Prevent an allergic reaction from happening at school.

Nasacort eent

Pronunciation

Generic Name: Triamcinolone Acetonide eent
Class: Corticosteroids
ATC Class: S02CA04
VA Class: NT200
Chemical Name: (11β,16α) - 9 - Fluoro - 11,21 - dihydroxy - 16,17 - [(1 - methylethylidene)bis(oxy)] - pregna - 1,4 - diene - 3,20 - dione
Molecular Formula: C24H31FO6
CAS Number: 76-25-5

Introduction

Synthetic corticosteroid.1 2 3

Uses for Nasacort

Allergic Rhinitis

Symptomatic treatment of seasonal or perennial allergic rhinitis.1 2 3 4 5 6 7 8 9 10 11 17

Slideshow: 2014 Update - First Time Brand-to-Generic Switches

Nasacort Dosage and Administration

General

  • For therapeutic effectiveness, use at regular intervals.b

Administration

Intranasal Administration

Administer by nasal inhalation using a metered-dose nasal spray pump.2 3 4 5 8 b

Shake inhaler gently immediately prior to use.b

Prior to initial use, the metered-dose pump spray must be primed with 5 actuations or until a fine mist appears.c Prime pump after a period of nonuse (i.e., > 2 weeks) by actuating once.2

Clear nasal passages prior to administration.c

Tilt the head slightly forward, insert the spray tip into one nostril, and point the tip toward the back of the nose.c Pump the drug into one nostril while holding the other nostril closed and concurrently inspire through the nose.c Repeat this procedure for the other nostril.c

Dosage

After priming, nasal spray pump delivers about 55 mcg of triamcinolone acetonide per metered spray and about 30 or 120 metered doses per 6.5-g or 16.5-g container, respectively.2 b

Once optimal symptomatic relief is achieved, reduce dosage gradually to the lowest effective level.1 2 3

Intranasal triamcinolone acetonide should not be continued beyond 3 weeks in the absence of adequate symptomatic improvement.1 2 16 b

Pediatric Patients

Seasonal Allergic Rhinitis
Intranasal Inhalation

Children 6–11 years of age: Initially 55 mcg (1 spray) in each nostril once daily (110 mcg total).2 May be increased to 110 mcg (2 sprays) in each nostril once daily (220 mcg total).2

Children ≥12 years of age: 110 mcg (2 sprays) in each nostril once daily (220 mcg total).2

Perennial Allergic Rhinitis
Intranasal Inhalation

Children 6–12 years of age: Initially 55 mcg (1 spray) in each nostril once daily (110 mcg total).2 b Maximum, 110 mcg (2 sprays) in each nostril once daily (220 mcg total).2 b

Children ≥12 years of age: Initially 110 mcg (2 sprays) in each nostril once daily (220 mcg total).2

Adults

Seasonal Allergic Rhinitis
Intranasal Inhalation

110 mcg (2 sprays) in each nostril once daily (220 mcg total).2

Perennial Allergic Rhinitis
Intranasal Inhalation

110 mcg (2 sprays) in each nostril once daily (220 mcg total).2

Prescribing Limits

Pediatric Patients

Seasonal or Perennial Allergic Rhinitis
Intranasal Inhalation

Children 6–12 years of age: Maximum 220 mcg (2 sprays in each nostril) daily.2 b

Adults

Seasonal or Perennial Allergic Rhinitis
Intranasal Inhalation

Maximum 220 mcg (2 sprays in each nostril) daily.b

Perennial Allergic Rhinitis
Intranasal Inhalation

Maximum 220 mcg (2 sprays in each nostril) daily.b

Special Populations

Hepatic Impairment

No specific dosage recommendations at this time.1 2 17

Renal Impairment

No specific dosage recommendations at this time.1 2 17

Geriatric Patients

No specific dosage recommendations at this time.1 2 17

Cautions for Nasacort

Contraindications

  • Known hypersensitivity to triamcinolone acetonide or any ingredient in the formulation.1 2 17

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 2 3 17

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

Taper the dosage of the systemic corticosteroid, and carefully monitor patients during dosage reduction.1 2 17 In general, the greater the dosage and duration of systemic corticosteroid therapy, the greater the time required for withdrawal of systemic corticosteroids and replacement by intranasal corticosteroids.16

