Azelastine 0.15% Nasal Sp(200 Dose)
It is used to ease allergy signs.It is used to treat a runny nose.
Drug Class
Antihistamine
Pharmacologic Class
H1-receptor antagonist; Mast cell stabilizer
Pregnancy Category
Not available
FDA Approved
May 2008
DEA Schedule
Not Controlled
Overview
What is this medicine?
Azelastine nasal spray is an antihistamine that helps relieve symptoms of seasonal and perennial allergies like sneezing, runny nose, and itchy nose. It works by blocking histamine, a natural substance that causes allergy symptoms.
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. Continue using the medication as directed, even if your symptoms improve.
Administration
Do not take this medication by mouth. It is for nasal use only. Avoid getting it in your mouth or eyes, as it may cause burning.
Before using, blow your nose to ensure the nasal passages are clear.
Spray the medication up into your nose, avoiding the septum (the wall between the nostrils).
If you experience a bitter taste, try tilting your head downward while using the medication to minimize this effect.
Priming the Pump
Some products may have specific priming instructions, which may vary depending on how often you use the medication. Follow the priming instructions provided by your doctor or outlined in the package insert.
Cleaning and Maintenance
After use, clean the spray tip with a clean tissue or cloth.
If the spray tip becomes clogged, follow the cleaning instructions provided by your doctor or outlined in the package insert.
Storage and Disposal
Store the medication upright at room temperature, away from freezing temperatures.
Keep it in a dry place, avoiding storage in a bathroom.
* Ensure all medications are kept 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 is close to the time for your next dose, skip the missed dose and resume 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. Continue using the medication as directed, even if your symptoms improve.
Administration
Do not take this medication by mouth. It is for nasal use only. Avoid getting it in your mouth or eyes, as it may cause burning.
Before using, blow your nose to ensure the nasal passages are clear.
Spray the medication up into your nose, avoiding the septum (the wall between the nostrils).
If you experience a bitter taste, try tilting your head downward while using the medication to minimize this effect.
Priming the Pump
Some products may have specific priming instructions, which may vary depending on how often you use the medication. Follow the priming instructions provided by your doctor or outlined in the package insert.
Cleaning and Maintenance
After use, clean the spray tip with a clean tissue or cloth.
If the spray tip becomes clogged, follow the cleaning instructions provided by your doctor or outlined in the package insert.
Storage and Disposal
Store the medication upright at room temperature, away from freezing temperatures.
Keep it in a dry place, avoiding storage in a bathroom.
* Ensure all medications are kept 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 is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not use two doses at the same time or take extra doses.
Lifestyle & Tips
- Avoid driving or operating machinery until you know how this medication affects you, as it may cause drowsiness.
- Avoid alcohol and other medications that cause drowsiness while using azelastine nasal spray, as this can increase sedative effects.
- Prime the pump before first use or if not used for 3 or more days by spraying into the air until a fine mist appears.
- Blow your nose gently to clear nostrils before use.
- Tilt your head slightly forward and insert the spray tip into one nostril, aiming slightly away from the nasal septum. Close the other nostril with your finger.
- Press down firmly and quickly on the pump while sniffing gently. Repeat for the other nostril.
- Wipe the spray tip with a clean tissue after each use and replace the cap.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
2 sprays per nostril twice daily (total 4 sprays per day) or 1 or 2 sprays per nostril twice daily (total 2 to 4 sprays per day)
Dose Range:
1 - 2 mg
Condition-Specific Dosing:
seasonalAllergicRhinitis:
2 sprays per nostril twice daily or 1 or 2 sprays per nostril twice daily
perennialAllergicRhinitis:
2 sprays per nostril twice daily or 1 or 2 sprays 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: 2 sprays per nostril twice daily or 1 or 2 sprays per nostril twice daily
Dose Adjustments
Renal Impairment:
Mild:
No adjustment recommended
Moderate:
No adjustment recommended
Severe:
No adjustment recommended
Dialysis:
No specific considerations due to low systemic absorption
Hepatic Impairment:
Mild:
No adjustment recommended
Moderate:
No adjustment recommended
Severe:
No adjustment recommended
Pharmacology
Mechanism of Action
Azelastine is a phthalazinone derivative that exhibits potent histamine H1-receptor antagonist activity and also inhibits the release of histamine and other mediators from mast cells. It also has anti-inflammatory properties.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 40% (nasal administration)
Tmax:
2-3 hours
FoodEffect:
Not applicable for nasal administration
Distribution:
Vd:
14.5 L/kg
ProteinBinding:
88-97%
CnssPenetration:
Limited, but can cause somnolence
Elimination:
HalfLife:
Azelastine: Approximately 22 hours; Desmethylazelastine: Approximately 54 hours
Clearance:
Not available
ExcretionRoute:
Primarily feces (approximately 75%), with a smaller amount in urine (approximately 25%)
Unchanged:
Less than 10% (urine)
Pharmacodynamics
OnsetOfAction:
Within 30 minutes
PeakEffect:
Not precisely defined, but symptom relief within hours
DurationOfAction:
Up to 12 hours
Confidence:
Medium
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following severe side effects, contact your doctor immediately or seek emergency medical attention. Although rare, some individuals may be at risk for life-threatening reactions. Be aware of the following symptoms that could indicate a serious side effect:
- Signs of an allergic reaction, such as rash, hives, itching, redness, swelling, blistering, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or speaking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
- Eye irritation
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not resolve, contact your doctor for advice:
