Pronunciation:

oh-loe-PA-ta-deen hye-droe-KLOR-ide

Brand Names:

• Pataday
• Patanol
• Pazeo

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Ophthalmologic Agent

Pharmacologic—

Olopatadine

Uses of This Medicine:

Olopatadine ophthalmic (eye) drops is used to treat itching of the eye caused by a condition known as allergic conjunctivitis (pink eye). This medicine is also used to treat eye itching or redness caused by pollen, ragweed, grass, animal hair, or dander. It works by preventing the effects of certain inflammatory substances (eg, histamine), which are produced by cells in your eyes and sometimes cause allergic reactions.

Olopatadine 0.1% ophthalmic solution and olopatadine 0.2% ophthalmic solution are available only with your doctor's prescription.

Pataday® 0.1% ophthalmic solution,Pataday® 0.2% ophthalmic solution, and Pataday® 0.7% ophthalmic solutionare available without a 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—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of olopatadine eye drops in children. However, safety and efficacy of olopatadine 0.1% ophthalmic solution have not been established in children younger than 3 years of age, and of olopatadine 0.2% ophthalmic solution, Pataday® 0.1% ophthalmic solution, Pataday® 0.2% ophthalmic solution, or Pataday® 0.7% ophthalmic solution have not been established in children younger than 2 years of age.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of olopatadine eye drops in the elderly.

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

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:

Your eye doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.

If you are wearing contact lenses, remove them before putting the drops in your eyes. Wait at least 10 minutes after using this medicine before putting them back in. Do not wear contact lenses if your eyes are red.

Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.

To use the eye drops:

• First, wash your hands. Tilt your 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 eye. Do not blink. Keep the eye closed for 1 or 2 minutes to allow the medicine to cover the eye.
• If you think you did not get the drop of medicine into your eye properly, repeat the directions with another drop.
• 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.

Do not use if the liquid changes color or become cloudy.

If you are also using other eye products while using Pataday®, wait at least 5 minutes between each product.

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 eye itching caused by allergic conjunctivitis:
  • For ophthalmic dosage form (eye drops):
    • Olopatadine 0.1% solution:
      • Adults and children 3 years of age and older—Put one drop in each affected eye two times a day, at least 6 to 8 hours apart.
      • Children younger than 3 years of age—Use and dose must be determined by your doctor.
    • Olopatadine 0.2% solution:
      • Adults and children 2 years of age and older—Put one drop in each affected eye once a day.
      • Children younger than 2 years of age—Use and dose must be determined by your doctor.
• For eye itching or redness caused by pollen, ragweed, grass, animal hair, or dander:
  • For ophthalmic dosage form (eye drops):
    • Pataday® 0.1% ophthalmic solution:
      • Adults and children 2 years of age and older—Put one drop in each affected eye two times a day, at least 6 to 8 hours apart.
      • Children younger than 2 years of age—Use and dose must be determined by your doctor.
    • Pataday® 0.2% ophthalmic solution or Pataday® 0.7% ophthalmic solution:
      • Adults and children 2 years of age and older—Put one drop in each affected eye once a day.
      • Children younger than 2 years of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, apply 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.

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.

Precautions While Using This Medicine:

Your eye doctor will want to examine your or your child's eye(s) at regular visits to make sure the medicine is working properly and is not causing unwanted effects.

If your or your child's symptoms do not improve or if your condition becomes worse, check with your doctor.

This medicine should not be used for irritation caused by contact lenses.

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

Blurred vision

burning, dryness, stinging of the eye

eye redness, irritation, or pain

swelling of the eyelid, face, lips, or feet

trouble breathing

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

Headache

runny or stuffy nose

sore throat

Less common

Back pain

body or muscle aches or pain

change in taste

chills

cough

diarrhea

feeling of something in the eye

general feeling of discomfort or illness

increased cough

lack or loss of strength

loss of appetite

nausea

pain or tenderness around the eyes and cheekbones

redness of the eye or inside of the eyelid

sensitivity of the eyes to light

shivering

sneezing

sweating

tender, swollen glands in the neck

trouble sleeping

trouble swallowing

unusual tiredness or weakness

voice changes

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.