Levalbuterol Inhalation Solution

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• Levalbuterol inhalation solution is for oral inhalation only.
• Administer by nebulization using with a standard jet nebulizer (with a face mask or mouthpiece) connected to an air compressor.
• Do not exceed recommended dose.
• Children 6 to 11 years old:
• The recommended dosage of levalbuterol inhalation solution for patients 6 to 11 years old is 0.31 mg administered three times a day, by nebulization.
• Routine dosing should not exceed 0.63 mg three times a day.
• Adults and Adolescents ≥12 years old:
• The recommended starting dosage of levalbuterol inhalation solution for patients 12 years of age and older is 0.63 mg administered three times a day, every 6 to 8 hours, by nebulization.
• Patients 12 years of age and older with more severe asthma or patients who do not respond adequately to a dose of 0.63 mg of levalbuterol inhalation solution may benefit from a dosage of 1.25 mg three times a day.
• Patients receiving the highest dose of levalbuterol inhalation solution should be monitored closely for adverse systemic effects, and the risks of such effects should be balanced against the potential for improved efficacy.
• The use of levalbuterol inhalation solution can be continued as medically indicated to help control recurring bouts of bronchospasm.
• During this time, most patients gain optimal benefit from regular use of the inhalation solution.
• If a previously effective dosage regimen fails to provide the usual response this may be a marker of destabilization of asthma and requires reevaluation of the patient and the treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids.
• The drug compatibility (physical and chemical), efficacy, and safety of levalbuterol inhalation solution when mixed with other drugs in a nebulizer have not been established.
• The safety and efficacy of levalbuterol inhalation solution have been established in clinical trials when administered using the PARI LC Jet TM and PARI LC Plus TM nebulizers, and the PARI Master ® Dura-Neb ® 2000 and Dura-Neb ® 3000 compressors.
• The safety and efficacy of levalbuterol inhalation solution when administered using other nebulizer systems have not been established.
• FOR ORAL INHALATION ONLY ( 2 )
• Children 6 to 11 years old :
• 0.31 mg administered three times a day, by nebulization.
• Routine dosing should not exceed 0.63 mg three times a day.
• ( 2 )
• Adults and Adolescents ≥12 years old :
• 0.63 mg administered three times a day, every 6 to 8 hours, by nebulization.
• The maximum recommended dose is 1.25 mg three times a day.
• ( 2 ) For use with a standard jet nebulizer (with a face mask or mouthpiece) connected to an air compressor.
• ( 2 )

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Use in children

• Pediatric Patients 6 Years of Age and Older The safety and efficacy of levalbuterol inhalation solution have been established in pediatric patients 6 years of age and older in an adequate and well-controlled clinical trial [see Adverse Reactions (6) and Clinical Studies (14)] .
• Pediatric Patients less than 6 Years of Age Levalbuterol inhalation solution is not indicated for pediatric patients less than 6 years of age.
• Clinical trials with levalbuterol inhalation solution in this age group failed to meet the primary efficacy endpoint and demonstrated an increased number of asthma-related adverse reactions following chronic levalbuterol inhalation solution treatment.
• Levalbuterol inhalation solution was studied in 379 pediatric patients less than 6 years of age with asthma or reactive airway disease – (291 patients 2 to 5 years of age, and 88 patients from birth to less than 2 years of age).
• Efficacy and safety data for levalbuterol inhalation solution in this age group are primarily available from one 3-week, multicenter, randomized, double-blind, active and placebo-controlled study (Study 1) in 211 pediatric patients between the ages of 2 and 5 years, of whom 119 received levalbuterol inhalation solution.
• Over the 3 week treatment period, there were no significant treatment differences in the Pediatric Asthma Questionnaire (PAQ) total score between groups receiving levalbuterol inhalation solution 0.31 mg, levalbuterol inhalation solution 0.63 mg, racemic albuterol, and placebo.
• Additional safety data following chronic dosing is available from a 4-week, multicenter, randomized, modified-blind, placebo-controlled study (Study 2) of 196 patients between the ages of birth and 3 years, of whom 63 received open-label levalbuterol inhalation solution.
• In these two studies, treatment-emergent asthma exacerbations or asthma-related adverse reactions and treatment discontinuations due to asthma occurred at a higher frequency in levalbuterol inhalation-treated subjects compared to control (Table 5).
• Other adverse reactions were consistent with those observed in the clinical trial population of patients 6 years of age and older [see Adverse Reactions (6.1)] .
• Table 5.
• Asthma-related Adverse Reactions in 3-and 4-Week Clinical Trials in Children Birth to <6 Years of Age Asthma Exacerbations* n (%) Treatment Discontinuations due to Asthma n (%) Asthma-related Adverse Reactions** n (%) Study 1 Levalbuterol inhalation solution 0.31 mg, n=58 6 (10) 4 (7) -- Levalbuterol inhalation solution 0.63 mg, n=51 7 (14) 6 (12) -- Racemic albuterol, n=52 3 (6) 2 (4) -- Placebo, n=50 2 (4) 2 (4) -- Study 2 Levalbuterol inhalation solution 0.31 mg, n=63 -- 2 (3) 6 (10) Levalbuterol HFA inhalation aerosol, n=65 -- 1 (2) 8 (12) Placebo, n=68 -- 0 3 (4) *Asthma exacerbation defined as worsening of asthma symptoms or pulmonary function that required any of the following:
• emergency department visit, hospitalization, therapeutic intervention with oral or parenteral steroids, unscheduled clinic visit to treat acute asthma symptoms **Includes the following Preferred Terms (whether considered by the investigator to be related or unrelated to drug):
• asthma, cough, hypoxia, status asthmaticus, tachypnea

