Label Changes for:

Nasacort AQ (triamcinolone acetonide) Nasal Spray

September 2008

Changes have been made to the WARNINGS, PRECAUTIONS, ADVERSE REACTIONS and PATIENT PACKAGE INSERT sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- September 2008

 

The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.


Summary View

 

Sections Modified

Summary of Changes to Contraindications and Warnings

WARNINGS AND PRECAUTIONS

  • Local Nasal Effects
    • Epistaxis
    • Nasal Septal Perforation
      • In clinical trials, nasal septum perforation was reported in one adult patient treated with Nasacort AQ Nasal Spray.
    • Candida Infection
  • Glaucoma and Cataracts
  • Immunosuppression
  • Hypothalamic-Pituitary-Adrenal Axis Effects
    • Hypercorticism and Adrenal Suppression
  • Effect on Growth

ADVERSE REACTIONS

  • Clinical Trials Experience
    • Table 2
    • A total of 474 children 2 to 5 years of age were studied in a 4-week double-blind, placebocontrolled clinical trial...
      • Table 3
  • Postmarketing Experience

USE IN SPECIFIC POPULATIONS

  • Pediatric Use
  • Geriatric Use

PATIENT COUNSELING INFORMATION

  • Local Nasal Effects
  • Cataracts and Glaucoma
  • Immunosuppression
  • Use Daily for Best Effect
  • Keep Spray Out of Eyes
  • Patient Package Information

PATIENT PACKAGE INSERT (new)

WARNINGS AND PRECAUTIONS

Local Nasal Effects: Epistaxis

In clinical studies of 2 to 12 weeks duration, epistaxis was observed more frequently in patients treated with Nasacort AQ Nasal Spray than those who received placebo [see Adverse Reactions (6)].

Local Nasal Effects: Candida Infection

...Therefore, patients using Nasacort AQ 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.

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.

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...

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 hypercoticism and adrenal suppression may appear...

Effect on Growth

Corticosteroids may cause a reduction in growth velocity when administered to pediatric patients. Monitor the growth routinely of pediatric patients receiving Nasacort AQ Nasal Spray. To minimize the systemic effects of intranasal corticosteroids, including Nasacort AQ Nasal Spray, titrate each patient’s dose to the lowest dosage that effectively controls his/her symptoms [see Use in Specific Populations (8.4)].

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