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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.2 3

Uses for Nasacort

Allergic Rhinitis

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

Slideshow: Top Prevention Tips - Seasonal Allergies

Self-medication for temporary symptomatic relief of hay fever or other upper respiratory allergies.22

Nasacort Dosage and Administration

Administration

Intranasal Administration

Administer by nasal inhalation using a metered-dose nasal spray pump.2 3 4 5 8 22

Prime metered-dose spray pump prior to first use and after a period of nonuse (i.e., ≥ 2 weeks).2 22

Gently blow the nose to clear nasal passages.2 Shake inhaler well prior to administration.2 22

Tilt head slightly backward, insert spray tip into one nostril, and point tip toward back of the nose.2 22 Pump the drug into one nostril while holding the other nostril closed and concurrently inspire through the nose.2 22 Repeat this procedure for the other nostril.2 22 Avoid blowing nose for 15 minutes after inhalation.2 22

Dosage

Nasal spray pump delivers about 55 mcg of triamcinolone acetonide per metered spray.2 22

Do not continue intranasal triamcinolone acetonide for >3 weeks in the absence of adequate symptomatic improvement.1 2 16

For self-medication, discontinue therapy and contact a clinician if no improvement after 1 week.22

Pediatric Patients

Seasonal or Perennial Allergic Rhinitis
Intranasal Inhalation

Children 2–5 years of age: 55 mcg (1 spray) in each nostril once daily (110 mcg total).2

Children 6–11 years of age: Initially 55 mcg (1 spray) in each nostril once daily (110 mcg total).2 If response inadequate, may increase dosage to 110 mcg (2 sprays) in each nostril once daily (220 mcg total); once symptomatic relief achieved, may reduce dosage to 55 mcg (1 spray) in each nostril once daily (110 mcg total).2

Children ≥12 years of age: 110 mcg (2 sprays) in each nostril once daily (220 mcg total); once symptomatic relief achieved, may reduce dosage to 55 mcg (1 spray) in each nostril once daily (110 mcg total) to maintain symptomatic control.2

Self-medication for Hay Fever or Other Upper Respiratory Allergies
Intranasal Inhalation

Children 2–5 years of age: 55 mcg (1 spray) in each nostril once daily (110 mcg total).22

Children 6–11 years of age: 55 mcg (1 spray) in each nostril once daily (110 mcg total).22 If response inadequate, may increase dosage to 110 mcg (2 sprays) in each nostril once daily (220 mcg total); once symptomatic relief achieved, reduce dosage to 55 mcg (1 spray) in each nostril once daily (110 mcg total).22

Children ≥12 years of age: Initially 110 mcg (2 sprays) in each nostril once daily (220 mcg total); once symptomatic relief achieved, reduce dosage to 55 mcg (1 spray) in each nostril once daily (110 mcg total).22

Adults

Seasonal or Perennial Allergic Rhinitis
Intranasal Inhalation

110 mcg (2 sprays) in each nostril once daily (220 mcg total); once symptomatic relief achieved, may reduce dosage to 55 mcg (1 spray) in each nostril once daily (110 mcg total) to maintain symptomatic control.2

Self-medication for Hay Fever or Other Upper Respiratory Allergies
Intranasal Inhalation

110 mcg (2 sprays) in each nostril once daily (220 mcg total); once symptomatic relief achieved, reduce dosage to 55 mcg (1 spray) in each nostril once daily (110 mcg total).22

Prescribing Limits

Pediatric Patients

Seasonal or Perennial Allergic Rhinitis
Intranasal Inhalation

Children 2–5 years of age: Maximum 110 mcg (1 spray in each nostril) daily.2

Children 6–11 years of age: Maximum 220 mcg (2 sprays in each nostril) daily.2

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

Self-medication for Hay Fever or Other Upper Respiratory Allergies
Intranasal Inhalation

