ALVESCO- ciclesonide aerosol, metered

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Physicians Total Care, Inc.

INN (الاسم الدولي):

CICLESONIDE

تركيب:

CICLESONIDE 80 ug

طريقة التعاطي:

RESPIRATORY (INHALATION)

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

ALVESCO is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and adolescent patients 12 years of age and older. ALVESCO is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. ALVESCO is contraindicated in patients with known hypersensitivity to ciclesonide or any of the ingredients of ALVESCO. Rare cases of hypersensitivity reactions with manifestations such as angioedema, with swelling of the lips, tongue and pharynx, have been reported. Teratogenic Effects : Pregnancy Category C Oral administration of ciclesonide in rats up to 900 mcg/kg/day (approximately 10 times the maximum human daily inhalation dose based on mcg/m2 /day) produced no teratogenicity or other fetal effects. However, subcutaneous administration of ciclesonide in rabbits at 5 mcg/kg/day (less than the maximum human daily inhalation dose based on mcg/m2 /day) or greater produced fetal toxicity. This included fetal loss, reduc

ملخص المنتج:

ALVESCO is available in the following strengths and canister presentations. ALVESCO 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. ALVESCO 160 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. ALVESCO canisters are for use with ALVESCO Inhalation Aerosol actuators only. The actuators are fitted with a dose indicator and should not be used with other inhalation aerosol 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° and 30°C (59° and 86°F) are permitted (see USP). For optimal results, the canister should be at room temperature when used. Keep out of reach of children. 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.

الوضع إذن:

New Drug Application

خصائص المنتج

ALVESCO - CICLESONIDE AEROSOL, METERED
PHYSICIANS TOTAL CARE, INC.
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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 (2.1)
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)]_.
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
corticoste roids
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 /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.
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,