Nasonex nasal spray 140dosesႏွာရည္ယို ႏွာမႊန္သက္သာေဆး
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ဗိုင်းရပ််စ် သို့ အလာဂျီကြောင့်ဖြစ်သော နှာရည်ယို နှာမွှန်သက်သာဆေး ဆရာဝန်ညွှန်ကြားချက်ဖြင့်သာသုံးရန်
Contents
Mometasone furoate monohydrate.
Description
NASONEX Aqueous Nasal Spray is a metered-dose, manual pump spray unit containing a suspension of mometasone furoate. Each metered-dose pump actuation of NASONEX Aqueous Nasal Spray delivers approximately 100 mg of mometasone furoate suspension, containing mometasone furoate monohydrate equivalent to 50 micrograms mometasone furoate.
Excipients/Inactive Ingredients: cellulose, glycerol, citric acid monohydrate, sodium citrate dihydrate, polysorbate 80 and purified water.
Preservatives: benzalkonium chloride 0.2 mg/g.
Excipients/Inactive Ingredients: cellulose, glycerol, citric acid monohydrate, sodium citrate dihydrate, polysorbate 80 and purified water.
Preservatives: benzalkonium chloride 0.2 mg/g.
Action
Mometasone furoate is a topical glucocorticosteroid with local anti-inflammatory properties at doses that are not systemically active.
Pharmacology: Pharmacodynamics: In studies utilizing nasal antigen challenge, mometasone furoate in NASONEX Aqueous Nasal Spray has shown anti-inflammatory activity in both the early- and late-phase allergic responses. This has been demonstrated by decreases (vs. placebo) in histamine and eosinophil activity and reductions (vs. baseline) in eosinophils, neutrophils, and epithelial cell adhesion proteins. Because of the low systemic availability of mometasone furoate after intranasal administration, any pharmacodynamic correlations have to be based upon sensitive indices of possible systemic exposure rather than measured mometasone furoate levels. Systemic activity of exogenous corticosteroids is commonly expressed by evaluating the hypothalamic-pituitary-adrenal (HPA) axis activity.
Pharmacokinetics: Mometasone furoate monohydrate, administered as an aqueous nasal spray, has a systemic bioavailability of <1% in plasma, using a sensitive assay with a lower quantitation limit (LLOQ) of 0.25 pg/ml. Mometasone furoate suspension is very poorly absorbed from the gastrointestinal tract, and the small amount that may be swallowed and absorbed undergoes extensive first-pass hepatic metabolism prior to excretion in urine and bile.
Pharmacology: Pharmacodynamics: In studies utilizing nasal antigen challenge, mometasone furoate in NASONEX Aqueous Nasal Spray has shown anti-inflammatory activity in both the early- and late-phase allergic responses. This has been demonstrated by decreases (vs. placebo) in histamine and eosinophil activity and reductions (vs. baseline) in eosinophils, neutrophils, and epithelial cell adhesion proteins. Because of the low systemic availability of mometasone furoate after intranasal administration, any pharmacodynamic correlations have to be based upon sensitive indices of possible systemic exposure rather than measured mometasone furoate levels. Systemic activity of exogenous corticosteroids is commonly expressed by evaluating the hypothalamic-pituitary-adrenal (HPA) axis activity.
Pharmacokinetics: Mometasone furoate monohydrate, administered as an aqueous nasal spray, has a systemic bioavailability of <1% in plasma, using a sensitive assay with a lower quantitation limit (LLOQ) of 0.25 pg/ml. Mometasone furoate suspension is very poorly absorbed from the gastrointestinal tract, and the small amount that may be swallowed and absorbed undergoes extensive first-pass hepatic metabolism prior to excretion in urine and bile.
Indications/Uses
Seasonal or Perennial Rhinitis: NASONEX Aqueous Nasal Spray is indicated for use in adults, adolescents, and children between the ages of 2 and 11 years to treat the symptoms of seasonal or perennial rhinitis.
In patients who have a history of moderate to severe symptoms of seasonal allergic rhinitis, prophylactic treatment with NASONEX Aqueous Nasal Spray is recommended two to four weeks prior to the anticipated start of the pollen season.
Treatment of Nasal Congestion Associated with Seasonal Allergic Rhinitis: NASONEX Aqueous 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.
Adjunctive Treatment of Acute Episodes of Sinusitis: NASONEX Aqueous Nasal Spray is also indicated for use in adults and adolescents 12 years of age and older as adjunctive treatment to antibiotics for acute episodes of sinusitis.
Adjunctive treatment of acute episodes of sinusitis.
Nasal Polyposis: NASONEX Aqueous Nasal Spray is also indicated for the treatment of nasal polyps and associated symptoms including congestion and loss of smell in adults patients 18 years of age and older.
Acute Rhinosinusitis: NASONEX Aqueous Nasal Spray is also indicated for the treatment of symptoms associated with acute rhinosinusitis in patients 12 years of age and older without signs or symptoms of bacterial infection.
In patients who have a history of moderate to severe symptoms of seasonal allergic rhinitis, prophylactic treatment with NASONEX Aqueous Nasal Spray is recommended two to four weeks prior to the anticipated start of the pollen season.
