AZELASTINE HYDROCHLORIDE (Page 4 of 4)

14.2 Vasomotor Rhinitis

The efficacy and safety of Azelastine Hydrochloride Nasal Spray were evaluated in two placebo-controlled clinical trials of Azelastine Hydrochloride Nasal Spray including 216 patients with vasomotor rhinitis who received two sprays per nostril twice a day for up to 4 weeks. These patients had vasomotor rhinitis for at least one year, negative skin tests to indoor and outdoor aeroallergens, negative nasal smears for eosinophils, and negative sinus X-rays. Azelastine Hydrochloride Nasal Spray demonstrated a significantly greater decrease in a symptom complex comprised of rhinorrhea, post nasal drip, nasal congestion, and sneezing compared to placebo.

16 HOW SUPPLIED/STORAGE AND HANDLING

NDC: 63629-2057-1: 30 mL Nasal Spray 0.1% in a BOTTLE, SPRAY

17 PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Patient Information and Instructions for Use).

Activities Requiring Mental Alertness

Somnolence has been reported in some patients taking Azelastine Hydrochloride Nasal Spray. Caution patients against engaging in hazardous occupations requiring complete mental alertness and motor coordination such as driving or operating machinery after administration of Azelastine Hydrochloride Nasal Spray [see Warnings and Precautions (5.1) ].

Concurrent Use of Alcohol and other Central Nervous System Depressants

Instruct patients to avoid concurrent use of Azelastine Hydrochloride Nasal Spray with alcohol or other central nervous system depressants because additional reductions in alertness and additional impairment of central nervous system performance may occur [see Warnings and Precautions (5.1) ].

Common Adverse Reactions

Inform patients that the treatment with Azelastine Hydrochloride Nasal Spray may lead to adverse reactions, which include bitter taste, headache, somnolence, dysesthesia, rhinitis, nasal burning, pharyngitis, epistaxis, sinusitis, paroxysmal sneezing, nausea, dry mouth, fatigue, dizziness, and weight increase [see Adverse Reactions (6.1) ].

Priming

Instruct patients to prime the pump before initial use and when Azelastine Hydrochloride Nasal Spray has not been used for 3 or more days [see Dosage and Administration (2.3) ].

Keep Spray Out of Eyes

Instruct patients to avoid spraying Azelastine Hydrochloride Nasal Spray into their eyes.

Keep Out of Children’s Reach

Instruct patients to keep Azelastine Hydrochloride Nasal Spray out of the reach of children. If a child accidentally ingests Azelastine Hydrochloride Nasal Spray, seek medical help or call a poison control center immediately.

Distributed by:
Breckenridge Pharmaceutical, Inc.
Berlin, CT 06037

Manufactured by:
Woodfield Pharmaceutical, LLC
Houston, TX 77099

Revised: 08/2019

PATIENT INFORMATION

Azelastine Hydrochloride Nasal Spray

Important: For use in your nose only.

What is Azelastine Hydrochloride Nasal Spray?

  • Azelastine Hydrochloride Nasal Spray is a prescription medicine used to treat symptoms of seasonal allergic rhinitis in people age 5 and older and vasomotor rhinitis in people age 12 and older.
  • Azelastine Hydrochloride Nasal Spray may help to reduce your nasal symptoms including stuffy nose, runny nose, itching and sneezing.

It is not known if Azelastine Hydrochloride Nasal Spray is safe and effective in children with seasonal allergic rhinitis under 5 years of age or in children with vasomotor rhinitis under 12 years of age.

What should I tell my healthcare provider before using Azelastine Hydrochloride Nasal Spray?

Before using Azelastine Hydrochloride Nasal Spray, tell your healthcare provider if you are:

  • allergic to any of the ingredients in Azelastine Hydrochloride Nasal Spray. See the end of this leaflet for a complete list of ingredients in Azelastine Hydrochloride Nasal Spray.
  • pregnant, or plan to become pregnant.
  • breastfeeding, or plan to breastfeed. It is not known if azelastine hydrochloride passes into your breast milk. You and your healthcare provider should decide if you will use Azelastine Hydrochloride Nasal Spray 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. Azelastine Hydrochloride Nasal Spray and other medicines may affect each other, causing side effects.

How should I use Azelastine Hydrochloride Nasal Spray?

