Is There A Less Expensive Substitute For Mometasone Furoate Spray

What are the most common alternative medications for mometasone furoate? Elocon, Mometasone, Hydrocortisone and more.Compare mometasone furoate to one of its alternatives. My bookmarks; Join Log in. Method of use: Dental Product, Inhalation, Injection, Nasal Spray, Ointment. Compare to mometasone furoate.

1. Is There A Less Expensive Substitute For Mometasone Furoate Spray Gel
2. Is There A Less Expensive Substitute For Mometasone Furoate Spray Cream

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For Intranasal Use Only. Treatment of Nasal Symptoms of Allergic RhinitisAdults & Adolescents (12 yrs.

And older): 2 sprays in each nostril once dailyChildren (2 to 11 yrs.): 1 spray in each nostril once daily. Treatment of Nasal Congestion Associated with Seasonal Allergic RhinitisAdults & Adolescents (12 yrs. And older): 2 sprays in each nostril once dailyChildren (2 to 11 yrs.): 1 spray in each nostril once daily. Prophylaxis of Seasonal Allergic RhinitisAdults & Adolescents (12 yrs.

And older): 2 sprays in each nostril once daily. Treatment of Nasal PolypsAdults (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. 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. Glaucoma and cataracts. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use mometasone furoate nasal spray long term. 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. Hypercorticism and adrenal suppression with higher than recommended dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue mometasone furoate nasal spray slowly. Potential reduction in growth velocity in children. Monitor growth routinely in pediatric patients receiving mometasone furoate nasal spray. 2.1 Treatment of Allergic RhinitisAdults and Adolescents 12 Years of Age and Older:The recommended dose for treatment of the nasal symptoms of seasonal allergic and perennial allergic rhinitis is 2 sprays (50 mcg of mometasone furoate in each spray) in each nostril once daily (total daily dose of 200 mcg).Children 2 to 11 Years of Age:The recommended dose for treatment of the nasal symptoms of seasonal allergic and perennial allergic rhinitis is 1 spray (50 mcg of mometasone furoate in each spray) in each nostril once daily (total daily dose of 100 mcg).

2.2 Treatment of Nasal Congestion Associated with Seasonal Allergic RhinitisAdults and Adolescents 12 Years of Age and Older:The recommended dose for treatment of nasal congestion associated with seasonal allergic rhinitis is 2 sprays (50 mcg of mometasone furoate in each spray) in each nostril once daily (total daily dose of 200 mcg).Children 2 to 11 Years of Age:The recommended dose for treatment of nasal congestion associated with seasonal allergic rhinitis is 1 spray (50 mcg of mometasone furoate in each spray) in each nostril once daily (total daily dose of 100 mcg). 2.3 Prophylaxis of Seasonal Allergic RhinitisAdults and Adolescents 12 Years of Age and Older:The recommended dose for prophylaxis treatment of nasal symptoms of seasonal allergic rhinitis is 2 sprays (50 mcg of mometasone furoate in each spray) in each nostril 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 mometasone furoate nasal spray 50 mcg (200 mcg/day) is recommended 2 to 4 weeks prior to the anticipated start of the pollen season. 5.1 Local Nasal EffectsEpistaxisIn clinical studies, epistaxis was observed more frequently in patients with allergic rhinitis with mometasone furoate nasal spray than those who received placebo see.Candida InfectionIn clinical studies with mometasone furoate nasal spray 50 mcg, the development of localized infections of the nose and pharynx with Candida albicans has occurred. When such an infection develops, use of mometasone furoate nasal spray 50 mcg should be discontinued and appropriate local or systemic therapy instituted, if needed.Nasal Septum PerforationInstances of nasal septum perforation have been reported following the intranasal application of corticosteroids. As with any long-term topical treatment of the nasal cavity, patients using mometasone furoate nasal spray 50 mcg over several months or longer should be examined periodically for possible changes in the nasal mucosa.Impaired Wound HealingBecause 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 CataractsGlaucoma and cataracts may be reported with systemic and topical (including intranasal, inhaled and intraocular) corticosteroid use. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use mometasone furoate long term see.Glaucoma and cataract formation was evaluated in one controlled study of 12 weeks’ duration and one uncontrolled study of 12 months’ duration in patients treated with mometasone furoate nasal spray, 50 mcg at 200 mcg/day, using intraocular pressure measurements and slit lamp examination. No significant change from baseline was noted in the mean intraocular pressure measurements for the 141 mometasone furoate-treated patients in the 12-week study, as compared with 141 placebo-treated patients. No individual mometasone furoate-treated patient was noted to have developed a significant elevation in intraocular pressure or cataracts in this 12-week study. Likewise, no significant change from baseline was noted in the mean intraocular pressure measurements for the 139 mometasone furoate-treated patients in the 12-month study and again, no cataracts were detected in these patients. Nonetheless, intranasal and inhaled corticosteroids have been associated with the development of glaucoma and/or cataracts.

