LEVALBUTEROL TARTRATE HFA INHALATION- levalbuterol tartrate aerosol, metered

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

LEVALBUTEROL TARTRATE (UNII: ADS4I3E22M) (LEVALBUTEROL - UNII:EDN2NBH5SS)

Dostupno od:

Preferred Pharmaceuticals Inc.

INN (International ime):

LEVALBUTEROL TARTRATE

Sastav:

LEVALBUTEROL 45 ug

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

Levalbuterol tartrate HFA inhalation aerosol is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 4 years of age and older with reversible obstructive airway disease. Levalbuterol tartrate HFA inhalation aerosol is contraindicated in patients with a history of hypersensitivity to levalbuterol, racemic albuterol, or any other component of Levalbuterol tartrate HFA inhalation aerosol. Reactions have included urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema. Teratogenic Effects: Pregnancy Category C There are no adequate and well-controlled studies of Levalbuterol tartrate HFA inhalation aerosol in pregnant women. Because animal reproduction studies are not always predictive of human response, Levalbuterol tartrate HFA inhalation aerosol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Rare instances of congenital anomalies, including cleft palate and limb defects, were reported in

Proizvod sažetak:

Levalbuterol tartrate HFA inhalation aerosol is supplied as a pressurized aluminum canister in a box:  Each canister is supplied with a blue plastic actuator mouthpiece, a red mouthpiece cap, and patient’s instructions. Shake well before using . Store between 20° and 25°C (68° and 77°F; see USP controlled room temperature). Protect from freezing temperatures and direct sunlight. Store inhaler with the actuator mouthpiece down. Contents under pressure Do not puncture or incinerate. Exposure to temperatures above 120°F may cause bursting. Keep out of reach of children. The blue actuator supplied with Levalbuterol tartrate HFA inhalation aerosol should not be used with any other product canisters. Actuators from other products should not be used with a Levalbuterol tartrate HFA inhalation aerosol canister. The correct amount of medication in each actuation cannot be assured after 200 actuations from the 15 g canister, even though the canister is not completely empty. The canister should be discarded when 200 actuations have been used from the 15 g canister.

Status autorizacije:

New Drug Application Authorized Generic

Svojstava lijeka

LEVALBUTEROL TARTRATE HFA INHALATION- LEVALBUTEROL TARTRATE AEROSOL,
METERED
PREFERRED PHARMACEUTICALS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEVALBUTEROL TARTRATE HFA INHALATION
AEROSOL SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
LEVALBUTEROL TARTRATE HFA INHALATION
AE RO SO L.
LEVALBUTEROL TARTRATE HFA INHALATION AEROSOL, FOR ORAL INHALATION USE
INITIAL U.S. APPROVAL: 1999
INDICATIONS AND USAGE
Levalbuterol tartrate HFA inhalation aerosol is a beta -adrenergic
agonist indicated for the treatment or prevention of
bronchospasm in patients 4 years of age and older with reversible
obstructive airway disease. (1.1)
DOSAGE AND ADMINISTRATION
For Oral Inhalation Only (2.2)
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DOSAGE FORMS AND STRENGTHS
Inhalation Aerosol: Each actuation delivers 59 mcg of levalbuterol
tartrate (equivalent to 45 mcg of levalbuterol free base)
from the actuator mouthpiece.
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CONTRAINDICATIONS
Hypersensitivity to levalbuterol, racemic albuterol or any other
component of Levalbuterol tartrate HFA inhalation aerosol.
(4)
WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most common adverse reactions (≥ 2% and > placebo) are accidental
injury, bronchitis, dizziness, pain, pharyngitis, rhinitis,
and vomiting. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CALL 1-877-737-7226 OR CONTACT
FDA AT 1-800-FDA-1088 OR
WWW.FDA.G O V/MEDWATCH.
DRUG INTERACTIONS
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2
Adults and children 4 years of age and older: 2 inhalations repeated
every 4 to 6 hours; in some patients, 1 inhalation
every 4 hours may be sufficient. (2.1)
Prime Levalbuterol tartrate HFA inhalation aerosol before using for
the first time and when the inhaler has not been
used for more than 3 days. To prime Levalbuterol tartrate HFA
inhalation aerosol, release 4 sprays into the air away
from the face. (2.2)
At least once a week, wash the actuator with warm water and let it
air-dry completely. (2.2)
15 g pressurized canister containing 200 actuations (3