LEVALBUTEROL HYDROCHLORIDE solution

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Cardinal Health

INN (International Adı):

LEVALBUTEROL HYDROCHLORIDE

Kompozisyon:

LEVALBUTEROL 1.25 mg in 0.5 mL

Reçete türü:

PRESCRIPTION DRUG

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

LEVALBUTEROL HYDROCHLORIDE- LEVALBUTEROL HYDROCHLORIDE SOLUTION
CARDINAL HEALTH
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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, USP (CONCENTRATE) FOR INHALATION USE
INITIAL U.S. APPROVAL: 1999
INDICATIONS AND USAGE
Levalbuterol inhalation solution, USP (concentrate) is a beta
-adrenergic agonist indicated for:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Inhalation Solution Concentrate (unit-dose vial for nebulization):
1.25 mg/0.5 mL. Dilute before use. (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Most common adverse reactions are: palpitations, chest pain,
tachycardia, headache, dizziness, tremor and nervousness.
(6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MYLAN PHARMACEUTICALS
INC. AT 1-877-446-3679 (1-877-
4-INFO-RX) OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
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2
Treatment or prevention of bronchospasm in adults, adolescents, and
children 6 years of age and older with
reversible obstructive airway disease. (1)
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 3 times a day, by
nebulization. Routine dosing should not exceed
0.63 mg 3 times a day. (2)
_Adults and Adolescents _≥ _12 Years Old: _0.63 mg administered 3
times a day, every 6 to 8 hours, by nebulization. The
maximum recommended dose is 1.25 mg 3 times a day. (2)
For use with a standard jet nebulizer (with a face mask or mouthpiece)
connected to an air compressor. (2)
Hypersensitivity to levalbuterol or racemic albuterol. (4)
Life-threatening paradoxical bronchospasm may occur. Discontinue
levalbuterol inhalation solution