5.4 ImmunosuppressionPersons 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 package inserts for complete VZIG and IG prescribing information.) 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.

6.1 Clinical Trials ExperienceBecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.Allergic RhinitisAdults and adolescents 12 years of age and olderIn controlled US and international clinical studies, a total of 3,210 adult and adolescent patients 12 years and older with allergic rhinitis received treatment with mometasone furoate nasal spray 50 mcg at doses of 50 mcg/day to 800 mcg/day. The majority of patients (n=2,103) were treated with 200 mcg/day. A total of 350 adult and adolescent patients have been treated for one year or longer.

Adverse events did not differ significantly based on age, sex, or race. Four percent or less of patients in clinical trials discontinued treatment because of adverse events and the discontinuation rate was similar for the vehicle and active comparators.All adverse events (regardless of relationship to treatment) reported by 5% or more of adult and adolescent patients ages 12 years and older who received mometasone furoate nasal spray 50 mcg, 200 mcg/day vs. Placebo and that were more common with mometasone furoate nasal spray 50 mcg than placebo, are displayed in TABLE 1 below.TABLE 1: ADULT AND ADOLESCENT PATIENTS 12 YEARS AND OLDER – ADVERSE EVENTS FROM CONTROLLED CLINICAL TRIALS IN SEASONAL ALLERGIC AND PERENNIAL ALLERGIC RHINITIS (PERCENT OF PATIENTS REPORTING).

No formal drug-drug interaction studies have been conducted with mometasone furoate nasal spray 50 mcg.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 co-administration of mometasone furoate nasal spray 50 mcg 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. Consider the benefit of co-administration versus the potential risk of systemic corticosteroid effects, in which case patients should be monitored for systemic corticosteroid side effects. 8.1 PregnancyTeratogenic Effects: Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. Mometasone furoate nasal spray 50 mcg, like other corticosteroids, should be used during pregnancy only if the potential benefits justify the potential risk to the fetus.

Experience with oral corticosteroids since their introduction in pharmacologic, as opposed to physiologic, doses suggests that rodents are more prone to teratogenic effects from corticosteroids than humans. In addition, because there is a natural increase in corticosteroid production during pregnancy, most women will require a lower exogenous corticosteroid dose and many will not need corticosteroid treatment during pregnancy.In mice, mometasone furoate caused cleft palate at subcutaneous doses (less than the MRDID in adults on a mcg/m 2 basis). Fetal survival was reduced at approximately 2 times the MRDID in adults on a mcg/m 2 basis.

Is There A Less Expensive Substitute For Mometasone Furoate Spray Gel

No toxicity was observed at less than the MRDID in adults on a mcg/m 2 basis.In rats, mometasone furoate produced umbilical hernia at topical dermal doses approximately 10 times the MRDID in adults on a mcg/m 2 basis. A topical dermal dose approximately 6 times the MRDID in adults on a mcg/m 2 basis produced delays in ossification, but no malformations.In rabbits, mometasone furoate caused multiple malformations (e.g., flexed front paws, gallbladder agenesis, umbilical hernia, and hydrocephaly) at topical dermal doses approximately 6 times the MRDID in adults on a mcg/m 2 basis. In an oral study, mometasone furoate increased resorptions and caused cleft palate and/or head malformations (hydrocephaly or domed head) at approximately 30 times the MRDID in adults on a mcg/m 2 basis. At approximately 110 times the MRDID in adults on a mcg/m 2 basis, most litters were aborted or resorbed. No toxicity was observed at approximately 6 times the MRDID in adults on a mcg/m 2 basis.When rats received subcutaneous doses of mometasone furoate throughout pregnancy or during the later stages of pregnancy, a dose less than the MRDID in adults on a mcg/m 2 basis caused prolonged and difficult labor and reduced the number of live births, birth weight, and early pup survival.Nonteratogenic Effects: Hypoadrenalism may occur in infants born to women receiving corticosteroids during pregnancy.

