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Indications/Uses
Treatment of Nasal Polyps: Mometasone furoate monohydrate Nasal Spray 50 mcg is indicated for the treatment of nasal polyps and associated symptoms including congestion and loss of smell in adult patients 18 years of age and older.
Treatment of symptoms of acute rhinosinusitis: Mometasone furoate monohydrate Nasal Spray 50 mcg is indicated for the treatment of symptoms associated with acute rhinosinusitis in patients 12 years of age and older wihtout signs and symptoms of severe bacterial infection.
Treatment of acute episodes of sinusitis as adjunctive treatment to antibiotic: Mometasone furoate monohydrate Nasal Spray 50 mcg is also indicated for use in adults and adolescents 12 years of age and older as adjunctive treatment to antibiotic for acute episodes of sinusitis.
Treatment of symptoms of acute rhinosinusitis: Mometasone furoate monohydrate Nasal Spray 50 mcg is indicated for the treatment of symptoms associated with acute rhinosinusitis in patients 12 years of age and older wihtout signs and symptoms of severe bacterial infection.
Treatment of acute episodes of sinusitis as adjunctive treatment to antibiotic: Mometasone furoate monohydrate Nasal Spray 50 mcg is also indicated for use in adults and adolescents 12 years of age and older as adjunctive treatment to antibiotic for acute episodes of sinusitis.
Dosage/Direction for Use
Administer Mometasone furoate monohydrate Nasal Spray 50 mcg by the intranasal route only. Prior to initial use of Mometasone furoate monohydrate Nasal Spray 50 mcg, 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. If unused for more than 1 week, reprime by actuating two times, or until a fine spray appears.
Treatment of Nasal Polyps: Adults 18 Years of Age and Older: The recommended dose 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.
Acute Rhinosinusitus: The usual recommended dose for acute rhinosinusitis is two actuations (50 micrograms/actuation) in each nostril twice daily (total daily dose of 400 micrograms). If symptoms worsen drug treatment, the patient should be advised to consult their physician.
Adjunctive treatment of acute episodes of sinusitis: Adults (including geriatric patients) and adolescents 12 years of age and older: The usual recommended dose is two sprays (50 micrograms/spray) in each nostril twice daily (total dose 400 micrograms).
If symptoms are inadequately controlled, the dose may be increased to four sprays (50 micrograms/spray) in each nostril twice daily (total dose 800 micrograms).
Treatment of Nasal Polyps: Adults 18 Years of Age and Older: The recommended dose 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.
Acute Rhinosinusitus: The usual recommended dose for acute rhinosinusitis is two actuations (50 micrograms/actuation) in each nostril twice daily (total daily dose of 400 micrograms). If symptoms worsen drug treatment, the patient should be advised to consult their physician.
Adjunctive treatment of acute episodes of sinusitis: Adults (including geriatric patients) and adolescents 12 years of age and older: The usual recommended dose is two sprays (50 micrograms/spray) in each nostril twice daily (total dose 400 micrograms).
If symptoms are inadequately controlled, the dose may be increased to four sprays (50 micrograms/spray) in each nostril twice daily (total dose 800 micrograms).
Overdosage
There are no data available on the effects of acute or chronic overdosage with Mometasone furoate monohydrate Nasal Spray 50 mcg. Because of low systemic bioavailablity 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 1600 mcg (4 times the recommended dose of Mometasone furoate monohydrate 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 4000 mcg and oral inhalation doses up to 8000 mcg have been studied in human volunteers with no adverse effects reported. Chronic overdosage with any corticosteroid may result in signs or symptoms of hypercorticism. Acute overdosage with this dosage form is unlikely since one bottle of Mometasone furoate monohydrate Nasal Spray 50 mcg contains approximately 8500 mcg of mometasone furoate.
Contraindications
Mometasone furoate monohydrate Nasal Spray is contraindicated in patients with known hypersensitivity to mometasone furoate or any of its ingredients. Mometasone furoate monohydrate Nasal Spray should not be used in the presence of untreated localised infection involving the nasal mucosa.
Because of the inhibitory effect of corticosteroids on wound healing patients who have experienced recent nasal surgery or trauma should not use a nasal corticosteroid until healing has occurred.
Because of the inhibitory effect of corticosteroids on wound healing patients who have experienced recent nasal surgery or trauma should not use a nasal corticosteroid until healing has occurred.
Special Precautions
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.
