LEVALBUTEROL- levalbuterol hydrochloride solution

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

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

থেকে পাওয়া:

Burel Pharmaceuticals, LLC

প্রশাসন রুট:

RESPIRATORY (INHALATION)

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

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, USP 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, USP in pregnant women. There are clinical considerations with the use of Levalbuterol Inhalation Solution, USP 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 on a mg/m2 basis

পণ্য সারাংশ:

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 one foil pouch of 25 unit-dose LDPE vials. Levalbuterol Inhalation Solution, USP, 0.31 mg/3 mL (foil pouch label color green ) contains 0.31 mg/3 mL (0.0103%) of levalbuterol (as 0.36 mg/3 mL of levalbuterol HCl) and is available in cartons as listed below. NDC 35573-443-25   25 vials per carton / 25 vials per foil pouch Levalbuterol Inhalation Solution, USP, 0.63 mg/3 mL (foil pouch label color yellow ) contains 0.63 mg/3 mL (0.021%) of levalbuterol (as 0.73 mg/3 mL of levalbuterol HCl) and is available in cartons as listed below. NDC 35573-444-25   25 vials per carton / 25 vials per foil pouch Levalbuterol Inhalation Solution, USP, 1.25 mg/3 mL (foil pouch label color red ) contains 1.25 mg/3 mL (0.042%) of levalbuterol (as 1.44 mg/3 mL of levalbuterol HCl) and is available in cartons as listed below. NDC 35573-445-25   25 vials per carton / 25 vials per foil pouch Store Levalbuterol Inhalation Solution, USP in the protective foil pouch at 20°- 25°C (68°- 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. Rx only

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

LEVALBUTEROL- LEVALBUTEROL HYDROCHLORIDE SOLUTION
BUREL PHARMACEUTICALS, LLC
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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, FOR ORAL INHALATION USE
INITIAL U.S. APPROVAL: 1999
RX ONLY
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,
USP immediately and treat with alternative therapy. (5.1)
Need for more doses of Levalbuterol Inhalation Solution, USP than
usual may be a sign of
deterioration of asthma and requires reevaluation of treatment. (5.2)
Levalbuterol Inhalation Solution, USP is not a substitute for
corticosteroids. (5.3)
Cardiovascular effects may occur. Consider discontinuation of
Levalbuterol Inhalation Solution, USP if
these effects occur. Use with caution in patients with underlying
cardiovascular disorders. (5.4)
Excessive use may be fatal. Do not exce