Description
Azelastine and fluticasone combination nasal spray is used to treat an itchy or runny nose, sneezing, or other symptoms caused by seasonal hay fever (allergic rhinitis).
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 is a steroid (cortisone-like medicine). It works by preventing the inflammation that occurs with allergic reactions.
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 6 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
- Ethinyl Estradiol
- Fedratinib
- Fexinidazole
- Fluconazole
- Fosnetupitant
- Idelalisib
- Indinavir
- Itraconazole
- Ivosidenib
- Josamycin
- Ketoconazole
- Larotrectinib
- Lefamulin
- Lenacapavir
- Lisdexamfetamine
- Lonafarnib
- Lopinavir
- Lorlatinib
- Lumacaftor
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.
- Auranofin
- 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. 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:
- Adrenal problems or
- Asthma or
- Cataracts, history of or
- Glaucoma, history of—Use with caution. May make these conditions worse.
- Chicken pox (includes recent exposure) or
- Herpes simplex infection of the eye or
- Infections (bacteria, fungus, virus, or parasite), active or untreated or
- Measles (includes recent exposure) or
- Tuberculosis, active or history of—Can reduce the body's ability to fight infections.
- Injury to the nose or
- Nose surgery, recent or
- Sores or ulcers in the nose, recent—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. 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® nasal spray for the first time, you must prime the spray. Press down fully on the top of the pump 6 times or until a fine spray comes out. Prime the spray if it has not been used for 14 days or more.
- Gently blow your nose before using the spray. 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.
- Close the opposite nostril with a finger. Release 1 spray and at the same time, breathe in gently through the nostril keeping your head tilted forward and down.
- Hold your breath for a few seconds then breathe out slowly through your mouth.
- Spray the opposite nostril using the same steps.
- Do not blow your nose 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.
- Throw this medicine away after you use 120 sprays.
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 two 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
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 nasal spray bottle upright at room temperature, away from heat and direct light. Do not store in the freezer or refrigerator.
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 may increase your risk of having some unwanted effects in the nose. Check with your doctor right away if you or your child have bloody mucus, sores inside the nose, unexplained nosebleeds, or a whistling sound when you breathe 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 thrush (a type of fungus infection) in the nose or throat. 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.
This medicine may cause dizziness or drowsiness. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert.
This medicine may increase your risk of having an adrenal gland that is less active than normal. The adrenal gland makes steroids for your body. This is more likely for people who use steroids for a long time or use high doses. Check with your doctor right away if you or your child have any of the following symptoms: darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.
This medicine may cause children to grow more slowly than normal. This would cause a child not to gain weight or get taller. Talk with your doctor if you think your child is not growing properly or if you have any questions about this.
This medicine will add to the effects of alcohol and other CNS depressants (medicines that make 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 or barbiturates muscle relaxants, or anesthetics, including some dental anesthetics. Check with your medical doctor or dentist before taking any of the above while you are taking this medicine.
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
- nasal congestion
- runny nose
- sneezing
- 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
- 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
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
- 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
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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