AHFS Class:

• Corticosteroids 52:08.08

Generic Name(s):

• Triamcinolone Acetonide

Triamcinolone acetonide is a synthetic corticosteroid.2,3

Allergic Rhinitis

Triamcinolone acetonide nasal inhalation aqueous suspension is used for the symptomatic treatment of seasonal or perennial allergic rhinitis.2,3,4,5,6,7,8,9,10,11 The aqueous suspension also is used for self-medication to provide temporary symptomatic relief of hay fever or other upper respiratory allergies.22

In patients with seasonal or perennial allergic rhinitis, intranasal administration of triamcinolone acetonide generally provides symptomatic relief of rhinorrhea, nasal congestion, sneezing, and itching.2,3,4,5,6,7,8,9,10,11,22 In addition to relief of nasal symptoms, improvement of ophthalmic signs and symptoms (e.g., itching, lacrimation) has occurred in some patients, possibly secondary to systemic absorption of the drug.1,3 Since intranasal triamcinolone acetonide is thought to exert a local effect on the nasal mucosa, the mechanism of these ophthalmic effects is not fully understood.1,3,16 In patients with seasonal or perennial rhinitis, symptomatic relief usually is evident within several days of continuous intranasal triamcinolone acetonide therapy; however, about 1-2 weeks of continuous therapy may be required for optimum effectiveness in some patients.1,2,3 Onset of response occasionally occurs within 10-16 hours following initiation of intranasal triamcinolone acetonide suspension in patients with seasonal4,5,12 or perennial8,16 allergic rhinitis.4,5,12

Results of several placebo-controlled trials in adults and children 12 years of age or older indicate that triamcinolone acetonide nasal aqueous suspension (220 mcg daily) is more effective than placebo in relieving symptoms of seasonal and perennial allergic rhinitis.2,3,4,5,6,8 In addition, evidence from a limited number of studies in children 6 to younger than 12 years of age indicate that triamcinolone acetonide nasal aqueous suspension (110 or 220 mcg daily) is more effective than placebo in relieving symptoms of seasonal and perennial allergic rhinitis.2,3,7,11 In a placebo-controlled trial in children 2-5 years of age with perennial allergic rhinitis with or without seasonal allergic rhinitis, triamcinolone acetonide nasal aqueous suspension (110 mcg daily) was more effective than placebo in improving the severity of nasal symptoms (i.e., congestion, pruritus, rhinorrhea, sneezing) reported over the previous 24 hours; however, there was no substantial difference in nasal symptom severity reported at the time just prior to study drug administration.2,21 Intranasal administration of triamcinolone acetonide suspension (220 mcg given once daily) appears to be as effective as intranasal beclomethasone (84, 166, or 169 mcg given twice daily), fluticasone (200 mcg given once daily), or flunisolide (100 mcg given twice daily) in the treatment of seasonal and perennial allergic rhinitis.3 In a limited number of studies, triamcinolone acetonide nasal suspension was at least as effective as oral antihistamines (e.g., astemizole [no longer commercially available in the US], loratadine) in relieving nasal and ophthalmic symptoms in adults.3

Administration

Triamcinolone acetonide is administered by nasal inhalation as an aqueous suspension using a spray pump.2,3,4,5,8,22 Patients should be carefully instructed in the use of the nasal inhalation spray pump, including the need to prime the pump prior to first use and after a period of nonuse (i.e., 2 weeks or more).2,22

Prior to administration of the nasal suspension, patients should be instructed to shake the container well.2,22 Patients should gently blow the nose to clear their nasal passages.2 Patients should tilt the head slightly backward and insert the spray tip into one nostril, pointing the tip toward the back of the nose.2,22 The drug suspension should be sprayed into one nostril while holding the other nostril closed and concurrently inspiring through the nose.2,22 This procedure should be repeated for the other nostril.2,22 Patients should avoid blowing the nose for 15 minutes after inhalation.2,22

Dosage

The nasal aqueous suspension spray pump delivers about 55 mcg of triamcinolone acetonide per metered spray.2,22

