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Levalbuterol

Pronunciation

Class: Selective beta-2-Adrenergic Agonists
CAS Number: 50293-90-8
Brands: Xopenex, Xopenex HFA

Introduction

Bronchodilator; synthetic sympathomimetic amine and relatively selective, short-acting β2-adrenergic agonist.216 b

Uses for Levalbuterol

Bronchospasm in Asthma

Symptomatic management or prevention of bronchospasm in patients with reversible, obstructive airway disease (e.g., asthma).216 219 221 259 b

Slideshow: Flashback: FDA Drug Approvals 2013

Levalbuterol Dosage and Administration

General

  • Adjust dosage carefully according to individual requirements and response.216

  • During acute asthma exacerbations, most patients obtain optimum benefit, at least initially, when nebulized levalbuterol is used regularly rather than on demand.216 249

Administration

Oral Inhalation

Administer by oral inhalation via a metered-dose inhaler or nebulization.216 b

Oral Inhalation Aerosol

Administer inhalation aerosol only with the actuator provided by the manufacturer.c

Shake the inhaler well before use.b c

Test-spray inhalation aerosol 4 times (away from the face) before first use and whenever the inhaler not used for >3 days.b c

Avoid spraying the aerosol into the eyes.b c

Exhale slowly and completely and place the mouthpiece of the inhaler well into the mouth with the lips closed around it.c While inhaling slowly and deeply through the mouth, actuate the aerosol inhaler, withdraw the mouthpiece, hold the breath for 10 seconds if possible, and exhale.c

Allow 1 minute to elapse between subsequent inhalations from the aerosol inhaler.c

Clean the metered-dose inhaler by removing the metal canister and red mouthpiece (actuator) cap and running warm water through the plastic mouthpiece for 30 seconds at least once a week.b c Shake off excess water and allow the mouthpiece to air-dry thoroughly, such as overnight.b c Insert the metal canister into the mouthpiece and replace the mouthpiece cap.c Do not attempt to clean the metal canister or allow the canister to become wet.b c If the inhaler is to be used before it is completely dry, shake off excess water, replace the canister, shake the inhaler well, and test the inhaler by spraying twice (away from the face) before administering the dose.b c

After such use, rewash the mouthpiece and allow to air dry.b c Proper cleaning of the mouthpiece will prevent medication build-up and blockage.b c If actuator becomes blocked, remove medication build-up by washing the actuator.b c

Discard canister after the labeled number of actuations used.b

Oral Inhalation Solution

For administration of levalbuterol hydrochloride solution for nebulization in single-use units via a nebulizer, open one single-use vial and squeeze the entire contents into the nebulizer reservoir.226

Attach the reservoir to the mouthpiece or face mask and to the compressor according to the manufacturer’s instructions.226

Place the mouthpiece of the nebulizer in the mouth or put on the nebulizer face mask and turn on the compressor.226 Breathe as calmly, deeply, and evenly as possible until the nebulizer stops producing mist (flow rate of nebulizer should be adjusted to provide the full dose over about 5–15 minutes).226 226

Clean the nebulizer after use according to the manufacturer’s instructions.226

Continue nebulization therapy as necessary to control recurrent bronchospasm.216 Optimum benefit is obtained when nebulization is used regularly.216

Dosage

Available as levalbuterol hydrochloride and levalbuterol tartrate; dosages are expressed in terms of levalbuterol.216 b

Pediatric Patients

Bronchospasm in Asthma
Oral Inhalation Aerosol

Children ≥4 years of age: Initially, 90 mcg every 4–6 hours.b Some patients may find 45 mcg every 4 hours to be sufficient.b

Oral Inhalation Solution

Children 6–11 years of age: Initially, 0.31 mg 3 times daily via nebulization.216 Children 6–11 years of age with more severe asthma or those not responding adequately to the 0.31-mg dose may benefit from a dosage of up to 0.63 mg 3 times daily.216 254 Some experts on asthma management recommend a dosage of 0.025 mg/kg (minimum 0.63 mg, maximum 1.25 mg) every 4-8 hours in children ≤12 years of age.259

