Lodoxamide Tromethamine (Alomide)
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Lodoxamide Tromethamine (Alomide)

ALOMIDE®
(lodoxamide tromethamine) Ophthalmic Solution 0.1%

DRUG DESCRIPTION

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

ALOMIDE® (lodoxamide tromethamine) Structural Formula Illustration

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.

What are the possible side effects of lodoxamide ophthalmic (Alomide)?

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...

Read All Potential Side Effects and See Pictures of Alomide »

What are the precautions when taking lodoxamide tromethamine (Alomide)?

Before using lodoxamide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like benzalkonium chloride), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

After you apply this drug, your vision may become temporarily blurred. Also, this drug may rarely make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

During pregnancy, this medication should be used only when clearly needed. Discuss...

Read All Potential Precautions of Alomide »

Last reviewed on RxList: 8/14/2008
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

ALOMIDE® (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.

DOSAGE AND ADMINISTRATION

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.

HOW SUPPLIED

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

10 mL: NDC 0065-0345-10

Storage

Store at 15°C - 27°C (59°F - 80°F).

ALCON LABORATORIES, INC., Fort Worth, Texas 76134 USA. FDA revision date: 06/26/03

Last reviewed on RxList: 8/14/2008
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

During clinical studies of ALOMIDE® (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.

Read the Alomide (lodoxamide tromethamine) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

No information provided.

Last reviewed on RxList: 8/14/2008
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

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.

PRECAUTIONS

General: Patients may experience a transient burning or stinging upon instillation of ALOMIDE® (lodoxamide tromethamine) Ophthalmic Solution. Should these symptoms persist, the patient should be advised to contact the prescribing physician.

Carcinogenesis, Mutagenesis, Impairment of Fertility

A long-term study with lodoxamide tromethamine in rats (two-year oral administration) showed no neoplastic or tumorigenic effects at doses 100 mg/kg/day (more than 5000 times the proposed human clinical dose). No evidence of mutagenicity or genetic damage was seen in the Ames SalmonellaAssay, Chromosomal Aberration in CHO Cells Assay, or Mouse Forward Lymphoma Assay. In the BALB/c-3T3 Cells Transformation Assay, some increase in the number of transformed foci was seen at high concentrations (greater than 4000 μg/mL). No evidence of impairment of reproductive function was shown in laboratory animal studies.

Pregnancy: Pregnancy Category B.Reproduction studies with lodoxamide tromethamine administered orally to rats and rabbits in doses of 100 mg/kg/day (more than 5000 times the proposed human clinical dose) produced no evidence of developmental toxicity. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, ALOMIDE® (lodoxamide tromethamine ophthalmic solution) 0.1% should be used during pregnancy only if clearly needed.

Nursing Mothers: It is not known whether lodoxamide tromethamine is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ALOMIDE® (lodoxamide tromethamine) Ophthalmic Solution 0.1% is administered to nursing women.

Pediatric Use: Safety and effectiveness in pediatric patients below the age of 2 years have not been established.

Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Last reviewed on RxList: 8/14/2008
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

There have been no reports of ALOMIDE® (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.

CONTRAINDICATIONS

Hypersensitivity to any component of this product.

Last reviewed on RxList: 8/14/2008
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Lodoxamide tromethamine is a mast cell stabilizer that inhibits the in vivo 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.

In vitro studies have demonstrated the ability of lodoxamide to stabilize rodent mast cells and prevent antigen-stimulated 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 inhibits eosinophil chemotaxis. Although lodoxamide's precise mechanism of action is unknown, the drug has been reported to prevent calcium influx into mast cells upon antigen stimulation.

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

The disposition of 14C-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 14C-lodoxamide was 8.5 hours in urine. In a study conducted in twelve healthy adult volunteers, topical administration of ALOMIDE® (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.

Last reviewed on RxList: 8/14/2008
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 8/14/2008
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

Last reviewed on RxList: 8/14/2008
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Alomide Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

LODOXAMIDE - OPHTHALMIC

(low-DOX-uh-mide)

COMMON BRAND NAME(S): Alomide

USES: This medication is used to treat certain allergic eye conditions (vernal keratoconjunctivitis, vernal conjunctivitis, vernal keratitis). It prevents itching of the eyes that can occur with these conditions. Lodoxamide is known as a mast cell stabilizer. It works by blocking certain natural substances (histamine, leukotriene) that cause allergic symptoms.

HOW TO USE: To apply eye drops, wash your hands first. To avoid contamination, do not touch the dropper tip or let it touch your eye or any other surface.

It is best to not wear contact lenses while using this medication.

This medication is used in the affected eye(s), usually 4 times daily or as directed by your doctor. Treatment may be continued for as long as 3 months.