Immunosuppressed Patients

Increased susceptibility to infections in patients who are taking immunosuppressant drugs.1 2 17 Certain infections (e.g., varicella [chickenpox], measles) can be serious or fatal in such patients, particularly in children.1 2 17

Exposure to varicella and measles should be avoided in previously unexposed patients.1 2 17 If exposure to varicella (chickenpox) or measles occurs in susceptible patients, consider administering varicella zoster immune globulin (VZIG) or pooled IM immune globulin (IG) respectively.1 2 17 Consider treatment with antiviral agents if varicella (chickenpox) develops.1 2

General Precautions

Systemic Corticosteroid Effects

Possible growth suppression in pediatric patients.1 2 17 (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., hypercortism or adrenal suppression).b Avoid exceeding the recommended dosages.1 2 17

Nasopharyngeal Effects

Rarely, localized candidial infections of the nose and/or pharynx has been reported.1 2 17 Local treatment of such infections and/or discontinuance of intranasal therapy may be required.1 2 17

Nasal septal perforations have been reported rarely.1 2 17

Use with caution until healing occurs in patients with recent nasal septal ulcers, nasal surgery, or nasal trauma.1 2 3 17

Concomitant Infections

Use with extreme caution, if at all, in patients with clinical tuberculosis or asymptomatic Mycobacterium tuberculosis infections of the respiratory tract; untreated fungal or bacterial infections; or ocular herpes simplex; or untreated, systemic viral infections.1 2 3 16 17

Specific Populations

Pregnancy

Category C.b Use during pregnancy may result in hypoadrenalism in infants;b monitor these infants carefully.b

Lactation

Not known whether triamcinolone acetonide is distributed in milk.1 2 17 Caution if used in nursing women.1 2 17

Pediatric Use

Safety and efficacy not established in children <6 years of age.1 2

Corticosteroids, particularly with high doses for extended periods may cause growth suppression in pediatric patients.1 2 17 Titrate dosage to the lowest possible effective level.b

Geriatric Use

Response similar to that in younger adults.b

Common Adverse Effects

Pharyngitis, epistaxis, increased cough.2 3

Nasacort Pharmacokinetics

Absorption

Bioavailability

Systemic absorption is minimal.1 2 3 Mean peak plasma concentrations achieved at 1.5 hours following nasal inhalation.2 3

Onset

Symptomatic relief may be evident 10–16 hours following initiation of therapy.4 5 8 12 16 Maximum benefit is usually achieved within 1 week.b

Distribution

Extent

The volume of distribution is 99.5 L.b

Special Populations

In pediatric patients, similar extent of absorption, peak concentrations, and time to peak concentrations compared to adult patients.b

Elimination

Metabolism

Metabolized to metabolites that are substantially less active than the parent drug.b

Half-life

3.1 hours.b

Stability

Storage

Intranasal Suspension

20–25°C.b

Actions

  • Potent glucocorticoid1 2 17 b and weak mineralocorticoid effects.3 16

  • May reduce the number of mediator cells (basophils, eosinophils, T-helper cells, mast cells, and neutrophils) in the nasal mucosa.

  • Decreases nasal reactivity to allergens and decreases release of inflammatory mediators and proteolytic enzymes.

Advice to Patients

  • Provide copy of manufacturer’s patient information.b

  • Importance of understanding proper storage, preparation, and administration techniques.1 2 17

  • Importance of shaking container gently prior to each use.1 2

  • Importance of avoiding spraying drug directly onto nasal septum.1 17

  • Advise patients that containers of triamcinolone acetonide nasal spray should be discarded after 120 actuations.1 2

  • Importance of taking as directed and not exceeding prescribed dosage.1 2 17

  • Importance of regular use to obtain therapeutic effectiveness.b

  • Importance of contacting a clinician if symptoms worsen or fail to improve after 3 weeks.1 2 17 b

  • Necessity of reporting recurrent epistaxis, nasal septum discomfort, irritation, burning, and/or stinging to clinicians.1 2 17

  • Importance of avoiding exposure to chickenpox or measles in patients receiving immunosuppressant doses of corticosteroids and, if exposure occurs, consulting a clinician.1 2 17 b

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.1 2 17

  • Importance of women informing clinicians if they are or plan to become pregnant or to breast-feed.1 2 17

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

Preparations

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

Triamcinolone Acetonide

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Nasal

Suspension

55 mcg/metered spray

Nasacort AQ Nasal Spray (with benzalkonium chloride)

Aventis

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.

