Description
Azelastine and fluticasone combination nasal spray is used to treat symptoms (eg, stuffy or runny nose, itching, sneezing) of seasonal (short-term) allergic rhinitis (hay fever).
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.
Fluticasone belongs to the family of medicines known as corticosteroids (cortisone-like medicine). It works by preventing certain cells from releasing substances that cause an allergic reaction.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Spray
Before Using
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.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Dymista® nasal spray in children 6 years of age and older. However, safety and efficacy have not been established in children younger than 4 years of age.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Dymista® nasal spray in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution in patients receiving Dymista® nasal spray.
Breastfeeding
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.
Drug Interactions
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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Desmopressin
- Levoketoconazole
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.
- Adagrasib
- Amifampridine
- Amphetamine
- Aspirin
- Atazanavir
- Avacopan
- Bemiparin
- Boceprevir
- Bupropion
- Carbamazepine
- Ceritinib
- Clarithromycin
- Cobicistat
- Conivaptan
- Cosyntropin
- Dabrafenib
- Darunavir
- Dasabuvir
- Dextroamphetamine
- Donepezil
- Duvelisib
- Encorafenib
- Ethinyl Estradiol
- Fedratinib
- Fexinidazole
- Fluconazole
- Fosnetupitant
- Hydroxychloroquine
- Idelalisib
- Indinavir
- Itraconazole
- Ivosidenib
- Josamycin
- Ketoconazole
- Landiolol
- Larotrectinib
- Lefamulin
- Lenacapavir
- Letermovir
- Lisdexamfetamine
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.
- Apalutamide
- Auranofin
- Cimetidine
- Mavacamten
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. 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 is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.
- Grapefruit Juice
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:
- Cataracts, history of or
- Glaucoma, history of or
- Increased intraocular pressure, history of—Use with caution. May make these conditions worse.
- Chicken pox, recent exposure or
- Herpes simplex (virus infection of the eye) or
- Infections (bacteria, fungus, virus, or parasite) or
- Measles, recent exposure or
- Tuberculosis, active or history of—This medicine can reduce the body's ability to fight off these infections.
- Injury to the nose, recent or
- Nose surgery, recent or
- Sores or ulcers in the nose, recent—This medicine may prevent proper healing of these conditions.
Proper 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.
This medicine comes with patient information leaflet and patient instructions. Read and follow these instructions carefully. Ask your doctor if you have any questions.
This medicine is only used in the nose. Do not get this medicine in your eyes or mouth. If it does get on these areas, rinse it off right away with water for at least 10 minutes and call your doctor right away.
Do not use this medicine for any other nose problem without checking with your doctor first.
To use the spray:
- Shake the bottle gently before each use.
- When you use the Dymista® for the first time, you must prime the spray. To do this, pump the bottle 6 times or until a fine spray comes out. Now it is ready to use.
- If you have not used the medicine for 14 days or longer, prime it again by releasing 1 spray.
- Before using the spray, gently blow your nose to clear the nostrils.
- Tilt your head slightly forward. Hold the bottle upright and insert the tip of the bottle into your nostril. Spray into your nostril.
- Tilt your head downward while spraying and breathe gently inward through the nostril and then breathe out through your mouth.
- Repeat in your other nostril using the same steps.
- Wipe the tip of the outside of the nose piece with a clean, dry tissue or cloth and put the cap back on.
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 (spray):
- For treatment of seasonal allergic rhinitis:
- Adults and children 6 years of age and older—1 spray in each nostril 2 times a day. Each spray contains 137 micrograms (mcg) of azelastine and 50 mcg of fluticasone.
- Children younger than 6 years of age—Use and dose must be determined by your doctor.
- For treatment of seasonal allergic rhinitis:
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
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
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.
Throw away the bottle after you have used 120 sprays, even if there is still some medicine left in it. It is best to keep track of the number of sprays used so you will know when it is time to throw the bottle away.
Precautions
It is very important that your doctor check the progress of you or your child at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you or your child should continue to use it.
If your or your child's 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.
This medicine may increase your risk of having problems with your nose. Check with your doctor right away if you or your child have bloody mucus, sores inside the nose, or unexplained nosebleeds while you are using this medicine.
You may get infections more easily while you are using this medicine. Avoid being around people who are sick or have infections such as chickenpox or measles or if you have never had these infections. This is especially important for children. Tell your doctor right away if you think you have been exposed to chickenpox or measles.
This medicine may cause fungus infection of the mouth or throat (thrush). Tell your doctor right away if you or your child have white patches in the throat, or pain when you eat or swallow.
Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want your eyes checked by an eye doctor.
Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. Talk to your doctor if you or your child have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or weight loss.
This medicine may cause children to grow more slowly than normal. Talk to your child's doctor if you have any concerns.
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
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:
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
- sneezing
- stuffy or runny nose
- tender, swollen glands in the neck
- trouble swallowing
- unusual tiredness or weakness
- voice changes
Incidence not known
- Blindness
- bloody mucus or unexplained nosebleeds
- blurred vision
- chest pain or tightness
- 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
- white patches in the mouth or on the tongue
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:
Less common
- Change in taste
- loss of taste
Incidence not known
- 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
- 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
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.
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