Tilt your head back, look upward, and pull down the lower eyelid to make a pouch. Hold the dropper directly over the eye and place 1 drop into the pouch. Look downward and gently close your eyes for 1 to 2 minutes. Place one finger at the corner of the eye near the nose and apply gentle pressure. This will prevent the medication from draining away from the eye. Try not to blink and do not rub the eye. Repeat these steps if your dose is for more than 1 drop and for the other eye if so directed.

Do not rinse the dropper. Replace the dropper cap tightly after each use.

If you are using another kind of eye medication (e.g., drops or ointments), wait at least 5 minutes before applying other medications. Use eye drops before eye ointments to allow the eye drops to enter the eye.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same times each day. Continue using it for the full time prescribed.

It may take up to several days of continued use to see a relief in symptoms. If immediate relief of symptoms (itching) is needed, use other quick-relief medication (such as eye drops containing antihistamines, decongestants, or nonsteroidal anti-inflammatory drugs-NSAIDs) along with lodoxamide as directed by your doctor. Tell your doctor if your condition persists or worsens.

Disclaimer

Alomide Consumer (continued)

SIDE EFFECTS: Eye burning/stinging/discomfort, feeling as if something is in your eye, dry nose, sneezing, headache, dizziness, drowsiness, blurred vision, watery eyes, dry eyes, sticky feeling in the eye, or crusting in the corner of the eye or on the eyelid may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but very serious side effects occur: eye pain, swelling in or around the eyes, warm feeling in the eye, vision changes.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Alomide (lodoxamide tromethamine) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before using lodoxamide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like benzalkonium chloride), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

After you apply this drug, your vision may become temporarily blurred. Also, this drug may rarely make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Disclaimer

Alomide Consumer (continued)

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use.

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: This medicine may be harmful if swallowed. If swallowing or overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms after swallowing lodoxamide may include: flushing, feeling of warmth, unusual tiredness, sweating, diarrhea.

NOTES: Avoid allergens that may be the cause of your allergies. Some common allergens that cause allergic eye conditions include pollen, grasses, weeds, dust mites, and pet dander.

Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another condition unless directed to do so by your doctor. A different medication may be necessary in that case.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store dropper bottle upright at room temperature between 59-80 degrees F (15-27 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised August 2010. Copyright(c) 2010 First Databank, Inc.

Alomide Patient Information Including Side Effects

Brand Names: Alomide

Generic Name: lodoxamide ophthalmic (Pronunciation: loe DOX a mide)

What is lodoxamide ophthalmic (Alomide)?

Lodoxamide is an allergy medication. It inhibits processes in the body that cause allergic symptoms in response to allergy-causing substances.

Lodoxamide ophthalmic (for the eyes) is used to treat seasonal eye symptoms such as inflammation, itching, redness, and burning.

Lodoxamide ophthalmic may also be used for other purposes not listed in this medication guide.

What are the possible side effects of lodoxamide ophthalmic (Alomide)?

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.

Read the Alomide (lodoxamide tromethamine) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about lodoxamide ophthalmic (Alomide)?

Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Do not use lodoxamide while you are wearing contact lenses. This medication may contain a preservative that can be absorbed by soft contact lenses and cause discoloration. Wait at least 15 minutes after using lodoxamide before putting your contact lenses in.

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.

Side Effects Centers

Alomide Patient Information including How Should I Take

What should I discuss with my healthcare provider before using lodoxamide ophthalmic (Alomide)?

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.

How should I use lodoxamide ophthalmic (Alomide)?

Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Do not use lodoxamide while you are wearing contact lenses. This medication may contain a preservative that can be absorbed by soft contact lenses and cause discoloration. Wait at least 15 minutes after using lodoxamide before putting your contact lenses in.

Wash your hands before using the eye drops.

To apply the eye drops:

  • Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the dropper tip down. Look up and away from the dropper as you squeeze out a drop, then close your eye.
  • Gently press your finger to the inside corner of the eye (near your nose) for about 1 minute to keep the liquid from draining into your tear duct. If you use more than one drop in the same eye, wait about 5 minutes before putting in the next drop.
  • Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Do not use the eye drops if the liquid has changed colors or has particles in it. Call your doctor for a new prescription.

Store the drops at cool room temperature away from heat and moisture. Keep the bottle tightly closed when not in use.

Side Effects Centers

Alomide Patient Information including If I Miss a Dose

What happens if I miss a dose (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.

What happens if I overdose (Alomide)?

Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of lodoxamide ophthalmic applied to the eyes is not likely to occur.

What should I avoid while using lodoxamide ophthalmic (Alomide)?

Do not touch the dropper to any surface, including your eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in your eye.

Do not use any other eye medications unless your doctor has prescribed them.

What other drugs will affect lodoxamide ophthalmic (Alomide)?

It is not likely that other drugs you take orally or inject will have an effect on lodoxamide ophthalmic. But many drugs can interact with each other. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about lodoxamide ophthalmic.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 3.09. Revision date: 12/15/2010.

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Side Effects Centers

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