ALVESCO- ciclesonide aerosol, metered

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

CICLESONIDE (UNII: S59502J185) (CICLESONIDE - UNII:S59502J185)

Mevcut itibaren:

Covis Pharma US, Inc

INN (International Adı):

CICLESONIDE

Kompozisyon:

CICLESONIDE 80 ug

Uygulama yolu:

RESPIRATORY (INHALATION)

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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

Ürün özeti:

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.

Yetkilendirme durumu:

New Drug Application

Ürün özellikleri

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