ALOCRIL® (nedocromil sodium ophthalmic solution) 2% is a clear, yellow, sterile solution for topical ophthalmic use.

Nedocromil sodium is represented by the following structural formula:

C₁₉H₁₅NNa₂O₇.................Mol. Wt. 415.30 CAS: 69049-74-7

Chemical name

4H-Pyrano[3,2-g] quinoline-2, 8-dicarboxylic acid, 9-ethyl-6, 9-dihydro-4, 6-dioxo-10-propyl-, disodium salt.

Each mL contains: Active: Nedocromil sodium 20 mg/mL (2%); Preservative: Benzalkonium chloride 0.01%; Inactives: Edetate disodium 0.05%, purified water, and sodium chloride 0.5%. It has a pH range of 4.0 to 5.5 and an osmolality range of 270 to 330 mOsm/kg.

Last updated on RxList: 8/5/2008

ALOCRIL® ophthalmic solution is indicated for the treatment of itching associated with allergic conjunctivitis.

The recommended dosage is one or two drops in each eye twice a day. ALOCRIL® ophthalmic solution should be used at regular intervals.

Treatment should be continued throughout the period of exposure (i.e., until the pollen season is over or until exposure to the offending allergen is terminated), even when symptoms are absent.

ALOCRIL® (nedocromil sodium ophthalmic solution) 2% is supplied sterile in opaque white LDPE plastic bottles with dropper tips and white high impact polystyrene (HIPS) caps as follows:

5 mL in 10 mL bottle NDC 0023-8842-05

Storage: Store at 2º - 25º C (36º - 77º F).

Revised June 2008. Allergan, Inc. IRVINE, CA 92612, U.S.A. www.allergan.com. FDA rev date: 07/07/08

Last updated on RxList: 8/5/2008

The most frequently reported adverse experience was headache (~40%). Ocular burning, irritation and stinging, unpleasant taste, and nasal congestion have been reported to occur in 10- 30% of patients. Other events occurring between 1 - 10% included asthma, conjunctivitis, eye redness, photophobia, and rhinitis.

Some of these events were similar to the underlying ocular disease being studied.

No information provided.

Last updated on RxList: 8/5/2008

No information provided.

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 allergic conjunctivitis.

Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye, surrounding structures, fingers, or any other surface in order to avoid contamination of the solution by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

A two-year inhalation carcinogenicity study of nedocromil sodium at a dose of 24 mg/kg/day (approximately 400 times the maximum recommended human daily ocular dose on a mg/kg basis) in Wistar rats showed no carcinogenic potential.

Nedocromil sodium showed no mutagenic potential in the Ames Salmonella/microsome plate assay, mitotic gene conversion in Saccharomyces cerevisiae, mouse lymphoma forward mutation and mouse micronucleus assays.

Reproduction and fertility studies in mice and rats showed no effects on male and female fertility at a subcutaneous dose of 100 mg/kg/day (more than 1600 times the maximum recommended human daily ocular dose).

Pregnancy

Teratogenic Effects: Pregnancy Category B

Reproduction studies performed in mice, rats and rabbits using a subcutaneous dose of 100 mg/kg/day (more than 1600 times the maximum human daily ocular dose on a mg/kg basis) revealed no evidence of teratogenicity or harm to the fetus due to nedocromil sodium. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, ALOCRIL® ophthalmic solution should be used during pregnancy only if clearly needed.

Nursing Mothers

After intravenous administration to lactating rats, nedocromil was excreted in milk. 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 ALOCRIL® ophthalmic solution is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in children below the age of 3 years have not been established.

Geriatric Use

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

Last updated on RxList: 8/5/2008

No information provided.

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

Last updated on RxList: 8/5/2008

Nedocromil sodium is a mast cell stabilizer. Nedocromil sodium inhibits the release of mediators from cells involved in hypersensitivity reactions. Decreased chemotaxis and decreased activation of eosinophils have also been demonstrated.

In vitro studies with adult human bronchoalveolar cells showed that nedocromil sodium inhibits histamine release from a population of mast cells having been defined as belonging to the mucosal sub type and inhibits beta-glucuronidase release from macrophages.

Pharmacokinetics and Bioavailability

Nedocromil sodium exhibits low systemic absorption. When administered as a 2% ophthalmic solution in adult human volunteers, less than 4% of the total dose was systemically absorbed following multiple dosing. Absorption is mainly through the nasolacrimal duct rather than through the conjunctiva. It is not metabolized and is eliminated primarily unchanged in urine (70%) and feces (30%).

Last updated on RxList: 8/5/2008

ALOCRIL®
(nedocromil sodium ophthalmic solution) 2% sterile

It is important to use ALOCRIL® ophthalmic solution 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 ALOCRIL® bottle upside down. Place tip as close as possible to the lower eyelid without touching the tip to the eye, and gently squeeze out the prescribed number of drops (Figure 5).
7. Do not touch the eye or eyelid with the bottle 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 ALOCRIL® ophthalmic solution 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 bottle cap after use. It is recommended that any remaining contents be discarded after treatment period prescribed by your physician.
3. Store at 2º - 25º C (36º - 77º F). Store in original carton.
4. Keep bottle tightly closed and out of the reach of children.
5. Do not use with any other ocular medication unless directed by your physician. Do not wear contact lenses during treatment with ALOCRIL® ophthalmic solution.

Last updated on RxList: 8/5/2008

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.

NEDOCROMIL SODIUM - OPHTHALMIC

(neh-DOCK-row-mill)

COMMON BRAND NAME(S): Alocril

USES: This medication is used to treat itchy eyes due to allergies. Nedocromil works by reducing the release of natural substances in your body that cause an allergic reaction.

HOW TO USE: Read the Patient Information Leaflet that comes with this product before you start using nedocromil and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.

For best results, this medication should be used routinely, usually in each eye twice daily at evenly spaced intervals (every 12 hours) or as directed by your doctor. To help you remember, use it at the same times each day. Continue to use this medication as prescribed until pollen season is over or you are no longer exposed to the allergic substance, even when allergic symptoms disappear or improve.

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.

Ask your doctor if you can wear contact lenses while you are being treated with this medication. If your doctor says you may continue wearing them, be aware that the preservative in this eye drop can be absorbed by your lenses. Remove your contact lenses before using the eye drops. Wait at least 15 minutes after each dose before putting in your lenses.

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

Do not rinse the dropper. Replace the dropper cap after each use, and keep the cap tightly closed.

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.

Inform your doctor if your condition persists or worsens.

SIDE EFFECTS: Burning/stinging/irritation of the eye, headache, stuffy/runny nose, bad taste in your mouth, and increased sensitivity to light may occur. If any of these effects persist or worsen, notify 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 unlikely but serious side effects occur: swelling of the eye.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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 taking nedocromil, tell your doctor or pharmacist if you are allergic to it; or to the preservative benzalkonium chloride; or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: any eye problems.

Use caution engaging in activities requiring clear vision such as driving or using machinery because your vision may be temporarily unstable after applying this drug.

This medication should be used only when clearly needed during pregnancy. 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 healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. 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: If 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. Canadian residents should call their local poison control center directly. This medicine may be harmful if swallowed.

NOTES: Do not share this medication with others.

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 between 36-77 degrees F (2-25 degrees C). Keep the container tightly closed. 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 July 2008 Copyright(c) 2008 First DataBank, Inc.