Nasonex

[Mometasone]

No statistically significant effect on growth velocity was observed for NASONEX Nasal Spray, 50 mcg compared to placebo. No evidence of clinically relevant HPA axis suppression was observed following a 30-minute cosyntropin infusion. The potential of NASONEX Nasal Spray, 50 mcg to cause growth suppression in susceptible patients or when given at higher doses cannot be ruled out.

Geriatric Use

A total of 203 patients above 64 years of age (age range 64 to 85 years) have been treated with NASONEX Nasal Spray, 50 mcg for up to 3 months. The adverse reactions reported in this population were similar in type and incidence to those reported by younger patients.

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PHARMACIST TEAR AT PERFORATION GIVE TO PATIENT

Patient's Instructions for Use

SHAKE WELL BEFORE EACH USE

NASONEX (mometasone furoate monohydrate)
Nasal Spray, 50 mcg* *calculated on the anhydrous basis

Shake the bottle well before each use. Read complete
instructions carefully and use only as directed.

1. Remove the plastic cap (Figure 1).

2. The very first time the spray is used, prime the pump by pressing downward on the shoulders of the white applicaIn tor using your forefinger and middle finger while supporting the base of the bottle with your thumb (Figure 2). Press down and release the pump ten times or until a fine spray appears. DO NOT spray into eyes. The pump is now ready to use. The pump may be stored unused for up to 1 week without repriming. If unused for more than 1 week, reprime by spraying two times or until a fine spray appears.

3. Gently blow your nose to clear the nostrils. Close one nostril. Tilt your head forward slightly and, keeping the bottle upright, carefully insert the nasal applito cator into the other nostril (Figure 3). DO NOT spray directly onto nasal septum.

4. For each spray, press firmly downward once on the shoulders of the white applicator using your forefinger and middle finger while supporting the base of the bottle with your thumb. Breathe gently inward through the nostril (Figure 4).

5. Then breathe out through the mouth.

6. Repeat in the other nostril.

7. Wipe the nasal applicator with a clean tissue and replace the plastic cap.

Pediatric Use

Administration to young children should be aided by an adult.

The Patient's Instructions for Use, Steps 1 to 7 should be followed. The correct amount of medication in each spray can only be assured up to 120 sprays from the bottle even though the bottle is not completely empty. You should keep track of the number of sprays used from each bottle of NASONEX Nasal Spray, 50 mcg and discard the bottle after using 120 sprays.

Cleaning

Please see Applicator Cleaning Instructions on reverse.

Caution:

NASONEX Nasal Spray, 50 mcg is formulated for once-daily dosing. You should use NASONEX Nasal Spray, 50 mcg only once daily at a regular interval. Since NASONEX Nasal Spray, 50 mcg is not intended to give rapid relief of your nasal symptoms, the prescribed dosage should not be increased by using more often than once daily in an attempt to increase its effectiveness.

INDICATIONS

NASONEX Nasal Spray, 50 mcg controls the underlying disorders responsible for your attacks so it is important that you use it regularly at the time recommended by your physician.

Based on single day studies done in a park during pollen season or in a controlled pollen exposure room, improvement in nasal symptoms of allergic rhinitis has been shown to occur within 11 hours after the first dose. In other studies that lasted up to 2 weeks, improvement in nasal symptoms of seasonal allergic rhinitis was shown to occur within 2 days after the first dose. The full benefit of NASONEX Nasal Spray, 50 mcg is usually achieved within 1 to 2 weeks.

NASONEX Nasal Spray, 50 mcg should not be sprayed into the eyes. Spraying NASONEX Nasal Spray, 50 mcg directly onto the nasal septum should be avoided.

Store at 25° C (77° F); excursions permitted to 15-30° C (59-86° F) [see USP Controlled Room Temperature]. Protect from light.

When NASONEX Nasal Spray, 50 mcg is removed from its cardboard container, prolonged exposure of the product to direct light should be avoided. Brief exposure to light, as with normal use, is acceptable.

SHAKE WELL BEFORE EACH USE.

Schering Corporation Kenilworth, NJ 07033 USA
Copyright © 1997, 2003, Schering Corporation.
All rights reserved.
U. S. Patent No. D355,844
Rev. 6/ 03 27110916

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