ALVESCO ® (ciclesonide) Inhalation - America[美国药品]

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ALVESCO ® (ciclesonide) Inhalation

2015-06-14 23:18:46 来源: 作者: 【大中小】浏览:323次评论:0条

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use ALVESCO ® safely and effectively. See full prescribing information for ALVESCO ®.
ALVESCO ® (ciclesonide) Inhalation Aerosol 80 mcg, 160 mcg
For Oral Inhalation Only
Initial U.S. Approval: 2006

INDICATIONS AND USAGE

ALVESCO is an inhaled corticosteroid indicated for: Maintenance treatment of asthma as prophylactic therapy in adult and adolescent patients 12 years of age and older. (1)

ALVESCO is NOT indicated for the relief of acute bronchospasm. (1)

DOSAGE AND ADMINISTRATION

FOR ORAL INHALATION ONLY (2)

1Prednisone should be reduced gradually, no faster than 2.5 mg/day on a weekly basis, beginning after at least 1 week of therapy with ALVESCO. Patients should be carefully monitored for signs of asthma instability, including monitoring of serial objective measures of airflow, and for signs of adrenal insufficiency during steroid taper and following discontinuation of oral corticosteroid therapy [see Warnings and Precautions (5.1)].
	Recommended Starting Dose	Highest Recommended Dose
Patients ≥ 12 years who received bronchodilators alone	80 mcg twice daily	160 mcg twice daily
Patients ≥ 12 years who received inhaled corticosteroids	80 mcg twice daily	320 mcg twice daily
Patients ≥ 12 years who received oral corticosteroids1	320 mcg twice daily	320 mcg twice daily

DOSAGE FORMS AND STRENGTHS

Inhalation Aerosol 80 mcg/actuation or 160 mcg/actuation (3)
CONTRAINDICATIONS

Patients with status asthmaticus or other acute episodes of asthma where intensive measures are required. (4.1)
Patients with a known hypersensitivity to ciclesonide or any of the ingredients of ALVESCO. (4.2)

WARNINGS AND PRECAUTIONS

Candida albicans infection of the mouth and pharynx. Monitor patients periodically for signs of adverse effects on the oral cavity. Advise patients to rinse mouth following inhalation. (5.1)
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 above because of the potential for worsening of these infections. (5.3)
Risk of impaired adrenal function when transferring from oral steroids to inhaled corticosteroids. Taper patients slowly from systemic corticosteroids if transferring to ALVESCO. (5.4)
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 ALVESCO slowly (