Treatment of Nasal Congestion Associated with Seasonal Allergic Rhinitis: NASONEX Aqueous 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.
Adjunctive Treatment of Acute Episodes of Sinusitis: NASONEX Aqueous Nasal Spray is also indicated for use in adults and adolescents 12 years of age and older as adjunctive treatment to antibiotics for acute episodes of sinusitis.
Adjunctive treatment of acute episodes of sinusitis.
Nasal Polyposis: NASONEX Aqueous Nasal Spray is also indicated for the treatment of nasal polyps and associated symptoms including congestion and loss of smell in adults patients 18 years of age and older.
Acute Rhinosinusitis: NASONEX Aqueous Nasal Spray is also indicated for the treatment of symptoms associated with acute rhinosinusitis in patients 12 years of age and older without signs or symptoms of bacterial infection.
Dosage/Direction for Use
Seasonal or Perennial Rhinitis: Adults (including geriatric patients) and adolescents: The usual recommended dose for prophylaxis and treatment is two sprays (50 micrograms/spray) in each nostril once daily (total dose 200 micrograms). Once symptoms are controlled, dose reduction to one spray in each nostril (total dose 100 micrograms) may be effective for maintenance.
If symptoms are inadequately controlled, the dose may be increased to a maximum daily dose of four sprays in each nostril once daily (total dose 400 micrograms). Dose reduction is recommended following control of symptoms.
Clinically significant onset of action occurs as early as 12 hours after the first dose.
Children between the ages of 2 and 11 years: The usual recommended dose is one spray (50 micrograms/spray) in each nostril once daily (total dose 100 micrograms).
Administration to young children should be aided by an adult.
Treatment of Nasal Congestion Associated with Seasonal Allergic Rhinitis: Adults and adolescents 12 years of age and older: The recommended dose for treatment of nasal congestion associated with seasonal allergic rhinitis is two 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 one spray (50 mcg of mometasone furoate in each spray) in each nostril once daily (total daily dose of 100 mcg).
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).
Nasal Polyposis: Adults (including geriatric patients) and adolescents 18 years of age and older: The usual recommended dose for polyposis is two sprays (50 micrograms/spray) in each nostril twice daily (total daily dose of 400 micrograms). Once symptoms are adequately controlled, dose reduction to two sprays in each nostril once daily (total daily dose 200 micrograms) is recommended.
Acute Rhinosinusitis: 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 during treatment, the patients should be advised to consult their physician.
Mode of Administration: After initial priming of the NASONEX Aqueous Nasal Pump (10 actuations, until a uniform spray is observed), each actuation delivers approximately 100 mg of mometasone furoate suspension, containing mometasone furoate monohydrate equivalent to 50 micrograms mometasone furoate. If the spray pump has not been used for 14 days or longer it should be re-primed 2 actuations, until a uniform spray is observed before next use.
Shake container well before each use.
If symptoms are inadequately controlled, the dose may be increased to a maximum daily dose of four sprays in each nostril once daily (total dose 400 micrograms). Dose reduction is recommended following control of symptoms.
Clinically significant onset of action occurs as early as 12 hours after the first dose.
Children between the ages of 2 and 11 years: The usual recommended dose is one spray (50 micrograms/spray) in each nostril once daily (total dose 100 micrograms).
Administration to young children should be aided by an adult.
Treatment of Nasal Congestion Associated with Seasonal Allergic Rhinitis: Adults and adolescents 12 years of age and older: The recommended dose for treatment of nasal congestion associated with seasonal allergic rhinitis is two 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 one spray (50 mcg of mometasone furoate in each spray) in each nostril once daily (total daily dose of 100 mcg).
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).
Nasal Polyposis: Adults (including geriatric patients) and adolescents 18 years of age and older: The usual recommended dose for polyposis is two sprays (50 micrograms/spray) in each nostril twice daily (total daily dose of 400 micrograms). Once symptoms are adequately controlled, dose reduction to two sprays in each nostril once daily (total daily dose 200 micrograms) is recommended.
Acute Rhinosinusitis: 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 during treatment, the patients should be advised to consult their physician.
Mode of Administration: After initial priming of the NASONEX Aqueous Nasal Pump (10 actuations, until a uniform spray is observed), each actuation delivers approximately 100 mg of mometasone furoate suspension, containing mometasone furoate monohydrate equivalent to 50 micrograms mometasone furoate. If the spray pump has not been used for 14 days or longer it should be re-primed 2 actuations, until a uniform spray is observed before next use.
Shake container well before each use.
Overdosage
Because the systemic bioavailability of NASONEX Aqueous Nasal Spray is <1% (using a sensitive assay with a lower quantitation limit of 0.25 pg/mL), overdose is unlikely to require any therapy other than observation, followed by initiation of the appropriate prescribed dosage.
Inhalation or oral administration of excessive doses of corticosteroids may lead to suppression of Hypothalamic-Pituitary-Adrenal axis function.
Inhalation or oral administration of excessive doses of corticosteroids may lead to suppression of Hypothalamic-Pituitary-Adrenal axis function.
Contraindications
Hypersensitivity to any ingredients of NASONEX Aqueous Nasal Spray.
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