Land: USA
Språk: engelsk
Kilde: NLM (National Library of Medicine)
LEVALBUTEROL HYDROCHLORIDE (UNII: WDQ1526QJM) (LEVALBUTEROL - UNII:EDN2NBH5SS)
Proficient Rx LP
LEVALBUTEROL HYDROCHLORIDE
LEVALBUTEROL 0.63 mg in 3 mL
RESPIRATORY (INHALATION)
PRESCRIPTION DRUG
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
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.
Abbreviated New Drug Application
LEVALBUTEROL- LEVALBUTEROL SOLUTION PROFICIENT RX LP ---------- 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: • DOSAGE AND ADMINISTRATION • • • • 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 • WARNINGS AND PRECAUTIONS • • • • • • • 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 DRUG.SAFETY@TEVAPHARM.COM; OR FDA AT 1-800-FDA-1088 OR www.fda.gov/medwatch. DRUG INTERACTIONS • • • • • 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 Les hele dokumentet