Mometasone Furoate

Name: Mometasone Furoate

What else should I know about mometasone furoate?

What preparations of mometasone furoate are available?

Aerosol or spray unit: 50 mcg/spray

How should I keep mometasone furoate stored?

Mometasone furoate should be kept at room temperature, 4 C - 30 C (39 F - 86 F). It should be shaken well before each use.

Description

Mometasone furoate monohydrate, the active component of NASONEX Nasal Spray, 50 mcg, is an antiinflammatory corticosteroid having the chemical name, 9,21-Dichloro-11ß,17-dihydroxy-16α- methylpregna-1,4-diene-3,20-dione17-(2 furoate) monohydrate, and the following chemical structure:

Mometasone furoate monohydrate is a white powder, with an empirical formula of C27H30C12O6•H2O, and a molecular weight of 539.45. It is practically insoluble in water; slightly soluble in methanol, ethanol, and isopropanol; soluble in acetone and chloroform; and freely soluble in tetrahydrofuran. Its partition coefficient between octanol and water is greater than 5000.

NASONEX Nasal Spray 50 mcg is a metered-dose, manual pump spray unit containing an aqueous suspension of mometasone furoate monohydrate equivalent to 0.05% w/w mometasone furoate calculated on the anhydrous basis; in an aqueous medium containing glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, sodium citrate, citric acid, benzalkonium chloride, and polysorbate 80. The pH is between 4.3 and 4.9.

Indications

Treatment Of Allergic Rhinitis

NASONEX® Nasal Spray 50 mcg is indicated for the treatment of the nasal symptoms of seasonal allergic and perennial allergic rhinitis, in adults and pediatric patients 2 years of age and older.

Treatment Of Nasal Congestion Associated With Seasonal Allergic Rhinitis

NASONEX Nasal Spray 50 mcg is indicated for the relief of nasal congestion associated with seasonal allergic rhinitis, in adults and pediatric patients 2 years of age and older.

Prophylaxis Of Seasonal Allergic Rhinitis

NASONEX Nasal Spray 50 mcg is indicated for the prophylaxis of the nasal symptoms of seasonal allergic rhinitis in adult and adolescent patients 12 years and older.

Treatment Of Nasal Polyps

NASONEX Nasal Spray 50 mcg is indicated for the treatment of nasal polyps in patients 18 years of age and older.

Clinical pharmacology

Mechanism Of Action

NASONEX Nasal Spray 50 mcg is a corticosteroid demonstrating potent anti-inflammatory properties. The precise mechanism of corticosteroid action on allergic rhinitis is not known. Corticosteroids have been shown to have a wide range of effects on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, and cytokines) involved in inflammation.

In two clinical studies utilizing nasal antigen challenge, NASONEX Nasal Spray, 50 mcg decreased some markers of the early- and late-phase allergic response. These observations included decreases (vs. placebo) in histamine and eosinophil cationic protein levels, and reductions (vs. baseline) in eosinophils, neutrophils, and epithelial cell adhesion proteins. The clinical significance of these findings is not known.

The effect of NASONEX Nasal Spray, 50 mcg on nasal mucosa following 12 months of treatment was examined in 46 patients with allergic rhinitis. There was no evidence of atrophy and there was a marked reduction in intraepithelial eosinophilia and inflammatory cell infiltration (e.g., eosinophils, lymphocytes, monocytes, neutrophils, and plasma cells).

Pharmacodynamics

Adrenal Function In Adults

Four clinical pharmacology studies have been conducted in humans to assess the effect of NASONEX Nasal Spray, 50 mcg at various doses on adrenal function. In one study, daily doses of 200 and 400 mcg of NASONEX Nasal Spray, 50 mcg and 10 mg of prednisone were compared to placebo in 64 patients (22 to 44 years of age) with allergic rhinitis. Adrenal function before and after 36 consecutive days of treatment was assessed by measuring plasma cortisol levels following a 6-hour Cortrosyn (ACTH) infusion and by measuring 24-hour urinary free cortisol levels. NASONEX Nasal Spray, 50 mcg, at both the 200- and 400-mcg dose, was not associated with a statistically significant decrease in mean plasma cortisol levels post-Cortrosyn infusion or a statistically significant decrease in the 24-hour urinary free cortisol levels compared to placebo. A statistically significant decrease in the mean plasma cortisol levels post-Cortrosyn infusion and 24-hour urinary free cortisol levels was detected in the prednisone treatment group compared to placebo.