Children 2–5 years of age: Maximum 110 mcg (1 spray in each nostril) daily.22

Children 6–11 years of age: Maximum 220 mcg (2 sprays in each nostril) daily.22

Children ≥12 years of age: Maximum 220 mcg (2 sprays in each nostril) daily.22

Adults

Seasonal or Perennial Allergic Rhinitis
Intranasal Inhalation

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

Self-medication for Hay Fever or Other Upper Respiratory Allergies
Intranasal Inhalation

Maximum 220 mcg (2 sprays in each nostril) daily.22

Special Populations

Hepatic Impairment

No specific dosage recommendations at this time.2 22

Renal Impairment

No specific dosage recommendations at this time.2 22

Geriatric Patients

Select dosage with caution, usually starting at low end of the dosage range, because of age-related decreases in hepatic, renal, and/or cardiac function and potential for concomitant disease and drug therapy.2 (See Geriatric Use under Cautions.)

Cautions for Nasacort

Contraindications

  • Known hypersensitivity to triamcinolone acetonide or any ingredient in the formulation.2 22

Warnings/Precautions

Nasopharyngeal Effects

Epistaxis reported more frequently in patients receiving triamcinolone than in those receiving placebo.2

Nasal septal perforation reported.2

Localized candidal infections of the nose and pharynx reported rarely.2 Local or systemic treatment of such infections and/or discontinuance of intranasal therapy may be required.2 Periodically evaluate patients receiving the drug over several months or longer for evidence of candidal infections or other adverse nasal mucosal effects.2

Avoid use until healing occurs in patients with recent nasal ulcers, surgery, or trauma.2

Glaucoma and Cataracts

Nasally and orally inhaled corticosteroid use may result in glaucoma and/or cataracts; carefully monitor patients with vision changes or those with history of increased IOP, glaucoma, and/or cataracts.2

Immunosuppressed Patients

Increased susceptibility to infections in patients receiving drugs that suppress the immune system.2 Certain infections (e.g., varicella [chickenpox], measles) can be serious or fatal in susceptible children or adults receiving corticosteroids.2 Not known how dosage, route, duration, or prior use of corticosteroid therapy and/or underlying disease affect risk of developing a disseminated infection.2

Avoid exposure to varicella and measles in children or adults without history of or not properly immunized against these diseases.2 If exposure to varicella or measles occurs in such individuals, consider administering varicella zoster immune globulin (VZIG) or pooled IM immune globulin (IG), respectively.2 Consider treatment with antiviral agents if varicella develops.2

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

Systemic Corticosteroid Effects

Possible reduction in growth velocity in pediatric patients.2 (See Pediatric Use under Cautions.)

Systemic corticosteroid effects (e.g., hypercorticism, adrenal suppression) may occur when intranasal corticosteroids used at higher than recommended dosages or in susceptible individuals at recommended dosages.2 If such effects occur, gradually discontinue the drug according to accepted procedures for discontinuing oral corticosteroid therapy.2

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

Sensitivity Reactions

Hypersensitivity reactions reported during postmarketing experience.2

Specific Populations

Pregnancy

Category C.2 Use during pregnancy may result in hypoadrenalism in infants; monitor these infants carefully.2

Lactation

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

Pediatric Use

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

May reduce growth velocity; routinely monitor (e.g., via stadiometry) growth of children receiving this drug.2 Weigh benefits of therapy against possibility of growth suppression and risks and benefits of alternative therapies.2 To minimize systemic effects of intranasal triamcinolone, titrate dosage to lowest possible effective level.2

Potential to cause growth suppression in susceptible patients and when used at higher than recommended dosages cannot be ruled out.2

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.2 No substantial differences in safety and efficacy observed relative to younger adults based on other clinical experience.2 (See Geriatric Patients under Dosage and Administration.)

