Astepro (Azelastine Hydrochloride Nasal Spray) Drug Information: Medication Guide and Patient Information

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May 25, 2012

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Allergy Drugs: Prescription and OTC »

Allergy medications overview

The arsenal of allergy drugs includes dozens of medications that relieve allergy symptoms when confronted with a trigger known as an allergen. That trigger could be something from a plant, such as pollen, or something from an animal (pet dander, dust mites, cockroaches). Other allergy triggers include certain fragrances or chemical substances.

What causes a person's allergic reaction is highly individual. But the reactions are often universal: swelling and inflammation, especially around the eyes, nose, and throat, usually accompanied by itching.

Some allergy medications work against the effects of histamines, which are released during an allergic reaction. Other medications reduce swelling, affect the immune system, or affect release of other substances associated with allergic reactions.

Many allergy drugs are available without a prescription.

For what conditions are allergy medicatio...

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PATIENT INFORMATION

ASTEPRO
[AS-ta-PRO]
(azelastine hydrochloride) Nasal Spray 0.1% and 0.15%

Important: For use in your nose only

Read this information carefully before you start using ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray?

ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray 0.1% and 0.15% is a prescription medicine used to relieve symptoms of seasonal allergies in people age 12 and older.
ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray 0.15% is also used to relieve symptoms of year-round allergies in people age 12 and older.
ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray contains an antihistamine that may help reduce the nasal symptoms of rhinitis (inflammation of the lining of the nose): stuffy nose, runny nose, itching and sneezing.

It is not known if ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray works and is safe or effective in children younger than age 12.

What should I tell my healthcare provider before using ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray? Before using ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray tell your healthcare provider about all your medical conditions, including if you are:

allergic to any of the ingredients in ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray. See the end of this leaflet for a complete list of ingredients in ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray.
pregnant, think you may be pregnant, or planning to become pregnant. It is not known if ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray will harm your unborn baby.
breastfeeding. It is not known if ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray passes into your breast milk.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal products. ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray and other medicines may affect each other, causing side effects.

Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider when you get a new medicine.

How should I use ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray?

ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray is to be sprayed in your nose only. Do not spray it into your eyes or mouth.
Use ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray exactly as your healthcare provider tells you. Do not use more than your healthcare provider tells you.
Read the Patient Instructions for Use at the end of this leaflet for detailed instructions about how to use ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray.
Before you use ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray for the first time, you will need to prime the bottle. See priming instructions at the end of this leaflet in the detailed Patient Instructions for Use.
Do not use ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray unless you see a fine mist after you do the priming sprays.
Throw away your ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray 0.1% bottle after using 200 sprays. Even though the bottle may not be completely empty, you may not get the correct dose of medicine.
Throw away your ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray 0.15% bottle after using 200 sprays. Even though the bottle may not be completely empty, you may not get the correct dose of medicine.
If a child accidentally swallows ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray, get medical help or call a poison control center right away.

What should I avoid while using ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray?

ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray can cause sleepiness:

Do not drive a car, operate machinery or do dangerous activities after you use ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray.
Avoid drinking alcohol or taking other medicines that may cause you to feel sleepy while using ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray.

What are the possible side effects of ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray?

Side effects of ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray include:

unusual taste (bitter or sweet)
nose pain or discomfort
nosebleeds
headache
fatigue
sleepiness
sneezing

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray. For more information, ask your healthcare provider or pharmacist.

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

How should I store ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray?

Keep ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray upright at 68° to 77°F (20° to 25°C).
Do not freeze ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray.
Do not use ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray after the expiration date “EXP” on the medicine label and box.

Keep ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray and all medicines out of reach of children.

General information about ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray.

Medicines are sometimes prescribed for conditions other than those mentioned in patient information leaflets. Do not use ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray for a condition for which it was not prescribed. Do not give ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray to other people, even if they have the same symptoms that you have. It may harm them.

This patient in formation le aflet s ummarizes t he mo st imp ortant in formation a bout ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray. If you would like more information, talk with your healthcare provider. Y ou c an ask y our ph armacist or he althcare pr ovider f or i nformation a bout ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray that is written for health professionals.

For more information, go to www.ASTEPRO (azelastine hydrochloride nasal spray) .com or call 1-800-598-4856.

What are the ingredients in ASTEPRO Nasal Spray?

Active ingredient: azelastine hydrochloride

Inactive ingredients: sorbitol, sucralose, hypromellose, sodium citrate, edetate disodium, benzalkonium chloride, and purified water.

Patient Instructions for Use

For use in your nose only

It is important that you read and follow these Patient Instructions for Use carefully to be sure you use ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray the right way.

For the correct dose of medicine:

Use ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray exactly as prescribed by your healthcare provider.
Keep your head tilted downward when spraying into your nostril.
Change nostrils each time you use the spray.
Breathe gently and do not tip your head back after using the spray. This will keep the medicine from running down into your throat. You may get a bitter taste in your mouth.

Follow the instructions below to use your ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray pump. See Figure 1.

Figure 1

Before you use ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray for the first time, you will need to prime the bottle.

To prime:

1. Remove the blue dust cover over the tip of the bottle and the blue safety clip just under the “shoulders” of the bottle. See Figure 2.

Figure 2

Remove the blue dust cover over the tip of the bottle and the blue safety clip - Illustration

2. Hold the bottle upright with two fingers on the shoulders of the spray pump unit and put your thumb on the bottom of the bottle. Press upward with your thumb and release for the pumping action. Repeat this until you see a fine mist. This should happen in 6 sprays or less. See Figure 3.

Now your pump is primed and ready to use.

Figure 3

Press upward with your thumb and release - Illustration

3. To get a fine mist you must pump the spray fast and use firm pressure against the bottom of the bottle. If you see a stream of liquid, the spray will not work right and may cause nasal discomfort.

4. If you do not use ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray for 3 or more days, you will need to prime the pump with 2 sprays or until you see a fine mist. If you do not see a fine mist, clean the tip of the spray nozzle. See the cleaning section below.

To Use ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray:

1. Gently blow your nose to clear nostrils.

2. Keep your head tilted downward toward your toes.

3. Place the spray tip ¼ to ½ inch into one nostril. Hold bottle upright and aim the spray tip toward the back of the nose. See Figure 4.

4. Close your other nostril with a finger. Press the pump one time and sniff gently at the same time, keeping your head tilted forward and down.

Figure 4

Hold bottle upright and aim the spray tip toward the back of the nose - Illustration

5. Repeat in other nostril.

6. If your healthcare provider tells you to use 2 sprays in each nostril, repeat Steps 2 through 5 above for the second spray in each nostril.

7. Breathe in gently, and do not tilt your head back after using ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray. This will help to keep the medicine from going into your throat.

When you finish using ASTEPRO (azelastine hydrochloride nasal spray) Nasal Spray, wipe the spray tip with a clean tissue or cloth. Put the safety clip and dust cover back on the bottle.

To Clean the Spray Tip:

1. If the spray tip opening is clogged, do not use a pin or pointed object to unclog the tip. Unscrew the spray pump unit from the bottle by turning it counter-clockwise (to the left). See Figure 5.

2. Soak only the spray pump unit in warm water. Squirt several times while holding it under water. Use the pumping action to clear the opening in the tip. See Figure 6.

Figure 5