Quoted from the official label, section “Pediatric Use”.

Use in older people

• 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.
• Only 5 patients 65 years of age and older were treated with levalbuterol inhalation solution in a 4-week clinical study [see Clinical Pharmacology ( 12 ) and Clinical Studies ( 14 ) ] (n=2 for 0.63 mg and n=3 for 1.25 mg).
• In these patients, bronchodilation was observed after the first dose on day 1 and after 4 weeks of treatment.
• In general, patients 65 years of age and older should be started at a dose of 0.63 mg of levalbuterol inhalation solution.
• If clinically warranted due to insufficient bronchodilator response, the dose of levalbuterol inhalation solution may be increased in elderly patients as tolerated, in conjunction with frequent clinical and laboratory monitoring, to the maximum recommended daily dose [see Dosage and Administration ( 2 ) ].

Quoted from the official label, section “Geriatric Use”.

Side effects

• The following serious adverse reactions are described below and elsewhere in the labeling:
• Paradoxical bronchospasm [see Warnings and Precautions ( 5.1 ) ] Cardiovascular effects [see Warnings and Precautions ( 5.4 ) ] Immediate hypersensitivity reactions [see Warnings and Precautions ( 5.6 ) ] Hypokalemia [see Warnings and Precautions ( 5.8 ) ] Most common adverse reactions are:
• palpitations, chest pain, tachycardia, headache, dizziness, tremor and nervousness.
• ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-818-4555 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
• 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of the drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
• Adults and Adolescents 12 Years of Age and Older Adverse reaction information concerning levalbuterol inhalation solution in
• adults and adolescents is derived from one 4-week, multicenter, randomized, double-blind, active-, and placebo-controlled trial in 362 patients with asthma 12 years of age and older.
• Adverse reactions reported in ≥2% of patients receiving levalbuterol inhalation solution or racemic albuterol and more frequently than in patients receiving placebo are listed in Table 1.
• Table 1:
• Adverse Reactions Reported in a 4-Week, Controlled Clinical Trial in
• Adults and Adolescents ≥12 Years Old Body System Preferred Term Percent of Patients One treatment group, racemic albuterol 1.25 mg, with 68 subjects is omitted.
• Placebo (n=75) Levalbuterol Inhalation Solution 1.25 mg (n=73) Levalbuterol Inhalation Solution 0.63 mg (n=72) Racemic albuterol 2.5 mg (n=74) Body as a Whole Allergic reaction 1.3 0 0
• 2.7 Flu syndrome 0 1.4 4.2
• 2.7 Accidental injury 0 2.7 0 0 Pain 1.3 1.4 2.8
• Back pain 0 0 0
• 2.7 Cardiovascular System Tachycardia 0 2.7 2.8
• 2.7 Migraine 0 2.7 0 0 Digestive System Dyspepsia 1.3 2.7 1.4
• 1.4 Musculoskeletal System Leg cramps 1.3 2.7 0
• 1.4 Central Nervous System Dizziness 1.3 2.7 1.4 0 Hypertonia 0 0 0
• 2.7 Nervousness 0 9.6 2.8
• 8.1 Tremor 0 6.8 0
• 2.7 Anxiety 0 2.7 0 0 Respiratory System Cough increased 2.7 4.1 1.4
• 2.7 Infection viral 9.3 12.3 6.9
• 12.2 Rhinitis 2.7 2.7 11.1
• 6.8 Sinusitis 2.7 1.4 4.2
• 2.7 Turbinate edema 0 1.4 2.8 0 The incidence of certain systemic beta-adrenergic adverse reactions (e.g., tremor, nervousness) was slightly less in the levalbuterol inhalation solution 0.63 mg group compared with the other active treatment groups.
• The clinical significance of these small differences is unknown.
• Changes in heart rate 15 minutes after drug administration and in plasma glucose and potassium 1 hour after drug administration on day 1 and day 29 were clinically comparable in the levalbuterol inhalation solution 1.25 mg and racemic albuterol 2.5 mg groups (see Table 2).
• Changes in heart rate and plasma glucose were slightly less in the levalbuterol inhalation solution 0.63 mg group compared with the other active treatment groups (see Table 2).
• The clinical significance of these small differences is unknown.
• After 4 weeks, effects on heart rate, plasma glucose, and plasma potassium were generally diminished compared with day 1 in all active treatment groups.
• Table 2:
• Mean Changes from Baseline Heart Rate at 15 Minutes and Glucose and Potassium at 1 Hour after First Dose (Day 1) in
• Adults and Adolescents ≥12 Years Old Treatment Mean Changes (day 1) Heart Rate (bpm) Glucose (mg/dL) Potassium (mEq/L) Levalbuterol Inhalation Solution 0.63 mg, n=72 2.4 4.6 -0.2 Levalbuterol Inhalation Solution 1.25 mg, n=73 6.9 10.3 -0.3 Racemic albuterol 2.5 mg, n=74 5.7 8.2 -0.3 Placebo, n=75 -2.8 -0.2 -0.2 No other clinically relevant laboratory abnormalities related to administration of levalbuterol inhalation solution were observed in this study.
