VENTOLIN HFA- albuterol sulfate aerosol, metered

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E)

থেকে পাওয়া:

H.J. Harkins Company, Inc.

INN (আন্তর্জাতিক নাম):

ALBUTEROL SULFATE

রচনা:

ALBUTEROL SULFATE 108 ug

প্রশাসন রুট:

RESPIRATORY (INHALATION)

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

VENTOLIN HFA is indicated for the treatment or prevention of bronchospasm in patients 4 years of age and older with reversible obstructive airway disease. VENTOLIN HFA is indicated for the prevention of exercise-induced bronchospasm in patients 4 years of age and older. VENTOLIN HFA is contraindicated in patients with a history of hypersensitivity to albuterol or any other components of VENTOLIN HFA. Rare cases of hypersensitivity reactions, including urticaria, angioedema, and rash have been reported after the use of albuterol sulfate. Teratogenic Effects: Pregnancy Category C. There are no adequate and well-controlled studies of VENTOLIN HFA or albuterol sulfate in pregnant women. During worldwide marketing experience, various congenital anomalies, including cleft palate and limb defects, have been reported in the offspring of patients being treated with albuterol. Some of the mothers were taking multiple medications during their pregnancies. No consistent pattern of defects can be discerned, and a relatio

পণ্য সারাংশ:

VENTOLIN HFA (albuterol sulfate) Inhalation Aerosol is supplied in the following packs as a pressurized aluminum canister fitted with a counter with a blue plastic actuator and a blue strapcap packaged within a moisture-protective foil pouch that also contains a desiccant: NDC 0173-0682-20 18-g canister containing 200 actuations NDC 0173-0682-21 8-g canister containing 60 actuations NDC 0173-0682-24 8-g institutional pack canister containing 60 actuations Before using, VENTOLIN HFA should be removed from the moisture-protective foil pouch. The pouch and dessicant should be discarded. VENTOLIN HFA should be discarded 12 months after removal from the pouch. Priming VENTOLIN HFA is essential to ensure appropriate albuterol content in each actuation. To prime the inhaler, release 4 sprays into the air away from the face, shaking well before each spray. The inhaler should be primed before using it for the first time, when the inhaler has not been used for more than 2 weeks, or when it has been dropped. After priming, each actuation delivers 120 mcg of albuterol sulfate, USP in 75 mg of suspension from the valve and 108 mcg of albuterol sulfate, USP from the mouthpiece (equivalent to 90 mcg of albuterol base from the mouthpiece). To ensure proper dosing and to prevent actuator orifice blockage, wash the actuator with warm water and let it air-dry completely at least once a week [see FDA-Approved Patient Labeling (17.8)]. The blue actuator supplied with VENTOLIN HFA should not be used with any other product canisters, and actuators from other products should not be used with a VENTOLIN HFA canister. VENTOLIN HFA has a counter attached to the canister. The counter starts at 204 or 64 and counts down each time a spray is released. The correct amount of medication in each inhalation cannot be assured after the counter reads 000, even though the canister is not completely empty and will continue to operate. VENTOLIN HFA should be discarded when the counter reads 000 or 12 months after removal from the moisture-protective foil pouch, whichever comes first. Never immerse the canister in water to determine the amount of drug remaining in the canister. Keep out of reach of children. Avoid spraying in eyes. 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 container into fire or incinerator. Store between 15° and 25°C (59° and 77°F). Store the inhaler with the mouthpiece down. For best results, the inhaler should be at room temperature before use. SHAKE WELL BEFORE EACH SPRAY. VENTOLIN HFA does not contain chlorofluorocarbons (CFCs) as the propellant.

অনুমোদন অবস্থা:

New Drug Application

পণ্য বৈশিষ্ট্য

VENTOLIN HFA- ALBUTEROL SULFATE AEROSOL, METERED
H.J. HARKINS COMPANY, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VENTOLIN HFA INHALATION AEROSOL SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VENTOLIN HFA
INHALATION AEROSOL.
VENTOLIN HFA (ALBUTEROL SULFATE) INHALATION AEROSOL
INITIAL U.S. APPROVAL: 1981
INDICATIONS AND USAGE
VENTOLIN HFA is a beta -adrenergic agonist indicated for: (1)
Treatment or prevention of bronchospasm in patients 4 years of age and
older with reversible obstructive airway
disease. (1.1)
Prevention of exercise-induced bronchospasm in patients 4 years of age
and older. (1.2)
DOSAGE AND ADMINISTRATION
FOR ORAL INHALATION ONLY. (2)
Treatment or prevention of bronchospasm in adults and children 4 years
of age and older: 2 inhalations every 4 to 6
hours. For some patients, 1 inhalation every 4 hours may be
sufficient. (2.1)
Prevention of exercise-induced bronchospasm in adults and children 4
years of age and older: 2 inhalations 15 to 30
minutes before exercise. (2.2)
Priming information: Prime VENTOLIN HFA before using for the first
time, when the inhaler has not been used for
more than 2 weeks, or when the inhaler has been dropped. To prime
VENTOLIN HFA, release 4 sprays into the air
away from the face, shaking well before each spray. (2.3)
Cleaning information: At least once a week, wash the actuator with
warm water and let it air-dry completely. (2.3)
DOSAGE FORMS AND STRENGTHS
Inhalation aerosol: 108 mcg albuterol sulfate (90 mcg albuterol base)
from mouthpiece per actuation. Supplied in 18-g
canister containing 200 actuations and 8-g canister containing 60
actuations. (3) (3)
CONTRAINDICATIONS
Hypersensitivity to albuterol sulfate or any of the ingredients of
VENTOLIN HFA. (4) (4)
WARNINGS AND PRECAUTIONS
Paradoxical bronchospasm may occur and should be treated immediately
with alternative therapy. (5.1)
Need for more doses of VENTOLIN HFA than usual may be a sign of
deterioration of asthma and requ