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Nasonex Nasal Spray eent

Pronunciation

Generic Name: Mometasone Furoate eent
Class: Corticosteroids
ATC Class: R03BA07
VA Class: NT200
Chemical Name: (11β,16α) - 9,21 - Dichloro - 17 - [(2 - furanylcarbonyl)oxy] - 11 - hydroxy - 16 - methyl - pregna - 1,4 - diene - 3,20 - dione
Molecular Formula: C27H30Cl2O6
CAS Number: 83919-23-7

Introduction

Synthetic nonfluorinated corticosteroid.e

Uses for Nasonex Nasal Spray

Allergic Rhinitis

Prophylaxis1 2 3 and treatment1 2 4 5 6 of nasal symptoms of seasonal allergic rhinitis.1 2 7 8

Slideshow: Top Prevention Tips: Springtime Allergies

Treatment of nasal symptoms of perennial allergic rhinitis.1 2 7 8

Nasonex Nasal Spray Dosage and Administration

General

  • For therapeutic effectiveness, use at regular intervals.1

Administration

Intranasal Administration

Administer by nasal inhalation using a a metered-dose nasal spray pump.1 2

Shake inhaler gently immediately prior to use.1

Prior to initial use, the metered-dose pump spray must be primed with 10 actuations or until a fine spray appears.1 b Prime pump after a period of nonuse (i.e., >1 week) by actuating twice or until a fine spray appears.1 b c

Clear nasal passages prior to administration.b

Tilt the head slightly forward, insert the nasal applicator into one nostril, b and point the tip of the applicator away from the nasal septum.b Pump the drug into the nostrilb while holding the other nostril closed and concurrently inspiring through the nose.b Repeat procedure for the other nostril.b

Clean nasal applicator by removing the nasal applicator and plastic cap.c Soak the nasal applicator in cold tap water and/or rinse in warm water and dry.c Rinse the plastic cap under cold water and dry.c Reassemble the nasal applicator with the pump by reinserting the pump stem into the center opening of the applicator.c Reprime the pump by actuating twice or until a fine spray appears.c

Dosage

Available as mometasone furoate monohydrate; dosage expressed in terms of anhydrous mometasone furoate.1

After priming, nasal spray pump delivers about 50 mcg of mometasone furoate per metered spray and about 120 metered doses per 17-g container.1

Pediatric Patients

Titrate dosage to the lowest possible effective level.1 (See Pediatric Use under Cautions.)

Allergic Rhinitis
Treatment of Seasonal or Perennial Allergic Rhinitis
Intranasal Inhalation

Children 2–11 years of age: 50 mcg (1 spray) in each nostril once daily (100 mcg total daily dosage).1 1 2 4 5 6 7 8 11

Children ≥12 years of age: 100 mcg (2 sprays) in each nostril once daily (200 mcg total daily dosage).1 2 4 5 6 7 8

Prophylaxis of Seasonal Allergic Rhinitis
Intransasl Inhalation

Children ≥12 years of age: 100 mcg (2 sprays) in each nostril once daily (200 mcg total daily dosage) starting 2–4 weeks prior to the anticipated start of the pollen season.1 2 3

Adults

Allergic Rhinitis
Treatment of Seasonal or Perennial Allergic Rhinitis
Intranasal Inhalation

100 mcg (2 sprays) in each nostril once daily (200 mcg total daily dosage).1 2 4 5 6 7 8

Prophylaxis of Seasonal Allergic Rhinitis
Intranasal Inhalation

100 mcg (2 sprays) in each nostril once daily (200 mcg total daily dosage) starting 2–4 weeks prior to the anticipated start of the pollen season.1 2 3

Cautions for Nasonex Nasal Spray

Contraindications

  • Known hypersensitivity to mometasone furoate or any ingredient in the formulation.1

Warnings/Precautions

Warnings

Withdrawal of Systemic Corticosteroid Therapy

Possible corticosteroid withdrawal symptoms (e.g., joint pain, muscular pain, lassitude, depression), acute adrenal insufficiency, or severe symptomatic exacerbation of asthma or other clinical conditions if prolonged systemic corticosteroid therapy is replaced with topical corticosteroid therapy; careful monitoring recommended.1

Use particular caution in patients with associated asthma or other conditions that may be exacerbated by too rapid a reduction in systemic corticosteroid dosage.1

Hypercorticism

Excessive intranasal dosages or use in patients who are particularly sensitive to corticosteroid effects due to recent systemic corticosteroid therapy may cause systemic corticosteroid effects (e.g., menstrual irregularities, acneiform lesions, cushingoid features).1 (See Systemic Corticosteroid Effects under Cautions.)

