LEVALBUTEROL INHALATION- levalbuterol inhalation 0.31mg/3ml solution LEVALBUTEROL INHALATION- levalbuterol inhalation 0.63mg/3m

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

Levalbuterol (UNII: EDN2NBH5SS) (Levalbuterol - UNII:EDN2NBH5SS)

متاح من:

Dr. Reddy’s Laboratories, Inc.

INN (الاسم الدولي):

Levalbuterol

تركيب:

Levalbuterol 0.31 mg in 3 mL

طريقة التعاطي:

RESPIRATORY (INHALATION)

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Levalbuterol Inhalation Solution, USP 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) ].   Teratogenic Effects: Pregnancy Category C . There are no adequate and well-controlled studies of Levalbuterol Inhalation Solution in pregnant women. Because animal reproduction studies are not always predictive of human response, Levalbuterol Inhalation Solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. During worldwide marketing experience, various congenital anomalies, including cleft palate and limb defects, have been reported in newborns of women treated with racemi

ملخص المنتج:

Levalbuterol Inhalation Solution, USP is supplied in 3 mL unit-dose, low-density polyethylene (LDPE) vials as a clear, colorless, sterile, preservative-free, aqueous solution, in three different strengths of levalbuterol (0.31 mg,0.63 mg, 1.25 mg). Each strength of Levalbuterol Inhalation Solution, USP is available in a shelf-carton containing 5 foil pouches, each containing 5 unit-dose LDPE vials. Levalbuterol Inhalation Solution, USP, 0.31 mg (strength in foil pouch label color green) contains 0.31 mg (0.0103%) of levalbuterol (as 0.36 mg of levalbuterol HCl) and is available in the following configuration: NDC 43598-412-25 : 5 foil pouches, each containing 5 unit-dose LDPE vials, total 25 vials per carton. Levalbuterol Inhalation Solution, USP, 0.63 mg (strength in foil pouch label color yellow) contains 0.63 mg (0.021%) of levalbuterol (as 0.73 mg of levalbuterol HCl) and is available in following package configuration: NDC 43598-410-25 : 5 foil pouches, each containing 5 unit-dose LDPE vials, total 25 vials per carton. Levalbuterol Inhalation Solution, USP, 1.25 mg (strength in foil pouch label color red) contains 1.25 mg (0.042%) of levalbuterol (as 1.44 mg of levalbuterol HCl) and is available in the following package configuration: NDC 43598-409-25 : 5 foil pouches, each containing 5 unit-dose LDPE vials, total 25 vials per carton. Store Levalbuterol Inhalation Solution, USP 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. Keep unopened vials in the foil pouch. Once the foil pouch is opened, the vials should be used within 2 weeks. Vials removed from the pouch, if not used immediately, should be protected from light and used within 1 week. Discard any vial if the solution is not colorless.

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

LEVALBUTEROL INHALATION- LEVALBUTEROL INHALATION 0.31MG/3ML SOLUTION
DR. REDDY’S LABORATORIES, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEVALBUTEROL INHALATION SOLUTION,
USP SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
LEVALBUTEROL INHALATION SOLUTION,
USP.
LEVALBUTEROL INHALATION SOLUTION, USP
FOR ORAL INHALATION ONLY
INITIAL U.S. APPROVAL: 1999
INDICATIONS AND USAGE
Levalbuterol Inhalation Solution, USP 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)
_Children 6-11 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 (unit-dose vial for nebulization): 0.31 mg/3 mL,
0.63 mg/3 mL and 1.25 mg/3 mL. (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 these effects occur.
Use with caution in patients with underlying cardiovascular disorders.
(5.4)
Excessive use may be fatal. Do not excee