Azelastine

Name: Azelastine

Azelastine and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Azelastine Dosage

Use azelastine exactly as prescribed. Follow the directions on your prescription bottle carefully.

Astelin Nasal Spray

Seasonal nasal allergies:

  • The recommended Astelin (azelastine) nasal spray dose in adults and adolescents 12 years of age and older: 1 or 2 sprays per nostril twice daily 
  • The recommended Astelin (azelastine) nasal spray dose in pediatric patients 5 to 11 years of age: 1 spray per nostril twice daily

Vasomotor rhinitis (Nasal symptoms not due by allergies):

  • The recommended Astelin (azelastine) nasal spray dose in adults and adolescents 12 years of age and older: 2 sprays per nostril twice daily

Astepro Nasal Spray

Seasonal nasal allergies:

  • 2 to 5 years: Astepro (azelastine) 0.1%: 1 spray per nostril twice daily
  • 6 to 11 years: Astepro 0.1% or Astepro 0.15%: 1 spray per nostril twice daily
  • Adults and adolescents 12 years of age and older: Astepro 0.1% or Astepro 0.15%: 1 or 2 sprays per nostril twice daily OR Astepro 0.15%: 2 sprays per nostril once daily 

Year-round (perennial) nasal allergies:

  • 6 months to 5 years: Astepro 0.1%: 1 spray per nostril twice daily
  •  6 to 11 years: Astepro 0.1% or Astepro 0.15%: 1 spray per nostril twice daily
  •  Adults and adolescents 12 years of age and older: Astepro 0.15%: 2 sprays per nostril twice daily 

Optivar to treat allergies of the eyes:

  • The recommended dose with Optivar (azelastine) eye drops is one drop instilled into each affected eye twice a day.

Azelastine Overdose

If you use too much azelastine call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

 

Azelastine Dosage and Administration

2.1 Seasonal Allergic Rhinitis

The recommended dosage of Azelastine HCl nasal spray, 0.1% in adults and adolescent patients 12 years and older with seasonal allergic rhinitis is one or two sprays per nostril twice daily. The recommended dosage of Azelastine HCl nasal spray, 0.1% in pediatric patients 5 years to 11 years of age is one spray per nostril twice daily.

2.2 Vasomotor Rhinitis

The recommended dosage of Azelastine HCl nasal spray, 0.1% in adults and adolescent patients 12 years and older with vasomotor rhinitis is two sprays per nostril twice daily.

2.3 Important Administration Instructions

Administer Azelastine HCl nasal spray, 0.1% by the intranasal route only.

Priming: Prime Azelastine HCl nasal spray, 0.1% before initial use by releasing 4 sprays or until a fine mist appears. When Azelastine HCl nasal spray, 0.1% has not been used for 3 or more days, reprime with 2 sprays or until a fine mist appears. Avoid spraying Azelastine HCl nasal spray, 0.1% into the eyes.

Warnings and Precautions

5.1 Somnolence in Activities Requiring Mental Alertness

In clinical trials, the occurrence of somnolence has been reported in some patients taking Azelastine HCl nasal spray, 0.1% [see Adverse Reactions (6.1)]. Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness and motor coordination such as operating machinery or driving a motor vehicle after administration of Azelastine HCl nasal spray, 0.1%. Concurrent use of Azelastine HCl nasal spray, 0.1% with alcohol or other central nervous system depressants should be avoided because additional reductions in alertness and additional impairment of central nervous system performance may occur [see Drug Interactions (7.1)].

Overdosage

There have been no reported overdosages with Azelastine HCl nasal spray, 0.1%. Acute overdosage by adults with this dosage form is unlikely to result in clinically significant adverse reactions, other than increased somnolence, since one bottle of Azelastine HCl nasal spray, 0.1% contains 30 mg of Azelastine(HCl). Clinical trials in adults with single doses of the oral formulation of Azelastine (HCl) (up to 16 mg) have not resulted in increased incidence of serious adverse reactions. General supportive measures should be employed if overdosage occurs. There is no known antidote to Azelastine HCl nasal spray, 0.1%. Oral ingestion of antihistamines has the potential to cause serious adverse effects in young children. Accordingly, Azelastine HCl nasal spray, 0.1% should be kept out of the reach of children.

How is Azelastine Supplied

Azelastine HCl nasal spray 0.1%, 137 mcg, is supplied as a 30-mL package (NDC 65162-676-84) delivering 200 metered sprays in a high-density polyethylene (HDPE) bottle fitted with a metered-dose spray pump unit. The spray pump unit consists of a nasal spray pump fitted with a white safety clip and a white or clear plastic dust cover. The net content of the bottle is 30 mL (net weight 30 gm of solution). Each bottle contains 30 mg (1 mg/mL) of Azelastine HCl, USP. After priming [see Dosage and Administration (2.3)], each spray delivers a fine mist containing a mean volume of 0.137 mL solution containing 137 mcg of Azelastine HCl, USP. The correct amount of medication in each spray cannot be assured before the initial priming and after 200 sprays have been used, even though the bottle is not completely empty. The bottle should be discarded after 200 sprays have been used. Azelastine HCl nasal spray, 0.1% should not be used after the expiration date “EXP” printed on the medicine label and carton.

Storage:

Store upright at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing.

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 HCl nasal spray, 0.1%. Caution patients against engaging in hazardous occupations requiring complete mental alertness and motor coordination such as driving or operating machinery after administration of Azelastine HCl nasal spray, 0.1% [see Warnings and Precautions (5.1)].

