Mometasone 50mcg Nasal Spray (120)

Manufacturer APOTEX Active Ingredient Mometasone Nasal Spray(moe MET a sone) Pronunciation moe MET a sone
It is used to treat and prevent allergy signs.It is used to treat nose polyps.
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Drug Class
Corticosteroid, Nasal
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Pharmacologic Class
Glucocorticoid
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Pregnancy Category
Category C
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FDA Approved
Sep 1997
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Mometasone nasal spray is a medicine that helps reduce inflammation in your nose. It's a type of steroid that works locally in your nose to relieve symptoms like sneezing, runny nose, stuffiness, and itching caused by allergies or nasal polyps. It's not meant for immediate relief but works best when used regularly.
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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 each use, 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 dosing schedule.
Do not use two doses at the same time or take extra doses.
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Lifestyle & Tips

  • Use regularly as prescribed, even if symptoms improve, for best results.
  • 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 to spray while gently breathing in through your nose.
  • Breathe out through your mouth.
  • Repeat for the other nostril.
  • Avoid blowing your nose immediately after use.
  • Clean the nasal applicator regularly as per instructions.
  • Avoid contact with eyes.

Dosing & Administration

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Adult Dosing

Standard Dose: 2 sprays (50 mcg/spray) in each nostril once daily
Dose Range: 100 - 200 mg

Condition-Specific Dosing:

allergicRhinitis: 2 sprays (50 mcg/spray) in each nostril once daily (total 200 mcg/day). Once symptoms are controlled, dose may be reduced to 1 spray in each nostril (total 100 mcg/day) for maintenance.
nasalPolyps: 2 sprays (50 mcg/spray) in each nostril twice daily (total 400 mcg/day).
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Ages 2-11 years: 1 spray (50 mcg/spray) in each nostril once daily (total 100 mcg/day) for allergic rhinitis. Ages 12 years and older: Same as adult dosing.
Adolescent: Ages 12 years and older: Same as adult dosing.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed
Dialysis: No specific recommendations; low systemic absorption suggests no significant impact.

Hepatic Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed; low systemic absorption suggests no significant impact.

Pharmacology

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Mechanism of Action

Mometasone furoate is a synthetic corticosteroid with potent anti-inflammatory properties. It exhibits a wide range of effects on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) involved in allergic and inflammatory responses. It works by binding to glucocorticoid receptors, leading to the transcription of anti-inflammatory proteins and the repression of pro-inflammatory genes.
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Pharmacokinetics

Absorption:

Bioavailability: <1% (systemic)
Tmax: Not applicable (due to negligible systemic absorption)
FoodEffect: Not applicable (nasal administration)

Distribution:

Vd: Not available (due to negligible systemic absorption)
ProteinBinding: 98-99% (in vitro, for systemically absorbed drug)
CnssPenetration: Limited

Elimination:

HalfLife: Not applicable (due to negligible systemic absorption)
Clearance: Not available
ExcretionRoute: Primarily bile, some urine (as metabolites)
Unchanged: <1% (in urine and feces)
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Pharmacodynamics

OnsetOfAction: Within 12 hours (for allergic rhinitis symptoms), full effect within 1-2 weeks
PeakEffect: 1-2 weeks
DurationOfAction: 24 hours

Safety & Warnings

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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 immediately or seek 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 stomach upset or vomiting
+ Severe dizziness or fainting
+ Muscle weakness
+ Extreme fatigue
+ Mood changes
+ Decreased appetite
+ Weight loss
Nose sores
Nose pain
Whistling sound while 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. 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, contact your doctor for advice:

Headache
Nose or throat irritation
Nosebleed
Common cold symptoms
Cough
* Muscle pain

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. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Nosebleeds that are severe or persistent
  • Nasal irritation, burning, or stinging that doesn't go away
  • Sores or white patches in the nose or throat (signs of fungal infection)
  • Changes in vision or eye pain
  • Signs of infection (fever, chills, body aches, increased pain or swelling)
  • Slowed growth in children
  • Symptoms of adrenal suppression (e.g., unusual tiredness, weakness, nausea, vomiting, dizziness)
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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 potential interactions with your doctor. To ensure your safety, provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your existing health problems

Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to confirm that it is safe to do so in conjunction with your other medications and health conditions.
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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 to monitor your eye health.

In children and adolescents, this drug may potentially affect growth. Regular growth checks may be necessary to monitor any changes. Consult your doctor to discuss the potential impact on growth and the need for regular assessments.

If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. It is essential to discuss the benefits and risks of this medication to both you and your baby to make an informed decision.
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Overdose Information

Overdose Symptoms:

  • Acute overdose is unlikely due to low systemic absorption. Chronic overdose or excessive use may lead to signs of hypercorticism (e.g., Cushing's syndrome) or adrenal suppression.

