levalbuterol

Therapeutic Classification: bronchodilators

Pharmacologic Classification: adrenergics

REMS

Bronchospasm due to reversible airway disease (short-term control agent).

R-enantiomer of racemic albuterol. Binds to beta-2 adrenergic receptors in airway smooth muscle, leading to activation of adenylcyclase and increased levels of cyclic-3′;, 5′;-adenosine monophosphate (cAMP). Increases in cAMP activate kinases, which inhibit the phosphorylation of myosin and decrease intracellular calcium. Decreased intracellular calcium relaxes bronchial smooth muscle.

Therapeutic effects:

Relaxation of airway smooth muscle with subsequent bronchodilation.
Relatively selective for beta-2 (pulmonary) receptors.

Absorption: Some absorption occurs following inhalation.

Distribution: Unknown.

Metabolism/Excretion: Metabolized in the liver to an inactive sulfate; 3–6% excreted unchanged in the urine.

Half-Life: 3.3–4 hr.

(bronchodilation)

ROUTE	ONSET	PEAK	DURATION
Inhaln	10–17 min	90 min	5–6 hr

Contraindicated in:

Hypersensitivity to levalbuterol or albuterol.

Use Cautiously in:

Cardiovascular disorders (including coronary insufficiency, hypertension, and arrhythmias);
History of seizures;
Hypokalemia;
Hyperthyroidism;
Diabetes mellitus;
Unusual sensitivity to adrenergic amines;
OB: Safety not established in pregnancy;
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
Pedi: Safety and effectiveness not established in children 6 yr (nebulized solution) or 4 yr (metered-dose inhaler).

Concurrent use or use within 2 wk of tricyclic antidepressants or MAO inhibitors may ↑ risk of adverse cardiovascular reactions.

CV: tachycardia

EENT: turbinate edema

Endo: hyperglycemia

F and E: hypokalemia

GI: dyspepsia, vomiting

Neuro: anxiety, dizziness, headache, nervousness, tremor

Resp: cough, PARADOXICAL BRONCHOSPASM (EXCESSIVE USE OF INHALERS)

Drug-drug:

Concurrent use or use within 2 wk of tricyclic antidepressants or MAO inhibitors may ↑ risk of adverse cardiovascular reactions (use with extreme caution).
Beta blockers block the beneficial pulmonary effects of adrenergic bronchodilators; choose cardioselective beta blockers if necessary and with caution.
May ↑ risk of hypokalemia from thiazide diuretics and loop diuretics.
May ↓ digoxin levels.
May ↑ risk of arrhythmias with hydrocarbon inhalation anesthetics or cocaine.

Drug-Natural Products:

Use with caffeine-containing herbs (guarana, tea, coffee) ↑ stimulant effect.

Inhaln
(Adults and Children ≥4 yr): 2 inhalations every 4–6 hr; some patients may respond to 1 inhalation every 4 hr.
Inhaln
(Adults and Children >12 yr): 0.63 mg via nebulization 3 times daily (every 6–8 hr); may be ↑ to 1.25 mg 3 times daily (every 6–8 hr).
Inhaln
(Children 6–11 yr): 0.31 mg via nebulization 3 times daily (not to exceed 0.63 mg 3 times daily).

(Generic available)

Inhalation aerosol: 45 mcg/actuation in 15-g canisters (200 metered actuations)
Inhalation solution: 0.31 mg/3 mL; 0.63 mg/3 mL; 1.25 mg/3 mL; 1.25 mg/0.5 mL

Assess lung sounds, pulse, and BP before administration and during peak of medication. Note amount, color, and character of sputum produced. Closely monitor patients on higher dose for adverse effects.
Monitor cardiac status (chest pain) and for ECG changes (flattening T wave, prolongation of QTc interval, and ST segment depression). Should be used with caution in patients with ischemic heart disease, arrhythmias, and hypertension.
Monitor pulmonary function tests before initiating therapy and periodically during course to determine effectiveness of medication.
Observe for paradoxical bronchospasm (wheezing, dyspnea, tightness in chest). If condition occurs, withhold medication and notify health care provider immediately.

Lab Test Considerations:

May cause ↑ serum glucose and ↓ serum potassium.

Inhaln: Allow at least 1 min between inhalations of aerosol medication.
- For metered-dose inhaler, shake well before using. Prime inhaler before using for the 1st time or if not used for >3 days; release 4 sprays into the air away from face. Use actuator that is supplied with the product. Clean actuator with warm water and let air-dry completely at least once a wk.
- For nebulization, concentrated solution should be diluted with 2.5 mL of NS prior to use, or per prescriber's order. Once the foil pouch is opened, vials must be used within 2 wk; open vials may be stored for 1 wk and should be protected from light. Discard vial if solution is not clear or colorless.

