"The U.S. Food and Drug Administration today approved Ragwitek, the first allergen extract administered under the tongue (sublingually) to treat short ragweed pollen induced allergic rhinitis (hay fever), with or without conjunctivitis (eye inflam"...
(azelastine hydrochloride and fluticasone propionate) Nasal Spray
Important: For use in your nose only
What is DYMISTA?
- DYMISTA is a prescription medicine used to treat symptoms of seasonal allergic rhinitis in people 6 years of age and older, who need treatment with both azelastine hydrochloride and fluticasone propionate.
- DYMISTA may help to reduce your nasal symptoms including stuffy nose, runny nose, itching, and sneezing.
It is not known if DYMISTA is safe or effective in children under 4 years of age.
What should I tell my healthcare provider before using DYMISTA?
Before using DYMISTA tell your healthcare provider if you:
- have had recent nasal sores, nasal surgery, or nasal injury
- have eye or vision problems, such as cataracts or glaucoma (increased pressure in your eye)
- have tuberculosis or any untreated fungal, bacterial, viral infections or eye infections caused by herpes
- have been near someone who has chickenpox or measles
- are not feeling well or have any other symptoms that you do not understand
- have any other medical conditions
- are pregnant or plan to become pregnant. It is not known if DYMISTA will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
- are breastfeeding or plan to breastfeed. It is not known if DYMISTA passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while using DYMISTA.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
DYMISTA and other medicines may affect each other, causing side effects.
Especially tell your healthcare provider if you take:
- ritanovir (Norvir) or medicines that contain ritanovir (commonly used to treat HIV infection or AIDS)
- ketoconazole, fluconazole, or itraconazole (for fungal infections)
Ask your healthcare provider or pharmacist for a list of these medications, if you are not sure.
Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine.
How should I use DYMISTA?
- Read the Instructions for Use at the end of this leaflet for information about the right way to use DYMISTA.
- An adult should help a young child use DYMISTA.
- DYMISTA is for use in your nose only. Do not spray it into your eyes or mouth. If you spray DYMISTA into your eyes, flush your eye(s) with large amounts of water for 10 minutes and then call your healthcare provider.
- Use DYMISTA exactly as your healthcare provider tells you to use it. Your healthcare provider will tell you how much DYMISTA to use and when to use it.
- If a child accidentally swallows DYMISTA or you use too much DYMISTA, call your healthcare provider or go to the nearest hospital emergency room right away.
What should I avoid while using DYMISTA?
- DYMISTA can cause sleepiness or drowsiness. Do not drive, operate machinery, or do anything that needs you to be alert until you know how DYMISTA affects you.
- Do not drink alcohol or take any other medicines that may cause you to feel sleepy while using DYMISTA. It can increase your chances of having serious side effects.
What are the possible side effects of DYMISTA?
DYMISTA may cause serious side effects including:
Sleepiness or drowsiness.
- Nasal Problems. Symptoms of nasal problems may
- crusting in the nose
- runny nose
- hole in the cartilage between your nose (nasal septal perforation). A whistling sound when you breathe may be a symptom of nasal septal perforation.
- Slow wound healing. You should not use DYMISTA until your nose has healed if you have a sore in your nose, if you have had surgery on your nose, or if your nose has been injured.
- Thrush (candida), a fungal infection in your nose and throat. Tell your healthcare provider if you have any redness or white colored patches in your nose or mouth.
- Eye problems, such as glaucoma or cataracts. Some people may have eye problems, including glaucoma and cataracts. You should have regular eye exams when using DYMISTA.
- Immune system problems that may increase your risk of
infections. DYMISTA may cause problems with the way your immune system protects
your body against infection and increase your risk of infection. Avoid contact
with people who have contagious diseases such as chickenpox or measles while
you use DYMISTA. Symptoms of infection may include:
- aches or pains
- feeling tired
- Adrenal Insufficiency. Adrenal insufficiency is a
condition in which the adrenal glands do not make enough steroid hormones.
Symptoms of adrenal insufficiency may include:
- low blood pressure
- Slowed or delayed growth in children. A child's growth should be checked regularly while using DYMISTA.
Call your healthcare provider or get medical help right away if you have symptoms of any of the serious side effects listed above.
The most common side effects of DYMISTA include:
- changes in taste
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all of the possible side effects of DYMISTA. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store DYMISTA?
- Store DYMISTA upright at controlled room temperature 68° to 77°F (20° to 25°C).
- Do not freeze or refrigerate DYMISTA.
- Protect DYMISTA from light.
- Safely throw away medicine that is out of date or no longer needed.
- Throw away your DYMISTA bottle after using 120 sprays after initial priming. Even though the bottle may not be completely empty, you may not get the correct dose of medicine if you continue to use it.