A second study assessed adrenal response to NASONEX Nasal Spray, 50 mcg (400 and 1600 mcg/day), prednisone (10 mg/day), and placebo, administered for 29 days in 48 male volunteers (21 to 40 years of age). The 24-hour plasma cortisol area under the curve (AUC0–24 ), during and after an 8-hour Cortrosyn infusion and 24-hour urinary free cortisol levels were determined at baseline and after 29 days of treatment. No statistically significant differences in adrenal function were observed with NASONEX Nasal Spray, 50 mcg compared to placebo.

A third study evaluated single, rising doses of NASONEX Nasal Spray, 50 mcg (1000, 2000, and 4000 mcg/day), orally administered mometasone furoate (2000, 4000, and 8000 mcg/day), orally administered dexamethasone (200, 400, and 800 mcg/day), and placebo (administered at the end of each series of doses) in 24 male volunteers (22 to 39 years of age). Dose administrations were separated by at least 72 hours. Determination of serial plasma cortisol levels at 8 AM and for the 24-hour period following each treatment were used to calculate the plasma cortisol area under the curve (AUC0–24 ). In addition, 24-hour urinary free cortisol levels were collected prior to initial treatment administration and during the period immediately following each dose. No statistically significant decreases in the plasma cortisol AUC, 8 AM cortisol levels, or 24-hour urinary free cortisol levels were observed in volunteers treated with either NASONEX Nasal Spray, 50 mcg or oral mometasone, as compared with placebo treatment. Conversely, nearly all volunteers treated with the three doses of dexamethasone demonstrated abnormal 8 AM cortisol levels (defined as a cortisol level <10 mcg/dL), reduced 24-hour plasma AUC values, and decreased 24-hour urinary free cortisol levels, as compared to placebo treatment.

In a fourth study, adrenal function was assessed in 213 patients (18 to 81 years of age) with nasal polyps before and after 4 months of treatment with either NASONEX Nasal Spray, 50 mcg, (200 mcg once or twice daily) or placebo by measuring 24-hour urinary free cortisol levels. NASONEX Nasal Spray, 50 mcg, at both doses (200 and 400 mcg/day), was not associated with statistically significant decreases in the 24-hour urinary free cortisol levels compared to placebo.

Three clinical pharmacology studies have been conducted in pediatric patients to assess the effect of mometasone furoate nasal spray on the adrenal function at daily doses of 50, 100, and 200 mcg vs. placebo. In one study, adrenal function before and after 7 consecutive days of treatment was assessed in 48 pediatric patients with allergic rhinitis (ages 6 to 11 years) by measuring morning plasma cortisol and 24-hour urinary free cortisol levels. Mometasone furoate nasal spray, at all three doses, was not associated with a statistically significant decrease in mean plasma cortisol levels or a statistically significant decrease in the 24-hour urinary free cortisol levels compared to placebo. In the second study, adrenal function before and after 14 consecutive days of treatment was assessed in 48 pediatric patients (ages 3 to 5 years) with allergic rhinitis by measuring plasma cortisol levels following a 30- minute Cortrosyn infusion. Mometasone furoate nasal spray, 50 mcg, at all three doses (50, 100, and 200 mcg/day), was not associated with a statistically significant decrease in mean plasma cortisol levels post-Cortrosyn infusion compared to placebo. All patients had a normal response to Cortrosyn. In the third study, adrenal function before and after up to 42 consecutive days of once-daily treatment was assessed in 52 patients with allergic rhinitis (ages 2 to 5 years), 28 of whom received mometasone furoate nasal spray, 50 mcg per nostril (total daily dose 100 mcg), by measuring morning plasma cortisol and 24-hour urinary free cortisol levels. Mometasone furoate nasal spray was not associated with a statistically significant decrease in mean plasma cortisol levels or a statistically significant decrease in the 24-hour urinary free cortisol levels compared to placebo.

