NDC 0115-9931 Levalbuterol

Levalbuterol Hydrochloride

NDC Product Code 0115-9931

NDC 0115-9931-78

Package Description: 1 POUCH in 1 CARTON > 25 AMPULE in 1 POUCH (0115-9931-76) > 3 mL in 1 AMPULE

NDC Product Information

Levalbuterol with NDC 0115-9931 is a a human prescription drug product labeled by Amneal Pharmaceuticals Of New York Llc. The generic name of Levalbuterol is levalbuterol hydrochloride. The product's dosage form is solution and is administered via respiratory (inhalation) form.

Labeler Name: Amneal Pharmaceuticals Of New York Llc

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Levalbuterol Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • LEVALBUTEROL HYDROCHLORIDE .63 mg/3mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • EDETATE DISODIUM DIHYDRATE (UNII: 7FLD91C86K)
  • EDETATE DISODIUM DIHYDRATE (UNII: 7FLD91C86K)
  • EDETATE DISODIUM DIHYDRATE (UNII: 7FLD91C86K)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.
  • Respiratory (inhalation) - Administration within the respiratory tract by inhaling orally or nasally for local or systemic effect.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Adrenergic beta2-Agonists - [MoA] (Mechanism of Action)
  • beta2-Adrenergic Agonist - [EPC] (Established Pharmacologic Class)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Amneal Pharmaceuticals Of New York Llc
Labeler Code: 0115
FDA Application Number: ANDA203653 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 03-22-2016 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Information for Patients

Levalbuterol Oral Inhalation

Levalbuterol Oral Inhalation is pronounced as (lev al byoo' ter ol)

Why is levalbuterol oral inhalation medication prescribed?
Levalbuterol is used to prevent or relieve the wheezing, shortness of breath, coughing, and chest tightness caused by lung disease such as asthma and chronic obstructive ...
[Read More]

* Please review the disclaimer below.

Levalbuterol Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

1 Indications And Usage

Levalbuterol Inhalation Solution, USP is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older with reversible obstructive airway disease.

2 Dosage And Administration

Levalbuterol Inhalation Solution, USP is for oral inhalation only. Administer by nebulization using a standard jet nebulizer (with a face mask or mouthpiece) connected to an air compressor. Do not exceed recommended dose.

3 Dosage Forms And Strengths

Inhalation Solution 3 mL unit-dose, vials in three dosage strengths of levalbuterol; 0.31 mg, 0.63 mg, 1.25 mg.

4 Contraindications

Levalbuterol Inhalation Solution, USP is contraindicated in patients with a history of hypersensitivity to levalbuterol or racemic albuterol. Reactions have included urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema [see



Warnings and Precautions (5.6)].

5.1 Paradoxical Bronchospasm

Levalbuterol Inhalation Solution, USP can produce paradoxical bronchospasm, which may be life-threatening. If paradoxical bronchospasm occurs, Levalbuterol Inhalation Solution, USP should be discontinued immediately and alternative therapy instituted. It should be recognized that paradoxical bronchospasm, when associated with inhaled formulations, frequently occurs with the first use of a new vial.

5.2 Deterioration Of Asthma

Asthma may deteriorate acutely over a period of hours or chronically over several days or longer. If the patient needs more doses of Levalbuterol Inhalation Solution, USP than usual, this may be a marker of destabilization of asthma and requires reevaluation of the patient and treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids.

5.3 Use Of Anti-Inflammatory Agents

Levalbuterol Inhalation Solution, USP is not a substitute for corticosteroids. The use of beta-adrenergic agonist alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents, e.g., corticosteroids, to the therapeutic regimen.

5.4 Cardiovascular Effects

Levalbuterol Inhalation Solution, USP, like other beta-adrenergic agonists, can produce clinically significant cardiovascular effects in some patients, as measured by heart rate, blood pressure, and symptoms. Although such effects are uncommon after administration of Levalbuterol Inhalation Solution, USP at recommended doses, if they occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce electrocardiogram (ECG) changes, such as flattening of the t-wave, prolongation of the QTc interval, and ST segment depression. The clinical significance of these findings is unknown. Therefore, Levalbuterol Inhalation Solution, USP, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.

