Axcel Mometasone Nasal Spray

Axcel Mometasone Nasal Spray

mometasone

Manufacturer:

Kotra Pharma

Distributor:

Kotra Pharma
Full Prescribing Info
Contents
Mometasone furoate.
Description
Each metered-dose pump actuation delivers approximately 100mg of Mometasone Furoate suspension which containing Mometasone Furoate 0.05%w/w.
Benzalkonium Chloride 0.02% w/w as a preservative.
Action
Pharmacology: Pharmacodynamics: Mechanism of Action: Mometasone furoate is a topical glucorticosteroid with local antiinflammatory properties. Mechanism for the antiallergic 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 leukocytes of allergic patients. In addition, it is an extremely potent inhibitor of the production of the Th2 cytokines IL-4 and IL-5 from human CD4+ T-cells.
Pharmacokinetics: Mometasone furoate, administered as a nasal spray, has negligible (≤0.1%) systemic bioavailability and is generally undetectable in plasma, despite the use of a sensitive assay with a lower quantitation limit of 50pg/ml: thus there 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 metabolism prior to excretion mostly as metabolites in the bile and to a limited extend in the urine.
Indications/Uses
Axcel Mometasone 0.05%w/w Nasal Spray is indicated for use in adults and children 3 years of age and older 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 Axcel Mometasone 0.05%w/w Nasal Spray is recommended two to four weeks prior to the anticipated start of the pollen season.
Axcel Mometasone 0.05%w/w Nasal Spray is indicated for the treatment of symptoms associated with acute rhinosinusitis in patients 12 years of age and older without signs or symptoms of severe bacterial infection.
Axcel Mometasone 0.05%w/w Nasal Spray is also indicated for the treatment of nasal polyps in patients 18 years of age and older.
Dosage/Direction for Use
Direction for use: After initial priming of the Axcel Mometasone 0.05%w/w Nasal Spray (Usually 10 actuation, until a uniform spray is observed), each actuation delivers approximately 100mg of mometasone furoate suspension, containing mometasone furoate monohydrate equivalent to 50mcg 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.
Shake container well before each use.
Seasonal allergic or perennial rhinitis: Adults (including geriatric patients) and adolescents: The usual recommended dose for prophylaxis and treatment is two sprays (50mcg/spray) in each nostril once daily (total dose 200mcg). Once symptoms are controlled, dose reduction to one spray in each nostril (total dose 100mcg) 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 400mcg). 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 3 and 11 years: The usual recommended dose is one spray (50mcg/spray) in each nostril once daily (total dose 100mcg). Administration to young children should be aided by an adult.
Acute Rhinosinusitis: Adults (including Geriatric Patients) and adolescents ≥ 12 years: 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 no improvement is seen after 15 days of twice daily administration, alternative therapies should be considered. If symptoms worsen during treatment, the patient should be advised to consult their physician.
Nasal polyposis: Adults (including geriatric patients) and adolescents 18 years of age and older: The usual recommended dose for polyposis is two sprays (50mcg/spray) in each nostril twice daily (total daily dose of 400mcg). Once symptoms are adequately controlled, dose reduction to two sprays in each nostril once daily (total daily dose 200mcg) is recommended.
Method of administration: Route: For intranasal administration only.
Overdosage
Because of the negligible (≤0.1%) systemic bioavailability of Axcel Mometasone 0.05%w/w Nasal Spray, overdose is unlikely to require any therapy other than observation, followed by initiation of the appropriate prescribed dosage.
Contraindications
Hypersensitivity to any ingredients of Axcel Mometasone 0.05%w/w Nasal Spray; severe nasal infection especially candidiasis; persons with hemorrhagic diathesis or with a history of recurrent nasal bleeding.
Special Precautions
Axcel Mometasone 0.05%w/w Nasal Spray should not be used in the presence of untreated localized 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. Following 12 months of treatment with Axcel Mometasone 0.05%w/w 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 Axcel Mometasone 0.05%w/w 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, discontinuance of Axcel Mometasone 0.05%w/w Nasal Spray or appropriate treatment may be required. Persistence of nasopharyngeal irritation may be an indication for discontinuing Axcel Mometasone 0.05%w/w Nasal Spray. Axcel Mometasone 0.05%w/w 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. There is no evidence of hypothalamic-pituitary-adrenal (HPA) axis suppression following prolonged treatment with Axcel Mometasone 0.05%w/w Nasal Spray. However, patients who are transferred from long-term administration of systemically active corticosteroids to Axcel Mometasone 0.05%w/w Nasal Spray require careful attention. Systemic corticosteroid withdrawal in such patients may result in adrenal insufficiency for a number of months until recovery of HPA axis function. If these patients exhibit signs and symptoms of adrenal insufficiency, systemic