OPTICROM (cromolyn sodium ophthalmic solution, USP) 4% is a clear, colorless, sterile solution intended for topical ophthalmic use.

Cromolyn sodium is represented by the following structural formula:

C₂₃H₁₄Na₂O₁₁....................Mol. Wt 512.34

Chemical Name: disodium 5-5' - [(2-hydroxytrimethylene) dioxy] bis [4-oxo-4H-1 -benzopyran-2-carboxylate].

Pharmacologic Category! Mast cell stabilizer

Each mL contains: Active: Cromolyn sodium 40 mg (4%); Preservative: Benzalkonium chloride 0.01%; Inactives: Edetate disodium 0.1% and purified water. It has a pH of 4.0 to 7.0.

OPTICROM is indicated in the treatment of vernal kerato conjunctivitis, vernal conjunctivitis, and vernal keratitis.

The dose is 1-2 drops in each eye 4-6 times a day at regular intervals. One drop contains approximately 1.6 mg cromolyn sodium.

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

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 OPTICROM.

OPTICROM (cromolyn sodium ophthalmic solution, USP) 4% is supplied as 10 mL of solution in an opaque polyethylene eye drop bottle.

10 mL NDC 0023-6422-10

Store at Controlled Room Temperature 20-25°C (68-77°F). Protect from light - store in original carton. Keep tightly closed and out of the reach of children.

Allergan Inc., Irvine, CA 92612 U.S.A. Revised October 2000. FDA rev date: 4/12/2002

The most frequently reported adverse reaction attributed to the use of OPTICROM (cromolyn sodium ophthalmic solution, USP) 4%, 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.

No information provided.

No information provided.

General

Patients may experience a transient stinging or burning sensation following application of OPTICROM (cromolyn sodium ophthalmic solution, USP) 4%.

The recommended frequency of administration should not be exceeded (see DOSAGE AND ADMINISTRATION).

Information for Patients

Patients should be advised to follow the patient instructions listed on the Information for Patients sheet.

Users of contact lenses should refrain from wearing lenses while exhibiting the signs and symptoms of vernal kerato conjunctivitis, vernal conjunctivitis, or vernal keratitis. Do not wear contact lenses during treatment with OPTICROM.

Carcinogenesis, Mutagenesis, and Impairment of Fertility:

Long term studies of cromolyn sodium in mice (12 months intraperitoneal administration at doses up to 150 mg/kg three days per week), hamsters (intraperitoneal administration at doses up to 52.6 mg/kg three days per week for 15 weeks followed by 17.5 mg/kg three days per week for 37 weeks), and rats (18 months subcutaneous administration at doses up to 75 mg/kg six days per week) showed no neoplastic effects. The average daily maximum dose levels administered in these studies were 192.9 mg/m² for mice, 47.2 mg/m² for hamsters and 385.8 mg/m² for rats. These doses correspond to approximately 6.8, 1.7, and 14 times the maximum daily human dose of 28 mg/m².

Cromolyn sodium showed no mutagenic potential in the Ames Salmonella/microsome plate assays, mitotic gene conversion in Saccharomyces cerevisiae and in an in vitro cytogenetic study in human peripheral lymphocytes.

No evidence of impaired fertility was shown in laboratory reproduction studies conducted subcutaneously in rats at the highest doses tested, 175 mg/kg/day (1050 mg/m²) in males and 100 mg/kg/day (600 mg/m²) in females. These doses are approximately 37 and 21 times the maximum daily human dose, respectively, based on mg/m².

Pregnancy

Teratogenic Effects: Pregnancy Category B: Reproduction studies with cromolyn sodium administered subcutaneously to pregnant mice and rats at maximum daily doses of 540 mg/kg (1620 mg/m²) and 164 mg/kg (984 mg/m²), respectively, and intravenously to rabbits at a maximum daily dose of 485 mg/kg (5820 mg/m²) produced no evidence of fetal malformation. These doses represent approximately 57,35, and 205 times the maximum daily human dose, respectively, on a mg/m² basis. 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 OPTICROM is administered to a nursing woman.

Pediatric use

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

Geriatric Use

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

No information provided.

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

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 anaphylaxis) from 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, antihistamine, 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.

OPTICROM
(cromolyn sodium ophthalmic) Solution, USP 4% Sterile

It is important to use OPTICROM regularly, as directed by your physician.

1. Thoroughly wash your hands.
2. Remove safety seal (Figure 1).
3. Remove cap (Figure 2).
4. Sit or stand comfortably, with your head tilted back (Figure 3).
5. Open eyes, look up, and draw the lower lid of your eye down gently with your index finger (Figure 4).
6. Hold the OPTICROM bottle upside down. Place dropper tip as close as possible to the lower eyelid and gently squeeze out the prescribed number of drops (Figure 5).
7. Do not touch the eye or eyelid with the dropper tip.
8. Blink a few times to make sure the eye is covered with the solution.
9. Close your eye and remove any excess solution with a clean tissue.
10. Repeat process in the other eye.

SPECIAL TIPS

1. Avoid placing OPTICROM (cromolyn sodium ophthalmic solution, USP) 4% directly on the cornea (the area just over the pupil), because it is especially sensitive. You will find the administration of eye drops more comfortable if you place the drops just inside the lower eyelid as shown in Figure 5 on the previous page.
2. To avoid contamination of the solution, do not touch dropper tip to the eye, fingers, or any other surface. Replace cap after use. It is recommended that any remaining contents be discarded after the treatment period prescribed by your physician.
3. Store at Controlled Room Temperature 20-25°C (68-77°F). Protect from light - store in original carton.
4. Keep tightly closed and out of the reach of children.
5. Do not use with any other ocular medications unless directed by your physician. Do not wear contact lenses during treatment with OPTICROM.

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.