pediatric efficacy

what is the efficacy mometasonefuroate nasal spray withallergic rhinitis patient
and is it safe ? (Tertiary information :micromedex)
FDA Labeled Indication
a) Overview
FDA Approval: Adult (nasal spray only), Pediatric (nasal spray only, 2 years
and older)
Efficacy: Adult ,Pediatric
Recommendation: Adult, Class IIa; Pediatric, Class IIa
Strength of Evidence: Adult, Category B; Pediatric, Category B
b) Summary:
Mometasonefuroate nasal spray is indicated for the treatment of nasal
symptoms associated with seasonal allergic rhinitis and perennial allergic
rhinitis in adults and children 2 years and older.
1) hypersensitivity to mometasonefuroate or any other component of the
2) known hypersensitivity to milk proteins (oral inhalation)
3) primary treatment of status asthmaticus or other acute episodes of asthma
requiring intensive intervention (oral inhalation)
Adverse reaction
 Gastrointestinal: Abdominal pain ,Indigestion, Nausea
Musculoskeletal: Backache, Musculoskeletal pain, Myalgia
 Neurologic: Headache
 Reproductive: Dysmenorrhea
 Respiratory: Allergic rhinitis, Candidiasis, Epistaxis, Pharyngitis, Upper
respiratory infection
 Endocrine metabolic: Secondary hypocortisolism
 Immunologic: Anaphylaxis
 Other: Angioedema
Monitoring Parameter
1) Therapeutic
 Perennial Allergic Rhinitis and Seasonal Allergic Rhinitis :Improvement in
nasal symptoms associated with indicative of efficacy.
2) Toxic
a) Laboratory Parameters
 Topical :Periodically evaluate for hypothalamic-pituitary-adrenal (HPA)
axis suppression (using adrenocorticotrophic hormone (ACTH)
stimulation, A.M. plasma cortisol, and urinary-free cortisol tests) in
patients applying mometasonefuroate to occluded or large surface areas
b) Physical Findings
 Nasal Spray and Oral Inhalation
o Routinely monitor growth (using stadiometry) in pediatric patients
treated with mometasone
o Closely monitor patients with a history of increased intraocular
pressure, glaucoma and/or cataracts during treatment .
 Nasal Spray
o Periodically examine patients on long-term (several months or
longer) mometasonefuroate nasal spray therapy for changes in
nasal mucosa .