Do not exceed the recommended dose. Fatalities have been reported in association with excessive use of inhaled sympathomimetic drugs in patients with asthma. The exact cause of death is unknown, but cardiac arrest following an unexpected development of a severe acute asthmatic crisis and subsequent hypoxia is suspected.

5.6 Immediate Hypersensitivity Reactions

Immediate hypersensitivity reactions may occur after administration of levalbuterol or racemic albuterol. Reactions have included urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema. The potential for hypersensitivity must be considered in the clinical evaluation of patients who experience immediate hypersensitivity reactions while receiving Levalbuterol Inhalation Solution, USP.

5.7 Coexisting Conditions

Levalbuterol Inhalation Solution, USP, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, hypertension, and cardiac arrhythmias; in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus; and in patients who are unusually responsive to sympathomimetic amines. Clinically significant changes in systolic and diastolic blood pressure have been seen in individual patients and could be expected to occur in some patients after the use of any beta-adrenergic bronchodilator.Changes in blood glucose may occur. Large doses of intravenous racemic albuterol have been reported to aggravate preexisting diabetes mellitus and ketoacidosis.

5.8 Hypokalemia

As with other beta-adrenergic agonist medications, Levalbuterol Inhalation Solution, USP may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects. The decrease is usually transient, not requiring supplementation.

6 Adverse Reactions

  • 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)]

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.

6.2 Post-Marketing 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, USP. 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, USP, 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.

7.1 Short-Acting Bronchodilators

Avoid concomitant use of other short-acting sympathomimetic bronchodilators or epinephrine in patients being treated with Levalbuterol Inhalation Solution, USP. If additional adrenergic drugs are to be administered by any route, they should be used with caution to avoid deleterious cardiovascular effects.

7.2 Beta-Blockers

Beta-adrenergic receptor blocking agents not only block the pulmonary effect of beta-adrenergic agonists such as Levalbuterol Inhalation Solution, USP, but may produce severe bronchospasm in asthmatic patients. Therefore, patients with asthma should not normally be treated with beta-blockers. However, under certain circumstances, e.g., prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-adrenergic blocking agents in patients with asthma. In this setting, cardioselective beta-blockers should be considered, although they should be administered with caution.

7.3 Diuretics

The ECG changes or hypokalemia that may result from the administration of non-potassium-sparing diuretics (such as loop and thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded. Although the clinical significance of these effects is not known, caution is advised in the coadministration of beta-agonists with non-potassium-sparing diuretics. Consider monitoring potassium levels.

7.4 Digoxin

Mean decreases of 16% and 22% in serum digoxin levels were demonstrated after single-dose intravenous and oral administration of racemic albuterol, respectively, to normal volunteers who had received digoxin for 10 days. The clinical significance of these findings for patients with obstructive airway disease who are receiving Levalbuterol Inhalation Solution, USP and digoxin on a chronic basis is unclear. Nevertheless, it would be prudent to carefully evaluate the serum digoxin levels in patients who are currently receiving digoxin and Levalbuterol Inhalation Solution, USP.

7.5 Monoamine Oxidase Inhibitors Or Tricyclic Antidepressants

Levalbuterol Inhalation Solution, USP should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents, because the action of levalbuterol on the vascular system may be potentiated. Consider alternative therapy in patients taking MAO inhibitors or tricyclic antidepressants.

8.2 Labor And Delivery

Because of the potential for beta-adrenergic agonists to interfere with uterine contractility, the use of Levalbuterol Inhalation Solution, USP for the treatment of bronchospasm during labor should be restricted to those patients in whom the benefits clearly outweigh the risk.Levalbuterol Inhalation Solution, USP has not been approved for the management of preterm labor. The benefit:risk ratio when levalbuterol HCl is administered for tocolysis has not been established. Serious adverse reactions, including maternal pulmonary edema, have been reported during or following treatment of premature labor with beta



2-agonists, including racemic albuterol.

