CrolomTM (Cromolyn Sodium Ophthalmic Solution USP, 4%) is a clear, colorless, sterile solution for topical ophthalmic use. It has an empirical formula of C₂₃H₁₄Na₂O₁₁.

Chemical Name: Disodium 5,5†- [(2-hydroxytrimethylene)dioxy]bis[4-oxo-4H-l-benzopyran-2-carboxylate] Pharmacologic Category: Mast cell stabilizer.

EACH mL CONTAINS: ACTIVE: Cromolyn Sodium 40 mg (4%); INACTIVES: Edetate Disodium 0.1% and Purified Water. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 - 7.0). PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%.

Cromolyn sodium ophthalmic solution is indicated in the treatment of vernal keratoconjunctivitis, vernal conjunctivitis, and vernal keratitis.

Symptomatic response to therapy (decreased itching, tearing, redness and discharge) is usually evident within a few days, but longer treatment for up to six weeks is sometimes required. Once symptomatic improvement has been established, therapy should be continued for as long as needed to sustain improvement.

If required, corticosteroids may be used concomitantly with cromolyn sodium ophthalmic solution.

Users of soft (hydrophilic) contact lenses should refrain from wearing lenses while under treatment with cromolyn sodium ophthalmic solution (see CONTRAINDICATIONS). Wear can be resumed within a few hours after discontinuation of the drug.

The dose for adults and children is 1 or 2 drops in each eye 4 to 6 times a day at regular intervals. One drop contains approximately 1.6 mg cromolyn sodium.

Patients should be advised that the effect of cromolyn sodium ophthalmic solution therapy is dependent upon its administration at regular intervals, as directed.

FOR OPHTHALMIC USE ONLY

CrolomTM (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

Storage: Store between 15†-30°C (59†-86°F).

Protect from light. Keep tightly closed.

KEEP OUT OF REACH OF CHILDREN.

Caution: Federal law prohibits dispensing without prescription.

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 attributable to the drug:

Conjunctival injection
Watery eyes
Itchy eyes
Dryness around the eye
Puffy eyes
Eye irritation
Styes

No information provided.

No infromation provided.

General

Patients may experience a transient stinging or burning sensation following application of cromolyn sodium ophthalmic solution.

The recommended frequency of administration should not be exceeded. The dose for adults and children is 1 or 2 drops in each eye 4 to 6 times a day at regular intervals.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Long-term studies in mice (12 months intraperitoneal treatment followed by six months observation), hamsters (12 months intraperitoneal treatment followed by 12 months observation) and rats (18 months subcutaneous treatment) showed no neoplastic effect of cromolyn sodium.

No evidence of chromosomal damage or cytotoxicity was obtained in various mutagenesis studies.

No evidence of impaired fertility was shown in laboratory animal reproduction studies.

Pregnancy

Teratogenic effects: Pregnancy Category B. Reproduction studies with cromolyn sodium administered parenterally to pregnant mice, rats and rabbits in doses up to 338 times the human clinical doses produced no evidence of fetal malformations. Adverse fetal effects (increased resorption and decreased fetal weight) were noted only at the very high parenteral doses that produced maternal toxicity. There are, however, no adequate and well controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when cromolyn sodium ophthalmic solution is administered to a nursing woman.

PediatricUse

Safety and effectiveness in children below the age of 4 years have not been established.

No information provided.

Cromolyn sodium ophthalmic solution is contraindicated in those patients who have shown hypersensitivity to cromolyn sodium or to any of the other ingredients.

As with all ophthalmic preparations containing benzalkonium chloride, patients are advised not to wear soft contact lenses during treatment with cromolyn sodium ophthalmic solution.

In vitro and in vivo animal studies have shown that cromolyn sodium inhibits the degranulation of sensitized mast cells which occurs after exposure to specific antigens, Cromolyn sodium acts by inhibiting the release of histamine and SRS-A (slow-reacting substance of anaphylaxisjfrom the mast cell.

Another activity demonstrated in vitro is the capacity of cromolyn sodium to inhibit the degranulation of non-sensitized rat mast cells by phospholipase A and the subsequent release of chemical mediators. Another study showed that cromolyn sodium did not inhibit the enzymatic activity of released phospholipase A on its specific substrate.

Cromolyn sodium has no intrinsic vasoconstrictor, antihistaminic or anti-inflammatory activity.

Cromolyn sodium is poorly absorbed. When multiple doses of cromolyn sodium ophthalmic solution are instilled into normal rabbit eyes, less than 0.07% of the administered dose of cromolyn sodium is absorbed into the systemic circulation (presumably by way of the eye, nasal passages, buccal cavity and gastrointestinal tract). Trace amounts (less than 0.01%) of the cromolyn sodium dose penetrate into the aqueous humor, and clearance from this chamber is virtually complete within 24 hours after treatment is stopped.

In normal volunteers, analysis of drug excretion indicates that approximately 0.03% of cromolyn sodium is absorbed following administration to the eye.

A study on cornea1 epithelial wound healing in albino rabbits failed to demonstrate any significant difference in the rate of cornea1 re-epithelialization between cromolyn sodium ophthalmic solution, sterile saline solution, no treatment and an ophthalmic corticosteroid.

(See CONTRAINDICATIONS and PRECAUTIONS).

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

CROMOLYN - OPHTHALMIC

(CROW-mow-lin)

COMMON BRAND NAME(S): Crolom

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. Cromolyn is known as a mast cell stabilizer. It works by blocking certain natural substances (histamine, SRS-A) that cause allergic symptoms.

HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using cromolyn and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

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 avoid wearing 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 and up to 6 weeks for full benefit. 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 cromolyn as directed by your doctor. Tell your doctor if your condition persists or worsens.

SIDE EFFECTS: Burning or stinging of the eye 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.

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, 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.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using cromolyn, tell your doctor or pharmacist if you are allergic to it; or to preservatives (e.g., benzalkonium chloride); or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: contact lens use.

After you apply this drug, your vision may become temporarily blurred. Use caution while driving, using machinery, or doing any other activity that requires clear vision.

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.

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.

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 68-77 degrees F (20-25 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets. Discard any remaining solution after 4 weeks if directed to do so by the product manufacturer.

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 July 2008 Copyright(c) 2008 First DataBank, Inc.