Lodoxamide Tromethamine

You should not use this medication if you are allergic to lodoxamide.

FDA pregnancy category B. Lodoxamide is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether lodoxamide passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Mast-cell stabilizer.1 2 4 6 7

Allergic Ocular Disorders

Symptomatic treatment of certain allergic ocular disorders including vernal keratoconjunctivitis, vernal conjunctivitis, and vernal keratitis (designated an orphan drug by FDA for such use).1 2 3 6 7

Administration

Ophthalmic Administration

Apply topically to the eye as an ophthalmic solution.1 Not for injection.1 Not for subconjunctival injection or introduction directly into anterior chamber of the eye.1 5

Avoid contamination of the solution container.1

Dosage

Available as lodoxamide tromethamine; dosage expressed in terms of lodoxamide.1

Pediatric Patients

Children ≥2 years of age: 1 or 2 drops of a 0.1% solution in the affected eye(s) 4 times daily for up to 3 months.1 2 6 7

Adults

1 or 2 drops of a 0.1% solution in the affected eye(s) 4 times daily for up to 3 months.1 2 6 7

Contraindications

• Known hypersensitivity to lodoxamide or any ingredient in the formulation.a

Warnings/Precautions

General Precautions

Possible ocular burning or stinging upon installation.a (See Advice to Patients.)

Specific Populations

Category B.a

Not known whether lodoxamide is distributed into milk.a Use with caution in nursing women.a

Safety and efficacy not established in children <2 years of age.1

No substantial differences in safety and efficacy relative to younger adults.a

Common Adverse Effects

Ocular burning, stinging, discomfort.a

Storage

Ophthalmic

15–27°C.a

• Prevents the activation and release of inflammatory mediators from cells involved in hypersensitivity reactions, including mast cells, and inhibits chemotaxis of eosinophils.1 2 4 6 7

• Exhibits no direct vasoconstrictor, antihistaminic, or anti-inflammatory activity.1 4 6

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.