allernaze

The U.S. Food and Drug Administration (FDA) has approved AllerNaze (triamcinolone acetonide, USP) Nasal Spray, 50 mcg, an aqueous based intranasal steroid indicated for the once daily treatment of nasal symptoms associated with both seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR) in adults and children twelve (12) years of age and older.

The safety and efficacy of AllerNaze Nasal Spray in both SAR and PAR have been well established in 14 controlled clinical trials involving almost 1,200 subjects. The studies assessed the safety and effectiveness of AllerNaze in treating the symptoms (runny nose, nasal itching, sneezing, and nasal congestion) in patients with allergic rhinitis.

AllerNaze Nasal Spray Information for the Patient

These instructions provide a summary of important information about AllerNaze. Please read it carefully before use. Ask your doctor or pharmacist if you have any additional questions.

What is AllerNaze?

AllerNaze is a prescription medicine called a corticosteroid used to treat seasonal and year-round allergies in adults and children age 12 and older. When AllerNaze is sprayed in your nose, this medicine helps lessen the symptoms of sneezing, runny nose, and nasal itching associated with nasal allergies.

Do not use AllerNaze if you

1. are pregnant or planning to become pregnant.
2. are breast feeding.
3. have had a reaction to triamcinolone acetonide or to any other nasal spray.

How do I use AllerNaze?

• Use AllerNaze on a regular schedule exactly as prescribed by your doctor
• Do not usemore AllerNaze or take it more often than your doctor tells you. It usually takes several days to one week of regular use to feel the medicine working.
• Protect your eyes from the spray.
• If your symptoms do not improve, or if they become worse, contact your doctor.
• Do not stop taking AllerNaze without contacting your doctor.
• AllerNaze does not relieve the red and itchy eye symptoms that some people have with allergic rhinitis. Ask your doctor for advice on treatment.
• Tell your doctor if you have irritation, burning or stinging inside your nose that does not go away when using AllerNaze.
• You may have nosebleeds after using AllerNaze. If so, contact your doctor right away. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Patient Instructions for Use

Read these instructions carefully before use. The following instructions tell you how to prepare your AllerNaze spray pump so that it is ready for your use.

Open the foil pouch and remove the pump unit.

Priming the Pump:

The pump needs to be primed before using it for the first time and then again if you have not used the spray for 2 weeks. You will prime the pump the same way each time.

1. Remove the blue plastic cap and the blue safety clip from the nasal applicator of the spray pump unit.
2. Prime the pump by holding the bottle with your thumb on the bottom and your index and middle fingers on top, on either side of the white nasal applicator.
3. Point the bottle up and away from your eyes. Press down on either side of the white nasal applicator using your forefinger and middle finger, while supporting the base of the bottle with your thumb.
4. Press down and release the pump several times until you get 3 sprays or until a fine mist is seen. A fine mist can only be made by a rapid and firm pumping action.

Using the spray correctly:

1. Gently blow your nose to clear it before using the medication.
2. Remove the blue plastic cap and the blue safety clip from the nasal applicator.
3. Prime the pump.
4. Tilt your head backward slightly. Breathe out slowly.
5. Use a finger on your other hand to close your nostril on the side not receiving the medication.
6. Insert spray tip into one nostril, as shown in the illustration. Do not insert too far back. Do not spray AllerNaze directly onto the nasal tissue inside your nose; aim the spray to the back of your nose.
7. Breathe in through the nostril and while breathing in press the applicator once to release the spray. You will need to press firmly and rapidly. Breathe out through your mouth.
8. If the doctor has prescribed 2 sprays on each side, repeat Step 7 (above) in the same nostril and then switch to use the nasal spray in the other nostril.
9. Do not blow your nose for 15 minutes.
10. After use, wipe the spray bottle applicator off with a tissue and put the cap and safety clip back on to the bottle.

If your nasal passages are severely swollen, your doctor may recommend a decongestant nasal spray or nose drops for 3 or 4 days before using AllerNaze.

Cleaning the nasal applicator:

If the nasal applicator becomes blocked, and does not spray, remove it and allow it to soak in warm water for 10-15 minutes. Then rinse the applicator with clean warm water, allow it to air dry dry and put it back on the bottle. Do not try to unblock the applicator by inserting a pin or other sharp object. This could change the amount of medicine you spray and cause an overdose.

Storing and Discarding AllerNaze:

• Store between 68o to 77o F (20o to 25o C).
• Do not freeze.
• Use AllerNaze within 2 months after opening the protective foil pouch or before the expiration date on the box or label, whichever comes first.
• After using 120 sprays of AllerNaze throw the bottle away - the dose may not be accurate.