Pharmacokinetics

Absorption

Mometasone furoate monohydrate administered as a nasal spray suspension has very low bioavailability (<1%) in plasma using a sensitive assay with a lower quantitation limit (LOQ) of 0.25 pcg/mL.

Distribution

The in vitro protein binding for mometasone furoate was reported to be 98% to 99% in concentration range of 5 to 500 ng/mL.

Metabolism

Studies have shown that any portion of a mometasone furoate dose which is swallowed and absorbed undergoes extensive metabolism to multiple metabolites. There are no major metabolites detectable in plasma. Upon in vitro incubation, one of the minor metabolites formed is 6ß-hydroxy-mometasone furoate. In human liver microsomes, the formation of the metabolite is regulated by cytochrome P-450 3A4 (CYP3A4).

Elimination

Following intravenous administration, the effective plasma elimination half-life of mometasone furoate is 5.8 hours. Any absorbed drug is excreted as metabolites mostly via the bile, and to a limited extent, into the urine.

Specific Populations

Hepatic Impairment

Administration of a single inhaled dose of 400 mcg mometasone furoate to subjects with mild (n=4), moderate (n=4), and severe (n=4) hepatic impairment resulted in only 1 or 2 subjects in each group having detectable peak plasma concentrations of mometasone furoate (ranging from 50 to 105 pcg/mL). The observed peak plasma concentrations appear to increase with severity of hepatic impairment, however, the numbers of detectable levels were few.

Renal Impairment

The effects of renal impairment on mometasone furoate pharmacokinetics have not been adequately investigated.

Pediatric

Mometasone furoate pharmacokinetics have not been investigated in the pediatric population [see Use In Specific Populations].

Gender

The effects of gender on mometasone furoate pharmacokinetics have not been adequately investigated.

Race

The effects of race on mometasone furoate pharmacokinetics have not been adequately investigated.

Drug-Drug Interactions

Inhibitors Of Cytochrome P450 3A4

In a drug interaction study, an inhaled dose of mometasone furoate 400 mcg was given to 24 healthy subjects twice daily for 9 days and ketoconazole 200 mg (as well as placebo) were given twice daily concomitantly on Days 4 to 9. Mometasone furoate plasma concentrations were <150 pcg/mL on Day 3 prior to coadministration of ketoconazole or placebo. Following concomitant administration of ketoconazole, 4 out of 12 subjects in the ketoconazole treatment group (n=12) had peak plasma concentrations of mometasone furoate >200 pcg/mL on Day 9 (211-324 pcg/mL).

Animal Toxicology And/Or Pharmacology

Reproduction Toxicology Studies

In mice, mometasone furoate caused cleft palate at subcutaneous doses of 60 mcg/kg and above (less than the MRDID in adults on a mcg/m2 basis). Fetal survival was reduced at 180 mcg/kg (approximately 2 times the MRDID in adults on a mcg/m2 basis). No toxicity was observed at 20 mcg/kg (less than the MRDID in adults on a mcg/m2 basis).

In rats, mometasone furoate produced umbilical hernia at topical dermal doses of 600 mcg/kg and above (approximately 10 times the MRDID in adults on a mcg/m2 basis). A dose of 300 mcg/kg (approximately 6 times the MRDID in adults on a mcg/m2 basis) produced delays in ossification, but no malformations. In rabbits, mometasone furoate caused multiple malformations (e.g., flexed front paws, gallbladder agenesis, umbilical hernia, hydrocephaly) at topical dermal doses of 150 mcg/kg and above (approximately 6 times the MRDID in adults on a mcg/m2 basis). In an oral study, mometasone furoate increased resorptions and caused cleft palate and/or head malformations (hydrocephaly or domed head) at 700 mcg/kg (approximately 30 times the MRDID in adults on a mcg/m2 basis). At 2800 mcg/kg (approximately 110 times the MRDID in adults on a mcg/m2 basis), most litters were aborted or resorbed. No toxicity was observed at 140 mcg/kg (approximately 6 times the MRDID in adults on a mcg/m2 basis).

