Triamcinolone (nasal)

Triamcinolone (nasal)
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];

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Overview

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Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

Triamcinolone Acetonide Nasal Spray is indicated for the treatment of the nasal symptoms of seasonal and perennial allergic rhinitis in adults and children 2 years of age and older.

Dosage

Administer Triamcinolone Acetonide Nasal Spray by the intranasal route only. Shake Triamcinolone Acetonide Nasal Spray well before each use.

2.1 Adults and Adolescents 12 Years of Age and Older The recommended starting and maximum dose is 220 mcg per day as two sprays in each nostril once daily. Titrate an individual patient to the minimum effective dose to reduce the possibility of side effects. When the maximum benefit has been achieved and symptoms have been controlled, reducing the dose to 110 mcg per day (one spray in each nostril once a day) has been shown to be effective in maintaining control of the allergic rhinitis symptoms.

2.2 Children 2 to 12 Years of Age Children 6 to 12 years of age: The recommended starting dose is 110 mcg per day given as one spray in each nostril once daily. Children not responding adequately to 110 mcg per day may use 220 mcg (2 sprays in each nostril) once daily. Once symptoms have been controlled, the dosage may be decreased to 110 mcg once daily [see WARNINGS AND PRECAUTIONS (5.5), USE IN SPECIFIC POPULATIONS (8.4) and CLINICAL PHARMACOLOGY (12.2)].

Children 2 to 5 years of age: The recommended and maximum dose is 110 mcg per day given as one spray in each nostril once daily [see WARNINGS AND PRECAUTIONS (5.5), USE IN SPECIFIC POPULATIONS (8.4) and CLINICAL PHARMACOLOGY (12.2)].

Triamcinolone Acetonide Nasal Spray is not recommended for children under 2 years of age.

2.3 Administration Information Priming: Prime Triamcinolone Acetonide Nasal Spray before using for the first time by shaking the contents well and releasing 5 sprays into the air away from the face. It will remain adequately primed for two weeks. If the product is not used for more than 2 weeks, then it can be adequately reprimed with one spray. Shake Triamcinolone Acetonide Nasal Spray well before each use.

If adequate relief of symptoms has not been obtained after 3 weeks of treatment, Triamcinolone Acetonide Nasal Spray should be discontinued [see WARNINGS AND PRECAUTIONS (5), PATIENT COUNSELING INFORMATION (17), and ADVERSE REACTIONS (6)].

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Triamcinolone (nasal) in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Triamcinolone (nasal) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Triamcinolone (nasal) FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Triamcinolone (nasal) in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Triamcinolone (nasal) in pediatric patients.

Contraindications

Triamcinolone Acetonide should not be administered to patients with a history of hypersensitivity to triamcinolone acetonide or to any of the other ingredients of this preparation.

Warnings

5.1 Local Nasal Effects Epistaxis: In clinical studies of 2 to 12 weeks duration, epistaxis was observed more frequently in patients treated with Triamcinolone Acetonide Nasal Spray than those who received placebo [see ADVERSE REACTIONS (6)].

Nasal Septal Perforation: In clinical trials, nasal septum perforation was reported in one adult patient treated with Triamcinolone Acetonide Nasal Spray.

Candida Infection: In clinical studies with Triamcinolone Acetonide Nasal Spray, the development of localized infections of the nose and pharynx with Candida albicans has rarely occurred. When such an infection develops it may require treatment with appropriate local or systemic therapy and discontinuation of Triamcinolone Acetonide Nasal Spray. Therefore, patients using Triamcinolone Acetonide Nasal Spray over several months or longer should be examined periodically for evidence of Candida infection or other signs of adverse effects on the nasal mucosa.

Impaired Wound Healing: Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal ulcers, surgery, or trauma should not use Triamcinolone Acetonide Nasal Spray until healing has occurred.

5.2 Glaucoma and Cataracts Nasal and inhaled corticosteroids may result in the development of glaucoma and/or cataracts. Therefore, close monitoring is warranted in patients with a change in vision or with a history of increased intraocular pressure, glaucoma and/or cataracts.

5.3 Immunosuppression Persons who are using drugs that suppress the immune system are more susceptible to infections than healthy individuals. Chickenpox and measles, for example, can have a more serious or even fatal course in susceptible children or adults using corticosteroids. In children or adults who have not had these diseases or have not been properly immunized, particular care should be taken to avoid exposure. How the dose, route, and duration of corticosteroid administration affect the risk of developing a disseminated infection is not known. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chickenpox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with pooled intramuscular immunoglobulin (IG) may be indicated. (See the respective package inserts for complete VZIG and IG prescribing information.) If chickenpox develops, treatment with antiviral agents may be considered.