Candida infection: In clinical studies with Mometasone furoate monohydrate 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 monohydrate Nasal Spray 50 mcg 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 intranasal application of corticosteroids. As with any long term topical treatment of the nasal cavity, patients using Mometasone furoate monohydrate Nasal Spray 50 mcg 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.
Glaucoma and Cataracts: Nasal and inhaled corticosteroids may result in the development of glaucoma and/or cataracts. Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts.
Hypersensitivity Reactions: Hypersensitivity reactions including instances of wheezing may occur after the intranasal administration of mometasone furoate monohydrate. Discontinue Mometasone Nasal Spray if such reactions occur.
Immunosuppression: 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 non-immune 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 corticosteroid treatment so the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immunoglobulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. 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 tuberculosis 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.
Hypothalamic-Pituitary-Adrenal Axis Effect: Hypercoticism and Adrenal Suppression: When intranasal 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.
Effect on Growth: Corticosteroids may cause a reduction in growth velocity when administered in pediatric patients. Monitor the growth routinely of pediatric patients receiving Mometasone furoate monohydrate Nasal Spray. To minimize the systemic effects of intranasal corticosteroids including Mometasone furoate monohydrate Nasal Spray, titrate each patient's dose to the lowest dosage that effectively controls his/her symptoms.
Use in Specific Populations: Hepatic Impairment: Concentrations of mometasone furoate appear to increase with severity of hepatic impairment.
Use in Children: 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. Controlled clinical studies have shown intranasal corticosteroids may cause a reduction in growth velocity in pediatric patients.
The potential of Mometasone furoate monohydrate Nasal Spray 50 mcg to cause growth suppression in susceptible patients or when given at higher dose cannot be ruled out.
Use in Elderly: The adverse reactions reported in geriatric population were similar in type and incidence to those reported by younger patients.
Candida infection: In clinical studies with Mometasone furoate monohydrate 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 monohydrate Nasal Spray 50 mcg 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 intranasal application of corticosteroids. As with any long term topical treatment of the nasal cavity, patients using Mometasone furoate monohydrate Nasal Spray 50 mcg 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.
Glaucoma and Cataracts: Nasal and inhaled corticosteroids may result in the development of glaucoma and/or cataracts. Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts.
Hypersensitivity Reactions: Hypersensitivity reactions including instances of wheezing may occur after the intranasal administration of mometasone furoate monohydrate. Discontinue Mometasone Nasal Spray if such reactions occur.
Immunosuppression: 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 non-immune 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 corticosteroid treatment so the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immunoglobulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. 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 tuberculosis 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.
Hypothalamic-Pituitary-Adrenal Axis Effect: Hypercoticism and Adrenal Suppression: When intranasal 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.
Effect on Growth: Corticosteroids may cause a reduction in growth velocity when administered in pediatric patients. Monitor the growth routinely of pediatric patients receiving Mometasone furoate monohydrate Nasal Spray. To minimize the systemic effects of intranasal corticosteroids including Mometasone furoate monohydrate Nasal Spray, titrate each patient's dose to the lowest dosage that effectively controls his/her symptoms.
Use in Specific Populations: Hepatic Impairment: Concentrations of mometasone furoate appear to increase with severity of hepatic impairment.
Use in Children: 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. Controlled clinical studies have shown intranasal corticosteroids may cause a reduction in growth velocity in pediatric patients.
The potential of Mometasone furoate monohydrate Nasal Spray 50 mcg to cause growth suppression in susceptible patients or when given at higher dose cannot be ruled out.
Use in Elderly: The adverse reactions reported in geriatric population were similar in type and incidence to those reported by younger patients.
Use In Pregnancy & Lactation
Use in Pregnancy: Pregnancy Teratogenic Effects: There are no adequate and well-controlled studies in pregnant women. Mometasone furoate monohydrate 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 do not need corticosteroid treatment during pregnancy.
Nonteratogenic Effects: Hypoadrenalism may occur in infants born to women receiving corticosteroids during pregnancy. Such infants should be carefully monitored.
Use in Lactation: It is not known if mometasone furoate is excreted in human milk. Because other corticosteroids are excreted in human milk, caution should be used when Mometasone furoate monohydrate Nasal Spray, 50 mcg is administered to nursing women.
Nonteratogenic Effects: Hypoadrenalism may occur in infants born to women receiving corticosteroids during pregnancy. Such infants should be carefully monitored.
Use in Lactation: It is not known if mometasone furoate is excreted in human milk. Because other corticosteroids are excreted in human milk, caution should be used when Mometasone furoate monohydrate Nasal Spray, 50 mcg is administered to nursing women.