Adolescents ≥12 years of age: Initially, 0.63 mg 3 times daily (every 6–8 hours) via nebulization.216 219 221 Adolescents ≥12 years of age with more severe asthma or those not responding adequately to the 0.63-mg dose may benefit from a dosage of 1.25 mg 3 times daily.216 219

Some experts on asthma management recommend a dosage of 0.63-2.5 mg/kg every 4-8 hours in adolescents >12 years of age.259

Adults

Bronchospasm in Asthma
Oral Inhalation Aerosol

Initially, 90 mcg every 4–6 hours.b Some patients may find 45 mcg every 4 hours to be sufficient.b

Oral Inhalation Solution

Initially, 0.63 mg of levalbuterol 3 times daily (every 6–8 hours) via nebulization.216 219 221 Patients with more severe asthma or those not responding adequately to the 0.63-mg dose may benefit from a dosage of 1.25 mg 3 times daily.216 219

Some experts on asthma management recommend a dosage of 0.63-2.5 mg/kg every 4-8 hours in adults.259

Prescribing Limits

Pediatric Patients

Bronchospasm in Asthma
Oral Inhalation Aerosol

Children ≥4 years of age: Maximum 90 mcg every 4–6 hours.b

Oral Inhalation Solution

Children 6-11 years of age: Maximum 0.63 mg 3 times daily.216

Adolescents ≥12 years of age: Maximum 1.25 mg 3 times daily.216 219

Adults

Bronchospasm in Asthma
Oral Inhalation Aerosol

Maximum 90 mcg every 4–6 hours.b

Oral Inhalation Solution

Maximum 1.25 mg 3 times daily.216 219

Special Populations

Renal Impairment

Inhalation aerosol: Use caution when administering high dosages.b

Geriatric Patients

Inhalation aerosol: Use caution and select initial dosage at the lower end of dosing range because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.b

Inhalation solution: Increase dosage as tolerated with careful monitoring.216

Cautions for Levalbuterol

Contraindications

  • Known hypersensitivity to levalbuterol or racemic albuterol or any ingredient in the formulation.216 b

Warnings/Precautions

Warnings

Acute or Worsening Asthma

Oral inhalation therapy is intended for the acute symptomatic relief of bronchospasm.188 189 190 191 192 249 If control of mild asthma deteriorates such that regular (i.e., more than 4 times daily) use of a short-acting β2-agonist becomes necessary, institute maintenance therapy (e.g., inhaled corticosteroids)188 189 191 249 and discontinue regular use of the short-acting β2-agonist in such patients; instead, use a short-acting β2-agonist only as a supplement for relief of acute asthma symptoms.188 189 190 191 192 194 197 249 Contact a clinician for reevaluation if control of mild asthma deteriorates.216

Failure to respond to a previously effective dosage of a short-acting β2-agonist may indicate seriously worsening asthma.156 157 181 188 189 190 191 192 193 194 196 197 216 241 242 243 244 249 b Reevaluate asthma therapy and institute alternative regimens or therapy.156 157 181 188 189 190 191 192 193 194 196 197 216 241 242 243 244 249 b Contact a clinician if decreased effectiveness occurs; do not increase the dose or frequency of administration.216 b

Excessive Doses

Possible fatalities associated with excessive use of inhaled sympathomimetic drugs.216 b Exact cause of death unknown; cardiac arrest following severe asthmatic attack accompanied by hypoxia suspected.b

Paradoxical Bronchospasm

Possible life-threatening acute bronchospasm.216 b Frequently occurs with the first use of a new canister or vial.216 b

Discontinue therapy immediately if bronchoconstriction occurs and institute alternative therapy.216 b

Cardiovascular Effects

Possible clinically important cardiovascular effects, as measured by pulse rate, blood pressure, and related symptoms.216 b ECG changes, including T-wave flattening, prolongation of the QTc interval, and ST-segment depression, also have been reported.216 b

Cautious use recommended in patients with cardiovascular disorders (e.g., coronary insufficiency, cardiac arrhythmias, hypertension).216 b

Sensitivity Reactions

Immediate hypersensitivity reactions (e.g., urticaria, angioedema, rash, bronchospasm, anaphylaxis, oropharyngeal edema) reported.216 b Possible acute bronchospasm.216 b (See Paradoxical Bronchospasm under Cautions.)