• In the clinical trials, a slightly greater number of serious adverse events, discontinuations due to adverse events, and clinically significant ECG changes were reported in patients who received levalbuterol 1.25 mg compared with the other active treatment groups.
• The following adverse reactions, considered potentially related to levalbuterol, occurred in less than 2% of the 292 subjects who received levalbuterol and more frequently than in patients who received placebo in any clinical trial:
• Body as a Whole:
• chills, pain, chest pain Cardiovascular System:
• ECG abnormal, ECG change, hypertension, hypotension, syncope Digestive System:
• diarrhea, dry mouth, dry throat, dyspepsia, gastroenteritis, nausea Hemic and Lymphatic System:
• lymphadenopathy Musculoskeletal System:
• leg cramps, myalgia Nervous System:
• anxiety, hyperesthesia of the hand, insomnia, paresthesia, tremor Special Senses:
• eye itch The following reactions, considered potentially related to levalbuterol, occurred in less than 2% of the treated subjects but at a frequency less than in patients who received placebo:
• asthma exacerbation, cough increased, wheezing, sweating, and vomiting.
• Pediatric Patients 6 to 11 Years of Age Adverse reaction information concerning levalbuterol inhalation solution in pediatric patients is derived from one 3-week, multicenter, randomized, double-blind, active-, and placebo-controlled trial in 316 pediatric patients 6 to 11 years of age.
• Adverse reactions reported in ≥2% of patients in any treatment group and more frequently than in patients receiving placebo are listed in Table 3.
• Table 3:
• Most Frequently Reported Adverse Reactions (≥2% in Any Treatment Group) and Those Reported More Frequently Than in Placebo during the Double-Blind Period (ITT Population, 6 to 11 Years Old) Body System Preferred Term Percent of Patients Placebo (n=59) Levalbuterol Inhalation Solution 0.31 mg (n=66) Levalbuterol Inhalation Solution 0.63 mg (n=67) Racemic albuterol 1.25 mg (n=64) Racemic albuterol 2.5 mg (n=60) Body as a Whole Abdominal pain 3.4 0 1.5 3.1
• 6.7 Accidental injury 3.4 6.1 4.5 3.1
• 5.0 Asthenia 0 3.0 3.0 1.6
• 1.7 Fever 5.1 9.1 3.0 1.6
• 6.7 Headache 8.5 7.6 11.9 9.4
• 3.3 Pain 3.4 3.0 1.5 4.7
• 6.7 Viral infection 5.1 7.6 9.0 4.7
• 8.3 Digestive System Diarrhea 0 1.5 6.0 1.6 0 Hemic and Lymphatic Lymphadenopathy 0 3.0 0 1.6 0 Musculoskeletal System Myalgia 0 0 1.5 1.6
• 3.3 Respiratory System Asthma 5.1 9.1 9.0 6.3
• 10.0 Pharyngitis 6.8 3.0 10.4 0
• 6.7 Rhinitis 1.7 6.1 10.4 3.1
• Skin and Appendages Eczema 0 0 0 0
• 3.3 Rash 0 0 7.5 1.6 0 Urticaria 0 0 3.0 0 0 Special Senses Otitis media 1.7 0 0 0
• 3.3 Note:
• Subjects may have more than one adverse event per body system and preferred term.
• Changes in heart rate, plasma glucose, and serum potassium are shown in Table 4.
• The clinical significance of these small differences is unknown.
• Table 4:
• Mean Changes from Baseline Heart Rate at 30 Minutes and Glucose and Potassium at 1 Hour after First Dose (Day 1) and Last Dose (Day 21) in
• Children 6 to 11 Years Old Treatment Mean Changes (Day 1) Heart Rate (bpm) Glucose (mg/dL) Potassium (mEq/L) Levalbuterol Inhalation Solution 0.31 mg, n=66 0.8 4.9 -0.31 Levalbuterol Inhalation Solution 0.63 mg, n=67 6.7 5.2 -0.36 Racemic albuterol 1.25 mg, n=64 6.4 8.0 -0.27 Racemic albuterol 2.5 mg, n=60 10.9 10.8 -0.56 Placebo, n=59 -1.8 0.6 -0.05 Treatment Mean Changes (Day 21) Heart Rate (bpm) Glucose (mg/dL) Potassium (mEq/L) Levalbuterol Inhalation Solution 0.31 mg, n=60 0 2.6 -0.32 Levalbuterol Inhalation Solution 0.63 mg, n=66 3.8 5.8 -0.34 Racemic albuterol 1.25 mg, n=62 5.8 1.7 -0.18 Racemic albuterol 2.5 mg, n=54 5.7 11.8 -0.26 Placebo, n=55 -1.7 1.1 -0.04
• 6.2 Postmarketing Experience In addition to the adverse reactions reported in clinical trials, the following adverse reactions have been observed in postapproval use of levalbuterol inhalation solution.
• Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
• These events have been chosen for inclusion due to their seriousness, their frequency of reporting, or their likely beta-mediated mechanism:
• angioedema, anaphylaxis, arrhythmias (including atrial fibrillation, supraventricular tachycardia, extrasystoles), asthma, chest pain, cough increased, dysphonia, dyspnea, gastrooesophageal reflux disease (GERD), metabolic acidosis, nausea, nervousness, rash, tachycardia, tremor, urticaria.
• In addition, levalbuterol inhalation solution, like other sympathomimetic agents, can cause adverse reactions such as hypertension, angina, vertigo, central nervous system stimulation, sleeplessness, headache, and drying or irritation of the oropharynx.

