mometasone furoate 50 MCG/ACTUAT Metered Dose Nasal Spray
Generic Name: MOMETASONE FUROATE MONOHYDRATE
Brand Name: Mometasone Furoate Monohydrate
- Substance Name(s):
- MOMETASONE FUROATE MONOHYDRATE
DRUG INTERACTIONS
7 No formal drug-drug interaction studies have been conducted with Mometasone Furoate Monohydrate Nasal Spray.
Inhibitors of Cytochrome P450 3A4: Studies have shown that mometasone furoate is primarily and extensively metabolized in the liver of all species investigated and undergoes extensive metabolism to multiple metabolites.
In vitro studies have confirmed the primary role of cytochrome CYP3A4 in the metabolism of this compound.
Concomitant administration of CYP3A4 inhibitors may inhibit the metabolism of, and increase the systemic exposure to, mometasone furoate and potentially increase the risk for systemic corticosteroid side effects.
Caution should be exercised when considering the coadministration of Mometasone Furoate Monohydrate Nasal Spray with long-term ketoconazole and other known strong CYP3A4 inhibitors (e.g., ritonavir, cobicistat-containing products, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, telithromycin) [see Clinical Pharmacology (12.3) ] .
Consider the benefit of coadministration versus the potential risk of systemic corticosteroid effects, in which case patients should be monitored for systemic corticosteroid side effects.
OVERDOSAGE
10 There are no data available on the effects of acute or chronic overdosage with Mometasone Furoate Monohydrate Nasal Spray.
Because of low systemic bioavailability, and an absence of acute drug-related systemic findings in clinical studies, overdose is unlikely to require any therapy other than observation.
Chronic overdosage with any corticosteroid may result in signs or symptoms of hypercorticism [see Warnings and Precautions (5.5) ] .
DESCRIPTION
11 Mometasone furoate monohydrate, the active component of Mometasone Furoate Monohydrate Nasal Spray, 50 mcg, is an anti-inflammatory 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 C 27 H 30 C l2 O 6 •H 2 O, 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.
Mometasone Furoate Monohydrate Nasal Spray is a metered-dose, manual pump spray.
After initial priming (10 actuations), each actuation of the pump delivers a metered spray containing 100 mcg or 100 microliter of aqueous suspension of mometasone furoate monohydrate equivalent to 50 mcg (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.
Chemical Structure
CLINICAL STUDIES
14 14.1 Allergic Rhinitis in Adults and Adolescents The efficacy and safety of Mometasone Furoate Monohydrate Nasal Spray 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 Mometasone Furoate Monohydrate Nasal Spray 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 Mometasone Furoate Monohydrate Nasal Spray 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 Mometasone Furoate Monohydrate Nasal Spray for 1 year or longer.
In patients with seasonal allergic rhinitis, Mometasone Furoate Monohydrate Nasal Spray demonstrated improvement in nasal symptoms (vs.
placebo) within 11 hours after the first dose based on one single-dose, parallel-group 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 Mometasone Furoate Monohydrate Nasal Spray, 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 Mometasone Furoate Monohydrate Nasal Spray 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 Mometasone Furoate Monohydrate Nasal Spray demonstrated a statistically significantly smaller mean increase in total nasal symptom scores with onset of the pollen season as compared to placebo patients.
14.2 Allergic Rhinitis in Pediatrics The efficacy and safety of Mometasone Furoate Monohydrate Nasal Spray 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 Mometasone Furoate Monohydrate Nasal Spray (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.
14.3 Nasal Polyps in Adults 18 Years of Age and Older Two studies were performed to evaluate the efficacy and safety of Mometasone Furoate Monohydrate Nasal Spray in the treatment of nasal polyps.
These studies involved 664 patients with nasal polyps, 441 of whom received Mometasone Furoate Monohydrate Nasal Spray.
These studies were randomized, double-blind, placebo-controlled, parallel-group, multicenter studies in patients 18 to 86 years of age with bilateral nasal polyps.
Patients were randomized to receive Mometasone Furoate Monohydrate 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 Mometasone Furoate Monohydrate Nasal Spray in Two Randomized, Placebo-Controlled Trials in Patients with Nasal Polyps Mometasone Furoate Monohydrate Nasal Spray 200 mcg qd Mometasone Furoate Monohydrate Nasal Spray 200 mcg bid Placebo P- value for Mometasone Furoate Monohydrate Nasal Spray 200 mcg qd vs.
placebo P- value for Mometasone Furoate Monohydrate Nasal Spray 200 mcg bid vs.
placebo Study 1 N=115 N=122 N=117 Baseline bilateral polyp grade 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).