Adverse Reactions
Epistaxis was generally self-limiting and mild in severity and occurred at a higher incidence comparable to placebo (5%), but at a comparable or lower incidence when compared to the active control nasal corticosteroids studied (up to 15%). The incidence of all other effects was comparable with that of placebo.
In the paediatric population the incidence of adverse events e.g. epistaxis (6%), headache (3%), nasal irritation (2%) and sneezing (2%) was comparable to placebo.
In patients treated for nasal polyposis, the overall incidence of adverse events was comparable to placebo and similar so that observed for patients with allergic rhinitis. Treatment-related adverse events reported in 1% of patients in clinical studies for polyposis are shown as follows. (See Table 2.)
In the paediatric population the incidence of adverse events e.g. epistaxis (6%), headache (3%), nasal irritation (2%) and sneezing (2%) was comparable to placebo.
In patients treated for nasal polyposis, the overall incidence of adverse events was comparable to placebo and similar so that observed for patients with allergic rhinitis. Treatment-related adverse events reported in 1% of patients in clinical studies for polyposis are shown as follows. (See Table 2.)
In patients treated for acute rhinosinusitis, the incidence of epistaxis for Mometasone was 3.3% vs 2.6% for placebo and similar to that observed for patients treated with allergic rhinitis.
Rarely immediate hypersensitivity reactions, including bronchospasm and dyspnoea, may occur after intranasal administration of mometasone furoate monohydrate. Very rarely, anaphylaxis and angioedema have been reported.
Systemic effects of nasal corticosteroids may occur particularly when prescribed at high doses for prolonged periods.
Acute Rhinosinusitis: In patients treated for acute rhinosinusitis, the overall incidence of adverse events was compared to placebo and similar to that observed for patients with allergic rhinitis.
Adjunctive treatment of acute episodes of sinusitis: In adult and adolescent patients receiving Mometasone furoate Aqueous Nasal Spray as adjunctive treatment for acute episodes of sinusitis, treatment-related adverse events, which occurred at an incidence comparable to placebo, included headache (2%), pharyngitis (1%), nasal burning (1%) and nasal irritation (1%). Epistaxis was mild in severity and also occurred at an incidence comparable to placebo (5% vs. 4%, respectively).
Post-Marketing Experience: The following adverse reactions have been identified during the post-marketing period for Mometasone furoate monohydrate Nasal Spray 50 mcg: nasal burning and irritation, anaphylaxis and angioedema, disturbances in taste and smell and nasal septal perforation. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Rarely immediate hypersensitivity reactions, including bronchospasm and dyspnoea, may occur after intranasal administration of mometasone furoate monohydrate. Very rarely, anaphylaxis and angioedema have been reported.
Systemic effects of nasal corticosteroids may occur particularly when prescribed at high doses for prolonged periods.
Acute Rhinosinusitis: In patients treated for acute rhinosinusitis, the overall incidence of adverse events was compared to placebo and similar to that observed for patients with allergic rhinitis.
Adjunctive treatment of acute episodes of sinusitis: In adult and adolescent patients receiving Mometasone furoate Aqueous Nasal Spray as adjunctive treatment for acute episodes of sinusitis, treatment-related adverse events, which occurred at an incidence comparable to placebo, included headache (2%), pharyngitis (1%), nasal burning (1%) and nasal irritation (1%). Epistaxis was mild in severity and also occurred at an incidence comparable to placebo (5% vs. 4%, respectively).
Post-Marketing Experience: The following adverse reactions have been identified during the post-marketing period for Mometasone furoate monohydrate Nasal Spray 50 mcg: nasal burning and irritation, anaphylaxis and angioedema, disturbances in taste and smell and nasal septal perforation. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Drug Interactions
No formal drug-drug interaction studies have been conducted with Mometasone furoate monohydrate Nasal Spray 50 mcg.
Inhibitors of Cytochrome P450 3A4: Ketoconazole: 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 rate of cytochrome CYP 3A4 in the metabolism of this compound. Coadministration with ketoconazole, a potent CYP 3A4 inhibitor, may increase the plasma concetrations of mometasone furoate.
Loratadine: A clinical interaction study was conducted with loratadine. No interactions were observed.
Inhibitors of Cytochrome P450 3A4: Ketoconazole: 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 rate of cytochrome CYP 3A4 in the metabolism of this compound. Coadministration with ketoconazole, a potent CYP 3A4 inhibitor, may increase the plasma concetrations of mometasone furoate.
Loratadine: A clinical interaction study was conducted with loratadine. No interactions were observed.
