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  • Albuterol
    (albuterol sulfate)

    THERAPEUTIC CLASS

    Beta<sub>2</sub>-agonist

    DEA CLASS

    RX

    INDICATIONS

    (Sol) Relief of bronchospasm in patients ≥2 yrs of age with reversible obstructive airway disease and acute attacks of bronchospasm. (Syrup) Relief of bronchospasm in patients ≥2 yrs of age with reversible obstructive airway disease. (Tab) Relief of bronchospasm in patients ≥6 yrs of age with reversible obstructive airway disease.

    ADULT DOSAGE

    Adults: Individualize dose. (Sol) Usual: 2.5mg tid-qid by nebulizer. (Syrup/Tab) Initial: 2mg or 4mg tid or qid. Max: 8mg qid. Elderly/Patients Sensitive to β-Adrenergic Stimulators: (Syrup/Tab) Initial: 2mg tid or qid.

    PEDIATRIC DOSAGE

    Pediatrics: Individualize dose. (Syrup) >14 Yrs: Initial: 2mg or 4mg tid or qid. Max: 8mg qid. 6-14 Yrs: Initial: 2mg tid or qid. Max: 24mg/day in divided doses. 2-5 Yrs: Initial: 0.1mg/kg tid; not to exceed 2mg tid. Titrate: May increase to 0.2mg/kg tid. Max: 4mg tid. (Tab) >12 Yrs: Initial: 2mg or 4mg tid or qid. Max: 8mg qid. 6-12 Yrs: Initial: 2mg tid or qid. Max: 24mg/day in divided doses. (Syrup/Tab) Patients Sensitive to β-Adrenergic Stimulators: Initial: 2mg tid or qid. 0.5% (Sol) >12 Yrs: Usual: 2.5mg tid-qid by nebulizer. 2-12 Yrs: Initial: 0.1-0.15mg/kg/dose. Max: 2.5mg tid-qid by nebulizer. Refer to PI for approximate dosing according to body weight. 0.083% (Sol) ≥2 Yrs: Usual: ≥15kg: 2.5mg (1 vial) tid-qid by nebulizer. <15kg: Use 0.5% sol if <2.5mg/dose is required.

    ADMINISTRATION

    Oral and inh route. (Sol) Refer to PI for preparation and administration instructions.

    HOW SUPPLIED

    Sol, Inhalation: 0.083% [3mL], 0.5% [20mL]; Syrup: 2mg/5mL [16 fl. oz.]; Tab: 2mg*, 4mg* *scored

    WARNINGS/PRECAUTIONS

    D/C if paradoxical bronchospasm or cardiovascular (CV) effects occur. Caution with CV disorders (eg, coronary insufficiency, cardiac arrhythmias, HTN), convulsive disorders, hyperthyroidism, diabetes mellitus (DM), and in patients unusually responsive to sympathomimetic amines. Immediate hypersensitivity reactions may occur. Aggravation of preexisting DM and ketoacidosis reported with large doses of IV albuterol. May produce significant hypokalemia. Reevaluate patient and treatment regimen if deterioration of asthma is observed. Consider adding anti-inflammatory agents (eg, corticosteroids) to adequately control asthma. (Sol) Fatalities reported with excessive use and with the home use of nebulizers. (Syrup/Tab) Rarely, erythema multiforme and Stevens-Johnson syndrome have been associated with oral administration in children.

    ADVERSE REACTIONS

    Tremors, nervousness, headache, tachycardia, dizziness, palpitations, bronchospasm. (Sol/Tab) Nausea. (Sol/Syrup) Cough. (Sol) Bronchitis. (Syrup) Shakiness, increased appetite, excitement, hyperkinesia. (Tab) Muscle cramps.

    DRUG INTERACTIONS

    Use extreme caution with MAOIs or TCAs, or within 2 weeks of discontinuation of such agents; action of albuterol may be potentiated. β-blockers and albuterol inhibit the effect of each other. (Sol) Do not use with other sympathomimetic aerosol bronchodilators or epinephrine; if additional adrenergic drugs are to be administered by any route, use with caution. (Syrup/Tab) Not recommended with other oral sympathomimetic agents; consider alternative therapy if regular coadministration with an aerosol bronchodilator of the adrenergic stimulant type is required. (0.5% Sol/Syrup/Tab) β-blockers may block pulmonary effects and produce severe bronchospasm in asthmatic patients; avoid concomitant use, but if needed, consider cardioselective β-blockers and use with caution. May acutely worsen ECG changes and/or hypokalemia caused by non-K+-sparing diuretics (eg, loop or thiazide diuretics); use with caution. May decrease digoxin levels; monitor levels.

    PREGNANCY AND LACTATION

    Category C, not for use in nursing.

    MECHANISM OF ACTION

    β2-agonist; stimulates intracellular adenyl cyclase, the enzyme that catalyzes the conversion of ATP to cAMP. Increased cAMP levels are associated with relaxation of bronchial smooth muscle and inhibition of release of mediators of immediate hypersensitivity from cells, especially from mast cells.

    PHARMACOKINETICS

    Absorption: (Syrup/Tab) Rapid. Cmax=18ng/mL, Tmax=2 hrs. (Sol) Cmax=2.1ng/mL, Tmax=0.5 hr. Elimination: (Syrup/Tab) Urine (76%), feces (4%); T1/2=5 hrs.

    ASSESSMENT

    Assess for history of drug hypersensitivity, CV disorders, convulsive disorders, hyperthyroidism, DM, pregnancy/nursing status, and possible drug interactions. Assess use in patients unusually responsive to sympathomimetic amines.

    MONITORING

    Monitor for paradoxical bronchospasm, CV effects, deterioration of asthma, immediate hypersensitivity reactions, hypokalemia, and other adverse effects.

    PATIENT COUNSELING

    Instruct not to use more frequently than recommended; advise not to increase dose or frequency without consulting physician. Instruct to seek medical attention immediately if treatment becomes less effective for symptomatic relief, symptoms worsen, and/or there is a need to use the product more frequently than usual. Counsel to take other asthma medications and inhaled drugs only ud by the physician. Inform of the common adverse effects. Instruct to inform physician if pregnant/nursing. Advise not to use the inh sol if it changes color or becomes cloudy. (0.5% Sol) Instruct to avoid microbial contamination by using proper aseptic techniques each time the bottle is opened.

    STORAGE

    (Sol) 2-25°C (36-77°F). (0.083% Sol) Protect from light. Store in pouch until time of use. (Syrup/Tab) 20-25°C (68-77°F).