Alomide

Use the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using lodoxamide and call your doctor at once if you have severe burning or stinging when you apply the eye drops, or for long periods of time after using the drops.

Less serious side effects may include:

• mild burning, stinging, or eye irritation;

• eye itching, watering, pain, or redness;

• blurred vision;

• dry eyes;

• swollen or puffy eye lids;

• feeling that something is in your eye; or

• crusting or drainage from your eyes.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

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

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.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Burning.
• Stinging.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Alomide® (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:

Structural Formula:

Chemical Name:

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

Molecular Formula: C19H28O12N5Cl

Each mL of Alomide® (lodoxamide tromethamine ophthalmic solution) 0.1% contains: Active: 1.78 mg lodoxamide tromethamine equivalent to 1 mg lodoxamide. Preservative: benzalkonium chloride 0.007%. Inactive: mannitol, hypromellose 2910, sodium citrate, citric acid, edetate disodium, tyloxapol, hydrochloric acid and/or sodium hydroxide (adjust pH), and purified water.

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.

NDC 0065-0345-10

Alcon®

Alomide® 0.1%
(lodoxamide tromethamine ophthalmic solution)

10 mL Sterile

EACH mL CONTAINS: lodoxamide tromethamine 1.78 mg, equivalent to 1 mg lodoxamide with benzalkonium chloride 0.007 %, mannitol, hypromellose 2910, sodium citrate, tyloxapol, citric acid, edetate disodium, sodium hydroxide and/or hydrochloric acid (to adjust pH), and purified water.

Rx Only

DROP-TAINER® Dispenser

STORAGE: Store at 15°-25°C (59°-77°F).

FOR TOPICAL OPHTHALMIC USE ONLY.

USUAL DOSAGE: Instill one to two drops in affected eye(s) four times daily.

PRECAUTION: Do not touch dropper tip to any surface, as this may contaminate the solution.

Alcon®
a Novartis Company

ALCON LABORATORIES, INC.
Fort Worth, Texas 76134 USA
Printed in USA
©2001, 2003, 2013, 2015 Novartis

9012549-1115

LOT:

EXP.:

NDC 0065-0345-10

Alcon®

Alomide® 0.1%
(lodoxamide tromethamine ophthalmic solution)

Sterile 10 mL

Rx Only

EACH mL CONTAINS: lodoxamide tromethamine 1.78 mg, equivalent to 1 mg lodoxamide

STORAGE: Store at 15°-25°C (59°-77°F).

FOR TOPICAL OPHTHALMIC USE ONLY.

PRECAUTION: Do not touch dropper tip to any surface, as this may contaminate the solution.

USUAL DOSAGE: Instill one to two drops in affected eye(s) four times daily.

ALCON LABORATORIES, INC.
Fort Worth, Texas 76134 USA
© 2001, 2004, 2015 Novartis 

LOT:

EXP.:

H14106-1115 

• Allergy Drugs: Prescription and OTC

Applies to lodoxamide ophthalmic: ophthalmic solution

General

The most common ocular side effects reported were a burning sensation, stinging or discomfort following instillation.[Ref]

Ocular

Very common (10% or more): Discomfort upon instillation (15%)
Common (1% to 10%): Blurred vision, dryness, pruritus, increased lacrimation, hyperemia
Uncommon (0.1% to 1%): Eye pain, edema, asthenopia, corneal deposits, abnormal or foreign body sensation in eye, discharge, irritation, eyelid exfoliation, lid margin crusting
Rare (0.01% to 0.1%): Corneal erosion, scar, abrasion, epitheliopathy; anterior chamber cell, keratitis, blepharitis, allergy, visual impairment, eyelid edema, conjunctival disorder
Very rare: Fatigue, warming sensation, keratopathy, keratitis, blepharitis, sticky sensation, corneal abrasion[Ref]

Gastrointestinal

Uncommon (0.1% to 1%): Nausea
Rare (0.01% to 0.1%): Abdominal discomfort[Ref]

Nervous system

Common (1% to 10%): Headache
Uncommon (0.1% to 1%): Dizziness
Rare (0.01% to 0.1%): Somnolence, dysgeusia[Ref]

Respiratory

Rare (0.01% to 0.1%): Nasal dryness, sneezing[Ref]

Cardiovascular

Frequency not reported: Palpitations[Ref]

Other

Uncommon (0.1% to 1%): Feeling hot[Ref]

Some side effects of Alomide may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Use is not recommended unless clearly needed. AU TGA pregnancy category: B1 US FDA pregnancy category: B

Animal studies using doses up to 5000 times the normal human dose have failed to reveal evidence of reproductive toxicity. Some manufacturers recommend avoiding use of this drug as a precautionary measure. There are no controlled data in human pregnancy. AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.