LEVALBUTEROL TARTRATE HFA INHALATION- levalbuterol tartrate aerosol, metered

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Proficient Rx LP

INN (Algemene Internationale Benaming):

LEVALBUTEROL TARTRATE

Samenstelling:

LEVALBUTEROL 45 ug

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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

Product samenvatting:

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.

Autorisatie-status:

New Drug Application Authorized Generic

Productkenmerken

LEVALBUTEROL TARTRATE HFA INHALATION- LEVALBUTEROL TARTRATE AEROSOL,
METERED
PROFICIENT RX LP
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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 AEROSOL.
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.GOV/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)
Life-threatening paradox