FDA Section 5 \u2022 cited verbatim

Mometasone - Warnings and Precautions

The following warnings and precautions are taken directly from the US FDA-approved drug label for Mometasone. This is the same information dispensing pharmacists read.

5 WARNINGS AND PRECAUTIONS Candida albicans infection of the mouth and pharynx.

Monitor patients periodically for signs of adverse effects in the mouth and pharynx.

After administration, advise patients to rinse mouth with water and spit out contents without swallowing.

Deterioration of asthma or acute episodes: ASMANEX TWISTHALER should not be used for relief of acute symptoms.

Patients require immediate re-evaluation during rapidly deteriorating asthma.

Hypersensitivity reactions including anaphylaxis, angioedema, pruritus, and rash have been reported with the use of ASMANEX TWISTHALER.

Discontinue ASMANEX TWISTHALER if such reactions occur.

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.

Use caution in patients with the above because of the potential for worsening of these infections.

Risk of impaired adrenal function when transferring from oral steroids to inhaled corticosteroids.

Taper patients slowly from systemic corticosteroids if transferring to ASMANEX TWISTHALER.

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

If such changes occur discontinue ASMANEX TWISTHALER slowly.

Reduction in bone mineral density with long-term administration.

Monitor patients with major risk factors for decreased bone mineral content.

Suppression of growth in children.

Monitor growth routinely in pediatric patients receiving ASMANEX TWISTHALER.

Glaucoma and cataracts.

Consider referral to an ophthalmologist in patients who develop ocular symptoms or use ASMANEX TWISTHALER long term.

Paradoxical bronchospasm may occur with ASMANEX TWISTHALER.

Treat bronchospasm immediately with a fast-acting inhaled bronchodilator and discontinue use of ASMANEX TWISTHALER.

Strong cytochrome P450 3A4 inhibitors (e.g., ritonavir): Risk of increased systemic corticosteroid effects.

Exercise caution when used with ASMANEX TWISTHALER.

5.1 Oropharyngeal Candidiasis In clinical trials, the development of localized infections of the mouth and pharynx with Candida albicans occurred in 195 of 3007 patients treated with ASMANEX TWISTHALER.

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