  • Read the Instructions for Use at the end of this leaflet for information about the right way to use Azelastine Hydrochloride Nasal Spray.
  • Spray Azelastine Hydrochloride Nasal Spray in your nose only. Do not spray it into your eyes or mouth.
  • Use Azelastine Hydrochloride Nasal Spray exactly as your healthcare provider tells you to use it.
  • Do not use more than your healthcare provider tells you.
  • Throw away your Azelastine Hydrochloride Nasal Spray 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 Azelastine Hydrochloride Nasal Spray, call your healthcare provider or go to the nearest hospital emergency room right away.

What should I avoid while using Azelastine Hydrochloride Nasal Spray?

Azelastine Hydrochloride Nasal Spray can cause sleepiness:

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

What are the possible side effects of Azelastine Hydrochloride Nasal Spray?

The most common side effects of Azelastine Hydrochloride Nasal Spray include:

  • unusual bitter taste
  • headache
  • sleepiness
  • nose burning, pain or discomfort
  • runny nose
  • scratchy or sore throat
  • nosebleeds
  • inflammation or swelling of the sinuses
  • sneezing
  • nausea
  • dry mouth
  • fatigue
  • dizziness
  • weight increase

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 Azelastine Hydrochloride 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 Azelastine Hydrochloride Nasal Spray?

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

Keep Azelastine Hydrochloride Nasal Spray and all medicines out of reach of children.

General information about the safe and effective use of Azelastine Hydrochloride Nasal Spray.

Medicines are sometimes prescribed for conditions other than those listed in a Patient Information leaflet. Do not use Azelastine Hydrochloride Nasal Spray for a condition for which it was not prescribed. Do not give Azelastine Hydrochloride Nasal Spray 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 Azelastine Hydrochloride Nasal Spray. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Azelastine Hydrochloride Nasal Spray that is written for health professionals.

For more information go to www.bpirx.com or call 1-800-367-3395.

What are the ingredients in Azelastine Hydrochloride Nasal Spray?

Active ingredient: azelastine hydrochloride

Inactive ingredients: benzalkonium chloride, edetate disodium, hypromellose, citric acid, dibasic sodium phosphate heptahydrate, sodium chloride, and purified water.

Instructions for Use

Azelastine Hydrochloride Nasal Spray

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 Azelastine Hydrochloride Nasal Spray pump

Figure A
Figure A

Before you use Azelastine Hydrochloride Nasal Spray for the first time, you will need to prime the bottle.

Priming your Azelastine Hydrochloride Nasal Spray

Remove the white dust cover over the tip of the pump and the white safety clip just under the “shoulders” of the pump (See Figure B).

Figure B
Figure B

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 4 sprays or less.

Now your pump is primed and ready to use.

Figure C
Figure C
  • Do not use Azelastine Hydrochloride Nasal Spray 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 Azelastine Hydrochloride Nasal Spray section below.
  • If you do not use Azelastine Hydrochloride Nasal Spray for 3 or more days, you will need to prime the pump with 2 sprays or until you see a fine mist.

Using your Azelastine Hydrochloride Nasal Spray

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
(click image for full-size original)
Figure D

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
(click image for full-size original)
Figure E

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 Azelastine Hydrochloride Nasal Spray. This will help to keep the medicine from going into your throat.

Step 8. When you finish using your Azelastine Hydrochloride Nasal Spray, 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 Azelastine Hydrochloride Nasal Spray

  • 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
    (click image for full-size original)

    Figure G

    Figure F Figure G
  • 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.

Distributed by:
Breckenridge Pharmaceutical, Inc.
Berlin, CT 06037

Manufactured by:
Woodfield Pharmaceutical, LLC
Houston, TX 77099

Revised: 08/2019

Azelastine Hydrochloride 0.1% Spray, #30ml

Label
(click image for full-size original)
AZELASTINE HYDROCHLORIDE
azelastine hydrochloride spray, metered
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63629-2057(NDC:51991-814)
Route of Administration NASAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AZELASTINE HYDROCHLORIDE (AZELASTINE) AZELASTINE HYDROCHLORIDE 137 ug in 0.137 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE
EDETATE DISODIUM
HYPROMELLOSE, UNSPECIFIED
CITRIC ACID MONOHYDRATE
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
SODIUM CHLORIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63629-2057-1 1 BOTTLE, SPRAY in 1 CARTON contains a BOTTLE, SPRAY
1 30 mL in 1 BOTTLE, SPRAY This package is contained within the CARTON (63629-2057-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090176 07/29/2015
Labeler — Bryant Ranch Prepack (171714327)
Registrant — Bryant Ranch Prepack (171714327)
Establishment
Name Address ID/FEI Operations
Bryant Ranch Prepack 171714327 REPACK (63629-2057), RELABEL (63629-2057)

Revised: 04/2021 Bryant Ranch Prepack

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