Crolom

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Cromolyn sodium is an anti-inflammatory medicine. It works by preventing the release of substances in the body that cause inflammation.

Cromolyn sodium ophthalmic (for the eyes) is used to treat allergy symptoms that affect the eyes, such as itching, burning, watering, swelling, redness, or sensitivity to light.

Cromolyn sodium ophthalmic may also be used for purposes not listed in this medication guide.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

You should not use this medicine if you are allergic to cromolyn sodium.

This medicine is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether cromolyn sodium ophthalmic passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Do not give this medication to a child younger than 4 years old.

No information provided.

Contraindications

Hypersensitivity to product or components

Cautions

Transient burning/stinging upon instillation

Do not exceed frequency of administration

Severe anaphylxis reactions may occur (rare)

Transient burning or stinging may occur with ophthalmic use

Symptoms may occur when tapering or wihdrawing the drug

• Bausch & Lomb Incorporated

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of cromolyn in children up to 4 years of age with use in other age groups. For older children, this medicine is not expected to cause different side effects or problems than it does in adults.

The most frequently reported adverse reaction attributed to the use of cromolyn sodium ophthalmic solution, on the basis of reoccurrence following readministration, is transient ocular stinging or burning upon instillation.

The following adverse reactions have been reported as infrequent events. It is unclear whether they are attributed to the drug:

Conjunctival injection; watery eyes; itchy eyes; dryness around the eye; puffy eyes; eye irritation; and styes.

Immediate hypersensitivity reactions have been reported rarely and include dyspnea, edema, and rash.

Read the entire FDA prescribing information for Crolom (Cromolyn Ophthalmic)

In the U.S.

• Crolom

Available Dosage Forms:

• Solution

Therapeutic Class: Ophthalmologic Agent

Pharmacologic Class: Mast Cell Stabilizer

Crolom® (cromolyn sodium ophthalmic solution USP, 4%) is supplied in a plastic bottle individually cartoned with a controlled drop tip in the following sizes:

10 mL bottle (NDC 24208-300-10) - AB30709

DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT.

Storage:

Store between 15°-30°C (59°-86°F). Protect from light – store in original carton. Keep tightly closed. Replace cap immediately after use.

KEEP OUT OF REACH OF CHILDREN.

Rx only

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Tampa, Florida 33637
©Bausch & Lomb Incorporated

XO50206 (Folded)
XM10005 (Flat)
R.1/04-83

Applies to cromolyn ophthalmic: ophthalmic solution

Along with its needed effects, cromolyn ophthalmic (the active ingredient contained in Crolom) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur while taking cromolyn ophthalmic:

• Rash or redness around the eyes
• swelling of the membrane covering the white part of the eye, redness of the white part of the eye, styes, or other eye irritation not present before therapy

Some side effects of cromolyn ophthalmic may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Burning or stinging of eye (mild and temporary)

• Dryness or puffiness around the eye
• watering or itching of eye (increased)