LEVALBUTEROL solution, concentrate

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

LEVALBUTEROL HYDROCHLORIDE (UNII: WDQ1526QJM) (LEVALBUTEROL - UNII:EDN2NBH5SS)

थमां उपलब्ध:

Teva Pharmaceuticals USA, Inc.

INN (इंटरनेशनल नाम):

LEVALBUTEROL HYDROCHLORIDE

रचना:

LEVALBUTEROL 1.25 mg in 0.5 mL

प्रशासन का मार्ग:

RESPIRATORY (INHALATION)

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Levalbuterol inhalation solution (concentrate) is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease. Levalbuterol inhalation solution is contraindicated in patients with a history of hypersensitivity to levalbuterol or racemic albuterol. Reactions have included urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema [see Warnings and Precautions (5.6) ]. Risk Summary There are no adequate and well-controlled studies of levalbuterol inhalation solution concentrate in pregnant women. There are clinical considerations with the use of levalbuterol inhalation solution concentrate 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 108 times the maximum recommended human daily inhalation dose (MRHDID) of levalbuterol HCl for adults

उत्पाद समीक्षा:

Levalbuterol Inhalation Solution USP (Concentrate) (foil pouch label color red) is supplied in 0.5 mL unit-dose, low-density polyethylene (LDPE) vials, and is a clear, colorless, sterile, preservative-free, aqueous solution. Each vial contains 1.25 mg/0.5 mL (0.25%) of levalbuterol (as 1.44 mg of levalbuterol hydrochloride, USP) and is available in cartons of 30 (NDC 0093-4147-56) individually pouched vials. Store Levalbuterol Inhalation Solution USP (Concentrate) in the protective foil pouch at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light and excessive heat. Open the foil pouch just prior to administration. Once the foil pouch is opened, the contents of the vial should be used immediately. Discard any vial if the solution is not colorless. Dilute Levalbuterol Inhalation Solution USP (Concentrate) with sterile normal saline before administration by nebulization. To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals USA, Inc. at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For more information, call Teva Pharmaceuticals USA, Inc. at 1-888-838-2872. All brand names listed are the registered trademarks of their respective owners and are not trademarks of Teva Pharmaceuticals USA.

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

LEVALBUTEROL- LEVALBUTEROL SOLUTION, CONCENTRATE
TEVA PHARMACEUTICALS USA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEVALBUTEROL
INHALATION SOLUTION (CONCENTRATE) SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING
INFORMATION FOR LEVALBUTEROL INHALATION SOLUTION (CONCENTRATE).
LEVALBUTEROL INHALATION SOLUTION (CONCENTRATE), FOR INHALATION USE
INITIAL U.S. APPROVAL: 1999
INDICATIONS AND USAGE
Levalbuterol inhalation solution (concentrate) is a beta -adrenergic
agonist indicated for:
Treatment or prevention of bronchospasm in adults, adolescents, and
children 6 years of age and older
with reversible obstructive airway disease. (1)
DOSAGE AND ADMINISTRATION
FOR ORAL INHALATION ONLY (2)
Dilute levalbuterol inhalation solution (concentrate) with sterile
normal saline before administration by
nebulization.
_Children 6 to 11 years old: _0.31 mg administered three times a day,
by nebulization. Routine dosing
should not exceed 0.63 mg three times a day. (2)
_Adults and Adolescents _≥ _12 years old: _0.63 mg administered
three times a day, every 6 to 8 hours, by
nebulization. The maximum recommended dose is 1.25 mg three times a
day. (2)
For use with a standard jet nebulizer (with a face mask or mouthpiece)
connected to an air compressor.
(2)
DOSAGE FORMS AND STRENGTHS
Inhalation Solution Concentrate (unit-dose vial for nebulization):
1.25 mg/0.5 mL Dilute before use. (3)
CONTRAINDICATIONS
Hypersensitivity to levalbuterol or racemic albuterol. (4)
WARNINGS AND PRECAUTIONS
Life-threatening paradoxical bronchospasm may occur. Discontinue
levalbuterol inhalation solution
immediately and treat with alternative therapy. (5.1)
Need for more doses of levalbuterol inhalation solution than usual may
be a sign of deterioration of
asthma and requires reevaluation of treatment. (5.2)
Levalbuterol inhalation solution is not a substitute for
corticosteroids. (5.3)
Cardiovascular effects may occur. Consider discontinuation of
levalbuterol inhalation solution if th