Immunosuppressed Patients

Increased susceptibility to infections in patients who are taking immunosuppressant drugs.1 Certain infections (e.g., varicella [chickenpox], measles) can be serious or even fatal in such patients, particularly in children.1

Exposure to varicella and measles should be avoided in previously unexposed patients.1 If exposure to varicella or measles occurs in susceptible patients, consider administering varicella zoster immune globulin (VZIG) or immune globulin (IG), respectively.1 Consider treatment with an antiviral agent if varicella develops.1

Sensitivity Reactions

Rarely, immediate hypersensitivity reactions or wheezing may occur.1 2

General Precautions

Systemic Corticosteroid Effects

Possible growth suppression in children or adolescents.1 (See Pediatric Use under Cautions.)

Excessive intranasal dosages or use in patients who are particularly sensitive to corticosteroid effects may increase risk of systemic corticosteroid effects (e.g., hypercorticism, adrenal suppression).1

Avoid use of higher than recommended dosages.1 If systemic effects occur, slowly reduce dosage and discontinue drug.1

Nasopharyngeal Effects

Rarely, localized candidial infections of the nose and/or pharynx have been reported.1 Local treatment of such infections and/or discontinuance of intranasal therapy may be required.1

Possible nasal burning and irritation.1 2 Rarely, nasal septum perforation has been reported.1

Periodically examine nasal passages for signs of mucosal changes during long-term therapy (several months or longer).1

Use not recommended in patients with recent nasal septal ulcers, nasal surgery, or nasal trauma until healing has occurred.1

Concomitant Infections

Use with caution, if at all, in patients with clinical or asymptomatic Mycobacterium tuberculosis infection of the respiratory tract; untreated fungal, bacterial, or systemic viral infections; or ocular herpes simplex infections.1

Ophthalmic Effects

No ophthalmologic abnormalities (i.e., elevation in intraocular pressure, cataracts) observed in long-term studies with mometasone furoate.1 Glaucoma, increased intraocular pressure, and cataracts have been reported rarely with other nasal or inhaled corticosteroids.1

Monitor patients who have a change in vision and those with a history of glaucoma or cataracts.1

Specific Populations

Pregnancy

Category C.1

Use during pregnancy may result in hypoadrenalism in infants; monitor these infants carefully.1

Lactation

Not known whether mometasone furoate is distributed into milk; caution if used in nursing women.1

Pediatric Use

Safety and efficacy not established in children <2 years of age.1

Intranasal corticosteroids may reduce growth velocity in pediatric patients.1 Routine monitoring of growth (e.g., via stadiometry) recommended.1 Titrate dosage to the lowest possible effective level.1

Geriatric Use

Adverse effects profiles similar to those in younger adults.1

Common Adverse Effects

Headache, viral infection, pharyngitis, epistaxis/blood-tinged mucus, coughing, upper respiratory tract infection, dysmenorrhea, musculoskeletal pain, sinusitis, vomiting.1 a

Nasonex Nasal Spray Pharmacokinetics

Absorption

Bioavailability

Bioavailability <0.1% administered as a nasal spray; virtually undetectable in plasma.1 2 11

Onset

Symptomatic relief may be evident within 5–11 hours after the initial dose.1 2 9 1 2 Maximum benefit is usually achieved within 1–2 weeks.1

Distribution

Extent

Not known whether mometasone furoate crosses the placenta or distributes into breast milk.1

Plasma Protein Binding

Approximately 98–99%.1

Elimination

Metabolism

Swallowed portion of dose is extensively metabolized to multiple derivatives;1 a minor metabolite is formed by CYP3A4.1

Elimination Route

Excreted as metabolites principally via bile and to a lesser extent in urine.1

Half-life

5.8 hours.1

Stability

Storage

Intranasal Inhalation

Suspension

25°C (may be exposed to 15–30°C); protect from light.1

Actions

  • Inhibits multiple cell types (e.g., mast cells, macrophages, lymphocytes, monocytes, plasma cells) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) involved in inflammation.2 11 a

  • Inhibits the expression of inflammatory mediators by cells involved in both the early and late phases of the allergic response,2 including reduced histamine and eosinophil cationic protein levels and reduced eosinophils, neutrophils, and epithelial adhesion proteins.a

  • Decreases nasal reactivity to allergensd and reduces intraepithelial eosinophilia and infiltration of inflammatory cells (e.g., eosinophils, lymphocytes, monocytes, neutrophils, plasma cells) in nasal mucosa.1 11 a

Advice to Patients

  • Importance of providing patients a copy of the manufacturer’s patient information.1

  • Importance of understanding proper storage, preparation, and administration techniques.1 b Importance of shaking container gently prior to each use.b

  • Importance of avoiding spraying drug into the eyes or directly on the nasal septum.1 b