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 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.
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 There were no clinically relevant differences in the effectiveness of Mometasone Furoate Monohydrate Nasal Spray in the studies evaluating treatment of nasal polyps across subgroups of patients defined by gender, age, or race.
14.4 Nasal Congestion Associated with Seasonal Allergic Rhinitis The efficacy and safety of Mometasone Furoate Monohydrate Nasal Spray 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 Mometasone Furoate Monohydrate 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 Mometasone Furoate Monohydrate 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 Tables 3 and 4 below).
Table 3: Effect of Mometasone Furoate Monohydrate Nasal Spray in Two Randomized, Placebo-Controlled Trials on Nasal Congestion in Patients with Seasonal Allergic Rhinitis Treatment (Patient Number) Baseline 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 LS Mean and p-value was from an ANCOVA model with treatment, baseline value, and center effects.
Change from Baseline LS Mean Difference from Placebo LS Mean P- value for Mometasone Furoate Monohydrate Nasal Spray 200 mcg qd vs.
placebo Study 1 Mometasone Furoate Monohydrate Nasal Spray 200 mcg qd (N=176) 2.63 -0.64 -0.15 0.006 Placebo (N=175) 2.62 -0.49 Study 2 Mometasone Furoate Monohydrate Nasal Spray 200 mcg qd (N=168) 2.62 -0.71 -0.31 <0.001 Placebo (N=164) 2.60 -0.40 Table 4: Effect of Mometasone Furoate Monohydrate Nasal Spray on TNSS in Two Randomized, Placebo-Controlled Trials in Patients with Seasonal Allergic Rhinitis Treatment (Patient Number) Baseline 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 LS Mean and p-value was from an ANCOVA model with treatment, baseline value, and center effects.
Change from Baseline LS Mean Difference from Placebo LS Mean P- value for Mometasone Furoate Monohydrate Nasal Spray 200 mcg qd vs.
placebo Study 1 Mometasone Furoate Monohydrate Nasal Spray 200 mcg qd (N=176) 9.60 -2.68 -0.83 <0.001 Placebo (N=175) 9.66 -1.85 Study 2 Mometasone Furoate Monohydrate Nasal Spray 200 mcg qd (N=168) 9.39 -3.00 -1.27 <0.001 Placebo (N=164) 9.50 -1.73 Based on results in other studies with Mometasone Furoate Monohydrate 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 Clinical Studies (14.2) ] .
HOW SUPPLIED
16 /STORAGE AND HANDLING Mometasone Furoate Monohydrate Nasal Spray: 50 mcg mometasone furoate monohydrate is supplied in a white, high-density, polyethylene bottle fitted with a white metered-dose, manual spray pump, and blue cap contains 17 g of product formulation (NDC 0781-6355-87) 120 sprays, each delivering 50 mcg of mometasone furoate per actuation Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].
Protect from light.
When Mometasone Furoate Monohydrate Nasal Spray, 50 mcg is removed from its cardboard container, prolonged exposure of the product to direct light should be avoided.
Brief exposure to light, as with normal use, is acceptable.
SHAKE WELL BEFORE EACH USE.
Keep out of reach of children.
GERIATRIC USE
8.5 Geriatric Use A total of 280 patients above 64 years of age with allergic rhinitis or nasal polyps (age range 64 to 86 years) have been treated with Mometasone Furoate Monohydrate Nasal Spray for up to 3 or 4 months, respectively.
The adverse reactions reported in this population were similar in type and incidence to those reported by younger patients.
DOSAGE FORMS AND STRENGTHS
3 Nasal spray: 50 mcg, metered-dose, manual pump spray.
After initial priming (10 actuations), each actuation of the pump delivers a metered spray containing 50 mcg of mometasone furoate.
Nasal spray: 50 mcg of mometasone furoate in each spray ( 3 )
MECHANISM OF ACTION
12.1 Mechanism of Action Mometasone Furoate Monohydrate Nasal Spray 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, Mometasone Furoate Monohydrate Nasal Spray 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 Mometasone Furoate Monohydrate Nasal Spray 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).