Such infants should be carefully monitored. 8.4 Pediatric UseThe safety and effectiveness of mometasone furoate nasal spray 50 mcg for allergic rhinitis in children 12 years of age and older have been established see and. Use of mometasone furoate nasal spray 50 mcg 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 and. 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. Safety and effectiveness of mometasone furoate nasal spray 50 mcg for allergic rhinitis in children less than 2 years of age have not been established.The safety and effectiveness of mometasone furoate 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 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 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 nasal spray in the treatment of nasal polyps in pediatric patients. The adverse events reported in this trial were similar to the adverse events reported in patients 18 years of age and older with nasal polyps.Controlled clinical studies have shown intranasal 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 intranasal corticosteroids, including the impact on final adult height, are unknown. The potential for “catch up” growth following discontinuation of treatment with intranasal corticosteroids has not been adequately studied.

The growth of pediatric patients receiving intranasal corticosteroids, including mometasone furoate nasal spray, 50 mcg, 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 intranasal corticosteroids, including mometasone furoate nasal spray, 50 mcg, each patient should be titrated to his/her lowest effective dose.A clinical study to assess the effect of mometasone furoate nasal spray 50 mcg (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 nasal spray 50 mcg 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 nasal spray 50 mcg to cause growth suppression in susceptible patients or when given at higher doses cannot be ruled out. There are no data available on the effects of acute or chronic overdosage with mometasone furoate nasal spray 50 mcg.

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. Intranasal administration of 1,600 mcg (4 times the recommended dose of mometasone furoate nasal spray 50 mcg for the treatment of nasal polyps in patients 18 years of age and older) daily for 29 days, to healthy human volunteers, showed no increased incidence of adverse events. Single intranasal doses up to 4,000 mcg and oral inhalation doses up to 8,000 mcg have been studied in human volunteers with no adverse effects reported. Chronic over dosage with any corticosteroid may result in signs or symptoms of hypercorticism see.

Acute overdosage with this dosage form is unlikely since one bottle of mometasone furoate nasal spray 50 mcg contains approximately 8,500 mcg of mometasone furoate. Mometasone furoate anhydrous, USP is a white to off-white powder, with an empirical formula of C 27H 30Cl 2O 6, and a molecular weight of 521.43 g/mol. 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 5,000.Mometasone furoate nasal spray 50 mcg is a metered-dose, manual pump spray unit containing an aqueous suspension of mometasone furoate, USP in an aqueous medium containing benzalkonium chloride, citric acid, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, polysorbate 80 and sodium citrate.

The pH is between 4.3 and 4.9. 12.1 Mechanism of ActionMometasone furoate 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, mometasone furoate 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 mometasone furoate 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).

12.2 PharmacodynamicsAdrenal Function in Adults: Four clinical pharmacology studies have been conducted in humans to assess the effect of mometasone furoate nasal spray, 50 mcg at various doses on adrenal function. In one study, daily doses of 200 and 400 mcg of mometasone furoate 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. Mometasone furoate 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 mometasone furoate nasal spray, 50 mcg (400 and 1,600 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 (AUC 0-24), 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 mometasone furoate nasal spray, 50 mcg compared to placebo.A third study evaluated single, rising doses of mometasone furoate nasal spray, 50 mcg (1,000, 2,000, and 4,000 mcg/day), orally administered mometasone furoate (2,000, 4,000, and 8,000 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 (AUC 0-24). 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 mometasone furoate 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. 12.3 PharmacokineticsAbsorption:Mometasone furoate administered as a nasal spray suspension has very low bioavailability (200 pcg/mL on Day 9 (211 to 324 pcg/mL). 13.1 Carcinogenesis, Mutagenesis, Impairment of FertilityIn a 2-year carcinogenicity study in Sprague Dawley rats, mometasone furoate demonstrated no statistically significant increase in the incidence of tumors at inhalation doses up to 67 mcg/kg (approximately 1 and 2 times the maximum recommended daily intranasal dose MRDID in adults 400 mcg and children 100 mcg, respectively, on a mcg/m 2 basis). In a 19-month carcinogenicity study in Swiss CD-1 mice, mometasone furoate demonstrated no statistically significant increase in the incidence of tumors at inhalation doses up to 160 mcg/kg (approximately 2 times the MRDID in adults and children, respectively, on a mcg/m 2 basis).Mometasone furoate increased chromosomal aberrations in an in vitro Chinese hamster ovary-cell assay, but did not increase chromosomal aberrations in an in vitro Chinese hamster lung cell assay. Mometasone furoate was not mutagenic in the Ames test or mouse-lymphoma assay, and was not clastogenic in an in vivo mouse micronucleus assay and a rat bone marrow chromosomal aberration assay or a mouse male germ-cell chromosomal aberration assay. Mometasone furoate also did not induce unscheduled DNA synthesis in vivo in rat hepatocytes.In reproductive studies in rats, impairment of fertility was not produced by subcutaneous doses up to 15 mcg/kg (less than the MRDID in adults on a mcg/m 2 basis).

