Alomide

Generic Name: Lodoxamide Tromethamine
Class: Antiallergic Agents
ATC Class: S01GX05
VA Class: OP900
Chemical Name: N,N′-2-(chloro-5-cyano-m-phenylene)dioxamic acid compound with 2-amino-2-(hydroxymethyl)-1,3-propanediol (1:2)
Molecular Formula: C11H6ClN3O6•2C4H11NO3
CAS Number: 63610-09-3

Introduction

Mast-cell stabilizer.1 2 4 6 7

Uses for Alomide

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

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Alomide Dosage and Administration

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

Allergic Ocular Disorders
Ophthalmic

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

Allergic Ocular Disorders
Ophthalmic

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

Cautions for Alomide

Contraindications

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

Warnings/Precautions

General Precautions

Ocular Effects

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

Specific Populations

Pregnancy

Category B.a

Lactation

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

Pediatric Use

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

Geriatric Use

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

Common Adverse Effects

Ocular burning, stinging, discomfort.a

Alomide Pharmacokinetics

Absorption

Bioavailability

Plasma concentrations are undetectable following topical application to the eye.1

Distribution

Extent

Not known whether lodoxamide is distributed into milk.a

Elimination

Elimination Route

Excreted principally in urine after oral administration.a

Half-life

8.5 hours following oral administration.a

Stability

Storage

Ophthalmic

Solution

15–27°C.a

Actions

  • 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

Advice to Patients

  • Importance of learning and adhering to proper administration techniques to avoid contamination of the product.a

  • Importance of not wearing soft contact lenses during therapy (since benzalkonium chloride preservative may be absorbed by the lenses).a

  • Importance of contacting clinician if burning or stinging experienced during instillation persists.a

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs as well as any concomitant illnesses.

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.a

  • Importance of informing patients of other important precautionary information.a (See Cautions.)

Preparations

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

Lodoxamide Tromethamine

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Solution

0.1% (of lodoxamide)

Alomide (with benzalkonium chloride)

Alcon

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Alomide 0.1% Solution (ALCON VISION): 10/$114.41 or 30/$333.43

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions August 1, 2005. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Alcon. Alomide (lodoxamide ophthalmic solution) 0.1% prescribing information. Fort Worth, TX; 1993 Nov.

2. Caldwell DR, Verin P, Hartwich-Young R et al. Efficacy and safety of lodoxamide 0.1% vs cromolyn sodium 4% in patients with vernal keratoconjunctivitis. Am J Ophthalmol. 1992; 113:632-7. [IDIS 297902] [PubMed 1598953]

3. Food and Drug Administration. Orphan designations pursuant to section 526 of the Federal Food and Cosmetic Act as amended by the Orphan Drug Act (P.L. 97-414), to June 30, 1993. Rockville, MD; 1993 Jul.

4. Yanni JM, Weimer LK, Glaser RL et al. Effect of lodoxamide on in vitro and in vivo conjunctival immediate hypersensitivity responses in rats. Int Arch Allergy Immunol. 1993; 101:102-6. [PubMed 7684628]

5. Alcon, Fort Worth, TX: Personal communication.

6. Anon. Lodoxamide for vernal keratoconjunctivitis. Med Lett Drugs Ther. 1994; 36:26. [PubMed 8121328]

7. Santos CI, Huang AJ, Abelson MB et al. Efficacy of lodoxamide 0.1% ophthalmic solution in resolving corneal epitheliopathy associated with vernal keratoconjunctivitis. Am J Ophthalmol. 1994; 117:488-97. [IDIS 328164] [PubMed 8154531]

a. Alcon. Alomide (lodoxamide ophthalmic solution) 0.1% prescribing information. Fort Worth, TX; 2003.

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