ATROVENT HFA- ipratropium bromide aerosol, metered

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

IPRATROPIUM BROMIDE (UNII: J697UZ2A9J) (IPRATROPIUM - UNII:GR88G0I6UL)

제공처:

Boehringer Ingelheim Pharmaceuticals, Inc.

INN (International Name):

IPRATROPIUM BROMIDE

구성:

IPRATROPIUM BROMIDE ANHYDROUS 17 ug

관리 경로:

RESPIRATORY (INHALATION)

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

ATROVENT HFA Inhalation Aerosol is indicated as a bronchodilator for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. ATROVENT HFA is contraindicated in the following conditions [see Warnings and Precautions (5.2) ]. - Hypersensitivity to ipratropium bromide or other ATROVENT HFA components - Hypersensitivity to atropine or any of its derivatives Risk Summary Ipratropium is negligibly absorbed systemically following oral inhalation; therefore, maternal use is not expected to result in fetal exposure to the drug [see Clinical Pharmacology (12.3)] . There is limited experience with ipratropium bromide use in pregnant women. Published literature, including cohort studies, case control studies and case series, over several decades have not identified a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Based on animal reproduction studies, no evidence of structural alteration

제품 요약:

ATROVENT HFA is supplied in a pressurized stainless steel canister as a metered-dose inhaler with a white mouthpiece that has a clear, colorless sleeve and a green protective cap (NDC 0597-0087-17). The mouthpiece has an actuation indicator visible through a small window. The indicator typically moves during every 5 to 7 actuations. It displays the approximate number of actuations remaining in increments of 20, starting at "200" and decreasing until it reaches "0". The ATROVENT HFA canister is to be used only with the accompanying ATROVENT HFA mouthpiece. This mouthpiece should not be used with other aerosol medications. Similarly, the canister should not be used with other mouthpieces. After priming, each actuation of ATROVENT HFA delivers 21 mcg of ipratropium bromide from the valve and 17 mcg from the mouthpiece. Each canister has a net weight of 12.9 grams and provides sufficient medication for 200 actuations. The inhaler should be discarded after the labeled number of actuations has been used when the indicator displays "0". The amount of medication in each actuation cannot be assured after this point, even though the canister is not completely empty. Storage Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. For optimal results, the canister should be at room temperature before use. Contents Under Pressure: Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 120°F may cause bursting. Never throw the inhaler into a fire or incinerator. Keep out of reach of children. Avoid spraying in eyes.

승인 상태:

New Drug Application

제품 특성 요약

ATROVENT HFA- IPRATROPIUM BROMIDE AEROSOL, METERED
BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ATROVENT HFA SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ATROVENT HFA.
ATROVENT® HFA (IPRATROPIUM BROMIDE HFA INHALATION AEROSOL), FOR ORAL
INHALATION USE
INITIAL U.S. APPROVAL: 2004
INDICATIONS AND USAGE
ATROVENT HFA is an anticholinergic indicated for the maintenance
treatment of bronchospasm associated
with chronic obstructive pulmonary disease (COPD), including chronic
bronchitis and emphysema (1)
DOSAGE AND ADMINISTRATION
For oral inhalation only
Two inhalations four times a day, not to exceed 12 inhalations in 24
hours (2)
DOSAGE FORMS AND STRENGTHS
Inhalation Aerosol: Each actuation of ATROVENT HFA Inhalation Aerosol
delivers 17 mcg of ipratropium
bromide from mouthpiece (3)
Supplied in a 12.9 g canister containing 200 actuations (3)
CONTRAINDICATIONS
Hypersensitivity to ipratropium bromide or other ATROVENT HFA
components (4)
Hypersensitivity to atropine or any of its derivatives (4)
WARNINGS AND PRECAUTIONS
Not indicated for the initial treatment of acute episodes of
bronchospasm where rescue therapy is
required for rapid response (5.1)
Hypersensitivity reactions including anaphylaxis: Discontinue ATROVENT
HFA at once and consider
alternative treatments (5.2)
Paradoxical bronchospasm: Discontinue ATROVENT HFA and consider other
treatments if paradoxical
bronchospasm occurs (5.3)
Ocular effects: Use with caution in patients with narrow-angle
glaucoma and instruct patients to consult
a physician immediately if signs or symptoms of narrow-angle glaucoma
develop (5.4)
Urinary retention: Use with caution in patients with prostatic
hyperplasia or bladder-neck obstruction
and instruct patients to consult a physician immediately if signs or
symptoms of urinary retention
develop (5.5)
ADVERSE REACTIONS
Most common adverse reactions (>5% incidence in the 12-week
placebo-controlled trials) we