LEVALBUTEROL solution

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Proficient Rx LP

INN (الاسم الدولي):

LEVALBUTEROL HYDROCHLORIDE

تركيب:

LEVALBUTEROL 0.63 mg in 3 mL

طريقة التعاطي:

RESPIRATORY (INHALATION)

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Levalbuterol inhalation solution 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 racemic albutero

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 strengths of levalbuterol 0.63 mg. Each strength of levalbuterol inhalation solution USP is available in a shelf-carton containing 6 foil pouches, each containing 4 unit-dose LDPE vials. Levalbuterol inhalation solution USP, 0.63 mg (foil pouch label color orange) contains 0.63 mg (0.021%) of levalbuterol (as 0.73 mg of levalbuterol HCl) and is available in cartons of 24 unit-dose LDPE vials. Each carton contains 6 foil pouches, each containing 4 unit-dose LDPE vials (NDC 63187-953-24). 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- LEVALBUTEROL SOLUTION
PROFICIENT RX LP
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
LEVALBUTEROL INHALATION SOLUTION
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
LEVALBUTEROL INHALATION SOLUTION.
LEVALBUTEROL INHALATION SOLUTION, FOR INHALATION USE
INITIAL U.S. APPROVAL: 1999
INDICATIONS AND USAGE
Levalbuterol inhalation solution USP is a beta -adrenergic agonist
indicated for:
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DOSAGE AND ADMINISTRATION
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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
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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 TEVA USA,
PHARMACOVIGILANCE AT 1-866-832-8537
OR [e-mail]; 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)
_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)
Hypersensitivity to levalbuterol or racemic albuterol. (4)
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 reevalu