corticosteroid administration should be resumed and other modes of therapy and appropriate measures instituted. Treatment with higher than recommended doses may result in clinically significant adrenal suppression. If there is evidence for higher than recommended dose being used, then additional systemic corticosteroid cover should be considered during periods of stress or elective surgery. Safety and efficacy of Axcel Mometasone 0.05%w/w Nasal Spray for the treatment of nasal polyposis in children and adolescents less than 18 years of age have not been studied. During transfer from systemic corticosteroids to Axcel Mometasone 0.05%w/w Nasal Spray, some patients may experience symptoms of withdrawal from systemically active corcosteroids (e.g joint and/or muscular pain, lassitude, and depression initially) despite relief from nasal symptoms and will require encouragement to continue Axcel Mometasone 0.05%w/w Nasal Spray therapy. Such transfer may also unmask pre-existing allergic conditions such as allergic conjunctivitis and eczema, previously suppressed by systemic corticosteroid therapy. Patients receiving corticosteroids who are potentially immunosuppressed should be warned of the risk of exposure to certain infections (e.g chickenpox, measles) and of the importance of obtaining medical advice if such exposure occurs. Following the use of intranasal aerosolized corticosteroids, instances of nasal septum perforation or increased intraocular pressure have been reported very rarely.
General Nasal Corticosteroid Warning: Systemic effects of nasal corticosteroids may occur, particularly at high doses prescribed for prolonged periods. Growth retardation has been reported in children receiving nasal corticosteroids at licensed doses. It is recommended that the height of children receiving prolonged treatment with nasal corticosteroids is regularly monitored. If growth is slowed, therapy should be reviewed with the aim of reducing the dose of nasal corticosteroid, if possible, to the lowest dose at which effective control of symptoms is maintained. In addition, consideration should be given to referring patient to a paediatric specialist.
Use in Pregnancy and Lactation: There are no adequate or well controlled studies in pregnant women. Following intranasal administration of the maximal recommended clinical dose to patients, mometasone plasma concentrations are not measurable, thus fetal exposure is expected to be negligible and the potential for reproductive toxicity, very low. As with other nasal corticosteroid preparations, Axcel Mometasone 0.05%w/w Nasal Spray should be used in pregnant women, nursing mother or women of childbearing age only if the potential benefit justifies the potential risk to the mother, fetus or infant. Infants born of mothers who received corticosteroids during pregnancy should be observed carefully for hypoadrenalism.
Use In Pregnancy & Lactation
There are no adequate or well controlled studies in pregnant women. Following intranasal administration of the maximal recommended clinical dose to patients, mometasone plasma concentrations are not measurable, thus fetal exposure is expected to be negligible and the potential for reproductive toxicity, very low. As with other nasal corticosteroid preparations, Axcel Mometasone 0.05%w/w Nasal Spray should be used in pregnant women, nursing mother or women of childbearing age only if the potential benefit justifies the potential risk to the mother, fetus or infant. Infants born of mothers who received corticosteroids during pregnancy should be observed carefully for hypoadrenalism.
Side Effects
Seasonal allergic or perennial rhinitis: In adult and adolescents: headache, epistaxis, frank bleeding, blood- tinged mucus, blood flecks, pharyngitis, nasal burning, nasal irritation and nasal ulceration which are typically observed with use of a costicosteroid nasal spray.
In pediatric population: headache, epistaxis, nasal irritation and sneezing.
Rarely, immediate hypersensitivity reactions (eg. bronchospasm, dyspnea) may occur after intranasal administration of mometasone furoate monohydrate. Very rarely, anaphylaxis and angioedema have been reported. Disturbances of taste and smell have been reported.
Acute Rhinosinusitis: In patients treated for acute rhinosinusitis, the overall incidence of adverse events was similar to that observed for patients with allergic rhinitis.
Nasal Polyposis: In patients treated for nasal polyposis, the overall incidence of adverse events was was similar to that observed for patients with allergic rhinitis.
Drug Interactions
Axcel Mometasone 0.05%w/w Nasal Spray has been administered concomitantly with loratadine with no apparent effect on plasma concentrations of loratadine or its major metabolite. Mometasone furoate plasma concentrations were not detectable. The combination therapy was well tolerated.
Storage
Store below 30C. Protect from light and heat. Do not freeze.
Shake container well before each use.
ATC Classification
R01AD09 - mometasone ; Belongs to the class of topical corticosteroids used for prophylaxis and treatment of allergic rhinitis.
Presentation/Packing
Nasal spray 0.05% w/w (white to off white susp) x 60 metered dose, 140 metered dose.
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in