Pronunciation:

ay-ze-LAS-teen

Brand Names:

• Astelin
• Astelin Ready-Spray
• Astepro

Dosage Forms:

• Spray

Classifications:

Therapeutic—

Nasal Agent

Pharmacologic—

Antihistamine

Uses of This Medicine:

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

Azelastine is an antihistamine. It works by preventing the effects of a substance called histamine, which is produced by the body. Histamine can cause itching, sneezing, runny nose, and watery eyes.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Astepro® nasal spray in children. However, safety and efficacy have not been established to treat seasonal allergic rhinitis in children younger than 2 years of age and perennial allergic rhinitis in children younger than 6 months of age.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Astepro® allergy nasal spray in children. However, use is not recommended in children younger than 6 years of age.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Astepro® nasal spray in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving this medicine.

No information is available on the relationship of age to the effects of Astepro® allergy nasal spray in geriatric patients.

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.

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 this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amifampridine
• Bupropion
• Donepezil
• Pitolisant

Using this medicine 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

Other interactions—

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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

Use this medicine 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.

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

Follow the instructions on the medicine label if you are using this medicine without a prescription.

This medicine 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 with water and call your doctor right away.

Do not use this medicine for any other nose problem (eg, ulcers or surgery, or injury that has not healed) without checking with your doctor first.

To use the spray:

• When you use the azelastine nasal spray for the first time, you must prime the spray. Press down fully 6 times or until a fine spray comes out.
• Prime the spray after each time you clean the pump, or if you have not used the medicine for 3 days or longer, by spraying the medicine 2 times or until a fine spray comes out.
• Blow your nose to clear your nostrils.
• Tilt your head down, looking at your toes, and insert the tip of the nose piece into your nostril. Hold bottle upright and aim the spray tip toward the back of your nose. Tilt your head downward while spraying to avoid a bitter taste in the mouth.
• 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.
• Repeat in your other nostril using the same steps.
• If your healthcare provider tells you to use 2 sprays in each nostril, repeat the steps above for the second spray in each nostril.
• Do not blow your nose or tip your head back after using the spray.
• Wipe the tip of the outside of the nose piece with a clean, dry tissue or cloth and put the cap back on.

Do not drink alcohol while you are using this medicine.

Dosing—

The dose of this medicine 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 this medicine. 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 (Astelin® spray):
  • For treatment of seasonal allergic rhinitis:
    • Adults and children 12 years of age and older—1 or 2 sprays in each nostril 2 times a day, or 2 sprays in each nostril once a day. Each spray contains 137 or 205.5 micrograms (mcg) of azelastine.
    • Children 6 to 11 years of age—1 spray in each nostril 2 times a day. Each spray contains 137 or 205.5 mcg of azelastine.
    • Children 2 to 5 years of age—1 spray in each nostril 2 times a day. Each spray contains 137 mcg of azelastine.
    • Children younger than 2 years of age—Use and dose must be determined by your doctor.
• For nasal dosage form (Astepro® spray):
  • For treatment of perennial allergic rhinitis:
    • Children 6 months to 11 years of age—1 spray in each nostril 2 times a day. Each spray contains 137 micrograms (mcg) of azelastine.
    • Children younger than 6 months of age—Use and dose must be determined by your doctor.
  • For treatment of seasonal allergic rhinitis:
    • Adults and children 12 years of age and older—1 or 2 sprays in each nostril 2 times a day. Each spray contains 137 micrograms (mcg) of azelastine.
    • Children 2 to 11 years of age—1 spray in each nostril 2 times a day. Each spray contains 137 mcg of azelastine.
    • Children younger than 2 years of age—Use and dose must be determined by your doctor.
• For nasal dosage form (Astepro® allergy spray):
  • For treatment of allergic rhinitis or other upper respiratory allergies:
    • Adults and children 12 years of age and older—2 sprays in each nostril once a day or 1 or 2 sprays in each nostril 2 times a day (every 12 hours). Do not use more than 4 sprays in each nostril per day (24 hour period). Each spray contains 205.5 micrograms (mcg) of azelastine.
    • Children 6 to 11 years of age—1 spray in each nostril 2 times a day (every 12 hours). Do not use more than 2 sprays in each nostril per day (24 hour period). Each spray contains 205.5 micrograms (mcg) of azelastine.
    • Children younger than 6 years of age—Use is not recommended.

Missed dose—

If you miss a dose of this medicine, 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—

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

Store the bottle upright with the pump tightly closed.

Precautions While Using This Medicine:

Your doctor should check you or your child at regular visits for any problems or unwanted effects that may be caused by this medicine. If your symptoms do not improve within a few days or if they become worse, check with your doctor.

This medicine 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 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 dizzy or 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.

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.

Side Effects of This Medicine:

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:

More common

Heavy nosebleeds

Less common

Burning or discomfort inside the nose

ear congestion

chills

cough

fever

sore throat

body aches or pain

headache

loss of voice

trouble breathing

unusual tiredness or weakness

Rare

Blood in the urine

blurred vision or other change in vision

chest tightness

eye pain or redness

hives, itching, or skin rash

rapid heartbeat

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:

More common

Bitter taste in the mouth

drowsiness or sleepiness

Less common

Bloody mucus or unexplained nosebleeds

dizziness

dryness of the mouth

muscle aches or pain

nausea

sudden outbursts of sneezing

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.