8.3 Nursing Mothers

Plasma concentrations of levalbuterol after inhalation of therapeutic doses are very low in humans. It is not known whether levalbuterol is excreted in human milk.Because of the potential for tumorigenicity shown for racemic albuterol in animal studies and the lack of experience with the use of Levalbuterol Inhalation Solution, USP by nursing mothers, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Caution should be exercised when Levalbuterol Inhalation Solution, USP is administered to a nursing woman.

8.4 Pediatric Use

Pediatric Patients 6 Years of Age and OlderThe safety and efficacy of Levalbuterol Inhalation Solution, USP 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 AgeLevalbuterol Inhalation Solution, USP is not indicated for pediatric patients less than 6 years of age.Clinical trials with Levalbuterol Inhalation Solution, USP 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, USP treatment.Additional information describing clinical studies in which safety and efficacy were not demonstrated in pediatric patients less than 6 years of age is approved for Oak Pharmaceuticals, Inc.’s XOPENEX



® (levalbuterol hydrochloride) Inhalation Solution. However, due to Oak Pharmaceuticals, Inc.’s marketing exclusivity rights, this product is not labeled with that pediatric information.

8.5 Geriatric Use

Clinical studies of Levalbuterol Inhalation Solution, USP 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, USP 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, USP. If clinically warranted due to insufficient bronchodilator response, the dose of Levalbuterol Inhalation Solution, USP 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)].

8.6 Renal Impairment

Albuterol is known to be substantially excreted by the kidney, and the risk of toxic reactions may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

10 Overdosage

The expected symptoms with overdosage are those of excessive beta-adrenergic receptor stimulation and/or occurrence or exaggeration of any of the symptoms listed under



Adverse Reactions (6), e.g., seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats/min., arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, and sleeplessness. Hypokalemia also may occur. As with all sympathomimetic medications, cardiac arrest and even death may be associated with the abuse of Levalbuterol Inhalation Solution, USP. Treatment consists of discontinuation of Levalbuterol Inhalation Solution, USP together with appropriate symptomatic therapy. The judicious use of a cardioselective beta-receptor blocker may be considered, bearing in mind that such medication can produce bronchospasm. There is insufficient evidence to determine if dialysis is beneficial for overdosage of Levalbuterol Inhalation Solution, USP.

11 Description

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 empirical formula is C
13H
21NO
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/3 mL (0.0103%) of levalbuterol (as 0.36 mg/3 mL of levalbuterol HCl) or 0.63 mg/3 mL (0.021%) of levalbuterol (as 0.73 mg/3 mL of levalbuterol HCl) or 1.25 mg/3 mL (0.042%) of levalbuterol (as 1.44 mg/3 mL of levalbuterol HCl), sodium chloride to adjust tonicity, edetate disodium (EDTA) as a stabilizer for the active pharmaceutical ingredient, and sulfuric acid to adjust the pH to 4.0 (3.3 to 4.5).

12.1 Mechanism Of Action

Activation of beta



2-adrenergic receptors on airway smooth muscle leads to the activation of adenylate cyclase and to an increase in the intracellular concentration of cyclic-3′, 5′-adenosine monophosphate (cyclic AMP). The increase in cyclic AMP is associated with the activation of protein kinase A, which in turn inhibits the phosphorylation of myosin and lowers intracellular ionic calcium concentrations, resulting in muscle relaxation. Levalbuterol relaxes the smooth muscles of all airways, from the trachea to the terminal bronchioles. Increased cyclic AMP concentrations are also associated with the inhibition of release of mediators from mast cells in the airway. Levalbuterol acts as a functional antagonist to relax the airway irrespective of the spasmogen involved, thus protecting against all bronchoconstrictor challenges. While it is recognized that beta



2-adrenergic receptors are the predominant receptors on bronchial smooth muscle, data indicate that there are beta-receptors in the human heart, 10% to 50% of which are beta



2-adrenergic receptors. The precise function of these receptors has not been established [see



Warnings and Precautions (5.4)]. However, all beta-adrenergic agonist drugs can produce a significant cardiovascular effect in some patients, as measured by pulse rate, blood pressure, symptoms, and/or electrocardiographic changes.

