Levalbuterol Inhalation Solution

LEVALBUTEROL INHALATION SOLUTION

Manufacturer: Sun Pharmaceutical Industries, Inc.

Score: 141.0

Quick Summary

Levalbuterol inhalation solution is a beta2-adrenergic agonist used for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease. The recommended dosage is 0.31 mg administered three times a day for children 6 to 11 years old, and 0.63 mg administered three times a day for adults and adolescents 12 years and older. Levalbuterol inhalation solution is contraindicated in patients with a history of hypersensitivity to levalbuterol or racemic albuterol. The most common adverse reactions include palpitations, chest pain, tachycardia, headache, dizziness, tremor, and nervousness.

Key Clinical Findings and Indications

Treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease
Relaxation of the smooth muscles of all airways, from the trachea to the terminal bronchioles
Increased cyclic AMP concentrations associated with the inhibition of release of mediators from mast cells in the airway

Important Safety Information

Warning

Paradoxical bronchospasm, cardiovascular effects, immediate hypersensitivity reactions, and hypokalemia

Contraindications

Hypersensitivity to levalbuterol or racemic albuterol

Adverse Reactions

Palpitations
Chest pain
Tachycardia
Headache
Dizziness
Tremor
Nervousness

Dosing Recommendations

General Guidance

Dose adjustments may be necessary for patients with renal impairment

Reversible obstructive airway disease

Adult Dose

0.63 mg administered three times a day

Pediatric Dose

0.31 mg administered three times a day for children 6 to 11 years old

Special Population Considerations

Pregnancy

There are no adequate and well-controlled studies of levalbuterol inhalation solution in pregnant women
Levalbuterol inhalation solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus

Nursing Mothers

It is not known whether levalbuterol is excreted in human milk
Caution should be exercised when levalbuterol inhalation solution is administered to a nursing woman

Pediatric Use

The safety and efficacy of levalbuterol inhalation solution have been established in pediatric patients 6 years of age and older
Levalbuterol inhalation solution is not indicated for pediatric patients less than 6 years of age

Geriatric Use

Clinical studies of levalbuterol inhalation solution did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently from younger subjects
In general, patients 65 years of age and older should be started at a dose of 0.63 mg of levalbuterol inhalation solution