Pharmacology: Pharmacodynamics: 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, 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 hepatic metabolism prior to excretion in urine and bile.
ELONIDE Nasal Spray is indicated for use in adults, adolescents and children between the ages of 3 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 ELONIDE Nasal Spray is recommended two to four weeks prior to the anticipated start of the pollen season.
ELONIDE Nasal Spray is also indicated for the treatment of nasal polyps in patients 18 years of age and older.
ELONIDE 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.
After initial priming of the ELONIDE Nasal Spray pump (5 sprays, until a uniform spray is observed), each spray delivers approximately 0.1 ml of mometasone furoate suspension, containing mometasone furoate 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 sprays, 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 (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 3 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.
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 mcg). Once symptoms are adequately controlled, dose reduction to two sprays in each nostril once daily (total daily dose 200 mcg) is recommended.
Acute Rhinosinusitis: Adults (including geriatric patients) and adolescents 12 years of age or older: The usual recommended dose for acute rhinosinusitis is two sprays (50 micrograms/spray) 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.
DIRECTION FOR USE: 1. Blow the nose gently to clear nostrils.
2. Shake the bottle gently. Remove the cap.
3. For first time use, hold the bottle upright and fill the pump by pressing the nozzle downwards and releasing it 5 times, until a fine spray is produced.
4. Close one nostril with finger. Hold the bottle upright and insert the nozzle into the nostril as far as is comfortable. Whilst breathing in gently through the nose with the mouth closed, press the bottle upwards once to deliver one spray.
5. Breathe out through the mouth.
6. Repeat steps 4 and 5 for the other nostril.
7. For patients aged 12 years and older, steps 4, 5 and 6 should be repeated once more to achieve the recommended dosage of 2 sprays into each nostril.
8. To keep the spray nozzle clean, wipe it carefully with a clean tissue after each use and replace back the cap.
If the nasal spray has not been used for 2 weeks or more, it needs to be sprayed once into the air before use. The nozzle should be pointed away while doing this. Always shake the bottle gently before use.
If the spray does not work and it may be blocked, clean it as follows. (See Directions for Cleaning as follows). NEVER try to unblock it or enlarge the tiny spray hole with a pin or other sharp object because this will destroy the spray mechanism.
The nasal spray should be cleaned at least once a week or more often if it gets blocked.
Directions for Cleaning: 1. Remove the cap and pull off the spray nozzle only.
2. Soak the dust-cap and spray nozzle in warm water for a few minutes, and then rinse under cold running tap water.
3. Shake or tap off the excess water and allow to air-dry.
4. Re-fit the spray nozzles.
5. Prime the unit as necessary until a fine mist is produced and use as normal.
Because of the negligible (≤0.1%) systemic bioavailability of ELONIDE Nasal Spray, overdosage 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 HPA axis function.
Hypersensitivity to any ingredients of ELONIDE Nasal Spray 50 mcg/dose.
ELONIDE Nasal Spray should be used with caution, if at all, 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 ELONIDE 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 ELONIDE Nasal Spray over several months or longer should be examined periodically for possible changes in the nasal mucosa. If localised fungal infection of the nose or pharynx develops, discontinuance of ELONIDE therapy or appropriate treatment may be required. Persistence of nasopharyngeal irritation may be an indication for discontinuing ELONIDE Nasal Spray.
Although ELONIDE Nasal Spray will control the nasal symptoms in most patients, the concomitant use of appropriate additional therapy may provide additional relief of the symptoms, particularly ocular symptoms.
There is no evidence of hypothalamic-pituitary adrenal (HPA) axis suppression following prolonged treatment with ELONIDE Nasal Spray. However, patients who are transferred from long-term administration of systemically active corticosteroids to ELONIDE 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.
During transfer from systemic corticosteroids to ELONIDE Nasal Spray some patients may experience symptoms of withdrawal from systemically active corticosteroids (e.g. joint and/or muscular pain, lassitude, and depression initially) despite relief from nasal symptoms and will require encouragement to continue ELONIDE Nasal Spray therapy. Such transfer may also unmask pre-existing allergic conditions, such as allergic conjunctivitis and eczema, previously suppressed by systemic corticosteroid therapy.
The safety and efficacy of ELONIDE Nasal Spray has not been studied for use in the treatment of unilateral polyps, polyps associated with cystic fibrosis, or polyps that completely obstruct the nasal cavities.
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 corticosteroids, instances of nasal septum perforation or increased intraocular pressure have been reported very rarely.
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 the patients to a paediatric specialist.
Treatment with higher than recommended doses may result in clinically significant adrenal suppression. If there is evidence for higher than recommended doses being used, then additional systemic corticosteroid cover should be considered during periods of stress or elective surgery.
There 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 foetal exposure is expected to be negligible and the potential for reproductive toxicity, very low. As with other nasal corticosteroid preparations, ELONIDE Nasal Spray should not be used in pregnancy or lactation unless the potential benefit to the mother justifies any potential risk to the mother, foetus or infant. Infants born of mothers who received corticosteroids during pregnancy should be observed carefully for hypoadrenalism.
Most severe side effects include allergic reaction: difficulty in breathing; swelling of the face, lips, tongue, or throat. Serious side effects include severe and ongoing nose bleed; sores in the nose; wheezing, troubled breathing; body aches, or flu symptoms. Less serious side effects may include headache; sore throat, cough; muscle or joint pain.
For intranasal use only. Store below 30°C.
Keep bottle in upright position.
Shelf-Life: 3 years.
R01AD09 - mometasone ; Belongs to the class of topical corticosteroids used for prophylaxis and treatment of allergic rhinitis.
Nasal spray 50 mcg/dose (opaque off-white slight viscous suspension) x 10 mL (60 doses), 20 mL (140 doses).