Duonase

Allergic Rhinitis, Conjunctivitis

Azelastine (Duonase) and Fluticasone (Duonase) combination nasal spray is used to treat an itchy or runny nose, sneezing, or other symptoms caused by seasonal hay fever (allergic rhinitis).

Azelastine (Duonase) 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.

Fluticasone (Duonase) is a steroid (cortisone-like medicine). It works by preventing the inflammation that occurs with allergic reactions.

Azelastine (Duonase) and Fluticasone (Duonase) is available only with your doctor's prescription.

Usual Adult Dose for Allergic Rhinitis

1 spray in each nostril twice a day

Uses: Relief of symptoms of seasonal allergic rhinitis

Usual Pediatric Dose for Allergic Rhinitis

6 years and older:

1 spray in each nostril twice a day

Uses: Relief of symptoms of seasonal allergic rhinitis

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

Safety and efficacy have not been established in patients younger than 4 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

-This drug should be administered by the intranasal route only.

-The bottle should be gently shaken before each use.

-This drug should not be sprayed into the eyes. If sprayed into the eyes, they should be flushed with water for at least 10 minutes.

-This drug should be primed before initial use by releasing 6 sprays or until a fine mist appears. When the drug has not been used for 14 or more days, it should be reprimed with 1 spray or until a fine mist appears.

Storage requirements:

-Store upright with the dust cap in place.

-Protect from light.

-Do not store in the freezer or refrigerator.

Monitoring:

-Endocrine: HPA-axis suppression (Urinary free-cortisol test, ACTH-stimulation test)

Patient advice:

-Fatigue, weariness, exhaustion, dizziness or weakness that may also be caused by the disease itself, may occur when using this drug. In these cases, the ability to drive and use machines may be impaired. Alcohol may enhance this effect.

See also:
What is the most important information I should know about Duonase?

Hypersensitivity.

Use Azelastine (Duonase)/Fluticasone (Duonase) spray as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Azelastine (Duonase)/Fluticasone (Duonase) spray. Talk to your pharmacist if you have questions about this information.
• Azelastine (Duonase)/Fluticasone (Duonase) spray is for the nose only. Do not spray it in your eyes or mouth. If you spray Azelastine (Duonase)/Fluticasone (Duonase) spray in your eyes, flush your eyes with large amounts of water for at least 10 minutes and then call your doctor.
• Avoid spraying Azelastine (Duonase)/Fluticasone (Duonase) spray directly onto the nasal septum (the wall between your nostrils).
• Shake gently before each use.
• Before using Azelastine (Duonase)/Fluticasone (Duonase) spray for the first time, you must prime the pump. Do this by gently shaking the bottle, pointing it away from you and others, and pressing down on the pump 6 times or until a fine mist appears.
• To use a nose spray, gently blow your nose. Sit down and tilt your head forward slightly. Keep the bottle upright and place the tip of the spray container 1/4 to 1/2 inch into the nose. Using a finger from your other hand, press against the opposite nostril to close it off. Breathe gently through the open nostril and squeeze the spray container. After using the medicine, wipe the tip of the spray unit with a clean tissue or cloth to prevent contamination. Put the dust cap back on the spray pump tip of the bottle.
• Do not tilt your head back while using Azelastine (Duonase)/Fluticasone (Duonase) spray.
• If Azelastine (Duonase)/Fluticasone (Duonase) spray is not used for 14 or more days in a row, you must reprime the pump. Do this by gently shaking the bottle, then pressing down on the pump 1 time or until a fine mist appears. If you do not see a fine mist, clean the tip of the spray nozzle.
• Throw the bottle away after 120 sprays (not counting the 6 sprays used to prime the pump). You may no longer receive the correct amount of medicine with each spray. Do not transfer any remaining medicine to another bottle.
• Clean Azelastine (Duonase)/Fluticasone (Duonase) spray at least 1 time each week according to the directions in the extra patient leaflet.
• Use Azelastine (Duonase)/Fluticasone (Duonase) spray on a regular schedule to get the most benefit from it.
• Using Azelastine (Duonase)/Fluticasone (Duonase) spray at the same time each day will help you remember to use it.
• Continue to use Azelastine (Duonase)/Fluticasone (Duonase) spray even if you feel well. Do not miss any doses.
• If you miss a dose of Azelastine (Duonase)/Fluticasone (Duonase) spray, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Azelastine (Duonase)/Fluticasone (Duonase) spray.

Additive effects with CNS depressants and ethanol.

See also:
What are the possible side effects of Duonase?

Applies to Azelastine (Duonase) / Fluticasone (Duonase) nasal: nasal spray

In addition to its needed effects, some unwanted effects may be caused by Azelastine (Duonase) / Fluticasone (Duonase) nasal. In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking Azelastine (Duonase) / Fluticasone (Duonase) nasal:

Less common:

• Bloody nose
• body aches or pain
• chills
• cold or flu-like symptoms
• congestion
• cough or hoarseness
• difficulty with breathing
• dryness or soreness of the throat
• ear congestion
• fever
• headache
• loss of voice
• nasal congestion
• runny nose
• sneezing
• tender, swollen glands in the neck
• trouble swallowing
• unusual tiredness or weakness
• voice changes

• Blindness
• bloody mucus or unexplained nosebleeds
• blurred vision
• chest pain
• darkening of the skin
• decreased vision
• delayed wound healing
• diarrhea
• difficult or labored breathing
• dizziness
• eye pain
• fainting
• fast, irregular, pounding, or racing heartbeat or pulse
• hives, itching, or skin rash
• lack or slowing of normal growth in children
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of appetite
• mental depression
• nausea or vomiting
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• sleepiness or unusual drowsiness
• sore mouth or tongue
• sores inside the nose
• tearing
• tightness in the chest
• white patches in the mouth or on the tongue

Minor Side Effects

Some of the side effects that can occur with Azelastine (Duonase) / Fluticasone (Duonase) nasal may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Less common:

• Change in taste
• loss of taste

• Burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• burning, dry, or itching eyes
• change in sense of smell
• changes in vision
• discharge or excessive tearing
• hives or welts
• irritation at the application site
• loss of smell
• mental or mood changes
• redness of the skin
• redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid