Dymista 137/50 Mcg Nasal Spr 120spr
It is used to ease allergy signs.
Drug Class
Nasal Antihistamine and Corticosteroid Combination
Pharmacologic Class
H1-receptor antagonist and Synthetic Trifluorinated Corticosteroid
Pregnancy Category
Category C
FDA Approved
May 2012
DEA Schedule
Not Controlled
Overview
What is this medicine?
Dymista is a nasal spray that combines two medicines: an antihistamine (azelastine) and a corticosteroid (fluticasone). It's used to treat symptoms of seasonal and year-round allergies like sneezing, runny nose, stuffy nose, and itchy nose. The antihistamine works quickly to block allergy symptoms, while the corticosteroid reduces inflammation over time.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. It's essential to use this medication as directed.
This medication is for nasal use only. Do not take it by mouth.
Avoid getting the medication in your eyes or mouth, as it may cause burning. If you accidentally get the medication in your eyes, rinse them with plenty of water for at least 10 minutes and contact your doctor.
Preparing the Nasal Spray
Before using the nasal spray for the first time, gently shake the bottle and prime the pump by spraying it 6 times or until a fine mist appears. If you haven't used the spray for more than 14 days, you'll need to prime the pump again with 1 spray or until you see a fine mist.
Using the Nasal Spray
1. Blow your nose before using the spray.
2. Close one nostril and tilt your head forward slightly.
3. Insert the nasal spray tube into the other nostril.
4. While breathing in through your nose, press the pump once to release the spray.
5. Breathe out through your mouth.
6. Spray the medication up into your nose, avoiding the wall between the nostrils.
7. Replace the cap after using the spray.
Storage and Disposal
Store the medication upright at room temperature, away from light.
Do not refrigerate or freeze the medication.
Discard any unused medication after 120 sprays, even if the bottle appears to be full.
Keep all medications in a safe place, out of the reach of children and pets.
Missed Dose
If you miss a dose, use it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and continue with your regular schedule. Do not use two doses at the same time or take extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. It's essential to use this medication as directed.
This medication is for nasal use only. Do not take it by mouth.
Avoid getting the medication in your eyes or mouth, as it may cause burning. If you accidentally get the medication in your eyes, rinse them with plenty of water for at least 10 minutes and contact your doctor.
Preparing the Nasal Spray
Before using the nasal spray for the first time, gently shake the bottle and prime the pump by spraying it 6 times or until a fine mist appears. If you haven't used the spray for more than 14 days, you'll need to prime the pump again with 1 spray or until you see a fine mist.
Using the Nasal Spray
1. Blow your nose before using the spray.
2. Close one nostril and tilt your head forward slightly.
3. Insert the nasal spray tube into the other nostril.
4. While breathing in through your nose, press the pump once to release the spray.
5. Breathe out through your mouth.
6. Spray the medication up into your nose, avoiding the wall between the nostrils.
7. Replace the cap after using the spray.
Storage and Disposal
Store the medication upright at room temperature, away from light.
Do not refrigerate or freeze the medication.
Discard any unused medication after 120 sprays, even if the bottle appears to be full.
Keep all medications in a safe place, out of the reach of children and pets.
Missed Dose
If you miss a dose, use it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and continue with your regular schedule. Do not use two doses at the same time or take extra doses.
Lifestyle & Tips
- Shake the bottle gently before each use.
- Prime the pump before first use or if not used for 7 days or more (spray into the air until a fine mist appears).
- Clear your nasal passages by gently blowing your nose before use.
- Tilt your head slightly forward and insert the spray tip into one nostril, pointing slightly away from the nasal septum (the wall between your nostrils).
- Close the other nostril with your finger.
- Press down firmly on the pump while sniffing gently.
- Repeat for the other nostril.
- Avoid blowing your nose for at least 15 minutes after use.
- Clean the nasal applicator after each use with a clean tissue and replace the cap.
- Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
- Avoid alcohol or other CNS depressants as they may increase drowsiness.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
1 spray per nostril twice daily
Dose Range:
1 - 1 mg
Condition-Specific Dosing:
seasonalAllergicRhinitis:
1 spray per nostril twice daily
perennialAllergicRhinitis:
1 spray per nostril twice daily
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
6 to 11 years: 1 spray per nostril twice daily
Adolescent:
12 years and older: 1 spray per nostril twice daily
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended
Moderate:
No specific adjustment recommended
Severe:
No specific adjustment recommended
Dialysis:
No specific adjustment recommended; systemic exposure is low
Hepatic Impairment:
Mild:
No specific adjustment recommended
Moderate:
No specific adjustment recommended
Severe:
Use with caution; systemic exposure of fluticasone propionate may increase
Pharmacology
Mechanism of Action
Dymista contains azelastine hydrochloride and fluticasone propionate. Azelastine is a phthalazinone derivative that exhibits potent histamine H1-receptor antagonist activity and also has mast cell stabilizing properties. Fluticasone propionate is a synthetic trifluorinated corticosteroid with potent anti-inflammatory activity. It inhibits multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) involved in allergic and non-allergic inflammation.
Pharmacokinetics
Absorption:
Bioavailability:
Azelastine: Approximately 40% (systemic); Fluticasone: <2% (systemic, due to low oral bioavailability and high first-pass metabolism)
Tmax:
Azelastine: 2-3 hours; Fluticasone: 1-2 hours (nasal)
FoodEffect:
Not significantly affected by food when administered nasally.
Distribution:
Vd:
Azelastine: 14.5 L/kg; Fluticasone: Approximately 318 L
ProteinBinding:
Azelastine: 80-90%; Fluticasone: >99%
CnssPenetration:
Azelastine: Limited, but can cause CNS effects (e.g., somnolence); Fluticasone: Limited
Elimination:
HalfLife:
Azelastine: Approximately 22 hours; Fluticasone: Approximately 7.8 hours (nasal)
Clearance:
Azelastine: 0.5 L/hr/kg; Fluticasone: High systemic clearance (1150 mL/min)
ExcretionRoute:
Azelastine: Primarily feces (75%) and urine (25%); Fluticasone: Primarily feces (as metabolites)
Unchanged:
Azelastine: <10% in urine; Fluticasone: <5% in urine
Pharmacodynamics
OnsetOfAction:
Within 30 minutes (for azelastine component); Full effect may take several days for fluticasone component.
PeakEffect:
Azelastine: 3 hours; Fluticasone: Several days of consistent use.
DurationOfAction:
Up to 12 hours (for azelastine component); Sustained with regular use for fluticasone component.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of infection, including:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or changed sputum production
+ Pain while urinating
+ Mouth sores
+ Wounds that do not heal
Signs of a weak adrenal gland, such as:
+ Severe stomach upset or vomiting
+ Severe dizziness or fainting
+ Muscle weakness
+ Feeling extremely tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Crusting in the nose
Runny nose
Whistling sound while breathing
Changes in vision, eye pain, or severe eye irritation
Redness or white patches in the mouth or throat
Excessive sleepiness
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
Headache
Nosebleed
Nose irritation
* Changes in taste
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of infection, including:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or changed sputum production
+ Pain while urinating
+ Mouth sores
+ Wounds that do not heal
Signs of a weak adrenal gland, such as:
+ Severe stomach upset or vomiting
+ Severe dizziness or fainting
+ Muscle weakness
+ Feeling extremely tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Crusting in the nose
Runny nose
Whistling sound while breathing
Changes in vision, eye pain, or severe eye irritation
Redness or white patches in the mouth or throat
Excessive sleepiness
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
Headache
Nosebleed
Nose irritation
* Changes in taste
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe nosebleeds
- Nasal sores that do not heal
- Signs of infection (e.g., fever, persistent sore throat, unusual tiredness)
- Vision changes (e.g., blurred vision, eye pain)
- White patches in the nose or throat (may indicate fungal infection)
- Worsening allergy symptoms despite proper use
- Significant drowsiness or dizziness
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are currently taking ritonavir, as this may interact with the medication.
