Alocril

Ophthalmic nedocromil is used to treat itchy eyes caused by allergies. Symptoms of allergies occur when cells in your body called mast cells release substances after you come in contact with something to which you are allergic. Nedocromil is in a class of drugs called mast cell stabilizers. It works by stopping the release of these substances.

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

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using nedocromil ophthalmic and call your doctor at once if you have:

• severe burning, stinging, or irritation after using this medicine.

Common side effects may include:

• headache;
• runny or stuffy nose;
• eye redness;
• your eyes may be more sensitive to light;
• mild eye irritation after using the eye drops.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

ALOCRIL®
(nedocromil sodium ophthalmic solution) 2% sterile

It is important to use ALOCRIL® (nedocromil) 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® (nedocromil) 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® (nedocromil) 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® (nedocromil) ophthalmic solution.

• Akorn, Inc.

Alocril is part of the drug class:

• Other antiallergics

Serious side effects have been reported with Alocril. See the “Drug Precautions” section.

Common side effects include:

• headache
• burning and/or stinging of the eyes
• nasal congestion
• unpleasant taste

This is not a complete list of Alocril side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Store at 2º–25º C (36º–77º F).

Store in original carton.

Keep bottle tightly closed and out of the reach of children.

In the U.S.

• Alocril

Available Dosage Forms:

• Solution

Therapeutic Class: Ophthalmologic Agent

Pharmacologic Class: Mast Cell Stabilizer

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• To gain the most benefit, do not miss doses.
• Use as you have been told, even if your signs get better.
• For the eye only.
• Do not wear contact lenses while using Alocril.
• Wash your hands before and after use.
• Do not touch the container tip to the eye, lid, or other skin.
• Tilt your head back and drop drug into the eye.
• After use, keep your eyes closed. Put pressure on the inside corner of the eye. Do this for 1 to 2 minutes. This keeps the drug in your eye.

What do I do if I miss a dose?

• Use a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not use 2 doses or extra doses.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Change in eyesight, eye pain, or very bad eye irritation.

sterile

>10%

Headache (40%)

Ocular burning/stinging (10-30%)

Unpleasant taste (10-30%)

Nasal congestion (10-30%)

1-10%

Asthma (<10%)

Conjunctivitis (<10%)

Eye redness (<10%)

Photophobia (<10%)

Rhinitis (<10%)

Animal studies failed to reveal evidence of teratogenicity or fetal harm when this drug was administered subcutaneously at doses more than 1600 times the maximum human daily ocular dose on a mg/kg basis. There are no controlled data in human pregnancy. US FDA pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.

This drug should be used during pregnancy only if clearly needed. US FDA pregnancy category: B