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Brand Name(s): Astelin^® Nasal Spray¶, Astepro Allergy^® Nasal Spray, Dymista^® Nasal Spray (as a combination product containing Fluticasone, Azelastine); also available generically

WHY is this medicine prescribed?

Prescription and nonprescription (over the counter) azelastine nasal spray is used to relieve symptoms of rhinitis such as sneezing and a runny, stuffy, or itchy nose and itchy, watery eyes caused by hay fever or other allergies (caused by an allergy to pollen, mold, dust, or pets). Prescription azelastine nasal spray is also used to relieve symptoms of nonallergic rhinitis such as sneezing and runny or stuffy nose which are not caused by allergies in adults and children 12 years of age or older. Azelastine is in a class of medications called antihistamines. It works by blocking the action of histamine, a substance in the body that causes allergic symptoms.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Azelastine comes as a liquid to spray in the nose. Azelastine nasal spray is usually is sprayed in each nostril one or two times a day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use azelastine nasal spray exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

An adult should help children younger than 12 years old to use azelastine nasal spray. Children younger than 6 years of age should not use nonprescription (over the counter) azelastine nasal spray.

Azelastine nasal spray is only for use in the nose. Do not swallow the nasal spray, and be careful not to spray it into your eyes or mouth.

Each bottle of azelastine nasal spray should only be used by one person. Do not share azelastine nasal spray because this may spread germs.

Azelastine nasal spray controls the symptoms of hay fever or allergies but does not cure these conditions.

Azelastine nasal spray is designed to provide a certain number of sprays. After the marked number of sprays has been used, the remaining sprays in the bottle might not contain the correct amount of medication. You should keep track of the number of sprays you have used and throw away the bottle after you have used the marked number of sprays even if it still contains some liquid.

Before you use azelastine nasal spray for the first time, read the written directions that come with it. Follow these steps:

1. Remove the cap and safety clip from the nasal spray pump.
2. If you are using the nasal spray pump for the first time, you must prime the pump. Hold the pump with the applicator between your forefinger and middle finger and the bottom of the bottle resting on your thumb. Point the bottle upright and away from your face. Press down and release the pump four times or until a fine mist appears. If you have not used your nasal spray for more than 3 days, reprime the pump with 2 sprays or until a fine mist appears.
3. Blow your nose until your nostrils are clear.
4. Close one nostril by gently placing your finger against the side of your nose, tilt your head slightly forward and, keeping the bottle upright, insert the nasal tip into the other nostril. Use your forefinger and middle finger to press firmly down on the nozzle and release a spray. Breath gently in through the nostril while keeping your head tilted forward to keep the medicine from going into your throat. Then, repeat in the second nostril.
5. If your doctor told you to use two sprays in each nostril, repeat step 4.
6. Wipe the applicator with a clean tissue and replace the plastic cap and safety clip on the bottle.

What SPECIAL PRECAUTIONS should I follow?

Before using azelastine,

• tell your doctor and pharmacist if you are allergic to azelastine, any other medications, or any of the ingredients in azelastine nasal spray. Check the package label or ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take, especially other cold and allergy products and antihistamines. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have recently had surgery on your nose, have injured your nose in any way, or if you have sores in your nose.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using azelastine nasal spray, call your doctor.

• you should know that azelastine nasal spray may make you drowsy. Do not drive a car or operate machinery until you know how this drug affects you.

• ask your doctor about the safe use of alcoholic beverages while you are taking azelastine nasal spray. Alcohol can make the side effects from azelastine worse.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Use the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not use a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Azelastine nasal spray may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• bitter taste
• nasal burning, pain, or discomfort
• sneezing
• headache
• sore throat
• dry mouth
• runny nose
• nose bleeds
• dizziness
• abnormal sensations (tingling, prickling, burning, aching)
• nausea
• tiredness
• weight increase
• muscle pain
• nasal burning

Azelastine nasal spray may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

If the spray tip is clogged, soak it in warm water, spray several times while in the water, and then dry it. Do not use pins or other sharp objects to remove the blockage.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

^¶ This branded product is no longer on the market. Generic alternatives may be available.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: February 15, 2023.