This is not an exhaustive list of potential interactions. To ensure your safety, it is crucial to disclose all of your medications, including:
Prescription and over-the-counter (OTC) drugs
Natural products
* Vitamins
Additionally, inform your doctor about any existing health problems. It is vital to verify that it is safe to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are currently taking ritonavir, as this may interact with the medication.
This is not an exhaustive list of potential interactions. To ensure your safety, it is crucial to disclose all of your medications, including:
Prescription and over-the-counter (OTC) drugs
Natural products
* Vitamins
Additionally, inform your doctor about any existing health problems. It is vital to verify that it is safe to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before engaging in activities that require alertness, such as driving, wait until you understand how this drug affects you.
When transitioning from an oral steroid to a different form of steroid, you may be at risk for severe and potentially life-threatening side effects. Be aware of symptoms such as weakness, fatigue, dizziness, nausea, vomiting, confusion, or low blood sugar, and contact your doctor immediately if you experience any of these.
In situations where you suffer a severe injury, undergo surgery, or develop an infection, you may require additional doses of oral steroids to help your body cope with the stress. Carry a warning card with you to alert medical professionals that you may need extra steroids in such situations.
If you are exposed to someone with chickenpox or measles and have not had these diseases or been vaccinated against them, consult your doctor. Additionally, if you have recently had nose surgery, an injury, ulcers, or sores, discuss this with your doctor.
Avoid consuming alcohol, marijuana, or other forms of cannabis, as well as prescription or over-the-counter medications that can impair your reactions.
This medication may increase your risk of developing cataracts or glaucoma. Discuss this with your doctor and undergo eye exams as recommended.
If this medication is ingested, it can be harmful. In the event of accidental ingestion, contact a doctor or poison control center immediately.
In some cases, this medication may affect growth in children and teenagers. Regular growth checks may be necessary, so consult your doctor.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. You will need to discuss the potential benefits and risks of this medication to both you and your baby.
When transitioning from an oral steroid to a different form of steroid, you may be at risk for severe and potentially life-threatening side effects. Be aware of symptoms such as weakness, fatigue, dizziness, nausea, vomiting, confusion, or low blood sugar, and contact your doctor immediately if you experience any of these.
In situations where you suffer a severe injury, undergo surgery, or develop an infection, you may require additional doses of oral steroids to help your body cope with the stress. Carry a warning card with you to alert medical professionals that you may need extra steroids in such situations.
If you are exposed to someone with chickenpox or measles and have not had these diseases or been vaccinated against them, consult your doctor. Additionally, if you have recently had nose surgery, an injury, ulcers, or sores, discuss this with your doctor.
Avoid consuming alcohol, marijuana, or other forms of cannabis, as well as prescription or over-the-counter medications that can impair your reactions.
This medication may increase your risk of developing cataracts or glaucoma. Discuss this with your doctor and undergo eye exams as recommended.
If this medication is ingested, it can be harmful. In the event of accidental ingestion, contact a doctor or poison control center immediately.
In some cases, this medication may affect growth in children and teenagers. Regular growth checks may be necessary, so consult your doctor.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor. You will need to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Drowsiness
- Dizziness
- Confusion
- Tachycardia (fast heart rate)
- Hypotension (low blood pressure)
- Prolonged systemic corticosteroid effects (e.g., Cushing's syndrome, adrenal suppression) with chronic excessive use
What to Do:
Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is supportive and symptomatic.
Drug Interactions
Major Interactions
- Ritonavir (strong CYP3A4 inhibitor) - significantly increases fluticasone systemic exposure, leading to potential systemic corticosteroid effects.
- Ketoconazole (strong CYP3A4 inhibitor) - significantly increases fluticasone systemic exposure.
Moderate Interactions
- Other strong CYP3A4 inhibitors (e.g., itraconazole, clarithromycin, cobicistat-containing products) - potential for increased fluticasone systemic exposure.
- CNS depressants (e.g., alcohol, sedatives, hypnotics, anxiolytics) - enhanced CNS depression with azelastine.