When rats received subcutaneous doses of mometasone furoate throughout pregnancy or during the later stages of pregnancy, 15 mcg/kg (less than the MRDID in adults on a mcg/m2 basis) caused prolonged and difficult labor and reduced the number of live births, birth weight, and early pup survival. Similar effects were not observed at 7.5 mcg/kg (less than the MRDID in adults on a mcg/m2 basis).

Clinical Studies

Allergic Rhinitis In Adults And Adolescents

The efficacy and safety of NASONEX Nasal Spray, 50 mcg in the prophylaxis and treatment of seasonal allergic rhinitis and the treatment of perennial allergic rhinitis have been evaluated in 18 controlled trials, and one uncontrolled clinical trial, in approximately 3000 adults (ages 17 to 85 years) and adolescents (ages 12 to 16 years). Of the total number of patients, there were 1757 males and 1453 females, including a total of 283 adolescents (182 boys and 101 girls) with seasonal allergic or perennial allergic rhinitis. Patients were treated with NASONEX Nasal Spray 50 mcg at doses ranging from 50 to 800 mcg/day. The majority of patients were treated with 200 mcg/day. The allergic rhinitis trials evaluated the total nasal symptom scores that included stuffiness, rhinorrhea, itching, and sneezing. Patients treated with NASONEX Nasal Spray 50 mcg, 200 mcg/day had a statistically significant decrease in total nasal symptom scores compared to placebo-treated patients. No additional benefit was observed for mometasone furoate doses greater than 200 mcg/day. A total of 350 patients have been treated with NASONEX Nasal Spray 50 mcg for 1 year or longer.

In patients with seasonal allergic rhinitis, NASONEX Nasal Spray 50 mcg, demonstrated improvement in nasal symptoms (vs. placebo) within 11 hours after the first dose based on one single-dose, parallelgroup study of patients in an outdoor "park" setting (park study) and one environmental exposure unit (EEU) study, and within 2 days in two randomized, double-blind, placebo-controlled, parallel-group seasonal allergic rhinitis studies. Maximum benefit is usually achieved within 1 to 2 weeks after initiation of dosing.

Prophylaxis of seasonal allergic rhinitis for patients 12 years of age and older with NASONEX Nasal Spray 50 mcg, given at a dose of 200 mcg/day, was evaluated in two clinical studies in 284 patients. These studies were designed such that patients received 4 weeks of prophylaxis with NASONEX Nasal Spray 50 mcg prior to the anticipated onset of the pollen season; however, some patients received only 2 to 3 weeks of prophylaxis. Patients receiving 2 to 4 weeks of prophylaxis with NASONEX Nasal Spray 50 mcg demonstrated a statistically significantly smaller mean increase in total nasal symptom scores with onset of the pollen season as compared to placebo patients.

Allergic Rhinitis In Pediatrics

The efficacy and safety of NASONEX Nasal Spray 50 mcg in the treatment of seasonal allergic and perennial allergic rhinitis in pediatric patients (ages 3 to 11 years) have been evaluated in four controlled trials. This included approximately 990 pediatric patients ages 3 to 11 years (606 males and 384 females) with seasonal allergic or perennial allergic rhinitis treated with mometasone furoate nasal spray at doses ranging from 25 to 200 mcg/day. Pediatric patients treated with NASONEX Nasal Spray 50 mcg (100 mcg total daily dose, 374 patients) had a significant decrease in total nasal symptom (nasal congestion, rhinorrhea, itching, and sneezing) scores, compared to placebo-treated patients. No additional benefit was observed for the 200-mcg mometasone furoate total daily dose in pediatric patients (ages 3 to 11 years). A total of 163 pediatric patients have been treated for 1 year.

Nasal Polyps In Adults 18 Years Of Age And Older

Two studies were performed to evaluate the efficacy and safety of NASONEX Nasal Spray in the treatment of nasal polyps. These studies involved 664 patients with nasal polyps, 441 of whom received NASONEX Nasal Spray. These studies were randomized, double-blind, placebo-controlled, parallelgroup, multicenter studies in patients 18 to 86 years of age with bilateral nasal polyps. Patients were randomized to receive NASONEX Nasal Spray 200 mcg once daily, 200 mcg twice daily or placebo for a period of 4 months. The co-primary efficacy endpoints were 1) change from baseline in nasal congestion/obstruction averaged over the first month of treatment; and 2) change from baseline to last assessment in bilateral polyp grade during the entire 4 months of treatment as assessed by endoscopy. Efficacy was demonstrated in both studies at a dose of 200 mcg twice daily and in one study at a dose of 200 mcg once a day (see TABLE 2 below).