General Precautions

Nervous System Effects

Cautious use recommended in patients with seizure disorders and in those with unusual responsiveness to sympathomimetic amines.216 b

Metabolic Effects

Possible hypokalemia, which may increase risk of adverse cardiovascular effects.216 b (See Cardiovascular Effects under Cautions.) Serum potassium decrease usually is transient and usually does not require supplementation.216 b

Increased blood glucose has occurred following inhalation via nebulization of levalbuterol.216 Effect may diminish during continued therapy.216

Cautious use recommended in patients with diabetes mellitus or hyperthyroidism.216 b

Specific Populations

Pregnancy

Category C.216 b

Lactation

Not known whether levalbuterol is distributed into milk.216 b Discontinue nursing or the drug.216 b

Pediatric Use

Oral inhalation solution: Safety and efficacy not established in children <6 years of age.216

Oral inhalation aerosol: Safety and efficacy not established in children <4 years of age.b

Geriatric Use

Data on the use of levalbuterol in geriatric patients ≥ 65 years of age are limited and are insufficient to determine whether the efficacy and safety of levalbuterol are different in geriatric patients versus younger patients.216 b

Substantially eliminated by kidneys; assess renal function periodically since geriatric patients are more likely to have decreased renal function.b

Common Adverse Effects

Inhalation aerosol in adults and adolescents ≥12 years of age: asthma, pharyngitis, rhinitis, pain (unspecified), dizziness.b

Inhalation aerosol in children 4–11 years of age: vomiting, accidental injury, pharyngitis, bronchitis.b

Inhalation solution in adults and adolescents ≥12 years of age: viral infection, rhinitis, nervousness, tremor, flu syndrome, sinusitis, increased cough, pain, tachycardia, turbinate edema, accidental injury, anxiety, dizziness, dyspepsia, leg cramps, migraine.216

Inhalation solution in children 6–11 years of age: headache, pharyngitis, rhinitis, asthma, fever, viral infection, rash, accidental injury, diarrhea, asthenia, pain, lymphadenopathy, urticaria, abdominal pain, myalgia.

Interactions for Levalbuterol

Specific Drugs

Drug

Interaction

Comments

β-Adrenergic blocking agents

Antagonism of pulmonary effects, resulting in severe bronchospasm in asthmatic patients216 b

If concomitant therapy required, consider cautious use of cardioselective β-adrenergic blocking agents216 b

Digoxin

Decreased serum digoxin concentrations216 b

Careful evaluation of serum digoxin concentration recommended216 b

Diuretics, nonpotassium-sparing

Possible decreased serum potassium concentrations and/or ECG changes, especially when the recommended β-agonist dose is exceeded216 b

Cautious use recommended216 b

MAO inhibitors

Increased effect on vascular system 216

Extreme caution recommended for concomitant therapy or in patients receiving levalbuterol within 2 weeks of discontinuance of these agents216 b

Sympathomimetic agents (e.g., epinephrine, other short-acting bronchodilators)

Increased cardiovascular adverse effectsb

Caution recommended for concomitant use of sympathomimetic agents administered by any route216 b

Levalbuterol Pharmacokinetics

Absorption

Bioavailability

Higher in children 6–11 years of age than in adults, supporting a lower dose for children.216 (See Pediatric Patients under Dosage.)

