Mometasone 50mcg Nasal Spray 10ml
It is used to treat and prevent allergy signs.It is used to treat nose polyps.
Drug Class
Corticosteroid, Nasal
Pharmacologic Class
Glucocorticoid receptor agonist
Pregnancy Category
Not available
FDA Approved
Oct 1997
DEA Schedule
Not Controlled
Overview
What is this medicine?
Mometasone nasal spray is a medicine that helps reduce inflammation and swelling in your nose. It's used to treat symptoms like sneezing, runny nose, stuffy nose, and itchy nose caused by allergies, and also to treat nasal polyps. It works by calming down your body's immune response in the nose.
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.
It may take up to 2 weeks to experience the full effects of the medication.
Before using the medication, shake the bottle well.
Prime the pump before the first use by spraying it 10 times or until a fine mist appears. If the pump is not used for more than 1 week, re-prime it by spraying 2 times or until a fine mist appears.
Blow your nose before using the medication.
Spray the medication up into your nose only. Avoid spraying it onto the nasal septum (the wall between the two nostrils).
Clean the spray tip as instructed or according to the package insert.
Storage and Disposal
Store the spray at room temperature.
Discard any unused portion after the labeled number of doses have been used.
Protect the medication from light.
Be aware of the storage duration for this medication. Check the storage information provided with the medication or consult your pharmacist if you have questions.
Missed Dose
If you miss a dose, use it as soon as you remember.
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.
It may take up to 2 weeks to experience the full effects of the medication.
Before using the medication, shake the bottle well.
Prime the pump before the first use by spraying it 10 times or until a fine mist appears. If the pump is not used for more than 1 week, re-prime it by spraying 2 times or until a fine mist appears.
Blow your nose before using the medication.
Spray the medication up into your nose only. Avoid spraying it onto the nasal septum (the wall between the two nostrils).
Clean the spray tip as instructed or according to the package insert.
Storage and Disposal
Store the spray at room temperature.
Discard any unused portion after the labeled number of doses have been used.
Protect the medication from light.
Be aware of the storage duration for this medication. Check the storage information provided with the medication or consult your pharmacist if you have questions.
Missed Dose
If you miss a dose, use it as soon as you remember.
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
- Use regularly as prescribed, even if symptoms improve.
- Shake the bottle well before each use.
- Prime the pump before first use or if not used for a week 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 nozzle 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.
- Breathe out through your mouth.
- Repeat for the other nostril if prescribed.
- Wipe the nozzle with a clean tissue after each use and replace the cap.
- Avoid spraying directly onto the nasal septum.
- Do not share your nasal spray with others.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Allergic Rhinitis: 2 sprays (50 mcg/spray) in each nostril once daily (total daily dose 200 mcg). Nasal Polyps: 2 sprays (50 mcg/spray) in each nostril twice daily (total daily dose 400 mcg).
Dose Range:
100 - 400 mg
Condition-Specific Dosing:
allergicRhinitis:
2 sprays (50 mcg/spray) in each nostril once daily (total daily dose 200 mcg).
nasalPolyps:
2 sprays (50 mcg/spray) in each nostril twice daily (total daily dose 400 mcg).
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Allergic Rhinitis (2-11 years): 1 spray (50 mcg/spray) in each nostril once daily (total daily dose 100 mcg).
Adolescent:
Allergic Rhinitis (âĨ12 years): 2 sprays (50 mcg/spray) in each nostril once daily (total daily dose 200 mcg). Nasal Polyps (âĨ18 years): 2 sprays (50 mcg/spray) in each nostril twice daily (total daily dose 400 mcg).
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No adjustment needed; systemic absorption is minimal.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed; systemic absorption is minimal.
Pharmacology
Mechanism of Action
Mometasone furoate is a synthetic corticosteroid with potent anti-inflammatory properties. It exerts its effects by binding to glucocorticoid receptors, leading to the transcription of anti-inflammatory proteins and the inhibition of pro-inflammatory mediators (e.g., cytokines, chemokines, eicosanoids). This action reduces inflammation, swelling, and mucus production in the nasal passages.
Pharmacokinetics
Absorption:
Bioavailability:
<0.1% (systemic)
Tmax:
Not applicable (minimal systemic absorption)
FoodEffect:
Not applicable (nasal administration)
Distribution:
Vd:
Not applicable (minimal systemic absorption)
ProteinBinding:
>98% (in vitro, for systemically absorbed drug)
CnssPenetration:
Limited
Elimination:
HalfLife:
Not precisely determined due to low systemic absorption; estimated terminal half-life of systemically absorbed drug is 5.8 hours.
