LEVALBUTEROL TARTRATE HFA INHALATION- levalbuterol tartrate aerosol, metered

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Actavis Pharma, Inc.

INN (International Name):

LEVALBUTEROL TARTRATE

Sammensetning:

LEVALBUTEROL 45 ug

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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. Risk Summary There are no adequate and well-controlled studies of Levalbuterol tartrate HFA inhalation aerosol in pregnant women.  There are clinical considerations with the use of Levalbuterol tartrate HFA inhalation aerosol in pregnant women [see Clinical Considerations] . Following oral administration of levalbuterol HCl to pregnant rabbits, there was no evidence of teratogenicity at doses up to 25 mg/kg/day [approximately 750 times the maximum recommended human daily inhalation d

Produkt oppsummering:

Levalbuterol tartrate HFA inhalation aerosol is supplied as a pressurized aluminum canister in a box:  Each canister is fitted with a dose indicator and 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.  Do not store near heat or open flame. Exposure to temperatures above 120°F may cause bursting.  Never throw container into fire or incinerator. 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, even though the canister is not completely empty.  When the dose indicator display window shows a red zone, approximately 20 inhalations are left, and a refill is required.  The canister should be discarded when the dose indicator display window shows zero, indicating that 200 actuations have been used.

Autorisasjon status:

New Drug Application Authorized Generic

Preparatomtale

LEVALBUTEROL TARTRATE HFA INHALATION- LEVALBUTEROL TARTRATE AEROSOL,
METERED
ACTAVIS PHARMA, INC.
----------
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
RECENT MAJOR CHANGES
Dosage and Administration, Administration Information. (2.2)
02/2017
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)
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)
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.
15 g pressurized canister containing 200 actuations (3)
CONTRAINDICATIONS
Hypersensitivity to levalbuterol, racemic albuterol or any other
component of Levalbuterol tartrate HFA
inhalation aerosol. (4)
WARNINGS AND PRECAUTIONS
Life-threatening paradoxical bronchospasm may occur. Discontinue
Levalbuterol tartrate HFA inhalation
aerosol immediately and treat with alternative therapy. (5.1)
Need for more doses of Levalbuterol tartrate HFA inhalation aerosol
than usual may be a sign of
deterioration of ast