ZYMOCORT Mometasone Furoate 50mcg / actuation Nasal Spray 120 actuations
RXDRUG-DRP-6145-01
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
Mometasone furoate is indicated for use in adults and children 12 years of age and older to treat the symptoms of seasonal allergic or perennial rhinitis.
Zymocort Nasal Spray is also indicated for use in children 6 to 11 years of age to treat the symptoms of seasonal allergic or perennial allergic rhinitis.
In patients who have a history of moderate to severe symptoms of seasonal allergic rhinitis, prophylactic treatment with Mometasone furoate (Zymocort) Nasal Spray may be initiated up to four weeks prior to the anticipated start of the pollen season.
Mometasone furoate (Zymocort) Nasal Spray is indicated for the treatment of nasal polyps in adults 18 years of age and older.
Zymocort Nasal Spray is also indicated for use in children 6 to 11 years of age to treat the symptoms of seasonal allergic or perennial allergic rhinitis.
In patients who have a history of moderate to severe symptoms of seasonal allergic rhinitis, prophylactic treatment with Mometasone furoate (Zymocort) Nasal Spray may be initiated up to four weeks prior to the anticipated start of the pollen season.
Mometasone furoate (Zymocort) Nasal Spray is indicated for the treatment of nasal polyps in adults 18 years of age and older.
Dosage/Direction for Use
After initial priming of the Mometasone furoate (Zymocort) Nasal Spray 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 reprimed with 2 actuations, until a uniform spray is observed, before next use.
Seasonal or Perennial Allergic Rhinitis: Adults (including geriatric patients) and children 12 years of age and older. The usual recommended dose is two actuations (50 micrograms/actuation) in each nostril once daily (total dose 200 micrograms). Once symptoms are controlled, dose reduction to one actuation 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 actuations in each nostril once daily (total dose 400 micrograms). Dose reduction is recommended following control of symptoms.
Children between the ages of 6 and 11 years: The usual recommended dose is one actuation (50 micrograms/actuation) in each nostril once daily (total dose 100 micrograms).
Mometasone furoate (Zymocort) Nasal Spray demonstrated a clinically significant onset of action within 12 hours after the first dose in some patients with seasonal allergic rhinitis, however, full benefit of treatment may not be achieve full therapeutic benefit.
Nasal Polyposis: The usual recommended starling dose for polyposis is two actuations (50 micrograms/actuation) in each nostril once daily (total daily dose of 200 micrograms). If after 5 to 6 weeks symptoms are inadequately controlled, the dose may be increased to daily of two sprays in each nostril twice daily (total daily dose of 400 micrograms). The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. If no improvement in symptoms is seen after 5 to 6 weeks of twice daily administration, alternative therapies should be considered.
The bottle should be discarded after the labelled number of actuations or within 2 months of first use.
Seasonal or Perennial Allergic Rhinitis: Adults (including geriatric patients) and children 12 years of age and older. The usual recommended dose is two actuations (50 micrograms/actuation) in each nostril once daily (total dose 200 micrograms). Once symptoms are controlled, dose reduction to one actuation 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 actuations in each nostril once daily (total dose 400 micrograms). Dose reduction is recommended following control of symptoms.
Children between the ages of 6 and 11 years: The usual recommended dose is one actuation (50 micrograms/actuation) in each nostril once daily (total dose 100 micrograms).
Mometasone furoate (Zymocort) Nasal Spray demonstrated a clinically significant onset of action within 12 hours after the first dose in some patients with seasonal allergic rhinitis, however, full benefit of treatment may not be achieve full therapeutic benefit.
Nasal Polyposis: The usual recommended starling dose for polyposis is two actuations (50 micrograms/actuation) in each nostril once daily (total daily dose of 200 micrograms). If after 5 to 6 weeks symptoms are inadequately controlled, the dose may be increased to daily of two sprays in each nostril twice daily (total daily dose of 400 micrograms). The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. If no improvement in symptoms is seen after 5 to 6 weeks of twice daily administration, alternative therapies should be considered.
The bottle should be discarded after the labelled number of actuations or within 2 months of first use.
Overdosage
Because of the negligible (≤0.1%) systemic bioavailabilty of Mometasone Furoate (Zymocort), 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 corticosteroid may lead to suppression of HPA axis function.
Contraindications
Hypersensitivity to any ingredients of Mometasone furoate (Zymocort) Nasal Spray.
Mometasone furoate (Zymocort) Nasal Spray should not be used in the presence on untreated localized infection involving the nasal mucosa.
Because of the inhibitory effect of corticosteroids on wound healing, patients who have experience recent nasal surgery or trauma should not use a nasal corticosteroid until healing has occurred.
Mometasone furoate (Zymocort) Nasal Spray should not be used in the presence on untreated localized infection involving the nasal mucosa.
Because of the inhibitory effect of corticosteroids on wound healing, patients who have experience recent nasal surgery or trauma should not use a nasal corticosteroid until healing has occurred.
