Mometasone Furoate Nasal Spray (Nasonex—Schering)

By William T. Elliott, MD, FACP and James Chan, PharmD, PhD

The fda has approved a nasal steroid for use in children as young as 3 years of age. Schering’s mometasone furoate nasal spray (Nasonex) is the first drug in this class to be approved for use in children this young for the treatment of allergic rhinitis. The approval was prompted by recent studies that reported that mometasone, in contrast to beclomethasone, did not affect bone growth in children after one year of treatment.1,2 Other nasal steroids are approved for use in children but beginning at somewhat older ages—fluticasone is approved for use down to the age of 4 and the others (flunisolide, triamcinolone, budesonide, becomethasone) down to the age of 6. Mometasone has been marketed for use in adults and children 12 years of age and older since 1997.

Indications

Mometasone is indicated for the treatment of the nasal symptoms of seasonal allergic and perennial allergic rhinitis in adults and pediatric patients 3 years of age and older.

Dosage

The recommended dose for adults and children 12 years of age and older is two sprays in each nostril once daily (200 mcg per day). For children 3-11 years of age the recommended dose is one spray in each nostril once daily (100 mcg per day).3

The pump needs to be primed by actuating 10 times or until a fine spray appears. If the spray has not been used for more than one week the pump should be reprimed by actuating two times.3 Mometasone is supplied as a metered dose nasal spray (17 g) containing 120 sprays (50 mcg per actuation).

Potential Advantages

Mometasone has low bioavailability (£ 0.1%) and is also extensively metabolized, which minimizes systemic exposure.4 In a one-year study in children (3-9 years of age) with perennial allergic rhinitis, mometasone 100 mcg daily did not affect growth or lead to suppression of the hypothalamic pituitary adrenal (HPA) axis.1 Height was measured at baseline and at 4, 8, 12, 26, 39, and 52 weeks with a calibrated stadiometer. HPA suppression was assessed by cosyntropin stimulation testing at baseline and at 26 and 52 weeks. Mometasone is approved for use in children as young as 3 years of age.

Potential Disadvantages

Nasal steroids in general have a slower onset of action than antihistamines for the treatment of allergic rhinitis. Maximum effect occurs about 7 to 14 days after initiation of treatment although effect may be noticed the first day.4

Comments

Mometasone furoate is a corticosteroid for intranasal administration which is dosed once daily and appears to have minimal systemic activity. Recently it gained FDA

approval for use in pediatric patients as young as 3 years of age. Data from comparative trials indicate that mometasone is comparable to other intranasal steroids (e.g., beclomethasone, fluticasone) in the treatment of perennial allergic rhinitis and seasonal allergic rhinitis.4,6 Median time to at least moderate symptom relief was 36 hours compared to 72 hours for placebo. Approximately 64% of treated patients experienced moderate symptom relief at 72 hours.5 In an acute exposure setting, mometasone was reported to produce statistically significant improvement in nasal symptoms in patients with seasonal allergic rhinitis by seven hours.7

Clinical Implications

The findings of a recent study, supported by Schering and Glaxo Wellcome, indicated that treatment with intranasal beclomethasone (168 mcg twice daily) can slow growth rate in prepubescent children without showing suppression of the HPA axis.2 The mean change in standing height after one year was 5.0 cm in the beclomethasone group compared to 5.9 cm in the placebo-treated group. The difference was evident as early as the first month of treatment. In another study of essentially identical design supported by Schering, mometasone (100 mcg daily) showed no suppression of growth.1 At the one-year point, the change in height was 6.95 cm vs. 6.35 cm for mometasone and placebo, respectively. Some data suggest that patients who experienced delays in growth may still achieve final height.8 The FDA is encouraging further studies in this area and has added a class labeling stating that these agents may cause a reduction in growth velocity in pediatric patients.

It is recommended that pediatric patients minimize exposure to total corticosteroids, from various routes, and physicians titrate each patient to the lowest effective dose.

References

1. Schenkel EJ, et al. Pediatrics 2000;105:E22.

2. Skoner DP, et al. Pediatrics 2000;105:E23.

3. Nasonex Product Information. Schering Corporation. December 1999.

4. Onrust SV, et al. Drugs 1998;56(4):725-745.

5. Berkowitz RB, et al. Allergy 1999;54(1):64-69.

6. Mandl M, et al. Ann Allergy Asthma Immunol 1997; 79:370-378.

7. Berkowitz RB, et al. Allergy Asthma Proc 1999; 20(3):167-172.

8. Balfour-Lynn L. Arch Dis Child 1986;61:1049-1055.

Which is not true about mometasone?

a. It has been approved for use in children as young as 3 years old.

b. It affected bone growth in children after one year of treatment.

c. It is a nasal spray.

d. The maximum effect occurs about seven to 14 days after initiation of treatment.