LEVALBUTEROL- levalbuterol solution

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Mylan Pharmaceuticals Inc.

INN (Tên quốc tế):

LEVALBUTEROL HYDROCHLORIDE

Thành phần:

LEVALBUTEROL 1.25 mg in 3 mL

Tuyến hành chính:

RESPIRATORY (INHALATION)

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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)] . 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 albuterol which contains the levalbuterol isomer

Tóm tắt sản phẩm:

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 is available in a shelf-carton containing two foil pouches, each containing 12 unit-dose LDPE vials. Levalbuterol Inhalation Solution USP, 0.31 mg (foil pouch label color green ) contains 0.31 mg/3 mL (0.0103%) of levalbuterol (as 0.36 mg/3 mL of levalbuterol hydrochloride) and is available in cartons of 24 unit-dose LDPE vials (NDC 0378-9680-44). Levalbuterol Inhalation Solution USP, 0.63 mg (foil pouch label color yellow ) contains 0.63 mg/3 mL (0.021%) of levalbuterol (as 0.73 mg/3 mL of levalbuterol hydrochloride) and is available in cartons of 24 unit-dose LDPE vials (NDC 0378-9681-44). Levalbuterol Inhalation Solution USP, 1.25 mg (foil pouch label color red ) contains 1.25 mg/3 mL (0.042%) of levalbuterol (as 1.44 mg/3 mL of levalbuterol hydrochloride) and is available in cartons of 24 unit-dose LDPE vials (NDC 0378-9682-44). Store levalbuterol inhalation solution 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 one week. Discard any vial if the solution is not colorless.

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

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
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 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 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)
_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 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