INDICATIONS AND USAGE
1 Mometasone Furoate Monohydrate Nasal Spray is a corticosteroid indicated for: Treatment of Nasal Symptoms of Allergic Rhinitis in patients ≥2 years of age ( 1.1 ) Treatment of Nasal Congestion Associated with Seasonal Allergic Rhinitis in patients ≥2 years of age ( 1.2 ) Prophylaxis of Seasonal Allergic Rhinitis in patients ≥12 years of age ( 1.3 ) Treatment of Nasal Polyps in patients ≥18 years of age ( 1.4 ) 1.1 Treatment of Allergic Rhinitis Mometasone Furoate Monohydrate Nasal Spray 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.
1.2 Treatment of Nasal Congestion Associated with Seasonal Allergic Rhinitis Mometasone Furoate Monohydrate Nasal Spray is indicated for the relief of nasal congestion associated with seasonal allergic rhinitis, in adults and pediatric patients 2 years of age and older.
1.3 Prophylaxis of Seasonal Allergic Rhinitis Mometasone Furoate Monohydrate Nasal Spray is indicated for the prophylaxis of the nasal symptoms of seasonal allergic rhinitis in adult and adolescent patients 12 years and older.
1.4 Treatment of Nasal Polyps Mometasone Furoate Monohydrate Nasal Spray is indicated for the treatment of nasal polyps in patients 18 years of age and older.
PEDIATRIC USE
8.4 Pediatric Use The safety and effectiveness of Mometasone Furoate Monohydrate Nasal Spray for allergic rhinitis in children 12 years of age and older have been established [see Adverse Reactions (6.1) and Clinical Studies (14.1) ] .
Use of Mometasone Furoate Monohydrate Nasal Spray for allergic rhinitis in pediatric patients 2 to 11 years of age is supported by safety and efficacy data from clinical studies.
Seven hundred and twenty (720) patients 3 to 11 years of age with allergic rhinitis were treated with mometasone furoate nasal spray 50 mcg (100 mcg total daily dose) in controlled clinical trials [see Adverse Reactions (6.1) and Clinical Studies (14.2) ] .
Twenty-eight (28) patients 2 to 5 years of age with allergic rhinitis were treated with mometasone furoate nasal spray 50 mcg (100 mcg total daily dose) in a controlled trial to evaluate safety [see Adverse Reactions (6.1) ] .
Safety and effectiveness of Mometasone Furoate Monohydrate Nasal Spray for allergic rhinitis in children less than 2 years of age have not been established.
The safety and effectiveness of Mometasone Furoate Monohydrate Nasal Spray for the treatment of nasal polyps in children less than 18 years of age have not been established.
One 4-month trial was conducted to evaluate the safety and efficacy of Mometasone Furoate Monohydrate Nasal Spray in the treatment of nasal polyps in pediatric patients 6 to 17 years of age.
The primary objective of the study was to evaluate safety; efficacy parameters were collected as secondary endpoints.
A total of 127 patients with nasal polyps were randomized to placebo or Mometasone Furoate Monohydrate Nasal Spray 100 mcg once or twice daily (patients 6 to 11 years of age) or 200 mcg once or twice daily (patients 12 to 17 years of age).
The results of this trial did not support the efficacy of Mometasone Furoate Monohydrate Nasal Spray in the treatment of nasal polyps in pediatric patients.
The adverse reactions reported in this trial were similar to the adverse reactions reported in patients 18 years of age and older with nasal polyps.
Controlled clinical studies have shown nasal corticosteroids may cause a reduction in growth velocity in pediatric patients.
This effect has been observed in the absence of laboratory evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression, suggesting that growth velocity is a more sensitive indicator of systemic corticosteroid exposure in pediatric patients than some commonly used tests of HPA axis function.
The long-term effects of this reduction in growth velocity associated with nasal corticosteroids, including the impact on final adult height, are unknown.
The potential for “catch up” growth following discontinuation of treatment with nasal corticosteroids has not been adequately studied.
The growth of pediatric patients receiving nasal corticosteroids, including Mometasone Furoate Monohydrate Nasal Spray, should be monitored routinely (e.g., via stadiometry).
The potential growth effects of prolonged treatment should be weighed against clinical benefits obtained and the availability of safe and effective noncorticosteroid treatment alternatives.
To minimize the systemic effects of nasal corticosteroids, including Mometasone Furoate Monohydrate Nasal Spray, each patient should be titrated to his/her lowest effective dose.
A clinical study to assess the effect of Mometasone Furoate Monohydrate Nasal Spray (100 mcg total daily dose) on growth velocity has been conducted in pediatric patients 3 to 9 years of age with allergic rhinitis.
No statistically significant effect on growth velocity was observed for Mometasone Furoate Monohydrate Nasal Spray compared to placebo following one year of treatment.
