LEVALBUTEROL solution

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Mylan Pharmaceuticals Inc.

Indgivelsesvej:

RESPIRATORY (INHALATION)

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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) ]. 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]; however,

Produkt oversigt:

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, each pouch containing 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 0378-9690-52 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 0378-9691-52 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 0378-9692-52 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

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

LEVALBUTEROL- LEVALBUTEROL SOLUTION
MYLAN PHARMACEUTICALS INC.
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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, USP, 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:
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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 MYLAN 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)
_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)
Hypersensitivity to levalbuterol or racemic albuterol. (4)
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 ree