Pronunciation:

oh-loe-PA-ta-deen

Brand Names:

• Patanase

Dosage Forms:

• Spray

Classifications:

Therapeutic—

Nasal Agent

Pharmacologic—

Antihistamine

Uses of This Medicine:

Olopatadine nasal spray is used to treat the symptoms of seasonal (short-term) allergic rhinitis (hay fever), such as sneezing, itchy or runny nose, or itchy eyes. It is an antihistamine and works by preventing the release of histamine in the body. Olopatadine will also block the effects of histamine, which prevents the allergic symptoms.

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—

Appropriate studies have not been performed on the relationship of age to the effects of olopatadine in children younger than 6 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of olopatadine in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving olopatadine.

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.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Injury to the inside of the nose or
• Nasal ulceration (sores or ulcers in the nose) or
• Nosebleeds—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.

This medicine is for use only in the nose. Do not get it in your eyes or on your skin. If it does get on these areas, rinse it off right away with water.

To use:

• When you use the spray for the first time, you must prime the bottle. To do this, pump the bottle 5 times or until the spray comes out. Now it is ready to use.
• If you do not use the bottle for 7 days or longer, prime it again by releasing 2 sprays.
• Before using the spray, gently blow your nose to clear the nostrils.
• After using the spray, wipe the tip of the bottle with a clean tissue and put the cap back on.

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 nasal dosage form (spray):
  • For symptoms of hay fever:
    • Adults, teenagers, and children 12 years of age and older—2 sprays in each nostril two times per day.
    • Children 6 to 11 years of age—1 spray in each nostril two times per day.
    • Children younger than 6 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.

Precautions While Using This Medicine:

It is very important that your doctor check you or your child at regular visits for any problems or unwanted effects that may be caused by this medicine.

This medicine may increase your risk of having nasal problems. Check with your doctor right away if you or your child have bloody mucus; sores inside the nose; or unexplained nosebleeds while you are using this medicine.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your medical doctor or dentist before taking any of the medicines above while you or your child are using this medicine.

This medicine may cause some people to become dizzy, drowsy, or less alert than they are normally. If any of these side effects occur, do not drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

If your or your child's 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

Bladder pain

bloody nose

bloody or cloudy urine

difficult, burning, or painful urination

frequent urge to urinate

lower back or side pain

sore throat

Rare

Chills

cough

diarrhea

fever

general feeling of discomfort or illness

headache

joint pain

loss of appetite

muscle aches and pains

nausea

runny nose

shivering

sweating

trouble sleeping

unusual tiredness or weakness

vomiting

Incidence not known

Difficulty with breathing or swallowing

dizziness

fast heartbeat

shortness of breath

skin itching, rash, or redness

swelling of the face, throat, or tongue

unpleasant breath odor

vomiting of blood

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Anxiety

deep or fast breathing with dizziness

dry mouth

irregular heartbeats

irritability

nervousness

numbness of the feet, hands, and around the mouth

restlessness

shaking

sleepiness

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

Rare

Throat irritation

Incidence not known

Thirst

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.