- Irritation of the nose or throat
- Sneezing
- Burning or stinging sensations
- Drowsiness
- Headache
- Cough
- Alteration in taste
- Dry mouth
- Nosebleed
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor. For medical advice regarding side effects, you can also contact your doctor. Additionally, you can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
If you experience any of the following severe side effects, contact your doctor immediately or seek emergency medical attention. Although rare, some individuals may be at risk for life-threatening reactions. Be aware of the following symptoms that could indicate a serious side effect:
- Signs of an allergic reaction, such as rash, hives, itching, redness, swelling, blistering, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or speaking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
- Eye irritation
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not resolve, contact your doctor for advice:
- Irritation of the nose or throat
- Sneezing
- Burning or stinging sensations
- Drowsiness
- Headache
- Cough
- Alteration in taste
- Dry mouth
- Nosebleed
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor. For medical advice regarding side effects, you can also contact your doctor. Additionally, you can 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 drowsiness or sedation
- Nosebleeds that are severe or do not stop
- Severe nasal irritation or pain
- Signs of an allergic reaction (e.g., rash, itching/swelling, severe dizziness, trouble breathing)
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, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any health problems you have, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose 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, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any health problems you have, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose 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. If you have recently undergone nose surgery, experienced a nose injury, or have nose ulcers or sores, consult with your doctor. While taking this medication, refrain from consuming alcohol. Prior to using marijuana, other cannabis products, or prescription or over-the-counter drugs that may cause drowsiness, discuss the potential risks with your doctor. If you accidentally ingest this medication orally, immediately seek medical attention or contact a poison control center. If you are pregnant, planning to become pregnant, or are breast-feeding, inform your doctor to discuss the potential benefits and risks to both you and your baby.
Overdose Information
Overdose Symptoms:
- Drowsiness
- Confusion
- Dizziness
- Tachycardia (fast heart rate)
- Hypotension (low blood pressure)
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is generally supportive and symptomatic.
Drug Interactions
Moderate Interactions
- Alcohol
- Other CNS depressants (e.g., sedatives, hypnotics, anxiolytics)
Monitoring
Routine Monitoring
Symptom relief (nasal congestion, sneezing, rhinorrhea, itching)
Frequency: Daily, as needed
Target: Reduction or resolution of symptoms
Action Threshold: Lack of improvement after several days of use, or worsening symptoms
Adverse effects (e.g., somnolence, bitter taste, nasal irritation)
Frequency: Daily, as needed
Target: Absence or tolerability of side effects
Action Threshold: Intolerable side effects requiring discontinuation or dose adjustment
Symptom Monitoring
- Nasal congestion
- Sneezing
- Rhinorrhea (runny nose)
- Nasal itching
- Post-nasal drip
- Somnolence/drowsiness
- Bitter taste
- Nasal irritation/burning
- Epistaxis (nosebleed)
Special Patient Groups
Pregnancy
Limited available data from published literature and postmarketing experience with azelastine hydrochloride nasal spray in pregnant women are not sufficient to identify a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Use only if clearly needed and potential benefits outweigh potential risks.
Trimester-Specific Risks:
First Trimester:
Limited data, risk not identified.
Second Trimester:
Limited data, risk not identified.
Third Trimester:
Limited data, risk not identified.
Lactation
There are no data on the presence of azelastine hydrochloride in human milk, the effects on the breastfed infant, or the effects on milk production. Due to the potential for adverse reactions in breastfed infants, including somnolence, consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for azelastine and any potential adverse effects on the breastfed infant from azelastine or from the underlying maternal condition. Caution should be exercised.
Infant Risk:
Unknown; potential for somnolence in infant.
Pediatric Use
Approved for children 6 years and older for seasonal and perennial allergic rhinitis. Dosing varies by age group (6-11 years vs. 12 years and older). Not recommended for children under 6 years for the 0.15% concentration.
Geriatric Use
No specific dose adjustment is generally required. However, elderly patients may be more sensitive to the sedative effects of azelastine. Monitor for drowsiness and other CNS effects.
Clinical Information
Clinical Pearls
- Azelastine nasal spray can cause a bitter taste, which is a common reason for discontinuation. Advise patients to avoid sniffing too hard after spraying to minimize this.
- Unlike nasal corticosteroids, azelastine has a rapid onset of action (within 30 minutes), making it suitable for 'as-needed' use or for quick relief.
- Patients should be advised about the potential for drowsiness and to avoid activities requiring mental alertness until they know how the medication affects them.
- Proper priming and administration technique are crucial for efficacy and to minimize side effects like bitter taste.
Alternative Therapies
- Intranasal corticosteroids (e.g., fluticasone, mometasone, budesonide)
- Oral antihistamines (e.g., loratadine, fexofenadine, cetirizine)
- Cromolyn sodium nasal spray
- Nasal saline rinses
- Decongestant nasal sprays (for short-term use)
Cost & Coverage
Average Cost:
Varies, typically $30-$60 per 200 dose bottle
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for 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 this 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 medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.