Concurrent Use of Alcohol and other Central Nervous System Depressants

Instruct patients to avoid concurrent use of Azelastine HCl nasal spray, 0.1% 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 HCl nasal spray, 0.1% 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 HCl nasal spray, 0.1% 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 HCl nasal spray, 0.1% into their eyes.

Keep Out of Children’s Reach

Instruct patients to keep Azelastine HCl nasal spray, 0.1% out of the reach of children. If a child accidentally ingests Azelastine HCl nasal spray, 0.1%, seek medical help or call a poison control center immediately.

Distributed by:
Amneal Pharmaceuticals LLC
Bridgewater, NJ  08807

Rev. 09-2017-01

Patient information

Azelastine (a-ZEL-uh-steen) HCl Nasal Spray, 0.1%

 Important: For use in your nose only.

What is Azelastine HCl nasal spray, 0.1%?

  • Azelastine HCl nasal spray, 0.1% 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 HCl nasal spray, 0.1% may help to reduce your nasal symptoms including stuffy nose, runny nose, itching and sneezing.

It is not known if Azelastine HCl nasal spray, 0.1% 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 HCl nasal spray, 0.1%?

Before using Azelastine HCl nasal spray, 0.1%, tell your healthcare provider if you are:

  • allergic to any of the ingredients in Azelastine HCl nasal spray, 0.1%. See the end of this leaflet for a complete list of ingredients in Azelastine HCl nasal spray, 0.1%.
  • pregnant, or plan to become pregnant. It is not known if Azelastine HCl nasal spray, 0.1% will harm your unborn baby.
  • breastfeeding, or plan to breastfeed. It is not known if Azelastine HCl passes into your breast milk. You and your healthcare provider should decide if you will use Azelastine HCl nasal spray, 0.1% 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 HCl nasal spray, 0.1% and other medicines may affect each other, causing side effects.

How should I use Azelastine HCl nasal spray, 0.1%?

  • Read the Instructions for Use at the end of this leaflet for information about the right way to use Azelastine HCl nasal spray, 0.1%.
  • Spray Azelastine HCl nasal spray, 0.1% in your nose only. Do not spray it into your eyes or mouth.
  • Use Azelastine HCl nasal spray, 0.1% exactly as your healthcare provider tells you to use it.
  • Do not use more than your healthcare provider tells you.
  • Throw away your Azelastine HCl 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.
  • If you use too much or a child accidentally swallows Azelastine HCl nasal spray, 0.1%, call your healthcare provider or go to the nearest hospital emergency room right away.

What should I avoid while using Azelastine HCl nasal spray, 0.1%?

Azelastine HCl nasal spray, 0.1% can cause sleepiness:

  • Do not drive, operate machinery, or do other dangerous activities until you know how Azelastine HCl nasal spray, 0.1% affects you.
  • Do not drink alcohol or take other medicines that may cause you to feel sleepy while using Azelastine HCl nasal spray, 0.1%. It may make your sleepiness worse.

What are the possible side effects of Azelastine HCl nasal spray, 0.1%?

The most common side effects of Azelastine HCl nasal spray, 0.1% 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 HCl nasal spray, 0.1%. 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 HCl nasal spray, 0.1%?

  • Keep Azelastine HCl nasal spray, 0.1% upright at 68°F to 77°F (20°C to 25°C).
  • Do not freeze Azelastine HCl nasal spray, 0.1%.
  • Do not use Azelastine HCl nasal spray, 0.1% after the expiration date “EXP” on the medicine label and box.

Keep Azelastine HCl nasal spray, 0.1% and all medicines out of reach of children.

General information about the safe and effective use of Azelastine HCl nasal spray, 0.1%.

Medicines are sometimes prescribed for conditions other than those listed in a Patient Information leaflet. Do not use Azelastine HCl nasal spray, 0.1% for a condition for which it was not prescribed. Do not give Azelastine HCl nasal spray, 0.1% 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 HCl nasal spray, 0.1%. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Azelastine HCl nasal spray, 0.1% that is written for health professionals.

For more information call 1-877-835-5472.

What are the ingredients in Azelastine HCl nasal spray, 0.1%?

Active ingredient: Azelastine HCl, USP

Inactive ingredients: benzalkonium chloride, citric acid, dibasic sodium phosphate, edetate disodium, hypromellose, purified water (pH 6.8) and sodium chloride.

* Trademarks are the property of their respective owners.

Distributed by:
Amneal Pharmaceuticals LLC
Bridgewater, NJ  08807

Rev. 09-2017-01

Instructions for Use

Azelastine (a-ZEL-uh-steen) HCl Nasal Spray, 0.1%

 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 HCl nasal spray, 0.1% pump

Before you use Azelastine HCl nasal spray, 0.1% for the first time, you will need to prime the bottle.

Priming your Azelastine HCl nasal spray, 0.1%

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

  • Do not use Azelastine HCl nasal spray, 0.1% 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 HCl nasal spray, 0.1%” section below.

  • If you do not use Azelastine HCl nasal spray, 0.1% 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 HCl nasal spray, 0.1%

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).

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).

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 HCl nasal spray, 0.1%. This will help to keep the medicine from going into your throat.

Step 8. When you finish using your Azelastine HCl nasal spray, 0.1%, 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 HCl nasal spray, 0.1%

  • 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 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).
  • 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:
Amneal Pharmaceuticals LLC
Bridgewater, NJ  08807

Rev. 09-2017-01

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