13.1 Carcinogenesis, Mutagenesis, Impairment Of Fertility

Although there have been no carcinogenesis studies with levalbuterol HCl, racemic albuterol sulfate has been evaluated for its carcinogenic potential.In a 2-year study in Sprague-Dawley rats, dietary administration of racemic albuterol sulfate resulted in a significant dose-related increase in the incidence of benign leiomyomas of the mesovarium at doses of 2 mg/kg/day and greater (approximately 4 times the MRDI dose of levalbuterol HCl for adults and approximately 5 times the MRDI dose of levalbuterol HCl for children on a mg/m



2 basis). In an 18-month study in CD-1 mice and a 22-month study in the golden hamster, dietary administration of racemic albuterol sulfate showed no evidence of tumorigenicity. Dietary doses in CD-1 mice were up to 500 mg/kg/day (approximately 540 times the MRDI dose of levalbuterol HCl for adults and approximately 630 times the MRDI dose of levalbuterol HCl for children on a mg/m



2 basis) and doses in the golden hamster study were up to 50 mg/kg/day (approximately 90 times the MRDI dose of levalbuterol HCl for adults on a mg/m



2 basis and approximately 105 times the MRDI dose of levalbuterol HCl for children on a mg/m



2 basis).



Levalbuterol HCl was not mutagenic in the Ames test or the CHO/HPRT Mammalian Forward Gene Mutation Assay. Levalbuterol HCl was not clastogenic in the



in vivo micronucleus test in mouse bone marrow. Racemic albuterol sulfate was not clastogenic in an



in vitro chromosomal aberration assay in CHO cell cultures.



No fertility studies have been conducted with levalbuterol hydrochloride. Reproduction studies in rats using racemic albuterol sulfate demonstrated no evidence of impaired fertility at oral doses up to 50 mg/kg/day (approximately 108 times the maximum recommended daily inhalation dose of levalbuterol HCl for adults on a mg/m



2 basis).

16 How Supplied/Storage And Handling

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).Levalbuterol Inhalation Solution, USP, 0.31 mg/3 mL (
foil pouch label color green) contains 0.31 mg/3 mL (0.0103%) of levalbuterol (as 0.36 mg/3 mL of levalbuterol HCl) and is available in cartons as listed below.
NDC 0115-9930-78 25 vials per carton / 25 vials per foil pouchLevalbuterol Inhalation Solution, USP, 0.63 mg/3 mL (
foil pouch label color yellow) contains 0.63 mg/3 mL (0.021%) of levalbuterol (as 0.73 mg/3 mL of levalbuterol HCl) and is available in cartons as listed below.
NDC 0115-9931-78 25 vials per carton / 25 vials per foil pouchLevalbuterol Inhalation Solution, USP, 1.25 mg/3 mL (
foil pouch label color red) contains 1.25 mg/3 mL (0.042%) of levalbuterol (as 1.44 mg/3 mL of levalbuterol HCl) and is available in cartons as listed below.
NDC 0115-9932-78 25 vials per carton / 25 vials per foil pouch

17 Patient Counseling Information

See FDA-approved patient labeling



(Patient Information Leaflet and



Instructions for Using Levalbuterol Inhalation Solution, USP).



Patients should be given the following information:

