XOPENEX HFA- levalbuterol tartrate aerosol, metered

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

levalbuterol tartrate (UNII: ADS4I3E22M) (levalbuterol - UNII:EDN2NBH5SS)

Disponible des:

Physicians Total Care, Inc.

Designació comuna internacional (DCI):

levalbuterol tartrate

Composición:

levalbuterol 45 ug

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

XOPENEX HFA (levalbuterol tartrate) 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. XOPENEX HFA (levalbuterol tartrate) Inhalation Aerosol is contraindicated in patients with a history of hypersensitivity to levalbuterol, racemic albuterol, or any other component of XOPENEX HFA Inhalation Aerosol. XOPENEX HFA ® (levalbuterol tartrate) Inhalation Aerosol Before using your XOPENEX HFA (levalbuterol tartrate) Inhalation Aerosol, read the complete instructions carefully. ABOUT XOPENEX HFA INHALATION AEROSOL Use only as directed by a doctor. Children should use XOPENEX HFA Inhalation Aerosol under adult supervision, as instructed by the patient's doctor. XOPENEX HFA Inhalation Aerosol is a pressurized metered-dose inhaler that produces an aerosol for oral inhalation. XOPENEX HFA Inhalation Aerosol does not contain chlorofluorocarbons (CFCs). The blue actuator (or mouthpiece)

Resumen del producto:

XOPENEX HFA (levalbuterol tartrate) Inhalation Aerosol is supplied as a pressurized aluminum canister in a box (NDC 54868-5689-0 ). The canister is labeled with a net weight of 15 g and contains 200 metered actuations (or inhalations), respectively. Each canister is supplied with a blue plastic actuator (or 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 (or mouthpiece) down. Avoid spraying in eyes. 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 XOPENEX HFA Inhalation Aerosol should not be used with any other product canisters. Actuators from other products should not be used with a XOPENEX HFA Inhalation Aerosol canister. The correct amount of medication in each actuation cannot be assured after 200 actuations from the 15 g canister or 80 actuations from the 8.4 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 or 80 actuations have been used from the 8.4 g canister. XOPENEX HFA Inhalation Aerosol does not contain chlorofluorocarbons (CFCs) as the propellant. Rx only. Manufactured for: Sepracor Inc. Marlborough, MA 01752 USA by 3M Drug Delivery Systems Northridge, CA 91324-3213 For customer service, call 1-888-394-7377. To report adverse events, call 1-877-737-7226. For medical information, call 1-800-739-0565. June 2009 900874R05 Additional barcode labeling by: Physicians Total Care, Inc. Tulsa, Oklahoma       74146 PHARMACIST — DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT. -----------------------------------------------------------------------------------------------------------

Estat d'Autorització:

New Drug Application

Fitxa tècnica

XOPENEX HFA - LEVALBUTEROL TARTRATE AEROSOL, METERED
PHYSICIANS TOTAL CARE, INC.
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XOPENEX HFA (LEVALBUTEROL TARTRATE) INHALATION AEROSOL
FOR ORAL INHALATION ONLY
PRESCRIBING INFORMATION
DESCRIPTION
The active component of XOPENEX HFA (levalbuterol tartrate) Inhalation
Aerosol is levalbuterol
tartrate, the (R)-enantiomer of albuterol. Levalbuterol tartrate is a
relatively selective beta -adrenergic
receptor agonist (see CLINICAL PHARMACOLOGY). Levalbuterol tartrate
has the chemical name
(R)-α
-[[(1,1-dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol
L-tartrate (2:1 salt), and it
has the following chemical structure:
The molecular weight of levalbuterol tartrate is 628.71, and its
empirical formula is (C
H NO ) ·
C H O . It is a white to light-yellow solid, freely soluble in water
and very slightly soluble in ethanol.
Levalbuterol tartrate is the generic name for (R)-albuterol tartrate
in the United States. XOPENEX HFA
Inhalation Aerosol is a pressurized metered-dose aerosol inhaler
(MDI), which produces an aerosol for
oral inhalation. It contains a suspension of micronized levalbuterol
tartrate, propellant HFA-134a
(1,1,1,2-tetrafluoroethane), Dehydrated Alcohol USP, and Oleic Acid
NF.
The inhaler should be primed by releasing 4 sprays into the air, away
from the face, before using it for
the first time and when the inhaler has not been used for more than 3
days. After priming with 4
actuations, each actuation delivers 59 mcg of levalbuterol tartrate
(equivalent to 45 mcg of levalbuterol
free base) from the actuator (or mouthpiece). Each 15 g canister
provides 200 actuations (or inhalations)
and each 8.4 g canister provides 80 actuations (or inhalations).
This product does not contain chlorofluorocarbons (CFCs).
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION: Activation of beta -adrenergic receptors on
airway smooth muscle leads to the
activation of adenylate cyclase and to an increase in the
intracellular concentration of cyclic-3', 5'-
adenosine monophosphate (cyclic AMP). The increase in cyclic