Clearance:
Not precisely determined
ExcretionRoute:
Primarily bile, some urine
Unchanged:
<0.1% (in urine)
Pharmacodynamics
OnsetOfAction:
Within 12 hours (for allergic rhinitis symptoms), full effect within 1-2 weeks.
PeakEffect:
1-2 weeks
DurationOfAction:
24 hours (with once-daily dosing)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when 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 discolored sputum
+ Painful urination
+ Mouth sores
+ Wounds that won't heal
Signs of a weak adrenal gland, such as:
+ Severe nausea or vomiting
+ Severe dizziness or fainting
+ Muscle weakness
+ Extreme fatigue
+ Mood changes
+ Decreased appetite
+ Weight loss
Nose sores
Nose pain
A whistling sound when breathing
Redness or white patches in the mouth or throat
Changes in vision
Painful menstrual periods
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're bothered by any of the following side effects or if they persist, contact your doctor:
Headache
Nose or throat irritation
Nosebleed
Symptoms of a common cold
Cough
* Muscle pain
This is not an exhaustive list of possible side effects. If you have questions or concerns, 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.
While rare, some people may experience severe and potentially life-threatening side effects when 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 discolored sputum
+ Painful urination
+ Mouth sores
+ Wounds that won't heal
Signs of a weak adrenal gland, such as:
+ Severe nausea or vomiting
+ Severe dizziness or fainting
+ Muscle weakness
+ Extreme fatigue
+ Mood changes
+ Decreased appetite
+ Weight loss
Nose sores
Nose pain
A whistling sound when breathing
Redness or white patches in the mouth or throat
Changes in vision
Painful menstrual periods
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're bothered by any of the following side effects or if they persist, contact your doctor:
Headache
Nose or throat irritation
Nosebleed
Symptoms of a common cold
Cough
* Muscle pain
This is not an exhaustive list of possible side effects. If you have questions or concerns, 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:
- Nosebleeds (epistaxis)
- Nasal irritation or burning
- Sore throat
- Headache
- Unusual taste or smell
- Signs of nasal infection (e.g., fever, persistent nasal discharge, facial pain)
- Signs of adrenal suppression (e.g., unusual tiredness, weakness, dizziness, nausea, vomiting)
- Slowed growth in children (with long-term use)
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 allergic reaction you experienced, including any symptoms that occurred.
If you have recently undergone nose surgery or have a nose injury, ulcers, or sores.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions.
Remember, do not start, stop, or change the dosage of any medication without first consulting your doctor. This will help ensure your safety and the effectiveness of your treatment.
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 allergic reaction you experienced, including any symptoms that occurred.
If you have recently undergone nose surgery or have a nose injury, ulcers, or sores.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions.
Remember, do not start, stop, or change the dosage of any medication without first consulting your doctor. This will help ensure your safety and the effectiveness of your treatment.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
While taking this drug, you may be more susceptible to infections. To minimize this risk, practice good hygiene by washing your hands frequently and avoid close contact with individuals who have infections, colds, or flu.
If you have not previously had chickenpox or measles, it is crucial to avoid exposure to these illnesses, as they can be severe or even life-threatening in people taking steroid medications like this one. If you have been exposed to chickenpox or measles, consult your doctor promptly.
This medication may increase your risk of developing cataracts or glaucoma. Discuss this potential risk with your doctor and follow their recommendation for regular eye exams.
In children and teenagers, this drug may potentially affect growth. Regular growth checks may be necessary, so be sure to discuss this with your doctor.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. It is vital to weigh the benefits and risks of this medication for both you and your baby, and your doctor will help you make an informed decision.
While taking this drug, you may be more susceptible to infections. To minimize this risk, practice good hygiene by washing your hands frequently and avoid close contact with individuals who have infections, colds, or flu.
If you have not previously had chickenpox or measles, it is crucial to avoid exposure to these illnesses, as they can be severe or even life-threatening in people taking steroid medications like this one. If you have been exposed to chickenpox or measles, consult your doctor promptly.
This medication may increase your risk of developing cataracts or glaucoma. Discuss this potential risk with your doctor and follow their recommendation for regular eye exams.
In children and teenagers, this drug may potentially affect growth. Regular growth checks may be necessary, so be sure to discuss this with your doctor.
