Pronunciation:

ay-ze-LAS-teen

Brand Names:

• Optivar

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Ophthalmologic Agent

Pharmacologic—

Antihistamine

Uses of This Medicine:

Azelastine ophthalmic (eye) solution is used to treat itching of the eye caused by a condition known as allergic conjunctivitis. It works by preventing the effects of certain inflammatory substances, which are produced by cells in your eyes and sometimes cause allergic reactions.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of azelastine in children under the age of 3 years with use in other age groups.

Older adults—

This medicine has been tested and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amifampridine
• Bupropion
• Donepezil
• Pitolisant

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Cimetidine

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of This Medicine:

Do not wear contact lenses if your eyes are red. If your eyes are not red, contact lenses should be removed before you use this medicine. Also, you should wait at least 10 minutes after using this medicine before putting the contact lenses back in.

To use:

• The bottle is only partially full to provide proper drop control.
• First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed for 1 to 2 minutes to allow the medicine to be absorbed by the eye.
• If you think you did not get the drop of medicine into your eye properly, use another drop.
• Immediately after using the eye drops, wash your hands to remove any medicine that may be on them.

To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed. Serious damage to the eye and possible loss of vision may result from using contaminated eye drops.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For ophthalmic dosage form (eye drops):
  • For eye allergy:
    • Adults and children 3 years of age and older—Use one drop in the affected eye twice a day.
    • Children younger than 3 years of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Keep bottle in an upright position.

Precautions While Using This Medicine:

If your symptoms do not improve within a few days or if they become worse, check with your doctor.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Cough

difficulty breathing

noisy breathing

shortness of breath

tightness in chest

wheezing

Some side effects 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:

More common

Bitter taste in mouth

headaches

temporary eye burning or stinging

Less common

Burning, dry or itching eyes

blurred vision, temporary

chills

diarrhea

eye discharge or excessive tearing

fever

general feeling of discomfort or illness

hoarseness or other voice changes

itching skin

joint pain

loss of appetite

muscle aches and pains

nausea

redness, pain, swelling of eye, eyelid, or inner lining of eyelid

runny nose

shivering

sneezing

sore throat

stuffy nose

sweating

tender, swollen glands in neck

trouble in swallowing

trouble sleeping

unusual tiredness or weakness

vomiting

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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