TABLE 2: EFFECT OF NASONEX NASAL SPRAY IN TWO RANDOMIZED, PLACEBOCONTROLLED TRIALS IN PATIENTS WITH NASAL POLYPS

  NASONEX
200 mcg
qd
NASONEX
200 mcg
bid
Placebo P-value for
NASONEX
200 mcg qd
vs . placebo
P-value for
NASONEX
200 mcg
bid vs .
placebo
Study 1 N=115 N=122 N=117    
Baseline bilateral polyp grade* 4.21 4.27 4.25    
Mean change from baseline in bilateral polyps grade -1.15 -0.96 -0.50 <0.001 0.01
Baseline nasal congestion† 2.29 2.35 2.28    
Mean change from baseline in nasal
congestion
-0.47 -0.61 -0.24 0.001 <0.001
Study 2 N=102 N=102 N=106    
Baseline bilateral polyp grade* 4.00 4.10 4.17    
Mean change from baseline in bilateral polyps grade -0.78 -0.96 -0.62 0.33 0.04
Baseline nasal congestion† 2.23 2.20 2.18    
Mean change from baseline in nasal
congestion
-0.42 -0.66 -0.23 0.01 <0.001
*polyps in each nasal fossa were graded by the investigator based on endoscopic visualization, using a scale of 0- 3 where 0=no polyps; 1=polyps in the middle meatus, not reaching below the inferior border of the middle turbinate; 2=polyps reaching below the inferior border of the middle turbinate but not the inferior border of the inferior turbinate; 3=polyps reaching to or below the border of the inferior turbinate, or polyps medial to the middle turbinate (score reflects sum of left and right nasal fossa grades).
†nasal congestion/obstruction was scored daily by the patient using a 0-3 categorical scale where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms and 3=severe symptoms.

There were no clinically relevant differences in the effectiveness of NASONEX Nasal Spray, 50 mcg, in the studies evaluating treatment of nasal polyps across subgroups of patients defined by gender, age, or race.

Nasal Congestion Associated With Seasonal Allergic Rhinitis

The efficacy and safety of NASONEX Nasal Spray 50 mcg for nasal congestion associated with seasonal allergic rhinitis were evaluated in three randomized, placebo-controlled, double blind clinical trials of 15 days duration. The three trials included a total of 1008 patients 12 years of age and older with nasal congestion associated with seasonal allergic rhinitis, of whom 506 received NASONEX Nasal Spray 200 mcg daily and 502 received placebo. Of the 1008 patients, the majority 784 (78 %) were Caucasians. The majority of the patients were between 18 to < 65 years of age with a mean age of 38.8 years and were predominantly women (66%). The primary efficacy endpoint was the change from baseline in average morning and evening reflective nasal congestion score over treatment day 1 to day 15. The key secondary efficacy endpoint was the change from baseline in average morning and evening reflective total nasal symptom score (TNSS=rhinorrhea [nasal discharge/runny nose or postnasal drip], nasal congestion/stuffiness, nasal itching, sneezing) averaged over treatment day 1 to 15. Two out of three studies demonstrated that treatment with NASONEX Nasal Spray significantly reduced the nasal congestion symptom score and the TNSS compared to placebo in patients 12 years of age and older with seasonal allergic rhinitis (see TABLE 3 and 4 below).

