Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
CICLESONIDE (UNII: S59502J185) (CICLESONIDE - UNII:S59502J185)
Covis Pharma US, Inc
CICLESONIDE
CICLESONIDE 80 ug
RESPIRATORY (INHALATION)
PRESCRIPTION DRUG
ALVESCO is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients 12 years of age and older. Limitations of Use : ALVESCO is not indicated for the relief of acute bronchospasm. ALVESCO is not indicated for children under 12 years of age. ALVESCO is contraindicated in: There are no available data on ALVESCO use in pregnant women to assess a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. There is low systemic exposure following ALVESCO oral inhalation administration at the recommended dose [see Clinical Pharmacology (12.3)] . In animal reproduction studies, ciclesonide administered by the oral route to pregnant rats during the period of organogenesis did not cause any evidence of fetal harm at doses up to 15 times the maximum recommended human daily oral inhalation dose (MRHDOID) of 640 mcg/day. Teratogenicity, characteristic of corticosteroids, decreased body weight and/or skeletal variations were observed in
ALVESCO is available in the following strengths and canister presentations. Micrograms per Actuation Number of Actuations per Canister Canister Weight Canister per Box NDC Number ALVESCO 80 mcg 60 6.1 g 1 70515-711-01 ALVESCO 160 mcg 60 6.1 g 1 70515-712-01 ALVESCO 80 mcg 30 4.7 g 1 70515-711-04 ALVESCO 160 mcg 30 4.7 g 1 70515-712-04 ALVESCO 80 mcg 60 6.1 g 1 70515-711-05 ALVESCO 160 mcg 60 6.1 g 1 70515-712-05 ALVESCO (ciclesonide) 80 mcg inhalation aerosol is supplied with a brown plastic actuator with a red dust cap. Each actuation of the inhaler delivers 80 mcg of ciclesonide from the actuator and contains 60 actuations fill/canister. ALVESCO 160 (ciclesonide) mcg inhalation aerosol is supplied with a red plastic actuator with a red dust cap. Each actuation of the inhaler delivers 160 mcg of ciclesonide from the actuator and contains 60 actuations fill/canister. ALVESCO canisters are for use with ALVESCO actuators only. The actuators are fitted with a dose indicator and should not be used with other medications. The correct amount of medication in each actuation cannot be assured from the canister labeled to contain 60 actuations when the dose indicator display window shows zero even though the canister is not completely empty. The canister should be discarded when the dose indicator display window shows zero. Store at 25°C (77°F). Excursions between 15°C and 30°C (59°F and 86°F) are permitted (see USP). For optimal results, the canister should be at room temperature when used. Contents under pressure. Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 49°C (120°F) may cause bursting. Never throw canister into fire or incinerator.
New Drug Application
ALVESCO- CICLESONIDE AEROSOL, METERED COVIS PHARMA US, INC ---------- 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, FOR ORAL INHALATION USE 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 pediatric patients 12 years of age and older. (1) Limitations of Use: ALVESCO is not indicated for the relief of acute bronchospasm or in pediatric patients less than 12 years of age. (1) DOSAGE AND ADMINISTRATION • • Prednisone 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)]_. PREVIOUS THERAPY 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 corticosteroids 320 mcg twice daily 320 mcg twice daily DOSAGE FORMS AND STRENGTHS Inhalation aerosol: 80 mcg per actuation or 160 mcg per actuation (3) CONTRAINDICATIONS • • WARNINGS AND PRECAUTIONS • • • • • ® ® ® For oral inhalation only. (2) Prime ALVESCO before first use or when inhaler not used for more than 10 days. (2) 1 1 Patients with status asthmaticus or other acute episodes of asthma where intensive measures are required. (4) Patients with a known hypersensitivity to ciclesonide or any of the ingredients of ALVESCO. (4) _Candida albicans_ infection of the mout Lire le document complet