No evidence of clinically relevant HPA axis suppression was observed following a 30-minute cosyntropin infusion.
The potential of Mometasone Furoate Monohydrate Nasal Spray to cause growth suppression in susceptible patients or when given at higher doses cannot be ruled out.
PREGNANCY
8.1 Pregnancy Risk Summary There are no adequate and well-controlled clinical studies of Mometasone Furoate Monohydrate Nasal Spray in pregnant women.
In animal reproduction studies with pregnant mice, rats, or rabbits, mometasone furoate caused increased fetal malformations and decreased fetal survival and growth following administration of doses that produced exposures approximately 1/3 to 8 times the maximum recommended human dose (MRHD) on a mcg/m 2 or AUC basis [see Data ] .
However, experience with oral corticosteroids suggests that rodents are more prone to teratogenic effects from corticosteroid exposure than humans.
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S.
general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
Data Animal Data In an embryofetal development study with pregnant mice dosed throughout the period of organogenesis, mometasone furoate produced cleft palate at a dose less than the maximum recommended daily nasal dose (MRDID) (on a mcg/m 2 basis with maternal subcutaneous doses of 60 mcg/kg and above) and decreased fetal survival at approximately 2 times the MRDID (on a mcg/m 2 basis with a maternal subcutaneous dose of 180 mcg/kg).
No toxicity was observed with a dose that produced an exposure less than the MRDID (on a mcg/m 2 basis with maternal topical dermal doses of 20 mcg/kg and above).
In an embryofetal development study with pregnant rats dosed throughout the period of organogenesis, mometasone furoate produced fetal umbilical hernia at exposures approximately 10 times the MRDID (on a mcg/m 2 basis with maternal topical dermal doses of 600 mcg/kg and above) and delays in fetal ossification at a dose approximately 6 times the MRDID (on a mcg/m 2 basis with maternal topical dermal doses of 300 mcg/kg and above).
In another reproductive toxicity study, pregnant rats were dosed with mometasone furoate throughout pregnancy or late in gestation.
Treated animals had prolonged and difficult labor, fewer live births, lower birth weight, and reduced early pup survival at a dose less than the MRDID (on a mcg/m 2 basis with a maternal subcutaneous dose of 15 mcg/kg).
There were no findings at a dose less than the MRDID (on a mcg/m 2 basis with a maternal subcutaneous dose of 7.5 mcg/kg).
Embryofetal development studies were conducted with pregnant rabbits dosed with mometasone furoate by either the topical dermal route or oral route throughout the period of organogenesis.
In the study using the topical dermal route, mometasone furoate caused multiple malformations in fetuses (e.g., flexed front paws, gallbladder agenesis, umbilical hernia, hydrocephaly) at doses approximately 6 times the MRDID (on a mcg/m 2 basis with maternal topical dermal doses of 150 mcg/kg and above).
In the study using the oral route, mometasone furoate caused increased fetal resorptions and cleft palate and/or head malformations (hydrocephaly and domed head) at a dose approximately 30 times of the MRDID (on a mcg/m 2 basis with a maternal oral dose of 700 mcg/kg).
At approximately 110 times the MRDID (on a mcg/m 2 basis with a maternal oral dose of 2800 mcg/kg), most litters were aborted or resorbed.
No effects were observed at a dose approximately 6 times the MRDID (on a mcg/m 2 basis with a maternal oral dose of 140 mcg/kg).
WARNING AND CAUTIONS
5 WARNINGS AND PRECAUTIONS Epistaxis, nasal ulceration, Candida albicans infection, nasal septal perforation, impaired wound healing.
Monitor patients periodically for signs of adverse effects on the nasal mucosa.
Avoid use in patients with recent nasal ulcers, nasal surgery, or nasal trauma.
( 5.1 ) Glaucoma and cataracts.
Consider referral to an ophthalmologist in patients who develop ocular symptoms or use Mometasone Furoate Monohydrate Nasal Spray long term.
( 5.2 ) Potential worsening of existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.
More serious or even fatal course of chickenpox or measles in susceptible patients.
Use caution in patients with the above because of the potential for worsening of these infections.
( 5.4 ) Hypercorticism and adrenal suppression with higher than recommended dosages or at the regular dosage in susceptible individuals.
If such changes occur, discontinue Mometasone Furoate Monohydrate Nasal Spray slowly.
( 5.5 ) Potential reduction in growth velocity in children.