Onset

Oral inhalation aerosol in adolescents and adults: 5.5–10.2 minutes for a 15% change in forced expiratory volume in 1 second (FEV1).b

Oral inhalation aerosol in children: 4.5 minutes.b

Oral inhalation solution: 10–17 minutes.216

Duration

Oral inhalation aerosol in adults: 3–6 hours.b

Oral inhalation aerosol in children: 3–6 hours.b

Oral inhalation solution: ≤ 8 hours in some patients.216

Distribution

Extent

It is not known whether levalbuterol distributes into milk.216

Elimination

Metabolism

Metabolized by sulfotransferase 1A3 (dopamine phenolsulfotransferase) in the intestinal wall and liver to levalbuterol 4’-O-sulfate, an inactive metabolite.b d e

Elimination Route

Excreted in urine (≥80%) mainly as parent compound or primary metabolite and in feces (<20%).b

Half-life

Inhalation aerosol propellant (tetrafluoroethane): 5–7 minutes.b

Levalbuterol inhalation solution: 3.3–4 hours in healthy adults.216

Special Populations

Pharmacokinetics of inhalation aerosol in patients with hepatic impairment not studied.b

Stability

Storage

Oral Inhalation

Aerosol

20–25°C with the actuator in downward position; protect from freezing and direct sunlight.b Do not puncture or incinerate the canister.b Exposure to temperatures >49°C may cause canister to burst.b

Solution

20–25°C.216 Store single-use vials in protective foil pouch to protect from light until used.216

Once the foil pouch has been opened, use any vials remaining in the pouch within 2 weeks.216 Use vials removed from the pouch within 1 week.216 Discard vials if the solution becomes discolored.216

Actions

  • Stimulates β-adrenergic receptors with little or no effect on α-adrenergic receptors.216

  • Stimulates the production of cyclic adenosine-3′,5′-monophosphate (AMP), which mediates numerous cellular responses, including smooth muscle relaxation and inhibiting the release of mediators from mast cells in the airways.216 b

  • Relaxes smooth muscles from the trachea to the terminal bronchial tree.216 b

Advice to Patients

  • Importance of providing patient with a copy of the manufacturer’s patient information.216

  • Importance of adequate understanding of proper storage, preparation, and inhalation techniques, including use of various delivery systems.216 b

  • Importance of adherence to dosing schedules of levalbuterol and concomitant therapy, including not exceeding the recommended dose or frequency of use unless otherwise instructed by a clinician.216 b

  • If decreased effectiveness occurs, contact a clinician immediately; do not increase the dose or frequency of administration.216 b

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.216

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription (e.g., other inhaled agents) and OTC drugs.216

  • Importance of informing patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Levalbuterol Tartrate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral Inhalation

Aerosol

45 mcg (of levalbuterol) per metered spray

Xopenex HFA (with dehydrated alcohol, hydrofluoroalkane propellant, and oleic acid)

Sepracor

Levalbuterol Hydrochloride

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral Inhalation

Solution, for nebulization

0.103 mg (of levalbuterol) per mL (0.31 mg)

Xopenex (available as polyethylene vials)

Sepracor

0.21 mg (of levalbuterol) per mL (0.63 mg)

Xopenex (available as polyethylene vials)

Sepracor

0.417 mg (of levalbuterol) per mL (1.25 mg)

Xopenex (available as polyethylene vials)

Sepracor

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Xopenex 0.31MG/3ML Aerosol (SUNOVION PHARMACEUTICALS): 72/$139.98 or 216/$399.97

Xopenex 0.63MG/3ML Aerosol (SUNOVION PHARMACEUTICALS): 72/$157.00 or 216/$451.99

Xopenex 1.25MG/3ML Aerosol (SUNOVION PHARMACEUTICALS): 72/$160.99 or 216/$459.96

Xopenex HFA 45MCG/ACT Aerosol (SUNOVION PHARMACEUTICALS): 15/$59.99 or 45/$155.97

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions June 1, 2012. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

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