Label Changes for:

Asmanex Twisthaler (mometasone furoate inhalation powder)

February 2008

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


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


Summary View

 

Sections Modified Summary of Changes to Contraindications and Warnings

CONTRAINDICATIONS

  • Hypersensitivity

WARNINGS AND PRECAUTIONS

  • Local Effects
  • Acute Asthma Episodes
  • Immunosuppression
  • Transferring Patients from Systemic Corticosteroid Therapy
  • Hypercorticism and Adrenal Suppression
  • Reduction in Bone Mineral Density
  • Effect on Growth
  • Glaucoma and Cataracts

ADVERSE REACTIONS

  • The most common adverse reactions (incidence >5%) are headache, allergic rhinitis, pharyngitis, upper respiratory tract infection, sinusitis, oral candidiasis, dysmenorrhea, musculoskeletal pain, back pain, and dyspepsia.

CONTRAINDICATIONS

Hypersensitivity

...In the clinical trials and post-marketing experience with Asmanex Twisthaler, cases of allergic reaction, facial edema, urticaria, hypersensitivity, and throat tightness have been reported.

WARNINGS AND PRECAUTIONS

Local Effects

Candida albicans infection of the mouth and pharynx. Monitor patients periodically for signs of adverse effects in the mouth and pharynx. Advise patients to rinse mouth after inhalation.

Acute Asthma Episodes

...Instruct patients to contact their physician immediately if episodes of asthma that are not responsive to bronchodilators occur during the course of treatment with Asmanex Twisthaler. During such episodes, patients may require therapy with oral corticosteroids.

Immunosuppression

Potential worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infection, or ocular herpes simplex. More serious or even fatal course of chickenpox or measles in susceptible patients...

Transferring Patients from Systemic Corticosteroid Therapy

Risk of impaired adrenal function when transferring from oral steroids to inhaled corticosteroids. Taper patients slowly from systemic corticosteroids...

Hypercorticism and Adrenal Suppression

Hypercorticism, suppression of hypothalamic-pituitary-adrenal (HPA) function with very high dosages or at the regular dosage in susceptible individuals...

Reduction in Bone Mineral Density

Reduction in bone mineral density with long-term administration. Monitor patients with major risk factors for decreased bone mineral content.

Effect on Growth

Suppression of growth in children. Monitor growth routinely in pediatric patients...

Glaucoma and Cataracts

Development of glaucoma, increased intraocular pressure and posterior subcapsular cataracts. Monitor patients with a change in vision or with a history of increased intraocular pressure, glaucoma, and/or cataracts closely.

Label approved 02/26/2008 is not available on Drugs@FDA

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