Monitor growth routinely in pediatric patients receiving Mometasone Furoate Monohydrate Nasal Spray.
( 5.6 , 8.4 ) 5.1 Local Nasal Effects Epistaxis In clinical studies, epistaxis was observed more frequently in patients with allergic rhinitis with Mometasone Furoate Monohydrate Nasal Spray than those who received placebo [see Adverse Reactions (6) ].
Candida Infection In clinical studies with Mometasone Furoate Monohydrate Nasal Spray, the development of localized infections of the nose and pharynx with Candida albicans has occurred.
When such an infection develops, use of Mometasone Furoate Monohydrate Nasal Spray should be discontinued and appropriate local or systemic therapy instituted, if needed.
Nasal Septum Perforation Instances of nasal septum perforation have been reported following the nasal application of corticosteroids.
As with any long-term topical treatment of the nasal cavity, patients using Mometasone Furoate Monohydrate Nasal Spray over several months or longer should be examined periodically for possible changes in the nasal mucosa.
Impaired Wound Healing Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal septum ulcers, nasal surgery, or nasal trauma should not use a nasal corticosteroid until healing has occurred.
5.2 Glaucoma and Cataracts Glaucoma and cataracts may be reported with systemic and topical (including nasal, inhaled and ophthalmic) corticosteroid use.
Consider referral to an ophthalmologist in patients who develop ocular symptoms or use Mometasone Furoate Monohydrate Nasal Spray long term [see Adverse Reactions (6) ] .
5.3 Hypersensitivity Reactions Hypersensitivity reactions including instances of wheezing may occur after the nasal administration of mometasone furoate monohydrate.
Discontinue Mometasone Furoate Monohydrate Nasal Spray if such reactions occur [see Contraindications (4) ].
5.4 Immunosuppression and Risk of Infections Persons who are on drugs which suppress the immune system are more susceptible to infections than healthy individuals.
Chickenpox and measles, for example, can have a more serious or even fatal course in nonimmune children or adults on corticosteroids.
In such children or adults who have not had these diseases, particular care should be taken to avoid exposure.
How the dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known.
The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known.
If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated.
If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated.
(See the respective Prescribing Information for VZIG and IG.) If chickenpox develops, treatment with antiviral agents may be considered.
Corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculous infection of the respiratory tract, or in untreated fungal, bacterial, systemic viral infections, or ocular herpes simplex because of the potential for worsening of these infections.
5.5 Hypercorticism and Adrenal Suppression When nasal steroids are used at higher than recommended dosages or in susceptible individuals at recommended dosages, systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear.
If such changes occur, the dosage of Mometasone Furoate Monohydrate Nasal Spray should be discontinued slowly, consistent with accepted procedures for discontinuing oral corticosteroid therapy.
5.6 Effect on Growth Corticosteroids may cause a reduction in growth velocity when administered to pediatric patients.
Monitor the growth routinely of pediatric patients receiving Mometasone Furoate Monohydrate Nasal Spray.
To minimize the systemic effects of nasal corticosteroids, including Mometasone Furoate Monohydrate Nasal Spray, titrate each patient’s dose to the lowest dosage that effectively controls his/her symptoms [see Use in Specific Populations (8.4) ] .
INFORMATION FOR PATIENTS
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information).
17.1 Local Nasal Effect Patients should be informed that treatment with Mometasone Furoate Monohydrate Nasal Spray may be associated with adverse reactions which include epistaxis (nose bleed) and nasal septum perforation.
Candida infection may also occur.
Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal septum ulcers, nasal surgery, or nasal trauma should not use a nasal corticosteroid until healing has occurred [see Warnings and Precautions (5.1) ] .
Patients should be cautioned not to spray Mometasone Furoate Monohydrate Nasal Spray directly onto the nasal septum.
17.2 Glaucoma and Cataracts Advise patients that long-term use of nasal and inhaled corticosteroids may increase the risk of some eye problems (glaucoma or cataracts); regular eye examinations should be considered.
Patients should be cautioned not to spray Mometasone Furoate Monohydrate Nasal Spray into the eyes [see Warnings and Precautions (5.2) ] .
17.3 Immunosuppression and Risk of Infections Persons who are on immunosuppressant doses of corticosteroids should be warned to avoid exposure to chickenpox or measles, and patients should also be advised that if they are exposed, medical advice should be sought without delay [see Warnings and Precautions (5.4) ] .
17.4 Use Regularly for Best Effect Patients should use Mometasone Furoate Monohydrate Nasal Spray on a regular basis for optimal effect.