Caution For Usage
Instructions for patient for using the mometasone furoate monohydrate nasal spray: 1. Remove the plastic cap.
2. Before using MOMETASONE FUROATE MONOHYDRATE NASAL SPRAY for the first time prime the pump by pressing downward on the shoulders of the white nasal applicator using the index finger and middle finger while holding the base of the bottle with the thumb. Do not pierce the nasal applicator. Press down and release the pump 10 times or until 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 the nose to clear the nostrils. Close 1 nostril. Tilt the head forward slightly. Keep the bottle upright, carefully insert the nasal applicator into the other nostril. Do not spray directly onto the nasal septum the wall between two nostrils).
4. Then breath out through the mouth.
5. Repeat in the other nostril.
6. Wipe the nasal applicator with a clean tissue and replace the plastic cap.
Patient instruction for cleaning applicator: 1. To clean the nasal applicator, remove the plastic cap.
2. Pull gently upward on the whole nasal applicator to remove.
3. Soak the nasal applicator in cold tap water and rinse both ends of the nasal applicator under cold tap water and dry. Do not try to unlock the nasal applicator by inserting a pin or other sharp object as it will damage the applicator and cause the patient not to get the right dose of medicine.
4. Rinse the plastic cap under cold water and dry.
5. Put the nasal applicator back together making sure the pump stem is reinserted into the applicator's center hole.
6. Reprime the pump by pressing downward on the shoulders of the white nasal applicator using the index and middle fingers while holding the base of the bottle with the 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.
7. Replace the plastic cap.
Incompatibilities: Not applicable.
2. Before using MOMETASONE FUROATE MONOHYDRATE NASAL SPRAY for the first time prime the pump by pressing downward on the shoulders of the white nasal applicator using the index finger and middle finger while holding the base of the bottle with the thumb. Do not pierce the nasal applicator. Press down and release the pump 10 times or until 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 the nose to clear the nostrils. Close 1 nostril. Tilt the head forward slightly. Keep the bottle upright, carefully insert the nasal applicator into the other nostril. Do not spray directly onto the nasal septum the wall between two nostrils).
4. Then breath out through the mouth.
5. Repeat in the other nostril.
6. Wipe the nasal applicator with a clean tissue and replace the plastic cap.
Patient instruction for cleaning applicator: 1. To clean the nasal applicator, remove the plastic cap.
2. Pull gently upward on the whole nasal applicator to remove.
3. Soak the nasal applicator in cold tap water and rinse both ends of the nasal applicator under cold tap water and dry. Do not try to unlock the nasal applicator by inserting a pin or other sharp object as it will damage the applicator and cause the patient not to get the right dose of medicine.
4. Rinse the plastic cap under cold water and dry.
5. Put the nasal applicator back together making sure the pump stem is reinserted into the applicator's center hole.
6. Reprime the pump by pressing downward on the shoulders of the white nasal applicator using the index and middle fingers while holding the base of the bottle with the 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.
7. Replace the plastic cap.
Incompatibilities: Not applicable.
Storage
Store below 30°C. Do not freeze. Protect from light.
Shake well before use. For intranasal use only.
Shake well before use. For intranasal use only.
Action
Pharmacology: Pharmacodynamics: Mechanism of Action: Mometasone furoate monohydrate is a corticosteroid demonstrating potent ant-inflammatory properties.
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 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.
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 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 6β-hydroxymometasone furoate. In human liver microsomes, the formation of the metabolite is regulated by cytochrome P450 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.
Special Populations: Hepatic Impairment: Administration of a single inhaled dose of 400 mcg mometasone furoate to subjects with mild, moderate, and severe 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 pharmacokinetivs has not been investigated in the pediatric population.
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.
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 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.
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 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 6β-hydroxymometasone furoate. In human liver microsomes, the formation of the metabolite is regulated by cytochrome P450 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.
Special Populations: Hepatic Impairment: Administration of a single inhaled dose of 400 mcg mometasone furoate to subjects with mild, moderate, and severe 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 pharmacokinetivs has not been investigated in the pediatric population.
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.
MedsGo Class
Nasal Decongestants & Other Nasal Preparations
Features
Brand
Momate
Full Details
Dosage Strength
50mcg / actuation
Drug Ingredients
- Mometasone
Drug Packaging
Suspension for Nasal Spray 60 act.
Generic Name
Mometasone Furoate
Dosage Form
Suspension For Nasal Spray
Registration Number
DR-XY45503
Drug Classification
Prescription Drug (RX)