Corticosteroids should be used with caution, if at all, in patients with active or quiescent tuberculosis infections of the respiratory tract; untreated local or systemic fungal or bacterial infections; systemic viral or parasitic infections, or ocular herpes simplex because of the potential for worsening of these infections.

5.4 Hypothalamic-Pituitary-Adrenal Axis Effects Hypercorticism and Adrenal Suppression: When intranasal steroids are used at higher than recommended dosages or in susceptible individuals at recommended dosages, systemic corticosteroid effects such as hypercorticism and adrenal suppression may appear. If such changes occur, the dosage of Triamcinolone Acetonide Nasal Spray should be discontinued slowly, consistent with accepted procedures for discontinuing oral corticosteroid therapy. The replacement of a systemic corticosteroid with a topical corticosteroid can be accompanied by signs of adrenal insufficiency. In addition, some patients may experience symptoms of corticosteroid withdrawal, e.g., joint and/or muscular pain, lassitude, and depression. Patients previously treated for prolonged periods with systemic corticosteroids and transferred to topical corticosteroids should be carefully monitored for acute adrenal insufficiency in response to stress. In those patients who have asthma or other clinical conditions requiring long-term systemic corticosteroid treatment, rapid decreases in systemic corticosteroid dosages may cause a severe exacerbation of their symptoms.

5.5 Effect on Growth Corticosteroids, including Triamcinolone Acetonide Nasal Spray, may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth routinely of pediatric patients receiving Triamcinolone Acetonide Nasal Spray. To minimize the systemic effects of intranasal corticosteroids, including Triamcinolone Acetonide Nasal Spray, titrate each patient's dose to the lowest dosage that effectively controls his/her symptoms [see USE IN SPECIFIC POPULATIONS (8.4)].

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Triamcinolone (nasal) Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Triamcinolone (nasal) Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Triamcinolone (nasal) Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): C There are no adequate and well-controlled studies of Triamcinolone Acetonide Nasal Spray in pregnant women. Triamcinolone acetonide was teratogenic in rats, rabbits, and monkeys. Triamcinolone Acetonide Nasal Spray, like other corticosteroids, should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Since their introduction, experience with oral corticosteroids in pharmacologic as opposed to physiologic doses suggests that rodents are more prone to teratogenic effects from corticosteroids than humans. In addition, because there is a natural increase in glucocorticoid production during pregnancy, most women will require a lower exogenous corticosteroid dose and many will not need corticosteroid treatment during pregnancy.

In reproduction studies in rats and rabbits, triamcinolone acetonide administered by inhalation produced cleft palate and/or internal hydrocephaly and axial skeletal defects at exposures less than and 2 times, respectively, the maximum recommended daily intranasal dose in adults on a mcg/m2 basis. In a monkey reproduction study, triamcinolone acetonide administered by inhalation produced cranial malformations at an exposure approximately 37 times the maximum recommended daily intranasal dose in adults on a mcg/m2 basis.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Triamcinolone (nasal) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Triamcinolone (nasal) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Triamcinolone (nasal) in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Triamcinolone (nasal) in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Triamcinolone (nasal) in geriatric settings.

Gender

There is no FDA guidance on the use of Triamcinolone (nasal) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Triamcinolone (nasal) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Triamcinolone (nasal) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Triamcinolone (nasal) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Triamcinolone (nasal) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Triamcinolone (nasal) in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Triamcinolone (nasal) Administration in the drug label.

Monitoring

There is limited information regarding Triamcinolone (nasal) Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Triamcinolone (nasal) and IV administrations.

Overdosage

There is limited information regarding Triamcinolone (nasal) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Triamcinolone (nasal) Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Triamcinolone (nasal) Mechanism of Action in the drug label.

Structure

There is limited information regarding Triamcinolone (nasal) Structure in the drug label.

Pharmacodynamics

There is limited information regarding Triamcinolone (nasal) Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Triamcinolone (nasal) Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Triamcinolone (nasal) Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Triamcinolone (nasal) Clinical Studies in the drug label.

How Supplied

There is limited information regarding Triamcinolone (nasal) How Supplied in the drug label.

Storage

There is limited information regarding Triamcinolone (nasal) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Triamcinolone (nasal) Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Triamcinolone (nasal) interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Triamcinolone (nasal) Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Triamcinolone (nasal) Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.