occurring in 1 to 5% of the subjects included ocular itching/pruritus, blurred vision, dry eye, tearing/discharge, hyperemia, crystalline deposits, and foreign body sensation. Events that occurred in less than 1% of the subjects included corneal erosion/ulcer, scales on lid/lash, eye pain, ocular edema/swelling, ocular warming sensation, ocular fatigue, chemosis, corneal abrasion, anterior chamber cells, keratopathy/keratitis, blepharitis, allergy, sticky sensation, and epitheliopathy.

Nonocular events reported were headache (1.5%) and (at less than 1%) heat sensation, dizziness, somnolence, nausea, stomach discomfort, sneezing, dry nose, and rash.

There have been no reports of Alomide (Lodoxamide tromethamine) ® (lodoxamide tromethamine ophthalmic solution) 0.1% overdose following topical ocular application. Accidental overdose of an oral preparation of 120 to 180 mg of lodoxamide resulted in a temporary sensation of warmth, profuse sweating, diarrhea, light-headedness, and a feeling of stomach distension; no permanent adverse effects were observed. Side effects reported following systemic oral administration of 0.1 mg to 10.0 mg of lodoxamide include a feeling of warmth or flushing, headache, dizziness, fatigue, sweating, nausea, loose stools, and urinary frequency/urgency. The physician may consider emesis in the event of accidental ingestion.

The dose for adults and children greater than two years of age is one to two drops in each affected eye four times daily for up to 3 months.

Alomide (Lodoxamide tromethamine) ® (lodoxamide tromethamine ophthalmic solution) 0.1% is supplied in plastic ophthalmic DROP-TAINER® dispenser as follows:

10 mL: 0065-0345-10

Store at 15°C - 27°C (59°F - 80°F).

(lodoxamide

tromethamine

ophthalmic solution)