Instruct patient in the proper use and side effects of inhalation aerosol nebulizer (see Medication Administration Techniques) and to take levalbuterol as directed. Caution patient not to exceed recommended dose; may cause adverse effects, paradoxical bronchospasm, or loss of effectiveness of medication.
Advise patient to readPatient Information before starting therapy.
Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking any OTC medications or alcoholic beverages concurrently with this therapy. Caution patient also to avoid smoking and other respiratory irritants.
Instruct patient to contact health care professional immediately if shortness of breath is not relieved by medication or is accompanied by diaphoresis, dizziness, palpitations, or chest pain.
Advise patients to use levalbuterol first if using other inhalation medications, and allow 5 min to elapse before administering other inhalant medications unless otherwise directed.
Advise patient to rinse mouth with water after each inhalation dose to minimize dry mouth.
Instruct patient to seek medical attention immediately if symptoms become worse, treatment is less effective for symptomatic relief, or the use of the product is more frequent than usual.
Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding. Encourage women who become pregnant while taking levalbuterol to enroll in the Asthma & Pregnancy Study to monitor pregnancy outcomes in women exposed to asthma medications by calling 1-877-311-8972 or visiting www.mothertobaby.org/ongoing-study/asthma.
Pedi: Children should use under adult supervision, as instructed by patient's physician.

Prevention or relief of bronchospasm.

NDC Code

0093- Teva Pharmaceuticals USA, Inc.
- 0093-4145- Levalbuterol
  - 0093-4145-56- 6 POUCH in 1 CARTON (0093-4145-56) > 5 VIAL, SINGLE-DOSE in 1 POUCH (0093-4145-45) > 3 mL in 1 VIAL, SINGLE-DOSE

0093- Teva Pharmaceuticals USA, Inc.
- 0093-4146- Levalbuterol
  - 0093-4146-56- 6 POUCH in 1 CARTON (0093-4146-56) > 5 VIAL, SINGLE-DOSE in 1 POUCH (0093-4146-45) > 3 mL in 1 VIAL, SINGLE-DOSE

0093- Teva Pharmaceuticals USA, Inc.
- 0093-4146- Levalbuterol
  - 0093-4146-64- 6 POUCH in 1 CARTON (0093-4146-64) > 4 VIAL, SINGLE-DOSE in 1 POUCH (0093-4146-04) > 3 mL in 1 VIAL, SINGLE-DOSE

0093- Teva Pharmaceuticals USA, Inc.
- 0093-4147- Levalbuterol
  - 0093-4147-56- 30 POUCH in 1 CARTON (0093-4147-56) > 1 VIAL, SINGLE-DOSE in 1 POUCH (0093-4147-19) > .5 mL in 1 VIAL, SINGLE-DOSE

0093- Teva Pharmaceuticals USA, Inc.
- 0093-4148- Levalbuterol
  - 0093-4148-56- 6 POUCH in 1 CARTON (0093-4148-56) > 5 VIAL, SINGLE-DOSE in 1 POUCH (0093-4148-45) > 3 mL in 1 VIAL, SINGLE-DOSE

0115- Amneal Pharmaceuticals of New York LLC
- 0115-9930- Levalbuterol
  - 0115-9930-78- 1 POUCH in 1 CARTON (0115-9930-78) > 25 AMPULE in 1 POUCH (0115-9930-76) > 3 mL in 1 AMPULE

0115- Amneal Pharmaceuticals of New York LLC
- 0115-9931- Levalbuterol
  - 0115-9931-78- 1 POUCH in 1 CARTON (0115-9931-78) > 25 AMPULE in 1 POUCH (0115-9931-76) > 3 mL in 1 AMPULE

0115- Amneal Pharmaceuticals of New York LLC
- 0115-9932- Levalbuterol
  - 0115-9932-78- 1 POUCH in 1 CARTON (0115-9932-78) > 25 AMPULE in 1 POUCH (0115-9932-76) > 3 mL in 1 AMPULE

0378- Mylan Pharmaceuticals Inc.
- 0378-6993- Levalbuterol
  - 0378-6993-93- 30 POUCH in 1 CARTON (0378-6993-93) > 1 VIAL in 1 POUCH (0378-6993-31) > .5 mL in 1 VIAL

