Alocril

DRUG DESCRIPTION

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:

ALOCRIL® (nedocromil sodium) Structural Formula Illustration

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.

What are the possible side effects of nedocromil ophthalmic (Alocril)?

Serious side effects are not expected with this medication.

Less serious side effects may be more likely to occur. Continue to use nedocromil ophthalmic and talk to your doctor if you experience

  • eye burning, stinging, irritation, itching, or redness;
  • eye sensitivity to light;
  • headache;
  • unpleasant taste; or
  • nasal congestion.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may...

Read All Potential Side Effects and See Pictures of Alocril »

What are the precautions when taking nedocromil (Alocril)?

Before using nedocromil, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like benzalkonium chloride), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

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

Your vision may be temporarily unstable after applying this drug. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

It is not known...

Read All Potential Precautions of Alocril »


Alocril Consumer (continued)

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 (especially of the face/tongue/throat), 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.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using nedocromil, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like benzalkonium chloride), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

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

Your vision may be temporarily unstable after applying this drug. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

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.


Alocril Patient Information Including Side Effects

Brand Names: Alocril

Generic Name: nedocromil ophthalmic (Pronunciation: ne DOK roe mil off THAL mik)

  • What is nedocromil ophthalmic (Alocril)?
  • What are the possible side effects of nedocromil ophthalmic (Alocril)?
  • What is the most important information I should know about nedocromil ophthalmic (Alocril)?
  • Who should not use nedocromil ophthalmic (Alocril)?
  • How should I use nedocromil ophthalmic (Alocril)?
  • What happens if I miss a dose (Alocril)?
  • What happens if I overdose (Alocril)?
  • What should I avoid while using nedocromil ophthalmic (Alocril)?
  • What other drugs will affect nedocromil ophthalmic (Alocril)?
  • Where can I get more information?

What is nedocromil ophthalmic (Alocril)?

Nedocromil is an anti-allergic medication. It inhibits processes in the body that cause allergic symptoms after exposure to an allergen.

Nedocromil ophthalmic is used to treat ocular (eye) symptoms of allergic conditions, such as inflammation, itching, watering, and burning.

Nedocromil ophthalmic may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of nedocromil ophthalmic (Alocril)?

Serious side effects are not expected with this medication.

Less serious side effects may be more likely to occur. Continue to use nedocromil ophthalmic and talk to your doctor if you experience

  • eye burning, stinging, irritation, itching, or redness;
  • eye sensitivity to light;
  • headache;
  • unpleasant taste; or
  • nasal congestion.

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. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about nedocromil ophthalmic (Alocril)?

Do not touch the dropper to any surface, including your eyes or hands. The dropper is sterile. If it becomes contaminated, it could cause an infection in your eye.

Do not wear contact lenses during treatment with nedocromil ophthalmic, unless otherwise directed by your doctor.

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