Allergic Rhinitis

For the symptomatic treatment of seasonal or perennial allergic rhinitis or for self-medication to provide temporary symptomatic relief of hay fever or other upper respiratory allergies, the usual initial dosage of intranasal triamcinolone acetonide as the aqueous suspension spray in adults and children 12 years of age or older is 110 mcg (2 sprays) in each nostril once daily (220 mcg total). Once optimal symptomatic relief is achieved, dosage reduction to 55 mcg (1 spray) in each nostril once daily (110 mcg total) has been shown to be effective in maintaining symptomatic control of allergic rhinitis.2,22 In children 6 to younger than 12 years of age, the usual initial dosage is 55 mcg (1 spray) in each nostril once daily (110 mcg total).2,22 If the response is inadequate, the dosage may be increased to 110 mcg (2 sprays) in each nostril once daily (220 mcg total); the dosage may be reduced to 55 mcg (1 spray) in each nostril once daily (110 mcg total) once optimal symptomatic relief is achieved.2,22 In children 2 to younger than 6 years of age, the usual dosage is 55 mcg (1 spray) in each nostril once daily (110 mcg total).2,22

The maximum recommended dosage of intranasal triamcinolone acetonide as the aqueous suspension spray in adults and children 6 years of age or older is 220 mcg (4 sprays) daily and in children 2 to younger than 6 years of age is 110 mcg (2 sprays) daily.2,22

Therapy with intranasal triamcinolone acetonide should not be continued beyond 3 weeks in the absence of adequate symptomatic improvement.1,2,16 For self-medication , if symptoms do not improve following 1 week of therapy, the drug should be discontinued and the patient should contact a clinician.22

Special Populations

Dosage selection for geriatric patients generally should be cautious, usually starting at the low end of the dosage range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and potential for concomitant disease or other drug therapy in these individuals.2 (See Geriatric Use under Warnings/Precautions: Specific Populations, in Cautions.)

The manufacturers make no specific dosage recommendations for patients with hepatic or renal impairment.2,22

Contraindications

Known hypersensitivity to triamcinolone acetonide or any ingredient in the respective formulations.2,22

Warnings/Precautions

Nasopharyngeal Effects

Epistaxis has been reported in patients receiving triamcinolone acetonide nasal spray, and was observed more frequently in patients receiving triamcinolone than in those receiving placebo in clinical studies of 2-12 weeks' duration.2

Nasal septal perforation has been reported in one adult patient who received triamcinolone acetonide nasal spray in a clinical study.2

Localized candidal infections of the nose and pharynx have occurred rarely during triamcinolone acetonide therapy.2 When infection occurs, appropriate local or systemic treatment of the infection may be necessary and/or discontinuance of intranasal triamcinolone acetonide therapy may be required.2 Therefore, patients receiving intranasal triamcinolone acetonide over several months or longer should be evaluated periodically for evidence of candidal infections or other signs of adverse effects on the nasal mucosa.2

Because corticosteroid therapy may inhibit wound healing, patients with recent nasal ulcers, surgery, or trauma should not use triamcinolone acetonide nasal spray until healing has occurred.2

Glaucoma and Cataracts

Since the use of intranasal and orally inhaled corticosteroids may result in the development of glaucoma and/or cataracts, careful monitoring is recommended in patients who have vision changes or in those with a history of increased intraocular pressure, glaucoma, and/or cataracts.2

Immunosuppressed Patients

Patients who are taking drugs that suppress the immune system have increased susceptibility to infections compared with healthy individuals, and certain infections (e.g., varicella [chickenpox], measles) can have a more serious or even fatal outcome in susceptible children and adults receiving corticosteroids.2 In children or adults who have not had these diseases or who have not been properly immunized, particular care should be taken to avoid exposure.2 It is not known how the dosage, route, duration of administration, and prior use of corticosteroid therapy affect the risk of developing a disseminated infection nor whether the underlying disease contributes to the risk.2 If exposure to varicella or measles occurs in such individuals, administration of varicella zoster immune globulin (VZIG) or pooled IM immune globulin (IG), respectively, may be indicated.2 If varicella develops, treatment with an antiviral agent may be considered.2

Corticosteroids should be used 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, because of the potential worsening of these infections.2 For additional information, see Cautions: Increased Susceptibility to Infection and also see Precautions and Contraindications, in the Corticosteroids General Statement 68:04.