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• See FDA-approved patient labeling (Patient Information and Instructions for Using Levalbuterol Inhalation Solution).
• Patients should be given the following information:
• Hypersensitivity Query patients about previously experienced hypersensitivity to levalbuterol or racemic albuterol and counsel patients to report any hypersensitivity reactions to their physician.
• Frequency of Use Inform patients not to increase the dose or use levalbuterol inhalation solution more frequently than recommended without consulting their physician.
• If patients find that treatment with levalbuterol inhalation solution becomes less effective for symptomatic relief, symptoms become worse, or they need to use the product more frequently than usual, they should seek medical attention immediately.
• Paradoxical Bronchospasm Inform patients that levalbuterol inhalation solution can produce paradoxical bronchospasm.
• Instruct patients to discontinue levalbuterol inhalation solution if paradoxical bronchospasm occurs.
• Concomitant Drug Use Inform patients using levalbuterol inhalation solution, that other inhaled drugs and asthma medications should be taken only as directed by their physician.
• Common Adverse Reactions Advise patients of the common adverse reactions of treatment with levalbuterol inhalation solution including palpitations, chest pain, fast heart rate, headache, dizziness, tremor and nervousness.
• Pregnancy Advise patients who are pregnant or nursing to contact their physician about the use of levalbuterol inhalation solution.
• There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to asthma medication, including levalbuterol inhalation solution, during pregnancy.
• To enroll in the Asthma & Pregnancy Study or for more information about the registry, call 1-877-311-8972 or visit www.mothertobaby.org/ongoingstudy/asthma [see Use in Specific Populations (8.1)] .
• General Information on Storage and Use Advise patients to store levalbuterol inhalation solution in the foil pouch between 20°C to 25°C (68°F to 77°F) protected from light and excessive heat.
• Do not use after the expiration date stamped on the container.
• Unused vials should be stored in the protective foil pouch.
• Once the foil pouch is opened, the vials should be used within 2 weeks.
• Vials removed from the pouch, if not used immediately, should be protected from light and used within 1 week.
• Discard any vial if the solution is not colorless.
• Advise patients not to mix levalbuterol inhalation solution with other drugs in a nebulizer.
• For customer service, To report adverse events and For medical information:
• call 1-800-818-4555.