Keep DYMISTA and all medicines out of reach of children.
General information about the safe and effective use of DYMISTA
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use DYMISTA for a condition for which it was not prescribed. Do not give DYMISTA to other people, even if they have the same symptoms that you have. It may harm them.
This Patient Information leaflet summarizes the most important information about DYMISTA. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about DYMISTA that is written for health professionals.
For more information, go to www.DYMISTA.com or call Meda Pharmaceuticals Inc. at 1-888-939-6478.
What are the ingredients in DYMISTA?
Active ingredients: azelastine hydrochloride and fluticasone propionate
Inactive ingredients: glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, phenylethyl alcohol, edetate disodium, benzalkonium chloride, polysorbate 80, and purified water.
Instructions for Use
(azelastine hydrochloride and fluticasone propionate) nasal spray
For use in your nose only. Do not spray in your eyes.
Read the Instructions for Use before you start to use DYMISTA and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your medical condition or treatment. Before you use DYMISTA, make sure your healthcare provider shows you the right way to use it.
Shake the bottle gently before each use.
Your DYMISTA pump. (See Figure A)
Instructions for using your DYMISTA Pump.
Before you use DYMISTA for the first time, you will need to shake the bottle gently and prime the pump.
For use in young children: An adult should help a young child use DYMISTA. (See Steps 1 through 12).
Priming your DYMISTA pump
Before you prime the bottle, shake it gently.
Remove the clear plastic dust cap from the spray pump tip of the bottle (See Figure B).
Hold the bottle upright with two fingers on the shoulders of the spray pump unit and put your thumb on the bottom of the bottle. Press upward with your thumb and release for the pumping action.
- Repeat the pumping action until you see a fine mist. You should see a fine mist of the medicine after 6 pumps or less (See Figure C).
- To get a fine mist of medicine, you must repeat the pumping action fast and use firm pressure against the bottom of the bottle.
- If you see a stream of liquid, the spray will not work right and may cause nasal discomfort.
- If you do not use DYMISTA for 14 or more days, you will need to shake the bottle gently, and prime the pump with 1 spray or until you see a fine mist. If you do not see a fine mist, clean the tip of the spray nozzle. See the cleaning section below.
Once you see the fine mist of medicine, your DYMISTA pump is ready for use.
Using your DYMISTA
For use in young children: An adult should help a young child use DYMISTA.
Step 3. Gently blow your nose to clear nostrils (See Figure D).
Shake the bottle gently. Close 1 nostril with a finger. Tilt your head forward slightly. Keep the bottle upright and carefully place the spray pump tip ¼ to ½ inch into your other nostril (See Figure E).
For each spray firmly press the pump 1 time. Keep your head tilted down and at the same time, gently breathe in through your nostril (See Figure F). Do not spray directly onto the nasal septum (the wall between your 2 nostrils).
- Repeat Step 5 in your other nostril.
- Do not tilt your head back. This will help to keep the medicine from going into your throat.
- If the medicine goes into your throat you may get a bitter taste in your mouth. This is normal.
When you finish using DYMISTA, wipe the spray tip with a clean tissue or cloth. Put the dust cap back on the spray pump tip of the bottle (See Figure G).
Each bottle of DYMISTA contains enough medicine for you to spray medicine from the bottle 120 times. After initial priming, do not use your bottle of DYMISTA after 120 sprays. You may not receive the right amount of medicine. Keep track of the number of sprays you use from your bottle of DYMISTA and throw away the bottle even if it has medicine left in it.
Do not count any sprays used for initially priming the bottle.
Cleaning the Spray Pump Tip:
Your DYMISTA should be cleaned at least 1 time each week. To do this:
Remove the dust cap and then gently pull upward on the spray pump unit to remove it from the bottle (See Figure H).
Step 8. Wash the spray pump unit and dust cap in warm tap water (See Figure I).
Allow to dry completely. When dry, place the spray pump unit and dust cap back on the bottle (See Figure J).
If the spray pump unit becomes blocked, it can be removed as instructed above in Step 7 and placed in warm water to soak.
Do not try to unblock the spray pump unit by inserting a pin or other sharp object. This will damage the spray pump unit and cause you not to get the right dose of medicine.
After the spray pump unit is unblocked, rinse the applicator and cap with cold water, and allow them to dry as in Step 10 above. When dry, place the spray pump unit back on the bottle and put the dust cap on the spray pump tip.
Reprime the bottle as in Steps 1 and 2 above. Replace the dust cap and your DYMISTA is ready for use.
This Patient Package Insert and Instructions for Use has been approved by the U.S. Food and Drug Administration.
Last reviewed on RxList: 3/9/2015
This monograph has been modified to include the generic and brand name in many instances.
Additional Dymista Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Allergies & Asthma
Improve treatments & prevent attacks.