Improvement in nasal symptoms of allergic rhinitis has been shown to occur within 1 to 2 days after initiation of dosing.
Maximum benefit is usually achieved within 1 to 2 weeks after initiation of dosing.
Patients should not increase the prescribed dosage but should contact their physician if symptoms do not improve, or if the condition worsens.
Administration to young children should be aided by an adult.
If a patient missed a dose, the patient should be advised to take the dose as soon as they remember.
The patient should not take more than the recommended dose for the day.
DOSAGE AND ADMINISTRATION
2 For Nasal Use Only Recommended Dosage for Treatment of Nasal Symptoms of Allergic Rhinitis ( 2.2 ) Adults & Adolescents (12 yrs.
and older): 2 sprays in each nostril once daily Children (2-11 yrs.): 1 spray in each nostril once daily Recommended Dosage for Treatment of Nasal Congestion Associated with Seasonal Allergic Rhinitis ( 2.3 ) Adults & Adolescents (12 yrs.
and older): 2 sprays in each nostril once daily Children (2-11 yrs.): 1 spray in each nostril once daily Recommended Dosage for Prophylaxis of Seasonal Allergic Rhinitis ( 2.4 ) Adults & Adolescents (12 yrs.
and older): 2 sprays in each nostril once daily Recommended Dosage for Treatment of Nasal Polyps ( 2.5 ) Adults (18 yrs.
and older): 2 sprays in each nostril twice daily.
2 sprays in each nostril once daily may also be effective in some patients.
2.1 Preparation and Administration Administer Mometasone Furoate Monohydrate Nasal Spray by the nasal route only.
Initial Priming Prior to initial use of Mometasone Furoate Monohydrate Nasal Spray, the pump must be primed by actuating ten times or until a fine spray appears.
The pump may be stored unused for up to 1 week without repriming.
Repriming (as needed) If unused for more than 1 week, reprime by actuating two times, or until a fine spray appears 2.2 Recommended Dosage for Treatment of Allergic Rhinitis Adults and Adolescents 12 Years of Age and Older: The recommended dosage for treatment of the nasal symptoms of seasonal allergic and perennial allergic rhinitis is mometasone furoate 200 mcg (administer as 2 sprays into each nostril, each spray containing 50 mcg of mometasone furoate) once daily (total daily dose of 200 mcg).
Children 2 to 11 Years of Age: The recommended dosage for treatment of the nasal symptoms of seasonal allergic and perennial allergic rhinitis is mometasone furoate 100 mcg (administer as 1 spray into each nostril, each spray containing 50 mcg of mometasone furoate) once daily (total daily dose of 100 mcg).
2.3 Recommended Dosage for Treatment of Nasal Congestion Associated with Seasonal Allergic Rhinitis Adults and Adolescents 12 Years of Age and Older: The recommended dosage for treatment of nasal congestion associated with seasonal allergic rhinitis is mometasone furoate 200 mcg (administer as 2 sprays into each nostril, each spray containing 50 mcg of mometasone furoate) once daily (total daily dose of 200 mcg).
Children 2 to 11 Years of Age: The recommended dosage for treatment of nasal congestion associated with seasonal allergic rhinitis is mometasone furoate 100 mcg (administer as 1 spray into each nostril, each spray containing 50 mcg of mometasone furoate) once daily (total daily dose of 100 mcg).
2.4 Recommended Dosage for Prophylaxis of Seasonal Allergic Rhinitis Adults and Adolescents 12 Years of Age and Older: The recommended dosage for prophylaxis treatment of nasal symptoms of seasonal allergic rhinitis is mometasone furoate 200 mcg (administer as 2 sprays into each nostril, each spray containing 50 mcg of mometasone furoate) once daily (total daily dose of 200 mcg).
In patients with a known seasonal allergen that precipitates nasal symptoms of seasonal allergic rhinitis, prophylaxis with 2 sprays in each nostril once daily (200 mcg/day) is recommended 2 to 4 weeks prior to the anticipated start of the pollen season.
2.5 Recommended Dosage for Treatment of Nasal Polyps Adults 18 Years of Age and Older: The recommended dosage for the treatment of nasal polyps is 2 sprays (50 mcg of mometasone furoate in each spray) in each nostril twice daily (total daily dose of 400 mcg).
A dose of 2 sprays (50 mcg of mometasone furoate in each spray) in each nostril once daily (total daily dose of 200 mcg) is also effective in some patients.