LEVALBUTEROL- levalbuterol hydrochloride solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Amneal Pharmaceuticals of New York LLC

INN (International Name):

LEVALBUTEROL HYDROCHLORIDE

Composition:

LEVALBUTEROL 0.31 mg in 3 mL

Administration route:

RESPIRATORY (INHALATION)

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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) ]. Teratogenic Effects: Pregnancy Category C. There are no adequate and well-controlled studies of Levalbuterol Inhalation Solution, USP in pregnant women. Because animal reproduction studies are not always predictive of human response, Levalbuterol Inhalation Solution, USP 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

Product summary:

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). 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 0115-9930-78 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 0115-9931-78 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 0115-9932-78 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

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

LEVALBUTEROL- LEVALBUTEROL HYDROCHLORIDE SOLUTION
AMNEAL PHARMACEUTICALS OF NEW YORK LLC
----------
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 INHALATION USE
INITIAL U.S. APPROVAL: 1999
RX ONLY
INDICATIONS AND USAGE
Levalbuterol Inhalation Solution, USP is a beta -adrenergic agonist
indicated for:
Treatment or prevention of bronchospasm in adults, adolescents, and
children 6 years of age and older with reversible
obstructive airway disease. (1)
DOSAGE AND ADMINISTRATION
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)
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
Hypersensitivity to levalbuterol or racemic albuterol. (4)
WARNINGS AND PRECAUTIONS
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 reevaluation of treatment. (5.2)
Levalbuterol Inhalation Solution, USP is not a substitute for
corticosteroids. (5.3)
Cardiovascular effects may occur. Consider discontinuation of
Levalbuterol Inhalation Solution, USP if these effects
occur. Use with caution in patients with underlying cardiovascular
disorders. (5.4)
Excessive use may be fatal.