13.2 Animal Toxicology and/or PharmacologyReproduction Toxicology StudiesIn mice, mometasone furoate caused cleft palate at subcutaneous doses of 60 mcg/kg and above (less than the MRDID in adults on a mcg/m 2 basis). Fetal survival was reduced at 180 mcg/kg (approximately 2 times the MRDID in adults on a mcg/m 2 basis). No toxicity was observed at 20 mcg/kg (less than the MRDID in adults on a mcg/m 2 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/m 2 basis). A dose of 300 mcg/kg (approximately 6 times the MRDID in adults on a mcg/m 2 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/m 2 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/m 2 basis). At 2,800 mcg/kg (approximately 110 times the MRDID in adults on a mcg/m 2 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/m 2 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/m 2 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/m 2 basis). 14.1 Allergic Rhinitis in Adults and AdolescentsThe efficacy and safety of mometasone furoate 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 3,000 adults (ages 17 to 85 years) and adolescents (ages 12 to 16 years).

Is There A Less Expensive Substitute For Mometasone Furoate Spray Cream

Of the total number of patients, there were 1,757 males and 1,453 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 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 mometasone furoate 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 mometasone furoate nasal spray 50 mcg for 1 year or longer.In patients with seasonal allergic rhinitis, mometasone furoate nasal spray 50 mcg, 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 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 mometasone furoate 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 mometasone furoate 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. 14.2 Allergic Rhinitis in PediatricsThe efficacy and safety of mometasone furoate 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 mometasone furoate 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. 14.3 Nasal Polyps in Adults 18 Years of Age and OlderTwo studies were performed to evaluate the efficacy and safety of mometasone furoate nasal spray in the treatment of nasal polyps.

These studies involved 664 patients with nasal polyps, 441 of whom received mometasone furoate 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 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 NASAL SPRAY IN TWO RANDOMIZED, PLACEBO-CONTROLLED TRIALS IN PATIENTS WITH NASAL POLYPS. Mometasone Furoate 200 mcg qdMometasone Furoate 200 mcg bidPlaceboP-value for Mometasone Furoate 200 mcg qd vs. PlaceboP-value for Mometasone Furoate 200 mcg bid vs.

PlaceboStudy 1N=115N=122N=117Baseline bilateral polyp grade.4.214.274.25Mean change from baseline in bilateral polyps grade-1.15-0.96-0.50. 14.4 Nasal Congestion Associated with Seasonal Allergic RhinitisThe efficacy and safety of mometasone furoate 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 1,008 patients 12 years of age and older with nasal congestion associated with seasonal allergic rhinitis, of whom 506 received mometasone furoate nasal spray 200 mcg daily and 502 received placebo. Of the 1,008 patients, the majority 784 (78%) were Caucasians. The majority of the patients were between 18 to. Treatment (Patient Number)Baseline.LS Mean†Change from Baseline LS Mean†Difference from Placebo LS Mean†P-value for Mometasone Furoate 200 mcg qd vs.

PlaceboStudy 1Mometasone furoate 200 mcg qd (N=176)2.63-0.64-0.150.006Placebo (N=175)2.62-0.49Study 2Mometasone furoate 200 mcg qd (N=168)2.62-0.71-0.31.