CICLESONIDE aerosol, metered

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Prasco Laboratories

প্রশাসন রুট:

RESPIRATORY (INHALATION)

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Ciclesonide Inhalation Aerosol is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and adolescent patients 12 years of age and older. Important Limitations of Use: Ciclesonide Inhalation Aerosol is NOT indicated for the relief of acute bronchospasm. Ciclesonide Inhalation Aerosol is NOT indicated for children under 12 years of age. Ciclesonide Inhalation Aerosol is contraindicated in the primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. Ciclesonide Inhalation Aerosol is contraindicated in patients with known hypersensitivity to ciclesonide or any of the ingredients of Ciclesonide Inhalation Aerosol. 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

পণ্য সারাংশ:

Ciclesonide Inhalation Aerosol is available in the following strengths and canister presentations. Micrograms per Actuation     Number of Actuations per Canister Canister Weight   Canister per Box     NDC Number     Ciclesonide Inhalation Aerosol 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. Ciclesonide Inhalation Aerosol 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. Ciclesonide Inhalation Aerosol canisters are for use with Ciclesonide Inhalation Aerosol 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.

অনুমোদন অবস্থা:

New Drug Application Authorized Generic

পণ্য বৈশিষ্ট্য

CICLESONIDE- CICLESONIDE AEROSOL, METERED
PRASCO LABORATORIES
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CICLESONIDE INHALATION
AEROSOL SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
CICLESONIDE INHALATION
AEROSOL.
CICLESONIDE INHALATION AEROSOL 80 MCG, 160 MCG
FOR ORAL INHALATION ONLY
INITIAL U.S. APPROVAL: 2006
INDICATIONS AND USAGE
Ciclesonide Inhalation Aerosol 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)
Ciclesonide Inhalation Aerosol is NOT indicated for the relief of
acute bronchospasm. (1)
DOSAGE AND ADMINISTRATION
FOR ORAL INHALATION ONLY (2)
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
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 Ciclesonide Inhalation Aerosol. 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)].
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 Ciclesonide Inhalation
Aerosol. (4.2)
WARNINGS AND PRECAUTIONS
_Candida albicans_ infection of the mouth and pharynx. Monitor
patients periodically for signs of adverse
effects on t