FDA records indicate that there are no current recalls for this drug.
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Side Effects & Adverse Reactions
The replacement of a systemic corticosteroid with a topical corticosteroid can be accompanied by signs of adrenal insufficiency and, in addition, some patients may experience symptoms of 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, too rapid a decrease in systemic corticosteroids may cause a severe exacerbation of their symptoms.
The concomitant use of intranasal corticosteroids with other inhaled corticosteroids could increase the risk of signs or symptoms of hypercorticism and/or suppression of the HPA axis.
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 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.
Avoid spraying in eyes.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Nasacort HFA Nasal Aerosol is indicated for the treatment of the nasal symptoms of allergic rhinitis (seasonal and perennial) in adults and children 6 years of age and older.
Safety and effectiveness of Nasacort HFA Nasal Aerosol in children below 6 years of age have not been adequately established.
History
There is currently no drug history available for this drug.
Other Information
Triamcinolone acetonide, USP, the active ingredient in Nasacort® HFA Nasal Aerosol, is a glucocorticosteroid with a molecular weight of 434.5, the chemical designation 9-Fluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone (C24H31FO6), and the following chemical structure:
Triamcinolone acetonide is a white to cream-colored crystalline powder, practically insoluble in water, very soluble in dehydrated alcohol, chloroform, and methyl alcohol.
Nasacort HFA Nasal Aerosol is a metered-dose aerosol unit containing a microcrystalline suspension of triamcinolone acetonide in tetrafluoroethane (HFA-134a) and dehydrated alcohol USP 0.7% w/w. Each canister contains 15 mg of triamcinolone acetonide.
The canister must be primed with 3 actuations prior to the first use or after a period of non-use (3 days). After priming, each actuation meters 100 mcg of triamcinolone acetonide in 65 mg of suspension from the valve and delivers 55 mcg of triamcinolone acetonide from the nasal actuator to the patient. If the product is not used for more than 3 days, it should be re-primed with 3 actuations.
Each 9.3 g canister of Nasacort HFA Nasal Aerosol provides 100 metered sprays. After 100 metered sprays, this amount of medication delivered per actuation may not be consistent and the unit should be discarded. Patients are provided with a check-off card to track usage as part of the PATIENT'S INSTRUCTIONS FOR USE tear-off sheet.
Sources
Nasacort Hfa Manufacturers
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Aventis Pharmaceuticals Inc.
Nasacort Hfa | Aventis Pharmaceuticals Inc.
Recommended Doses Adults and Adolescents 12 years of age and olderThe recommended starting dose of Nasacort HFA Nasal Aerosol is 220 mcg per day given as 2 sprays (55 mcg/spray) in each nostril once daily. If needed, the dose may be increased to 440 mcg per day given as 4 sprays (55 mcg/spray) in each nostril once daily. Once the maximal effect has been achieved, it is always desirable to titrate the patient to the minimum effective dose.
Children 6 through 11 years of ageThe recommended dose of Nasacort HFA Nasal Aerosol is 220 mcg per day given as 2 sprays (55 mcg/spray) in each nostril once daily. Once the maximal effect has been achieved, it is always desirable to titrate the patient to the minimum effective dose.
Safety and effectiveness have not been established in pediatric patients below the age of 6 years (see PRECAUTIONS, Pediatric Use).
Directions for UseIllustrated PATIENT'S INSTRUCTIONS FOR USE accompanies each package.
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