Common Adverse Effects

Adults and children ≥12 years of age: Pharyngitis, epistaxis, increased cough.2 3

Children 2–12 years of age: Flu syndrome, headache, increased cough, pharyngitis, pharyngolaryngeal pain, epistaxis, nasopharyngitis, bronchitis, asthma, rhinorrhea, dyspepsia, upper abdominal pain, diarrhea, tooth disorder, rash, excoriation.2

Nasacort Pharmacokinetics

Absorption

Bioavailability

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

Onset

Symptomatic relief may be evident 10–16 hours following initiation of therapy.4 5 8 12 16

Distribution

Extent

Volume of distribution is 99.5 L in adults.2

Not known whether distributed into milk.2

Special Populations

In children 2–5 years of age receiving 110 mcg daily, systemic exposure reported similar to that achieved in adults 20–40 years of age receiving 220 mcg daily.2 Apparent clearance and volume of distribution approximately half that in adults.2

In children 6–12 years of age, similar extent of absorption, peak concentrations, and time to peak concentrations compared with adults.2

Elimination

Metabolism

Metabolites substantially less active than the parent drug.2

Half-life

3.1 hours.2

Stability

Storage

Intranasal Suspension

20–25°C.2 22

Actions

  • Potent glucocorticoid1 2 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

  • Importance of instructing patients in the use of the nasal spray pump and to read the manufacturer’s patient information prior to using the drug.2

  • Risk of localized adverse nasal effects (e.g., epistaxis, nasal ulceration, candidal infections, nasal septal perforation, impaired wound healing).2

  • Risk of developing glaucoma or cataracts with intranasal corticosteroid use.2 Importance of informing clinician if vision changes occur during therapy.2

  • Importance of avoiding exposure to chickenpox or measles in patients receiving immunosuppressant doses of corticosteroids and, if exposed, of immediately consulting a clinician.2

  • Risk of worsening existing tuberculosis; fungal, bacterial, viral, or parasitic infections; or ocular herpes simplex.2

  • Importance of shaking container well prior to each use.2

  • Importance of children receiving therapy under adult supervision.22

  • Importance of taking the drug as directed and not exceeding the prescribed dosage.2 Importance of informing clinicians if symptoms worsen or fail to improve.2

  • Importance of following dosage instructions and not exceeding recommended dosages when used for self-medication.22 Importance of discontinuing use as self-medication, and consulting a clinician if symptoms fail to improve following 1 week of therapy.22

  • Importance of not using as self-medication for the common cold.22

  • Importance of advising patients to consult a clinician before using for self-medication following recent nasal ulcers or surgery, or a nasal injury not fully healed.22

  • Importance of advising patients to consult a clinician before using for self-medication in those receiving corticosteroids for asthma, allergies, or skin rash; with existing eye infections; or with existing or history of glaucoma or cataracts.22

  • Importance of advising patients to discontinue use for self-medication and to consult a clinician if they have existing chickenpox, measles, or tuberculosis or following contact with infected individuals.22

  • Importance of advising patients to discontinue use for self-medication and to consult a clinician if symptoms of infection (e.g., persistent fever), any vision changes, or severe or frequent nosebleeds occur.22

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.2 22

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.2 22

  • Importance of informing patients of other important precautionary information.2 22 (See Cautions.)

Preparations

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

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Triamcinolone Acetonide

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Nasal

Suspension*

55 mcg per metered spray

Nasacort Allergy 24HR Nasal Spray

Chattem

Triamcinolone Acetonide Nasal Spray

AHFS DI Essentials. © Copyright, 2004-2016, Selected Revisions September 30, 2015. 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. Teva Pharmaceuticals USA. Triamcinolone acetonide nasal spray prescribing information. Sellersville, PA; 2013 Aug.

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.

21. Weinstein S, Qaqundah P, Georges G et al. Efficacy and safety of triamcinolone acetonide aqueous nasal spray in children aged 2 to 5 years with perennial allergic rhinitis: a randomized, double-blind, placebo-controlled study with an open-label extension. Ann Allergy Asthma Immunol. 2009; 102:339-47. [PubMed 19441606]

22. Chattem, Inc. Nasacort Allergy 24HR (triamcinolone acetonide) nasal spray product information. From FDA website. 2013 Oct.

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