August 3, 2015
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Astepro

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Astepro

PATIENT INFORMATION

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

Important: For use in your nose only.

What is ASTEPRO Nasal Spray?

  • ASTEPRO is a prescription medicine used to treat symptoms of seasonal allergic rhinitis in patients 2 years of age and older and year-round allergic rhinitis in people age 6 months and older.
  • ASTEPRO may help to reduce your nasal symptoms including stuffy nose, runny nose, itching and sneezing.

It is not known if ASTEPRO is safe and effective in children under 6 months of age.

What should I tell my healthcare provider before using ASTEPRO?

Before using ASTEPRO, tell your healthcare provider if you are:

  • allergic to any of the ingredients in ASTEPRO. See the end of this leaflet for a complete list of ingredients in ASTEPRO.
  • pregnant, or plan to become pregnant. It is not known if ASTEPRO will harm your unborn baby.
  • breastfeeding, or plan to breastfeed. It is not known if ASTEPRO passes into your breast milk. You and your healthcare provider should decide if you will use ASTEPRO if you plan to breastfeed.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. ASTEPRO and other medicines may affect each other, causing side effects.

How should I use ASTEPRO?

  • Read the Instructions for Use at the end of this leaflet for information about the right way to use ASTEPRO.
  • An adult should help a young child use ASTEPRO.
  • Spray ASTEPRO in your nose only. Do not spray it into your eyes or mouth.
  • Use ASTEPRO exactly as your healthcare provider tells you to use it.
  • Do not use more than your healthcare provider tells you.
  • Throw away your ASTEPRO 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 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 you use too much or a child accidentally swallows ASTEPRO, call your healthcare provider or go to the nearest hospital emergency room right away.

What should I avoid while using ASTEPRO?

ASTEPRO can cause sleepiness:

  • Do not drive, operate machinery, or do other dangerous activities until you know how ASTEPRO affects you.
  • Do not drink alcohol or take other medicines that may cause you to feel sleepy while using ASTEPRO. It may make your sleepiness worse.

What are the possible side effects of ASTEPRO?

The most common side effects of ASTEPRO include:

  • fever
  • unusual taste
  • nose pain or discomfort
  • nosebleeds
  • headache
  • sneezing
  • fatigue
  • sleepiness
  • upper respiratory tract infections
  • cough
  • vomiting
  • middle ear infection
  • skin rash
  • sore throat

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. 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?

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

Keep ASTEPRO and all medicines out of reach of children.

General information about the safe and effective use of ASTEPRO.

Medicines are sometimes prescribed for conditions other than those listed in a Patient Information leaflet. Do not use ASTEPRO for a condition for which it was not prescribed. Do not give ASTEPRO to other people, even if they have the same symptoms that you have. It may harm them.

This Patient Information leaflet summarizes the most important information about ASTEPRO. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about ASTEPRO that is written for health professionals.

For more information, go to www.ASTEPRO.com or call 1-800-598-4856.

What are the ingredients in ASTEPRO?

Active ingredient: azelastine hydrochloride

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

Instructions for Use

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

Important: For use in your nose only.

For the correct dose of medicine:

  • 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.

Figure A identifies the parts of your ASTEPRO Nasal Spray pump

Figure A

Parts of ASTEPRO Nasal Spray pump - Illustration

Before you use ASTEPRO for the first time, you will need to prime the bottle.

For use in young children: An adult should help a young child use ASTEPRO. (See “Using your ASTEPRO” Steps 1 through 8).

Priming your ASTEPRO

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 B).

Figure B

Remove dust cover and safety clip - Illustration

  • Hold the bottle upright with 2 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 (See Figure C).
  • 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 pump is not working correctly and you may have nasal discomfort.
  • This should happen in 6 sprays or less.

Now your pump is primed and ready to use.

Figure C

Priming the pump - Illustration

  • Do not use ASTEPRO unless you see a fine mist after you do the priming sprays. If you do not see a fine mist, clean the tip of the spray nozzle. See the “Cleaning the Spray Tip of your ASTEPRO” section below.
  • If you do not use ASTEPRO for 3 or more days, you will need to prime the pump with 2 sprays or until you see a fine mist.

Using your ASTEPRO

For use in young children: An adult should help a young child use ASTEPRO. (See Steps 1 through 8).

Step 1. Blow your nose to clear your nostrils.

Step 2. Keep your head tilted downward toward your toes.

Step 3. Place the spray tip about ¼ inch to ½ inch into 1 nostril. Hold bottle upright and aim the spray tip toward the back of your nose (See Figure D).

Figure D

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

Step 4. Close your other nostril with a finger. Press the pump 1 time and sniff gently at the same time, keeping your head tilted forward and down (See Figure E).

Figure E

Close your other nostril with a finger - Illustration

Step 5. Repeat Step 3 and Step 4 in your other nostril.

Step 6. If your healthcare provider tells you to use 2 sprays in each nostril, repeat Steps 2 through 4 above for the second spray in each nostril.

Step 7. Breathe in gently, and do not tilt your head back after using ASTEPRO. This will help to keep the medicine from going into your throat.

Step 8. When you finish using your ASTEPRO, wipe the spray tip with a clean tissue or cloth. Put the safety clip and dust cover back on the bottle.

Cleaning the Spray Tip of your ASTEPRO

  • 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 to the left (counter-clockwise) (See Figure F).
  • Soak only the spray pump unit in warm water. Squirt the spray unit several times while holding it under water. Use the pumping action to clear the opening in the tip (See Figure G).

Figure F

Unscrew the spray pump - Illustration

Figure G

Soak only the spray pump unit in warm water - Illustration

  • Let the spray pump unit air dry. Make sure it is dry before you put it back onto the bottle.
  • Put the spray pump unit back into the open bottle and tighten it by turning clockwise (to the right).
  • To keep the medicine from leaking out, use firm pressure when you put the pump back onto the bottle.
  • After cleaning, follow the instructions for priming.

This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 3/5/2015
This monograph has been modified to include the generic and brand name in many instances.

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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