0378- Mylan Pharmaceuticals Inc.
- 0378-9690- Levalbuterol
  - 0378-9690-52- 1 POUCH in 1 CARTON (0378-9690-52) > 25 AMPULE in 1 POUCH (0378-9690-62) > 3 mL in 1 AMPULE

0378- Mylan Pharmaceuticals Inc.
- 0378-9691- Levalbuterol
  - 0378-9691-52- 1 POUCH in 1 CARTON (0378-9691-52) > 25 AMPULE in 1 POUCH (0378-9691-62) > 3 mL in 1 AMPULE

0378- Mylan Pharmaceuticals Inc.
- 0378-9692- Levalbuterol
  - 0378-9692-52- 1 POUCH in 1 CARTON (0378-9692-52) > 25 AMPULE in 1 POUCH (0378-9692-62) > 3 mL in 1 AMPULE

0591- Actavis Pharma, Inc.
- 0591-2927- Levalbuterol tartrate HFA inhalation
  - 0591-2927-54- 1 INHALER in 1 CARTON (0591-2927-54) > 200 AEROSOL, METERED in 1 INHALER

17478- Akorn, Inc.
- 17478-171- Xopenex
  - 17478-171-30- 30 POUCH in 1 CARTON (17478-171-30) > 1 VIAL, SINGLE-DOSE in 1 POUCH (17478-171-01) > .5 mL in 1 VIAL, SINGLE-DOSE

17478- Akorn, Inc.
- 17478-172- Xopenex
  - 17478-172-24- 2 POUCH in 1 CARTON (17478-172-24) > 12 VIAL, SINGLE-DOSE in 1 POUCH (17478-172-12) > 3 mL in 1 VIAL, SINGLE-DOSE

17478- Akorn, Inc.
- 17478-173- Xopenex
  - 17478-173-24- 2 POUCH in 1 CARTON (17478-173-24) > 12 VIAL, SINGLE-DOSE in 1 POUCH (17478-173-12) > 3 mL in 1 VIAL, SINGLE-DOSE

17478- Akorn, Inc.
- 17478-174- Xopenex
  - 17478-174-24- 2 POUCH in 1 CARTON (17478-174-24) > 12 VIAL, SINGLE-DOSE in 1 POUCH (17478-174-12) > 3 mL in 1 VIAL, SINGLE-DOSE

63187- Proficient Rx LP
- 63187-876- Levalbuterol tartrate HFA inhalation
  - 63187-876-15- 1 INHALER in 1 CARTON (63187-876-15) > 200 AEROSOL, METERED in 1 INHALER

63187- Proficient Rx LP
- 63187-953- Levalbuterol
  - 63187-953-24- 24 VIAL, SINGLE-DOSE in 1 CARTON (63187-953-24) > 3 mL in 1 VIAL, SINGLE-DOSE

63402- Sunovion Pharmaceuticals Inc.
- 63402-510- Xopenex HFA
  - 63402-510-01- 1 INHALER in 1 CARTON (63402-510-01) > 200 AEROSOL, METERED in 1 INHALER

65862- Aurobindo Pharma Limited
- 65862-942- LEVALBUTEROL
  - 65862-942-03- 30 POUCH in 1 CARTON (65862-942-03) > 1 VIAL, SINGLE-DOSE in 1 POUCH (65862-942-50) > .5 mL in 1 VIAL, SINGLE-DOSE

65862- Aurobindo Pharma Limited
- 65862-943- Levalbuterol
  - 65862-943-24- 2 POUCH in 1 CARTON (65862-943-24) > 12 VIAL, SINGLE-DOSE in 1 POUCH (65862-943-12) > 3 mL in 1 VIAL, SINGLE-DOSE

65862- Aurobindo Pharma Limited
- 65862-944- Levalbuterol
  - 65862-944-24- 2 POUCH in 1 CARTON (65862-944-24) > 12 VIAL, SINGLE-DOSE in 1 POUCH (65862-944-12) > 3 mL in 1 VIAL, SINGLE-DOSE

65862- Aurobindo Pharma Limited
- 65862-945- Levalbuterol
  - 65862-945-24- 2 POUCH in 1 CARTON (65862-945-24) > 12 VIAL, SINGLE-DOSE in 1 POUCH (65862-945-12) > 3 mL in 1 VIAL, SINGLE-DOSE

66993- Prasco Laboratories
- 66993-021- Levalbuterol Hydrochloride
  - 66993-021-27- 2 POUCH in 1 CARTON (66993-021-27) > 12 VIAL, SINGLE-DOSE in 1 POUCH (66993-021-35) > 3 mL in 1 VIAL, SINGLE-DOSE

