País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
LEVALBUTEROL TARTRATE (UNII: ADS4I3E22M) (LEVALBUTEROL - UNII:EDN2NBH5SS)
Preferred Pharmaceuticals Inc.
LEVALBUTEROL TARTRATE
LEVALBUTEROL 45 ug
ORAL
PRESCRIPTION DRUG
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
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.
New Drug Application Authorized Generic
LEVALBUTEROL TARTRATE HFA INHALATION- LEVALBUTEROL TARTRATE AEROSOL, METERED PREFERRED PHARMACEUTICALS 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 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) • • • 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. • CONTRAINDICATIONS Hypersensitivity to levalbuterol, racemic albuterol or any other component of Levalbuterol tartrate HFA inhalation aerosol. (4) WARNINGS AND PRECAUTIONS • • • • • • • 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 • • • 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 Leia o documento completo