TABLE 3: EFFECT OF NASONEX NASAL SPRAY IN TWO RANDOMIZED, PLACEBOCONTROLLED TRIALS ON NASAL CONGESTION IN PATIENTS WITH SEASONAL ALLERGIC RHINITIS

Treatment (Patient Number) Baseline*
LS Mean†
Change from
Baseline
LS Mean†
Difference
from
Placebo
LS Mean†
P-value for
NASONEX 200
mcg qd vs . placebo
Study 1        
  NASONEX 200 mcg qd (N=176) 2.63 -0.64 -0.15 0.006
  Placebo (N=175) 2.62 -0.49    
Study 2        
  NASONEX 200 mcg qd (N=168) 2.62 -0.71 -0.31 <0.001
  Placebo (N=164) 2.60 -0.40    
*nasal congestion/obstruction was scored daily by the patient using a 0-3 categorical scale where 0=no symptoms, 1=mild symptoms, 2=moderate symptoms and 3=severe symptoms.
†LS Mean and p-value was from an ANCOVA model with treatment, baseline value, and center effects.

TABLE 4: EFFECT OF NASONEX NASAL SPRAY ON TNSS IN TWO RANDOMIZED, PLACEBO-CONTROLLED TRIALS IN PATIENTS WITH SEASONAL ALLERGIC RHINITIS

Treatment (Patient Number) Baseline*
LS Mean†
Change from
Baseline
LS Mean†
Difference
from
Placebo
LS Mean†
P-value for
NASONEX 200
mcg qd vs . placebo
Study 1        
  NASONEX 200 mcg qd (N=176) 9.60 -2.68 -0.83 <0.001
  Placebo (N=175) 9.66 -1.85    
Study 2        
  NASONEX 200 mcg qd (N=168) 9.39 -3.00 -1.27 <0.001
  Placebo (N=164) 9.50 -1.73    
*TNSS was the sum of four individual symptom scores: rhinorrhea, nasal congestion/stuffiness, nasal itching and sneezing. Each symptom was to be rated on a scale of 0=none, 1=mild, 2=moderate, 3=severe.
†LS Mean and p-value was from an ANCOVA model with treatment, baseline value, and center effects.

Based on results in other studies with NASONEX Nasal Spray in pediatric patients, effects on nasal congestion associated with seasonal allergic rhinitis in patients below 12 years of age is similar to those seen in adults and adolescents [see Allergic Rhinitis In Pediatrics].

Patient information

NASONEX
(mometasone furoate monohydrate) Nasal Spray, 50 mcg

FOR INTRANASAL USE ONLY

Read the Patient Information that comes with NASONEX before you start using it and each time you get a refill. There may be new information. This Patient Information does not take the place of talking to your healthcare provider about your medical condition or treatment. If you have any questions about NASONEX, ask your healthcare provider.

What is NASONEX?

NASONEX Nasal Spray is a man-made (synthetic) corticosteroid medicine that is used to:

  • treat the nasal symptoms of seasonal and year-round allergic rhinitis (inflammation of the lining of the nose) in adults and children 2 years of age and older.
  • treat nasal congestion that happens with seasonal allergic rhinitis in adults and children 2 years of age and older.
  • prevent nasal symptoms of seasonal allergic rhinitis in people 12 years of age and older.
  • treat nasal polyps in people 18 years and older.

The safety and effectiveness of NASONEX has not been shown:

  • in children under 2 years of age to treat allergic rhinitis.
  • in children under 18 years of age to treat nasal polyps.

Who should not use NASONEX?

Do not use NASONEX if you are allergic to any of the ingredients in NASONEX. See the end of this leaflet for a complete list of ingredients in NASONEX.

What should I tell my healthcare provider before using NASONEX?

Before you take NASONEX, tell your healthcare provider if you:

  • have had recent nasal sores, nasal surgery, or nasal injury.
  • have eye or vision problems, such as cataracts or glaucoma (increased pressure in your eye).
  • have tuberculosis or any untreated fungal, bacterial, viral infections, or eye infections caused by herpes.
  • have been near someone who has chickenpox or measles.
  • are not feeling well or have any other symptoms that you do not understand.
  • have any other medical conditions.
  • are pregnant or planning to become pregnant. It is not known if NASONEX will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
  • are breastfeeding or planning to breastfeed. It is not known whether NASONEX passes into your breast milk.

Tell your healthcare provider about all the medicines you take including prescription and nonprescription medicines, vitamins, and herbal supplements.

NASONEX and other medicines may affect each other and cause side effects. NASONEX may affect the way other medicines work, and other medicines may affect how NASONEX works.