66993- Prasco Laboratories
- 66993-022- Levalbuterol Hydrochloride
  - 66993-022-27- 2 POUCH in 1 CARTON (66993-022-27) > 12 VIAL, SINGLE-DOSE in 1 POUCH (66993-022-35) > 3 mL in 1 VIAL, SINGLE-DOSE

66993- Prasco Laboratories
- 66993-023- Levalbuterol Hydrochloride
  - 66993-023-27- 2 POUCH in 1 CARTON (66993-023-27) > 12 VIAL, SINGLE-DOSE in 1 POUCH (66993-023-35) > 3 mL in 1 VIAL, SINGLE-DOSE

68071- NuCare Pharmaceuticals,Inc.
- 68071-5027- Levalbuterol
  - 68071-5027-5- 3 mL in 1 AMPULE (68071-5027-5)

68788- Preferred Pharmaceuticals, Inc.
- 68788-6777- Levalbuterol
  - 68788-6777-2- 6 POUCH in 1 CARTON (68788-6777-2) > 4 VIAL, SINGLE-DOSE in 1 POUCH > 3 mL in 1 VIAL, SINGLE-DOSE

68788- Preferred Pharmaceuticals Inc.
- 68788-6845- Levalbuterol tartrate HFA inhalation
  - 68788-6845-1- 1 INHALER in 1 CARTON (68788-6845-1) > 200 AEROSOL, METERED in 1 INHALER

70518- REMEDYREPACK INC.
- 70518-0526- levalbuterol hydrochloride
  - 70518-0526-0- 3 mL in 1 VIAL, SINGLE-DOSE (70518-0526-0)

70518- REMEDYREPACK INC.
- 70518-1227- Xopenex
  - 70518-1227-0- 2 POUCH in 1 CARTON (70518-1227-0) > 12 VIAL, SINGLE-DOSE in 1 POUCH > 3 mL in 1 VIAL, SINGLE-DOSE

76204- Ritedose Pharmaceuticals, LLC
- 76204-700- Levalbuterol
  - 76204-700-01- 30 POUCH in 1 CARTON (76204-700-01) > 1 AMPULE in 1 POUCH (76204-700-11) > 3 mL in 1 AMPULE

76204- Ritedose Pharmaceuticals, LLC
- 76204-700- Levalbuterol
  - 76204-700-25- 1 POUCH in 1 CARTON (76204-700-25) > 25 AMPULE in 1 POUCH (76204-700-15) > 3 mL in 1 AMPULE

76204- Ritedose Pharmaceuticals, LLC
- 76204-700- Levalbuterol
  - 76204-700-55- 5 POUCH in 1 CARTON (76204-700-55) > 5 AMPULE in 1 POUCH (76204-700-05) > 3 mL in 1 AMPULE

76204- Ritedose Pharmaceuticals, LLC
- 76204-800- Levalbuterol
  - 76204-800-01- 30 POUCH in 1 CARTON (76204-800-01) > 1 AMPULE in 1 POUCH (76204-800-11) > 3 mL in 1 AMPULE

76204- Ritedose Pharmaceuticals, LLC
- 76204-800- Levalbuterol
  - 76204-800-25- 1 POUCH in 1 CARTON (76204-800-25) > 25 AMPULE in 1 POUCH (76204-800-15) > 3 mL in 1 AMPULE

76204- Ritedose Pharmaceuticals, LLC
- 76204-800- Levalbuterol
  - 76204-800-55- 5 POUCH in 1 CARTON (76204-800-55) > 5 AMPULE in 1 POUCH (76204-800-05) > 3 mL in 1 AMPULE

76204- Ritedose Pharmaceuticals, LLC
- 76204-900- Levalbuterol
  - 76204-900-01- 30 POUCH in 1 CARTON (76204-900-01) > 1 AMPULE in 1 POUCH (76204-900-11) > 3 mL in 1 AMPULE

76204- Ritedose Pharmaceuticals, LLC
- 76204-900- Levalbuterol
  - 76204-900-25- 1 POUCH in 1 CARTON (76204-900-25) > 25 AMPULE in 1 POUCH (76204-900-15) > 3 mL in 1 AMPULE

76204- Ritedose Pharmaceuticals, LLC
- 76204-900- Levalbuterol
  - 76204-900-55- 5 POUCH in 1 CARTON (76204-900-55) > 5 AMPULE in 1 POUCH (76204-900-05) > 3 mL in 1 AMPULE

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