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Nasal symptoms (e.g., congestion, rhinorrhea, sneezing, itching)
Rationale: To establish baseline severity and track treatment efficacy.
Timing: Prior to initiation of therapy
Nasal mucosa examination
Rationale: To assess for pre-existing conditions or potential adverse effects (e.g., septal perforation, candidiasis).
Timing: Prior to initiation of therapy
Routine Monitoring
Nasal symptoms
Frequency: Regularly, as needed to assess efficacy
Target: Reduction in symptom severity
Action Threshold: Lack of improvement after 1-2 weeks, or worsening symptoms
Nasal mucosa examination
Frequency: Periodically, especially with long-term use
Target: Absence of irritation, bleeding, candidiasis, or septal perforation
Action Threshold: Presence of adverse effects requiring intervention or discontinuation
Growth monitoring (in pediatric patients)
Frequency: Regularly (e.g., every 3-6 months)
Target: Normal growth velocity
Action Threshold: Growth retardation; consider dose reduction or discontinuation
Intraocular pressure (IOP) and cataracts (for long-term use)
Frequency: Periodically, especially in patients with a history of increased IOP, glaucoma, and/or cataracts
Target: Normal IOP, absence of cataracts
Action Threshold: Increased IOP or development/worsening of cataracts
Symptom Monitoring
- Nasal congestion
- Rhinorrhea (runny nose)
- Sneezing
- Nasal itching
- Post-nasal drip
- Eye itching/watering
- Nosebleeds
- Nasal irritation/soreness
- Unusual taste (bitter taste)
- Drowsiness or fatigue
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Azelastine and fluticasone are Category C. Limited human data are available.
Trimester-Specific Risks:
First Trimester:
Potential for developmental risks, though systemic exposure is low with nasal administration.
Second Trimester:
Potential for developmental risks, though systemic exposure is low with nasal administration.
Third Trimester:
Potential for developmental risks, though systemic exposure is low with nasal administration. Consider potential for adrenal suppression in the infant if maternal systemic exposure is high.
Lactation
Caution should be exercised when Dymista is administered to a nursing woman. Both azelastine and fluticasone are excreted in human milk in small amounts. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Dymista and any potential adverse effects on the breastfed infant from Dymista or from the underlying maternal condition.
Infant Risk:
Low risk of adverse effects due to low systemic absorption and low levels in breast milk, but monitor for drowsiness in infant (azelastine) or signs of adrenal suppression (fluticasone) with prolonged high-dose maternal use.
Pediatric Use
Approved for children 6 years of age and older. Corticosteroids can cause growth suppression; monitor growth in pediatric patients receiving long-term therapy. The lowest effective dose should be used.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly and younger patients. Dose adjustment is generally not required, but caution should be exercised in patients with severe hepatic impairment.
Clinical Information
Clinical Pearls
- Dymista offers the convenience of two active ingredients (antihistamine and corticosteroid) in one nasal spray, providing both rapid symptom relief and sustained anti-inflammatory action.
- Patients should be instructed on proper nasal spray technique, including shaking the bottle, priming, and aiming away from the nasal septum to prevent irritation or nosebleeds.
- A common side effect is a bitter taste, which can be minimized by avoiding sniffing too hard and tilting the head slightly forward after spraying.
- While systemic absorption is low, long-term use of corticosteroids, even topically, warrants monitoring for potential systemic effects like growth suppression in children, cataracts, or glaucoma.
- Advise patients to avoid concurrent use of alcohol or other CNS depressants due to the potential for additive drowsiness from azelastine.
Alternative Therapies
- Intranasal corticosteroids (e.g., fluticasone propionate, mometasone furoate, budesonide)
- Oral antihistamines (e.g., loratadine, fexofenadine, cetirizine)
- Intranasal antihistamines (e.g., azelastine nasal spray)
- Oral decongestants (e.g., pseudoephedrine, phenylephrine)
- Leukotriene receptor antagonists (e.g., montelukast)
- Cromolyn sodium nasal spray
Cost & Coverage
Average Cost:
$200 - $300 per 120-spray bottle
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Brand name), Tier 1 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.