Systemic Corticosteroid Effects

When intranasal corticosteroids are used at higher than recommended dosages or in susceptible individuals at recommended dosages, systemic corticosteroid effects, such as hypercorticism and adrenal suppression, may occur.2 If such effects occur, triamcinolone acetonide nasal spray should be discontinued gradually according to accepted procedures for discontinuing oral corticosteroid therapy.2

Intranasal corticosteroids may cause a reduction in growth velocity in pediatric patients, and clinicians should routinely monitor (e.g., via stadiometry) the growth of children receiving these drugs.2 The benefits of corticosteroid therapy should be weighed against the possibility of growth suppression and the risks and benefits of alternative therapies.2 The potential for intranasal triamcinolone acetonide to cause growth suppression in susceptible patients and when used at higher than recommended dosages cannot be ruled out.2

To minimize the systemic effects of intranasal corticosteroids, including triamcinolone acetonide, dosage should be titrated to the lowest possible effective level.2

Withdrawal of Systemic Corticosteroid Therapy

Patients who have received systemic corticosteroids for prolonged periods and are being switched to treatment with intranasal triamcinolone acetonide should be carefully monitored, since corticosteroid withdrawal symptoms (e.g., joint pain, muscular pain, lassitude, depression), acute adrenal insufficiency, or severe symptomatic exacerbation of asthma or other clinical conditions may occur.1,2,3 For additional information, see Discontinuance of Therapy under Dosage and Administration: Dosage, in the Corticosteroids General Statement 68:04.

Sensitivity Reactions

Hypersensitivity reactions have been reported during postmarketing experience.2

Specific Populations

Pregnancy

Category C.2 (See Users Guide.) Hypoadrenalism may occur in infants born to women receiving corticosteroids during pregnancy; these infants should be monitored carefully.2

Lactation

Not known whether triamcinolone acetonide is distributed into milk.2 Caution is advised if the drug is administered in nursing women.2

Pediatric Use

Safety and efficacy of intranasal triamcinolone acetonide suspension have not been established in children younger than 2 years of age.2 Intranasal corticosteroids may cause a reduction in growth velocity in pediatric patients.2 (See Systemic Corticosteroid Effects under Cautions: Warnings/Precautions.)

Geriatric Use

Experience from clinical trials in those 65 years of age or older is insufficient to determine whether they respond differently from younger adults.2 Based on other reported clinical experience to date, no substantial differences in safety and efficacy relative to younger adults is apparent.2 (See Dosage and Administration: Special Populations.)

Common Adverse Effects

Adverse effects occurring in at least 2% of adults and children 12 years of age or older receiving triamcinolone acetonide nasal aqueous suspension in clinical trials and more frequently than with placebo included pharyngitis, epistaxis, and increased cough.2,3

Adverse effects occurring in more than 2% of children 4-12 years of age receiving triamcinolone acetonide nasal aqueous suspension in clinical trials and more frequently than with placebo included flu syndrome, increased cough, pharyngitis, bronchitis, dyspepsia, and tooth disorder.2

Adverse effects occurring in at least 2% of children 2-5 years of age receiving triamcinolone acetonide nasal aqueous suspension in one study and more frequently than with placebo included headache, pharyngolaryngeal pain, epistaxis, nasopharyngitis, upper abdominal pain, diarrhea, asthma, rash, excoriation, and rhinorrhea.2

Description

Triamcinolone acetonide is a synthetic glucocorticoid.1,2,3 In animals, triamcinolone acetonide has relatively little mineralocorticoid activity;1,3,16 as a glucocorticoid, the drug is about 8 times more potent than prednisone.1,2 (For further information on the pharmacology of triamcinolone acetonide, see Pharmacology in the Corticosteroids General Statement 68:04 and in the EENT Corticosteroids General Statement 52:08.08.)

Systemic absorption of triamcinolone acetonide has been shown to be minimal following intranasal administration of the drug.2,3 Following intranasal administration of a single 220-mcg dose of triamcinolone acetonide as an aqueous suspension aerosol, mean peak plasma concentrations of about 0.5 ng/mL (range: 0.1-1 ng/mL) were achieved at 1.5 hours following administration.2

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 clinicians if vision changes occur during therapy with the drug.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 infections (e.g., tuberculosis; fungal, bacterial, viral, or parasitic infections; ocular herpes simplex).2

Importance of shaking containers of triamcinolone acetonide suspension 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 an infected individual.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.)

Additional Information

The American Society of Health-System Pharmacists, Inc. represents that the information provided in the accompanying monograph was formulated with a reasonable standard of care, and in conformity with professional standards in the field. Readers are advised that decisions regarding use of drugs are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and that the information contained in the monograph is provided for informational purposes only. The manufacturer's labeling should be consulted for more detailed information. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information contained in the monograph is not a substitute for medical care.

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. [Web]