Know the list of medicine you take. Keep a list of your medications with you to show your healthcare provider and pharmacist when a new medication is prescribed.

How should I use NASONEX?

  • Use NASONEX exactly as prescribed by your healthcare provider.
  • This medicine is for use in the nose only. Do not spray it into your mouth or eyes.
  • An adult should help a young child use this medicine.
  • For best results, you should keep using NASONEX regularly each day without missing a dose. If you do miss a dose of NASONEX, take it as soon as you remember. However, do not take more than the daily dose prescribed by your doctor.
  • Do not use NASONEX more often than prescribed. Ask your healthcare provider if you have any questions.
  • For detailed instructions on how to use NASONEX Nasal Spray, see the "Patient Instructions for Use" at the end of this leaflet.

See your healthcare provider regularly to assess your symptoms while taking NASONEX and to check for side effects.

What should I avoid while taking NASONEX?

If you are taking other corticosteroid medicines for allergy, either by mouth or injection, your healthcare provider may advise you to stop taking them once you begin using NASONEX.

What are the possible side effects of NASONEX?

NASONEX may cause serious side effects, including:

  • Thrush (candida), a fungal infection in your nose and throat. Tell your doctor if you have any redness or white colored patches in your nose or throat.
  • Slow wound healing. Do not use NASONEX until your nose has healed if you have a sore in your nose, if you have surgery on your nose, or if your nose has been injured.
  • Some people may have eye problems , including glaucoma and cataracts. You should have regular eye exams.
  • Immune system problems that may increase your risk of infections. You are more likely to get infections if you take medicines that weaken your immune system. Avoid contact with people who have contagious diseases such as chicken pox or measles while using NASONEX. Symptoms of infection may include: fever, pain, aches, chills, feeling tired, nausea and vomiting. Tell your doctor about any signs of infection while you are using NASONEX.
  • Adrenal insufficiency. Adrenal insufficiency is a condition in which the adrenal glands do not make enough steroid hormones. Symptoms of adrenal insufficiency can include: tiredness, weakness, nausea and vomiting and low blood pressure.

The most common side effects of NASONEX include:

  • headache
  • viral infection
  • sore throat
  • nosebleeds
  • cough

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of NASONEX. For more information ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800- FDA-1088.

How should I store NASONEX?

  • Store NASONEX at room temperature between 59°F to 86°F (15°C to 30°C).
  • Avoid prolonged exposure of NASONEX container to bright light.
  • Shake well before each use.

Keep NASONEX and all medicines out of the reach of children.

General information about NASONEX

Medicines are sometimes prescribed for conditions that are not listed in a Patient Information leaflet. Do not use NASONEX for a condition for which it was not prescribed. Do not give NASONEX to other people even if they have the same symptoms you have. It may harm them.

This Patient Information leaflet provides a summary of the most important information about NASONEX. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about NASONEX that is written for health professionals.

For more information, go to www.NASONEX.com or call 1-800-622-4477.

What are the ingredients in NASONEX?

Active Ingredients: mometasone furoate monohydrate

Inactive Ingredients: glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, sodium citrate, citric acid, benzalkonium chloride, and polysorbate 80.

Patient Instructions for Use

For use in your nose only.

Read the Patient Instructions for Use carefully before you start to use your NASONEX Nasal Spray. If you have any questions, ask your healthcare provider.

Shake the bottle well before each use.

  1. Remove the plastic cap (See Figure 1).
  2. Before you use NASONEX for the first time, prime the pump by pressing downward on the shoulders of the white nasal applicator using your index finger and middle finger while holding the base of the bottle with your thumb (See Figure 2). Do Not pierce the nasal applicator. Press down and release the pump 10 times or until a fine spray appears. Do Not spray into eyes. The pump is now ready to use. The pump may be stored unused for up to 1 week without repriming. If unused for more than 1 week, reprime by spraying 2 times or until a fine spray appears.
  3. Gently blow your nose to clear the nostrils. Close 1 nostril. Tilt your head forward slightly, keep the bottle upright, carefully insert the nasal applicator into the other nostril (See Figure 3). Do Not spray directly onto the nasal septum (the wall between the two nostrils).
  4. For each spray, hold the spray bottle upright and press firmly downward 1 time on the shoulders of the white nasal applicator using your index and middle fingers while supporting the base of the bottle with your thumb. Breathe gently inward through the nostril (See Figure 4).
  5. Note: It is important to keep the NASONEX unit in an upright orientation (as seen in Figure 4). Failure to do so may result in an incomplete or non-existent spray.

