In the U.S.—

• Antihistaminic (H₁-receptor), nasal

Azelastine (a-ZEL-as-teen) nasal solution is used to help treat the symptoms (runny nose, sneezing, itching) of seasonal (short-term) allergic rhinitis and vasomotor rhinitis.

This medicine works by blocking the effect of histamine on certain cells.

This medicine is available only with your doctor's prescription, in the following dosage form(s):

Nasal
• Nasal solution (U.S.)

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

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to azelastine. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Azelastine has not been studied in pregnant women. However, studies in animals have found that very large doses of azelastine cause birth defects and other problems. Before using this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether azelastine passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are using this medicine and who wish to breast-feed should discuss this with their doctor.

Children—This medicine has been tested in children and, in effective doses, has not been shown to cause different side effects or problems in children, older than 5 years of age, than it does in adults.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of nasal azelastine in the elderly with use in other age groups, this medicine has been used in a small number of older patients and is not expected to cause different side effects or problems in older people than it does in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking azelastine, it is especially important that your health care professional know if you are taking any of the following:

• Alcohol or
• Central nervous system (CNS) depressants (medicine that causes drowsiness) or
• Tricyclic antidepressants (amitriptyline [e.g., Elavil], amoxapine [e.g., Asendin], clomipramine [e.g., Anafranil], desipramine [e.g., Pertofrane], doxepin [e.g., Sinequan], imipramine [e.g., Tofranil], nortriptyline [e.g., Aventyl], protriptyline [e.g., Vivactil], trimipramine [e.g., Surmontil])—Use of these medicines with azelastine may increase the risk of drowsiness

• Cimetidine—May cause an increase in the blood levels of azelastine, which may result in increased effects

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

This medicine usually comes with patient directions. Read them carefully before using the medicine.

Before using this medicine, clear the nasal passages by blowing your nose.

To prepare this medicine:

• 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 four 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.

Use this medicine only as directed. 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.

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.

• For nasal dosage form (nose spray):
  • For treatment of seasonal allergic rhinitis:
    • Adults and teenagers—Use 2 sprays in each nostril two times a day.
    • Children 5 to 11 years of age—Use 1 spray in each nostril two times a day.
    • Children younger than 5 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 this medicine, use 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—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Store the bottle upright at room temperature, with the pump tightly closed.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). 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 this medicine.

This medicine 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 this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert.

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

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 as soon as possible if any of the following side effects occur:

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

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Bitter taste in mouth;  drowsiness or sleepiness 
  
  

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

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