ELCOMED

nasal spray

 

Composition:

Each actuation delivers 50 mcg of mometasone furoate monohydrate.

Elcomed nasal spray provides 120 actuations.

 

Description & properties:

-         Mometasone furoate monohydrate, the active component of Elcomed nasal spray is an anti-inflammatory corticosteroid.

-         Elcomed nasal spray is a metered-dose, manual pump spray unit containing an aqueous suspension of mometasone furoate monohydrate equivalent to 0.05% w/w mometasone furoate calculated on the anhydrous basis.

-         After initial priming (10 actuations), each actuation of the pump delivers a metered spray containing 100mg of suspension containing mometasone furoate monohydrate equivalent to 50mg of mometasone furoate calculated on the anhydrous basis.

 

Mechanism of Actions:

Corticosteroids such as mometasone primarily reduce or prevent inflammation of the lining of the airways, reduce the allergic respoce onse to inhaled allergens, and inhibit the secretion of mucus within the airways.

 

Pharmacokinetics:

-         Mometasone furoate monohydrate administered as Elcomed nasal spray is virtually undetectable in plasma despite the use of a sensitive assay with a lower quantitation limit (LOQ) of 50 pcg/ml.

-         Studies have shown that any portion of a mometasone furoate dose which is swallowed and absorbed undergoes extensive metabolites to multiple metabolites.

-         Following intravenous administration, the effecttive plasma elimination half-life of mometasone furoate is 5.8 hours.

-         Any absorbed drug is excreted as metabolites mostly bile, and to a limited extent, into the urine.

 

Indications & usage:

-         Elcomed nasal spray is indicated for treatment of nasal symptoms of seasonal and perennial allergic rhinitis in adults and children 3 years of age and older.

-         It also indicated in prophylaxic of this symptoms in adults and children 12 yeas of age and older.

 

Contraindications:

-         Hypersensitivity to any of the ingredients of this preparation contraindicates its use.

-         Nasal corticosteroids should be used with caution, if at all, in patients with tuberculosis infection of respiratory tract, or in untreated fungal, bacterial, systemic viral infections, or ocular herpes simplex.

 

Side effects:

Side effects that may occur while using this medicine include headache, nosebleed or pink color to the mucus, sore throat, burning or irritation inside the nose and menstrual irregularities.

 

Precautions:

-         The replacement of systemic corticosteriod with a topical corticosteriod can be accompanied by signs of adrenal insufficiency and in addition, some patients may experience symptoms of withdrawal, such as joint and/or muscular pain, lassitude, and depression.

-         Careful attention must be given to such cases, particularly, when patients previously treated for prolonged periods with systemic corticosteroids are transferred to topical corticosteriods.

-         This is particularly important in those patients who have associated asthma or other clinical conditions where too rapid a decrease in systemic corticosteriod dosing may cause a severe exacerbation of their symptoms.

-         If recommended doses of intranasal corticosteriods are exceeded or individuals are particularly sensitive or predisposed by virtue of recent systemic steroid therapy, symptoms of hypercorticism may occur, including very rare of menstrual irregularities, acneiform lesions, and cushingoid features. If such changes occur, topical corticosteroids should be discontinued slowly, consistent with accepted procedures for discontinuing oral steroid therapy.

-         Persons who are on drugs which supperss the immune system are more susceptible to infections than healthy individuals. Chickenpox and meals, for example, can have a more serious or even fatal course in nonimmune children or adults on corticosteriods. In such children or adults who have not had these diseases, particular care should be taken to avoid exposure.

-         In clinical studies with Elcomed nasal spray, the development of localized infections of the nose and pharynex with candida albicans has occurred only rarely. When such an infection develops, use of Elcomed nasal spray should be discontinued and appropriate local or systemic therapy instituted, if needed.

-         Rarely, immediate hypersensitivity reactions may occur after the intranasal administration of mometasone furoate monohydrate. Extreme rare instances of wheezing have been reported,

-         As with any long-term topical treatment of the nasal cavity, patients using Elcomed nasal spray over several months or longer should be examined periodically for possible changes in the nasal mucosa.

-         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.

-         Very rarely, nasal and inhaled corticosteroids have been associated with the development of glaucoma and/or cataracts.

-         Therefore, close follow-up is warranted in patients with a change in vision and with a history of glaucoma and/or cataracts.

 

 

Pregnancy (category C):

-         Elcomed nasal spray should be used during pregnancy only if the potential benefits justify the potential risk to the fetus and the dose should be reduced in this case because of normal increase in cortisone level during pregnancy.

 

Lactation:

Caution should be used when Elcomed nasal spray is administered to nursing women.

 

Drug & food interactions:                                                      

Systemic corticosteroids, other inhaled corticosteroids or any drugs that suppress the immune system should be avoided during treatment with Elcomed nasal spray.

               

Dosage & Administration:

-         Adults and children 12 year of age and older:

-         The usual recommended dose for prophylaxis and treatment of the nasal systems of seasonal rhinitis and treatment of the nasal symptoms of perennial allergic rhinitis is tow spray (50mg of mometasone furoate in each spray) in each nostril once daily (total daily dose of 200mg).

-         Children 3 – 11 years: one spray in each nostril once daily.

-         In patients with a known seasonal allergen that precipitates nasal symptoms of seasonal allergic rhinitis, prophylaxix with Elcomed nasal spray (200 mg/day) is recommended 2 to 4 weeks prior to the anticipated start of the pollen season.

-         Improvement in nasal symptoms generally occurs within 2 days after the first dose.

-         Maximum benefit is usually achieved within 1 to 2 weeks.

-         Patients should use Elcomed nasal spray only once daily at a regular interval.

-         Prior to initial use of Elcomed nasal spray, the pump must be primed by actuating ten time or until a fine spray appears. The pump may be stored unused for up to one week without repriming. If unused for more than one week, reprime by actuation two times, or until a fine spray appears.

 

Overdosage:

Because of low systemic biovailability, and an absence of acute drug-related systemic findings in clinical studies, overdose is unlikely to require any therapy other than observation.

 

Presentation:

Bottle contains 8 g of Elcomed nasal spray.