  6. Then breathe out through the mouth.
  7. Repeat in the other nostril.
  8. Wipe the nasal applicator with a clean tissue and replace the plastic cap.

Each bottle of NASONEX Nasal Spray contains enough medicine for you to spray medicine from the bottle 120 times. Do not use the bottle of NASONEX Nasal Spray after 120 sprays. Additional sprays after the 120 sprays may not contain the right amount of medicine, you s hould keep track of the number of s prays us ed from each bottle of NASONEX Nas al Spray, and throw away the bottle even if it has medicine still left in. Do not count any s prays us ed for priming the device. Talk with your healthcare provider before your supply runs out to see if you should get a refill of your medicine.

Pediatric Use: Administration to young children should be done by an adult. Steps 1 through 7 from the Patient Instructions for Use, should be followed.

Cleaning: Do not try to unblock the nasal applicator with a sharp object. Please see Patient Instructions for Cleaning Applicator.

Patient Instructions for Cleaning Applicator

  1. To clean the nasal applicator, remove the plastic cap (See Figure 5).
  2. Pull gently upward on the white nasal applicator to remove (See Figure 6).
  3. Soak the nasal applicator in cold tap water and rinse both ends of the nasal applicator under cold tap water and dry (See Figure 7). Do not try to unblock the nasal applicator by inserting a pin or other sharp object as this will damage the applicator and cause you not to get the right dose of medicine.
  4. Rinse the plastic cap under cold water and dry (See Figure 8).
  5. Put the nasal applicator back together making sure the pump stem is reinserted into the applicator's center hole (See Figure 9).
  6. Reprime the pump by pressing downward on the shoulders of the white nasal applicator using your index and middle fingers while holding the base of the bottle with your thumb. Press down and release the pump 2 times or until a fine spray appears. Do Not spray into eyes. The pump is now ready to use. The pump may be stored unused for up to 1 week without repriming. If unused for more than 1 week, reprime by spraying 2 times or until a fine spray appears (See Figure 10).

  7. Replace the plastic cap (See Figure 11).

Where can i get more information?

Your pharmacist can provide more information about mometasone inhalation.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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What is mometasone nasal (nasonex)?

Mometasone is a steroid. It prevents the release of substances in the body that cause inflammation.

Mometasone nasal is used to treat nasal symptoms such as congestion, sneezing, and runny nose caused by seasonal or year-round allergies. Mometasone is also used to treat nasal polyps in adults.

Mometasone may also be used for other purposes not listed in this medication guide.

What should i discuss with my healthcare provider before using mometasone nasal (nasonex)?

You should not use this medication if you are allergic to mometasone.

Before using mometasone, tell your doctor if you have been sick or had an infection of any kind. You may not be able to use mometasone nasal until you are well.

Also tell your doctor if you are allergic to any drugs, or if you have:

  • glaucoma or cataracts;
  • herpes simplex virus of your eyes;
  • tuberculosis or any other infection or illness;
  • sores or ulcers inside your nose; or
  • if you have recently had injury of or surgery on your nose.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether mometasone passes into breast milk or if it could harm a nursing baby. Do not use mometasone nasal without telling your doctor if you are breast-feeding a baby.

Steroid medicines can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using mometasone nasal.

What happens if i miss a dose (nasonex)?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

Actions

  • Reduces the inflammatory asthmatic response by inhibiting multiple cell types (e.g., mast cells, eosinophils, lymphocytes, neutrophils, macrophages).1

  • Inhibits mediator production or secretion (e.g., eicosanoids, leukotrienes, cytokines, histamine) involved in the asthmatic response.1

  • Improves lung function (e.g., forced expiratory volume in 1 second [FEV1], morning and evening peak expiratory flow rate).1 3 4

Warnings

Included as part of the PRECAUTIONS section.

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