If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. It is vital to weigh the benefits and risks of this medication for both you and your baby, and your doctor will help you make an informed decision.
Overdose Information
Overdose Symptoms:
- Acute overdose is unlikely due to low systemic absorption.
- Chronic overdose or excessive use may lead to systemic corticosteroid effects such as Cushing's syndrome, adrenal suppression, or growth retardation in children.
What to Do:
Call 1-800-222-1222 (Poison Control Center). Management is supportive. Gradual withdrawal may be necessary if chronic overdose has led to adrenal suppression.
Drug Interactions
Major Interactions
- Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, cobicistat): May increase systemic exposure to mometasone, potentially leading to Cushing's syndrome or adrenal suppression. Co-administration should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side effects, in which case patients should be monitored for systemic corticosteroid effects.
Monitoring
Routine Monitoring
Nasal mucosa examination
Frequency: Periodically, especially with long-term use
Target: Normal, without signs of irritation, candidiasis, or septal perforation
Action Threshold: If irritation, bleeding, or signs of infection occur, re-evaluate treatment.
Growth monitoring (in pediatric patients)
Frequency: Regularly (e.g., every 3-6 months) with long-term use
Target: Normal growth velocity for age
Action Threshold: If growth suppression is observed, consider dose reduction or discontinuation.
Signs/symptoms of systemic corticosteroid effects (e.g., adrenal suppression, Cushing's syndrome)
Frequency: Periodically, especially with high doses or prolonged use, or if co-administered with strong CYP3A4 inhibitors
Target: Absence of symptoms
Action Threshold: If symptoms develop, consider dose reduction, discontinuation, or alternative therapy.
Symptom Monitoring
- Improvement in nasal congestion
- Reduction in rhinorrhea (runny nose)
- Decrease in sneezing
- Relief of nasal itching
- Reduction in post-nasal drip
- Improvement in sense of smell (for nasal polyps)
Special Patient Groups
Pregnancy
Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Limited data on mometasone use in pregnant women are insufficient to inform a drug-associated risk for major birth defects or miscarriage. Animal studies have shown teratogenicity at high doses.
Trimester-Specific Risks:
First Trimester:
Limited human data; animal studies show teratogenicity at high doses. Use with caution.
Second Trimester:
Limited human data; use with caution.
Third Trimester:
Limited human data; use with caution. Potential for neonatal adrenal suppression with prolonged high-dose use of systemic corticosteroids, though unlikely with nasal mometasone due to low systemic absorption.
Lactation
Mometasone is considered moderately safe during breastfeeding (L3). Systemic absorption is minimal, making infant exposure unlikely to be significant. However, caution is advised, and the benefits of breastfeeding should be weighed against the potential risks.
Infant Risk:
Low risk of adverse effects to the breastfed infant due to minimal systemic absorption and low levels in breast milk (if any).
Pediatric Use
Mometasone nasal spray is approved for allergic rhinitis in children 2 years of age and older. Long-term use in children should be monitored for potential effects on growth velocity. The lowest effective dose should be used.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly and younger patients. Dosage adjustment is generally not required.
Clinical Information
Clinical Pearls
- Mometasone nasal spray has very low systemic bioavailability, minimizing systemic side effects compared to oral corticosteroids.
- Full therapeutic effect for allergic rhinitis may take 1-2 weeks of consistent use.
- Patients should be instructed on proper nasal spray technique to ensure optimal delivery and minimize local side effects.
- Regular, daily use is more effective than as-needed use for chronic conditions like allergic rhinitis and nasal polyps.
- If symptoms do not improve after 2-4 weeks of consistent use, re-evaluate diagnosis and treatment plan.
- Patients should be advised to avoid spraying directly onto the nasal septum to reduce the risk of septal perforation.
Alternative Therapies
- Other intranasal corticosteroids (e.g., fluticasone propionate, budesonide, triamcinolone acetonide, ciclesonide)
- Oral antihistamines
- Nasal antihistamines (e.g., azelastine)
- Nasal mast cell stabilizers (e.g., cromolyn sodium)
- Nasal decongestants (short-term use only)
- Leukotriene receptor antagonists (e.g., montelukast)
- Immunotherapy (allergy shots/sublingual tablets)
Cost & Coverage
Average Cost:
$100 - $200 per 10ml bottle (120 sprays)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (generic), Tier 3 (brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea 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 emergency medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.