azelastine (Nasal route)

a-ZEL-as-teen

Commonly used brand name(s):

In the U.S.

• Astelin
• Astelin Ready-Spray
• Astepro

Available Dosage Forms:

• Spray

Therapeutic Class: Nasal Agent

Pharmacologic Class: Antihistamine

Uses For azelastine

Azelastine nasal spray is used to help relieve symptoms (e.g., stuffy or runny nose, itching, sneezing) of seasonal (short-term) or perennial (year-round) allergic rhinitis (hay fever), and vasomotor rhinitis.

azelastine works by preventing certain cells to release substances that cause the allergic reaction.

azelastine is available only with your doctor's prescription.

Before Using azelastine

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For azelastine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to azelastine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of azelastine in children below 12 years of age. Safety and efficacy have not been established.

Geriatric

Although appropriate studies on the relationship of age to the effects of azelastine have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution in patients receiving azelastine.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Using azelastine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Cimetidine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of azelastine. Make sure you tell your doctor if you have any other medical problems, especially:

• Kidney disease—Blood levels of azelastine may be increased, leading to increased effects.

Proper Use of azelastine

Use azelastine only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of side effects.

azelastine usually comes with patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

azelastine is for use only in the nose. Do not get any of it in your eyes or on your mouth. If it does get on these areas, rinse it off right away.

Before using azelastine, gently blow your nose to clear the nostrils.

To prepare azelastine:

• Before you use a new bottle of azelastine spray, the spray pump will need to be primed (started). If your pharmacist assembled the unit for you, check to see if it has already been primed by pumping the unit once. If a full spray comes out, the unit has already been primed; if not you must prime the pump.
• To prime a new bottle, hold the bottle upright and away from you, then pump it six times or until you see a fine spray.
• If you have not used the spray for 3 or more days, pump it two times or until you see a fine spray.

To keep the applicator clean, wipe the nosepiece with a clean tissue and replace the dust cap after each use.

Dosing

The dose of azelastine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of azelastine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For nasal dosage form (spray):
  • For symptoms of seasonal allergic rhinitis:
    • Adults, teenagers, and children 12 years of age and older—1 or 2 sprays in each nostril two times a day, or 2 sprays in each nostril once a day.
    • Children up to 12 years of age—Use and dose must be determined by your doctor.
  • For symptoms of perennial allergic rhinitis:
    • Adults, teenagers, and children 12 years of age and older—2 sprays in each nostril two times a day.
    • Children up to 12 years of age—Use and dose must be determined by your doctor.
  • For treatment of vasomotor rhinitis:
    • Adults and teenagers—Use 2 sprays in each nostril two times a day.
    • Children younger than 12 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of azelastine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the bottle upright with the pump tightly closed.

Precautions While Using azelastine

Your doctor should check you or your child at regular visits for any problems or unwanted effects that may be caused by azelastine.

azelastine will add to the effects of alcohol and other CNS depressants (medicines that makes you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using azelastine.

azelastine may cause some people to become dizzy, drowsy, or less alert than they are normally. Even if used at bedtime, it may cause some people to feel drowsy or less alert on arising. Make sure you know how you react to azelastine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Keep the spray away from the eyes because azelastine may cause irritation or blurred vision. Closing your eyes while you are using azelastine may help keep it out of your eyes.

If your symptoms do not improve within a few days or if they become worse, check with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

azelastine Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Blood in the urine
• cough
• eye pain, eye redness, blurred vision or other change in vision
• rapid heartbeat
• shortness of breath, tightness in the chest, troubled breathing, or wheezing
• skin rash, hives, or itching
• sores in the mouth or on the lips

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Bitter taste in the mouth
• drowsiness or sleepiness

• Bloody mucus or unexplained nosebleeds
• burning inside the nose
• dizziness
• dryness of the mouth
• headache
• muscle aches or pain
• nausea
• sore throat
• sudden outbursts of sneezing
• unusual tiredness or weakness
• weight gain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

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