  • Advise patients that containers of mometasone nasal spray should be discarded after 120 actuations.1

  • Importance of regular use to obtain therapeutic effectiveness.1 11 Importance of not exceeding prescribed dosage.1 11

  • Advise that the drug usually will provide symptomatic relief within 2 days, but 1–2 weeks of continuous therapy usually are required for optimum effects.1

  • Importance of contacting a clinician if symptoms worsen or fail to improve.1

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.1

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

  • Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Mometasone Furoate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Nasal

Suspension

0.05% w/w [50 mcg (of anhydrous mometasone furoate) per metered spray]

Nasonex Nasal Spray (with benzalkonium chloride)

Schering-Plough

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Nasonex 50MCG/ACT Suspension (SCHERING): 17/$130.99 or 51/$365.98

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions April 1, 2010. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

Only references cited for selected revisions after 1984 are available electronically.

1. Schering. Nasonex (mometasone furoate monohydrate) nasal spray prescribing information. Kenilworth, NJ; 2001 Feb.

2. Onrust SV, Lamb HM. Mometasone furoate: a review of its intranasal use in allergic rhinitis. Drugs. 1998; 56:725-45. [PubMed 9806113]

3. Graft D, Aaronson D, Chervinsky P et al. A placebo- and active-controlled randomized trial of prophylactic treatment of seasonal allergic rhinitis with mometasone furoate aqueous nasal spray. J Allergy Clin Immunol. 1996; 98:724-31. [IDIS 375007] [PubMed 8876546]

4. Bronsky EA, Aaronson DW, Berkowitz RB et al. Dose ranging study of mometasone furoate (Nasonex) in seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 1997; 79:51-6. [IDIS 390360] [PubMed 9236500]

5. Meltzer EO, Jalowayski AA, Orgel HA et al. Subjective and objective assessments in patients with seasonal allergic rhinitis: effects of therapy with mometasone furoate nasal spray. J Allergy Clin Immunol. 1998; 102:39-49. [IDIS 410793] [PubMed 9679846]

6. Hebert JR, Nolop K, Lutsky BN. Once-daily mometasone furoate aqueous nasal spray (Nasonex) in seasonal allergic rhinitis: an active- and placebo-controlled study. Allergy. 1996; 51:569-76. [PubMed 8874661]

7. Mandl M, Nolop K, Lutsky BN. Comparison of once daily mometasone furoate (Nasonex) and fluticasone propionate aqueous nasal sprays for the treatment of perennial rhinitis. 194-079 Study Group. Ann Allergy Asthma Immunol. 1997; 79:370-8. [IDIS 396140] [PubMed 9357385]

8. Drouin M, Yang WH, Bertrand B et al. Once daily mometasone furoate aqueous nasal spray is as effective as twice daily beclomethasone dipropionate for treating perennial allergic rhinitis patients. Ann Allergy Asthma Immunol. 1996; 77:153-60. [IDIS 371952] [PubMed 8760782]

9. Berkowitz RB, Roberson S, Zora J et al. Mometasone furoate nasal spray is rapidly effective in the treatment of seasonal allergic rhinitis in an outdoor (park), acute exposure setting. Allergy Asthma Proc. 1999; 20:167-72. [PubMed 10389549]

10. Minshall E, Ghaffar O, Cameron L et al. Assessment by nasal biopsy of long-term use of mometasone furoate aqueous nasal spray (Nasonex) in the treatment of perennial rhinitis. Otolaryngol Head Neck Surg. 1998; 118:648-54. [PubMed 9591864]

11. Schering, Kenilworth, NJ: Personal communication.

12. Schenkel EJ, Skoner DP, Bronsky EA et al. Absence of growth retardation in children with perennial allergic rhinitis after one year of treatment with mometasone furoate aqueous nasal spray. Pediatrics. 2000; 105:E22. [IDIS 443258] [PubMed 10654982]

a. Schering. Nasonex (mometasone furoate monohydrate) nasal spray prescribing information. Kenilworth, NJ; 2003 Jun.

b. Schering. Nasonex (mometasone furoate monohydrate) nasal spray patient instructions. Kenilworth, NJ; 2003 Jun.

c. Schering. Nasonex (mometasone furoate monohydrate) nasal spray applicator cleaning instructions. Kenilworth, NJ; 2003 Jun.

d. AHFS Drug Information 2004. McEvoy GK, ed. EENT Corticosteroids General Statement. American Society of Health-System Pharmacists; 2004: page 2656-8.

e. AHFS Drug Information 2004. McEvoy GK, ed. Mometasone Furoate. American Society of Health-System Pharmacists; 2004: page 2676-78. AHFS DI

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