What to Do:

If you suspect an overdose or chronic excessive use, contact a poison control center or emergency medical services immediately. Call 1-800-222-1222. Management is supportive and symptomatic. Gradual withdrawal may be necessary if adrenal suppression is suspected.

Drug Interactions

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Major Interactions

  • Strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, cobicistat): May increase systemic exposure to mometasone, potentially leading to Cushing's syndrome and adrenal suppression. Co-administration should be avoided unless the benefit outweighs the increased risk of systemic corticosteroid side effects. Patients should be monitored for systemic corticosteroid effects.

Monitoring

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Baseline Monitoring

Nasal examination

Rationale: To assess baseline nasal mucosa, presence of polyps, or any pre-existing infections/lesions.

Timing: Prior to initiation of therapy

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Routine Monitoring

Nasal examination

Frequency: Periodically, especially with long-term use

Target: Healthy, non-irritated mucosa; absence of septal perforation or candidiasis

Action Threshold: If irritation, epistaxis, septal perforation, or candidiasis occurs, discontinue or adjust dose.

Growth monitoring (in pediatric patients)

Frequency: Regularly (e.g., every 3-6 months)

Target: Normal growth velocity for age

Action Threshold: If growth suppression is observed, consider dose reduction or discontinuation.

Signs/symptoms of adrenal suppression or Cushing's syndrome

Frequency: Periodically, especially with high doses or prolonged use

Target: Absence of symptoms

Action Threshold: If symptoms occur, evaluate adrenal function and consider dose adjustment or discontinuation.

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Symptom Monitoring

  • Improvement in nasal congestion
  • Reduction in sneezing
  • Decrease in rhinorrhea
  • Relief of nasal itching
  • Reduction in post-nasal drip
  • Absence of nasal irritation or bleeding
  • Signs of fungal infection (e.g., white patches in nose/throat)
  • Signs of systemic corticosteroid effects (e.g., weight gain, moon face, easy bruising, fatigue)

Special Patient Groups

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Pregnancy

Use during pregnancy should only be considered if the potential benefit justifies the potential risk to the fetus. Animal studies have shown teratogenic effects at high doses, but human data are limited. Low systemic absorption minimizes fetal exposure.

Trimester-Specific Risks:

First Trimester: Limited data, theoretical risk of teratogenicity based on animal studies at high doses. Low systemic absorption likely minimizes risk.
Second Trimester: Low systemic absorption, generally considered low risk.
Third Trimester: Low systemic absorption, generally considered low risk. No known adverse effects on labor or delivery.
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Lactation

It is not known whether mometasone furoate is excreted in human milk. Due to low systemic absorption, infant exposure is expected to be minimal. Use with caution; consider the benefits of breastfeeding versus the potential risks to the infant.

Infant Risk: Low risk (L3 - Moderately safe, based on low systemic absorption and lack of reported adverse effects in infants).
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Pediatric Use

Mometasone nasal spray is approved for allergic rhinitis in children 2 years and older. Long-term use in children may affect growth velocity; growth should be monitored. The lowest effective dose should be used.

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Geriatric Use

No specific dose adjustment is required. Efficacy and safety profiles are generally similar to younger adults. However, elderly patients may be more susceptible to systemic corticosteroid effects if significant absorption occurs, though this is rare with nasal administration.

Clinical Information

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Clinical Pearls

  • Mometasone nasal spray is a preventative medication and may take several days to 2 weeks to achieve full therapeutic effect. Patients should be advised to use it consistently.
  • Proper administration technique is crucial for efficacy and to minimize local side effects. Emphasize pointing the spray away from the nasal septum.
  • Patients should be warned about the potential for local side effects like epistaxis (nosebleeds), nasal irritation, and rarely, septal perforation or candidiasis.
  • If symptoms do not improve after 2 weeks of regular use, or if they worsen, patients should consult their healthcare provider.
  • For patients with severe nasal congestion, a decongestant nasal spray may be used for a few days prior to starting mometasone to help clear the nasal passages and allow the steroid to reach the inflamed areas.
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Alternative Therapies

  • Other intranasal corticosteroids (e.g., fluticasone propionate, budesonide, triamcinolone acetonide, ciclesonide)
  • Oral antihistamines
  • Nasal antihistamines (e.g., azelastine)
  • Nasal cromolyn
  • Oral decongestants
  • Leukotriene receptor antagonists (e.g., montelukast)
  • Immunotherapy (allergy shots)
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Cost & Coverage

Average Cost: Varies widely, typically $30-$100+ per 120-spray bottle
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic), Tier 3 (brand)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is 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 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 discuss them with 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 overdose, including the medication taken, the amount, and the time it occurred.