levalbuterol (Rx)

Brand and Other Names:Xopenex, Xopenex HFA
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

nebulizer solution

  • 0.31mg/3mL
  • 0.63mg/3mL
  • 1.25mg/3mL
  • 1.25mg/0.5mL

aerosol

  • 45mcg/actuation

Bronchospasm

Nebulizer solution: 0.63-1.25 mg 3 times daily q6-8hr

Aerosol: 90 mcg (2 actuations of metered-dose inhaler) q4-6hr

Asthma Exacerbation

Nebulizer solution: 1.25-2.5 mg q20min for 3 doses, then 1.25-5 mg q1-4hr PRN

Aerosol: 180-360 mcg (4-8 actuations of metered-dose inhaler) q20min for ≤4 hr, then q1-4hr PRN

Dosage Forms & Strengths

nebulizer solution

  • 0.31mg/3mL
  • 0.63mg/3mL
  • 1.25mg/3mL
  • 1.25mg/0.5mL

aerosol

  • 45mcg/actuation

Bronchospasm

Nebulizer solution

  • <5 years: 0.31-1.25 mg q4-6hr PRN
  • 5-12 years: 0.31 mg q8hr; not to exceed 0.63 mg q8hr PRN
  • >12 years: 0.63-1.25 mg q8hr PRN

Aerosol

  • <4 years: Safety and efficacy not established
  • ≥4 years: 90 mcg (2 actuations of metered-dose inhaler) q4-6hr PRN

Asthma Exacerbation

Nebulizer solution

  • <12 years: 0.075 mg/kg (≥1.25 mg) q20min for 3 doses, then 0.075-0.15 mg/kg (≤5 mg) q1-4hr PRN  
  • ≥12 years: 1.25-2.5 mg q20min for 3 doses, then 1.25-5 mg q1-4hr PRN

Aerosol

  • <4 years: Safety and efficacy not established
  • ≥4 years: 180-360 mcg (4-8 actuations of metered-dose inhaler) q20min for 3 doses, then q1-4hr PRN

Nebulizer solution: 0.63 mg initially in patients >65 years

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Interactions

Interaction Checker

and levalbuterol

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Headache (8-12%)

            Viral infection (7-12%)

            Rhinitis (3-11%)

            1-10%

            Pharyngitis (3-10%)

            Tremor (7%)

            Sinusitis (1-4%)

            Flu (1-4%)

            Dyspepsia (1-3%)

            Leg cramps (<3%)

            Generalized pain (2.8%)

            Nasal edema (2.8%)

            Nervousness (2.8%)

            Tachycardia (2.8%)

            Postmarketing Reports

            Dysphonia

            Gastroesophageal reflux disease, nausea

            Angioedema, anaphylaxis, rash, urticaria

            Chest pain, tachycardia, arrhythmias (including atrial fibrillation, supraventricular tachycardia, extrasystoles)

            Asthma, increased cough, dyspnea, dysphonia

            Metabolic acidosis

            Nervousness, tremor

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            Warnings

            Contraindications

            Hypersensitivity to levalbuterol or racemic albuterol

            Cautions

            Cardiovascular disorder (eg, arrhythmias, hypertension, coronary insufficiency)

            Risk of paradoxical bronchospasm

            Has higher affinity for beta1- and beta2-adrenergic receptors than racemic albuterol has

            Risk of hypersensitivity reactions

            Use with caution in diabetes mellitus (beta2 agonists may increase glucose)

            Risk of hypokalemia (usually transient)

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            Pregnancy & Lactation

            Pregnancy

            There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to asthma medication during pregnancy; to enroll in MotherToBaby Pregnancy Studies’ Asthma & Pregnancy Study or for more information about the registry, call 1-877-311-8972 or visit www.mothertobaby.org/ongoing-study/asthma

            There are no adequate and well-controlled studies in pregnant women; there are clinical considerations with use in pregnant women

            In women with poorly or moderately controlled asthma, there is increased risk of preeclampsia in mother and prematurity, low birth weight, and small for gestational age in neonate; pregnant women should be closely monitored and medication adjusted as necessary to maintain optimal control

            Lactation

            There are no available data on presence of levalbuterol in human milk, effects on breastfed child, or effects on milk production

            Developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from therapy or from underlying maternal condition

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Beta2-receptor agonist with some beta1 activity; relaxes bronchial smooth muscle

            Absorption

            Onset: Nebulizer solution, 10-17 min; aerosol, 5.5-10.2 min

            Duration: Nebulizer solution, 5-6 hr; aerosol, 3-4 hr

            Peak plasma time (children): Nebulizer solution, 0.3-0.6 hr; aerosol, 0.8 hr

            Peak plasma time (adults): Nebulizer solution, 0.2 hr; aerosol, 0.5 hr

            Time to peak effect: Nebulizer solution, 1.5 hr; aerosol, 77 min

            Elimination

            Half-life: 3-3.4 hr

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
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            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.