Nedocromil Ophthalmic Solution

Name: Nedocromil Ophthalmic Solution

Adverse Reactions

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 to 30% of patients. Other events occurring between 1 to 10% included asthma, conjunctivitis, eye redness, photophobia, and rhinitis.

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

Principal Display Panel Text for Carton Label

NDC 17478-066-10
Nedocromil
Sodium
Ophthalmic
Solution
2%
5 mL
Rx only Akorn Logo

NEDOCROMIL SODIUM 
nedocromil sodium solution/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:17478-066
Route of Administration OPHTHALMIC DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Nedocromil Sodium (Nedocromil) Nedocromil Sodium 20 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
Edetate Disodium  
Water  
Sodium Chloride  
Benzalkonium Chloride  
Packaging
# Item Code Package Description
1 NDC:17478-066-10 1 BOTTLE, DROPPER (1 BOTTLE) in 1 CARTON
1 5 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090638 09/10/2012
Labeler - Akorn, Inc. (062649876)
Establishment
Name Address ID/FEI Operations
Akorn, Inc. 603980319 MANUFACTURE(17478-066), ANALYSIS(17478-066), STERILIZE(17478-066), LABEL(17478-066), PACK(17478-066)
Revised: 09/2012   Akorn, Inc.

Highlights for nedocromil

Nedocromil sodium is used to treat itching of inflamed eyes caused by allergies.

This drug comes in the form of a solution you drop into your eye.

Nedocromil is available as a brand-name drug called Alocril. It’s also available as a generic drug.

The more common side effects of this drug include headache and burning, stinging, or irritation in your eye. They also include an unpleasant taste in your mouth, stuffy nose, symptoms of asthma, redness and inflammation of your eye, and eye sensitivity to light.

You shouldn’t wear contact lenses while using nedocromil eye drops. Be careful not to let the dropper tip of the eye drops touch your eye when giving yourself the medication.

IMPORTANT INFORMATION

  • Use of contact lenses See Details

  • Contamination of dropper tip and solution See Details

What is nedocromil?

Nedocromil is a prescription drug. It’s available as an ophthalmic solution (eye drop).

Nedocromil is available as a generic drug. Generic drugs usually cost less. In some cases, they may not be available in every strength or form as the brand-name version. Talk to your doctor to see if the generic version will work for you.

Nedocromil may be used as part of a combination therapy. This means you may need to take it with other medications.

Why it's used

Nedocromil eye drops are used to treat itching of inflamed eyes caused by allergies.

How it works

Nedocromil belongs to a class of drugs called mast cell stabilizers.

More Details

Nedocromil Side Effects

More Common Side Effects

The more common side effects of nedocromil include:

  • headache

  • burning, stinging, or irritation in your eye

  • unpleasant taste in your mouth

  • stuffy nose

  • symptoms of asthma, such as shortness of breath or wheezing

  • redness and inflammation of your eye

  • eye sensitivity to light

If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare provider who knows your medical history.
Share
(web3)