Nedocromil eent

Administration

Ophthalmic Administration

Apply topically to the eye as an ophthalmic solution.1 3 Administer at regular intervals.1

If more than 1 topical ophthalmic drug is used, administer the drugs at least 10–15 minutes apart.a

Avoid contamination of the solution container.2

Continue therapy throughout period of exposure (i.e., until pollen season is over or until exposure to offending allergen is terminated), even in absence of symptoms.1 2 3

Dosage

Available as nedocromil sodium; dosage expressed in terms of the salt.1

Pediatric Patients

Children ≥3 years of age: 1 or 2 drops of a 2% solution in each eye twice daily.1 3

Adults

1 or 2 drops of a 2% solution in each eye twice daily.1 3

No formal drug interaction studies to date.3

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Applies to nedocromil ophthalmic: ophthalmic solution

Some side effects of nedocromil ophthalmic may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Blurred vision
• change in color vision
• cough
• difficulty breathing
• noisy breathing
• shortness of breath, tightness in chest, or wheezing
• difficulty seeing at night
• dry or itching eyes
• headache
• increased sensitivity of eyes to sunlight
• redness, pain, or swelling of eye, eyelid, or inner lining of the eye
• runny or stuffy nose
• sneezing
• stinging, irritation or burning of your eyes
• unpleasant taste
• unusual watering of eyes or discharge

Applies to nedocromil ophthalmic: ophthalmic solution

General

The most frequently reported side effect was headache.[Ref]

Nervous system

Very common (10% or more): Headache (up to 40%), unpleasant taste (10% to 30%)
Common (1% to 10%): Dysgeusia[Ref]

Ocular

Very common (10% or more): Ocular burning (10% to 30%), ocular irritation (10% to 30%), ocular stinging (10% to 30%)
Common (1% to 10%): Conjunctivitis, photophobia, eye redness, eye soreness[Ref]

Respiratory

Very common (10% or more): Nasal congestion (10% to 30%)
Common (1% to 10%): Asthma, rhinitis[Ref]

Some side effects of nedocromil ophthalmic may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Administration advice:
-For ophthalmic use only.

Patient advice:
-Follow the patient instructions provided on the Information for Patients sheet.
-Avoid wearing contact lenses while exhibiting signs/symptoms of allergic conjunctivitis.
-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; use of contaminated solutions can lead to serious damage to the eye and loss of vision.