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• FORMS AND STRENGTHS Levalbuterol inhalation solution, USP is supplied in 3 mL unit-dose, low-density polyethylene (LDPE) vials as a clear, colorless, sterile, preservative-free, aqueous solution, in three different strengths of levalbuterol (0.31 mg, 0.63 mg, 1.25 mg).
• Each strength of levalbuterol inhalation solution, USP is available in a shelf carton containing two foil pouches, each containing 12 unit-dose LDPE vials, five foil pouches, each containing 5 unit-dose LDPE vials and six foil pouches, each containing 5 unit-dose LDPE vials.
• Inhalation Solution (unit-dose vial for nebulization):
• 0.31 mg/3 mL, 0.63 mg/3 mL and 1.25 mg/3 mL.
• ( 3 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• Levalbuterol inhalation solution, USP is supplied in 3 mL unit-dose, low-density polyethylene (LDPE) vials as a clear, colorless, sterile, preservative-free, aqueous solution, in three different strengths of levalbuterol (0.31 mg, 0.63 mg, 1.25 mg).
• Each strength of levalbuterol inhalation solution, USP is available in a shelf carton containing two foil pouches, each containing 12 unit-dose LDPE vials, five foil pouches, each containing 5 unit-dose LDPE vials and six foil pouches, each containing 5 unit-dose LDPE vials.
• Levalbuterol inhalation solution, USP, 0.31 mg contains 0.31 mg of levalbuterol (as 0.36 mg of levalbuterol HCl) and is available in cartons of 24 unit-dose LDPE vials (NDC 47335-743-49), 25 unit-dose LDPE vials (NDC 47335-743-01) and 30 unit-dose LDPE vials (NDC 47335-743-52).
• Levalbuterol inhalation solution, USP, 0.63 mg contains 0.63 mg of levalbuterol (as 0.73 mg of levalbuterol HCl) and is available in cartons of 24 unit-dose LDPE vials (NDC 47335-746-49), 25 unit-dose LDPE vials (NDC 47335-746-01) and 30 unit-dose LDPE vials (NDC 47335-746-52).
• Levalbuterol inhalation solution, USP, 1.25 mg contains 1.25 mg of levalbuterol (as 1.44 mg of levalbuterol HCl) and is available in cartons of 24 unit-dose LDPE vials (NDC 47335-753-49), 25 unit-dose LDPE vials (NDC 47335-753-01) and 30 unit-dose LDPE vials (NDC 47335-753-52).
• Storage:
• Store levalbuterol inhalation solution, USP in the protective foil pouch at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature].
• Protect from light and excessive heat.
• Keep unopened vials in the foil pouch.
• Once the foil pouch is opened, the vials should be used within 2 weeks.
• Vials removed from the pouch, if not used immediately, should be protected from light and used within 1 week.
• Discard any vial if the solution is not colorless.

Quoted from the official label, section “How Supplied”.

What is in it

• Levalbuterol inhalation solution, USP is a sterile, clear, colorless, preservative-free solution of the hydrochloride salt of levalbuterol, the (R)-enantiomer of the drug substance racemic albuterol. Levalbuterol HCl is a relatively selective beta 2 -adrenergic receptor agonist [see Clinical Pharmacology ( 12 ) ]. The chemical name for levalbuterol HCl is (R)-α 1 -[[(1,1­ dimethylethyl)amino]methyl]-4-hydroxy-1,3-benzenedimethanol hydrochloride, and its established chemical structure is as follows:
• The molecular weight of levalbuterol HCl is 275.8, and its molecular formula is C 13 H 21 NO 3
• HCl. It is a white to off-white, crystalline solid, with a melting point of approximately 187°C and solubility of approximately 180 mg/mL in water. Levalbuterol HCl is the USAN modified name for (R)-albuterol HCl in the United States. Levalbuterol inhalation solution, USP is supplied in unit-dose vials and requires no dilution before administration by nebulization. Each 3 mL unit-dose vial contains 0.31 mg of levalbuterol (as 0.36 mg of levalbuterol HCl, USP) or 0.63 mg of levalbuterol (as 0.73 mg of levalbuterol HCl, USP) or 1.25 mg of levalbuterol (as 1.44 mg of levalbuterol HCl, USP), sodium chloride to adjust tonicity, 0.30 mg of edetate disodium and sulfuric acid to adjust the pH to 4.0 (3.3 to 4.5). levalbuterol-chemical-structure

Quoted from the official label, section “Description”.

Ingredients people check for

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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