Special Precautions
Mometasone furoate (Zymocort) Nasal Spray should be used with caution, if at all, in patients with active or quiescent tuberculous infections of the respiratory tract, or in untreated fungal bacterial, systemic viral infections or ocular herpes simplex.
Following 12 months of treatment with Mometasone furoate (Zymocort) Nasal Spray there was no evidence of atrophy of the nasal mucosa, also mometasone furoate tended to reverse the nasal mucosa closer to a normal histologic phenotype.
As with any long-term treatment, patients using Mometasone furoate (Zymocort) Nasal Spray over several months or longer should be examined periodically for possible changes in the nasal mucosa. If localized fungal infection of the nose or pharynx develops discontinuation of Mometasone furoate (Zymocort) Nasal Spray therapy or appropriate treatment may be required. Persistence of nasopharyngeal irritation may be an indication for discontinuing Mometasone furoate (Zymocort) Nasal Spray. Although Mometasone furoate (Zymocort) will control the nasal symptoms in most patients, the concomitant use of appropriate additional therapy may provide additional relief of other symptoms, particularly ocular symptoms.
Effect to drive and use the machine: None known.
Following 12 months of treatment with Mometasone furoate (Zymocort) Nasal Spray there was no evidence of atrophy of the nasal mucosa, also mometasone furoate tended to reverse the nasal mucosa closer to a normal histologic phenotype.
As with any long-term treatment, patients using Mometasone furoate (Zymocort) Nasal Spray over several months or longer should be examined periodically for possible changes in the nasal mucosa. If localized fungal infection of the nose or pharynx develops discontinuation of Mometasone furoate (Zymocort) Nasal Spray therapy or appropriate treatment may be required. Persistence of nasopharyngeal irritation may be an indication for discontinuing Mometasone furoate (Zymocort) Nasal Spray. Although Mometasone furoate (Zymocort) will control the nasal symptoms in most patients, the concomitant use of appropriate additional therapy may provide additional relief of other symptoms, particularly ocular symptoms.
Effect to drive and use the machine: None known.
Use In Pregnancy & Lactation
The are no adequate or well-controlled studies in pregnant women. Following intranasal administration of the maximal recommended clinical dose, mometasone plasma concentrations are not measurable; thus fetal exposure is expected to be negligible and potential for reproductive toxicity very low. As with other nasal corticosteroid preparatons, Mometasone furoate (Zymocort) Nasal Spray should not be used in pregnancy or lactation unless the potential benefit to the mother justifies any potential risk to the mother, fetus or infant. Infants born of mothers who received corticosteroids during pregnancy should be observed carefully for hypoadrenalism.
Adverse Reactions
Treatment-related adverse events headache, viral infection, pharyngitis, epistaxis and cough ulceration, Candida albicans infection, impaired wound healing, cataracts and glaucoma. Hypothalamic pituitary adrenal (HPA) axis effects, including growth reduct upper Respiratory Tract infection, dysmenorrhea, musculoskeletal pain, sinusitis, arthralgia, asthma bronchitis, chest pain, conjunctivitis, diarrhea, dyspepsia, earache, flu-like symptoms, myalgia, nausea and rhinitis for allergic rhinitis in adult and adolescent patients are shown as follows. (See Table 1.)
Epistaxis was generally self-limiting and mild in severity, and occurred at a higher incidence compared to placebo (5%), but at a comparable or lower incidence when compared to the active control nasal corticosteroids studies (up to 15%).
Storage
Store at temperatures not exceeding 30°C. Protect from light.
Do not freeze. Keep out of reach of children. Shake well before use.
Do not freeze. Keep out of reach of children. Shake well before use.
Action
Pharmacology: Mometasone furoate is a topical glucocorticosteroid with local anti-inflammatory properties at doses that are not systemically active. It is likely that much of the mechanism for the anti-allergic and anti-inflammatory effects of mometasone furoate lies in its ability to inhibit the release of mediators of allergic reactions. Mometasone furoate significantly inhibits the release of leukotrienes from leucocytes of allergic patients.
Pharmacokinetics: Mometasone furoate, administered as an aqueous nasal spray, has a negligible (≤0.1%) systemic bioavailability and is generally undetectable in plasma, despite the use of a sensitive assay with a lower quantitation limit of 50 pg/mL; thus, are no relevant pharmacokinetic data for this dosage form 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.
Pharmacokinetics: Mometasone furoate, administered as an aqueous nasal spray, has a negligible (≤0.1%) systemic bioavailability and is generally undetectable in plasma, despite the use of a sensitive assay with a lower quantitation limit of 50 pg/mL; thus, are no relevant pharmacokinetic data for this dosage form 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.
MedsGo Class
Nasal Decongestants & Other Nasal Preparations
Features
Brand
Zymocort
Full Details
Dosage Strength
50 mcg / actuation
Drug Ingredients
- Mometasone
Drug Packaging
Nasal Spray 120act.
Generic Name
Mometasone Furoate
Dosage Form
Nasal Spray
Registration Number
DRP-6145-01
Drug Classification
Prescription Drug (RX)
Please sign in so that we can notify you about a reply