Triamcinolone Acetonide 55MCG/ACT Inhaler (WINTHROP US): 17/$105.99 or 50/$299.95

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions November 1, 2004. 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. Aventis. Nasacort (triamcinolone acetonide) nasal inhaler prescribing information. In: Physicians’ desk reference. 55th ed. Montvale, NJ; Medical Economics Company Inc; 2001:717-9.

2. Aventis. Nasacort AQ (triamcinolone acetonide) prescribing information (dated 1997 Oct). In: Physician’s desk reference. 55th ed. Montvale, NJ: Medical Economics Company, Inc; 2001:719-20.

3. Jeal W, Faulds D. Triamcinolone acetonide: a review of its pharmacological properties and therapeutic efficacy in the management of allergic rhinitis. Drugs. 1997; 53:257-80.

4. Settipane G, Korenblat PE, Winder J et al. Triamcinolone acetonide aqueous nasal spray in patients with seasonal ragweed allergic rhinitis: a placebo-controlled, double-blind study. Clin Ther. 1995; 17:252-63.

5. Munk ZM, LaForce C, Furst JA et al. Efficacy and safety of triamcinolone acetonide aqueous nasal spray in patients with seasonal allergic rhinitis. Ann Allergy Asthma Immunol. 1996; 77:277-81.

6. Findlay S, Huber F, Garcia J et al. Efficacy of once-a-day intranasal administration of triamcinolone acetonide in patients with seasonal allergic rhinitis. Ann Allergy. 1992; 68:228-32.

7. Banov CH, Silvers WS, Green AW et al. Placebo-controlled, double-blind study of the efficacy and safety of triamcinolone acetonide aerosol nasal inhaler in pediatric patients with seasonal allergic rhinitis. Clin Ther. 1996; 18:265-72.

8. Kobayashi RH, Beaucher WN, Koepke JW et al. Triamcinolone acetonide aqueous nasal spray for the treatment of patients with perennial allergic rhinitis: a multicenter, randomized, double-blind, placebo-controlled study. Clin Ther. 1995; 17:503-13.

9. Spector S, Bronsky E, Chervinsky P et al. Multicenter, double-blind, placebo-controlled trial of triamcinolone acetonide nasal aerosol in the treatment of perennial allergic rhinitis. Ann Allergy. 1990; 64:300-5.

10. Storms W, Bronsky E, Findlay S et al. Once daily triamcinolone acetonide nasal spray is effective for the treatment of perennial allergic rhinitis [published erratum appears in Ann Allergy 1991; 66:457]. Ann Allergy. 1991; 66:329-34.

11. Welch MJ, Bronsky EA, Grossman J et al. Clinical evaluation of triamcinolone acetonide nasal aerosol in children with perennial allergic rhinitis.Ann Allergy. 1991; 67:493-8.

12. Day JH, Buckeridge DL, Clark RH et al. A randomized, double-blind, placebo-controlled, controlled antigen delivery study of the onset of action of aerosolized triamcinolone acetonide nasal spray in subjects with ragweed-induced allergic rhinitis. J Allergy Clin Immunol. 1996; 97:1050-7.

13. Howland WC III, Dockhorn R, Gillman S et al. A comparison of effects of triamcinolone acetonide aqueous nasal spray, oral prednisone, and placebo on adrenocortical function in male patients with allergic rhinitis. J Allergy Clin Immunol. 1996; 98:32-8.

14. Feiss G, Morris R, Rom D et al. A comparative study of the effects of intranasal triamcinolone acetonide aerosol (ITAA) and prednisone on adrenocortical function. J Allergy Clin Immunol. 1992; 89:1151-6.

15. Nayak AS, Ellis MH, Gross GN et al. The effects of triamcinolone acetonide aqueous nasal spray on adrenocortical function in children with allergic rhinitis. J Allergy Clin Immunol. 1998; 101(2 Pt 1):157-62.

16. Aventis, Bridgewater, NJ: Personal communication.

17. Muro. Tri-Nasal (triamcinolone acetonide) nasal spray prescribing information. Tewksbury, MA; 2000 Feb.

b. Aventis. Nasacort AQ (triamcinolone acetonide) prescribing information. Bridgewater, NJ; 2004 Mar.

c. Aventis. Nasacort AQ (triamcinolone acetonide) patient information. Bridgewater, NJ; 2004 Mar.

Hide
(web1)