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HIGHLIGHTS OF PRESCRIBING INFORMATION |
These highlights do not include all the information needed to use ASMANEX ®TWISTHALER® safely and effectively. See full prescribing information for ASMANEX TWISTHALER.
ASMANEX TWISTHALER 110 mcg, 220 mcg (mometasone furoate inhalation powder)
Initial U.S. Approval: 1987
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RECENT MAJOR CHANGES
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Contraindications (4.2) |
[09/2010] |
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Warnings and Precautions (5.3) |
[09/2010] |
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INDICATIONS AND USAGE
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ASMANEX TWISTHALER is a corticosteroid indicated for:
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Maintenance treatment of asthma as prophylactic therapy in patients 4 years of age and older. (1.1)
ASMANEX TWISTHALER is NOT indicated for the relief of acute bronchospasm (1.1, 5.2) or in children less than 4 years of age (1.1, 8.4).
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DOSAGE AND ADMINISTRATION
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FOR ORAL INHALATION ONLY. (2)
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Instruct patients to inhale rapidly and deeply and to rinse mouth after inhalation. (2)
Recommended Dosages for ASMANEX TWISTHALER Treatment
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Previous Therapy |
Recommended Starting Dose |
Highest Recommended Daily Dose |
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*†‡§Please refer to section 2.1 for full dosage recommendations and details. |
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Patients ≥12 years who received bronchodilators alone |
220 mcg once daily in the evening* |
440 mcg† |
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Patients ≥12 years who received inhaled corticosteroids |
220 mcg once daily in the evening* |
440 mcg† |
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Patients ≥12 years who received oral corticosteroids‡ |
440 mcg twice daily |
880 mcg |
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Children 4 – 11 years of age§ |
110 mcg once daily in the evening* |
110 mcg* |
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DOSAGE FORMS AND STRENGTHS
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220 mcg TWISTHALER: delivers 200 mcg mometasone furoate per actuation. (3)
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110 mcg TWISTHALER: delivers 100 mcg mometasone furoate per actuation. (3)
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CONTRAINDICATIONS
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Patients with status asthmaticus or other acute episodes of asthma where intensive measures are required. (4.1)
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Patients with a known hypersensitivity to milk proteins or any ingredients of ASMANEX TWISTHALER. (4.2)
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WARNINGS AND PRECAUTIONS
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Candida albicans infection of the mouth and pharynx. Monitor patients periodically for signs of adverse effects in the
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