Patient Information Leaflet

  • Levalbuterol Inhalation Solution, USP
  • (pronounced lev" al bue' ter ol)
  • 0.31 mg, 0.63 mg, 1.25 mg3 mL Unit-Dose VialsFor Oral Inhalation OnlyRx onlyLevalbuterol Inhalation Solution, USP is only for use with a nebulizer.Read this Patient Information Leaflet before you start to use Levalbuterol Inhalation Solution, USP and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment.What is Levalbuterol Inhalation Solution, USP?Levalbuterol Inhalation Solution, USP is an inhaled prescription medicine used for the treatment or prevention of bronchospasm in people 6 years of age and older.Levalbuterol Inhalation Solution, USP has not been shown to be safe and effective in children younger than 6 years of age.Levalbuterol Inhalation Solution, USP is supplied in 3 mL unit-dose vials in three different strengths of levalbuterol (0.31 mg, 0.63 mg, 1.25 mg). The vials do not require dilution before use.Who should not use Levalbuterol Inhalation Solution, USP?Do not use Levalbuterol Inhalation Solution, USP if you are allergic to levalbuterol, racemic albuterol, or any of the ingredients in Levalbuterol Inhalation Solution, USP. See the end of this leaflet for a complete
  • List of ingredients in Levalbuterol Inhalation Solution, USP.
  • What should I tell my doctor before using Levalbuterol Inhalation Solution, USP?Before you use Levalbuterol Inhalation Solution, USP, tell your doctor if you have:had an allergic reaction to levalbuterol or racemic albuterolheart problemshigh blood pressureseizuresdiabetesthyroid problemsany other medical conditionsare pregnant or planning to become pregnant. It is not known if Levalbuterol Inhalation Solution, USP will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.are breastfeeding or plan to breastfeed. It is not known if Levalbuterol Inhalation Solution, USP passes into your breast milk. You and your doctor should decide if you will use Levalbuterol Inhalation Solution, USP or breastfeed. You should not do both.Tell your doctor about all the medicines you take including prescription and over-the-counter medicines, vitamins, and herbal supplements. Levalbuterol Inhalation Solution, USP may affect the way other medicines work, and other medicines may affect how Levalbuterol Inhalation Solution, USP works.
  • Especially tell your doctor if you take:other asthma medicinesheart medicinesmedicines that increase urination (diuretics)antidepressantsmedicine to treat chronic obstructive pulmonary disease (COPD)Ask your doctor if you are not sure if any of your medicines are the kinds listed above.Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.How should I use Levalbuterol Inhalation Solution, USP?Read the step-by-step Instructions for Using Levalbuterol Inhalation Solution, USP at the end of this leaflet.Use Levalbuterol Inhalation Solution, USP exactly as your doctor tells you to.
  • Do not change your dose without talking to your doctor first.
  • Your doctor will tell you how many times and when to use your Levalbuterol Inhalation Solution, USP.An adult should help a child use Levalbuterol Inhalation Solution, USP.Do not use your Levalbuterol Inhalation Solution, USP more often than your doctor tells you to.Get medical help right away if Levalbuterol Inhalation Solution, USP:does not work as well for your asthma symptoms oryour asthma symptoms get worse oryou need to use your Levalbuterol Inhalation Solution, USP more often than usualIf you also use another medicine by inhalation, you should ask your doctor for instructions on when to use it while you are also using Levalbuterol Inhalation Solution, USP.Do not mix Levalbuterol Inhalation Solution, USP with other medicines in your nebulizer.
  • Only use Levalbuterol Inhalation Solution, USP if it is colorless. Throw away the Levalbuterol Inhalation Solution, USP vial if the liquid medicine is not colorless.
  • Do not use Levalbuterol Inhalation Solution, USP after the expiration date on the vial.What are the possible side effects of Levalbuterol Inhalation Solution, USP?Levalbuterol Inhalation Solution, USP can cause serious side effects including:sudden shortness of breath (bronchospasm). Sudden shortness of breath can happen right away after using Levalbuterol Inhalation Solution, USP.
  • Worsening asthmaheart problemsdeath. If you use too much Levalbuterol Inhalation Solution, USP you can have heart or lung problems that can lead to death.
  • Serious allergic reactions. Call your doctor and stop using Levalbuterol Inhalation Solution, USP right away if you have any symptoms of an allergic reaction such as:
  • Swelling of the face, throat or tonguehivesrashbreathing problemslow potassium levels in your bloodCall your doctor or go to the nearest hospital emergency room right away if you have any of the serious side effects listed above or if you have worsening lung symptoms.The most common side effects of Levalbuterol Inhalation Solution, USP include:palpitationschest painfast heart rateheadachedizzinesstremornervousnessTell your doctor if you have any side effects that bother you or that do not go away.These are not all the possible side effects of Levalbuterol Inhalation Solution, USP. For more information, ask your doctor or pharmacist.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.How should I store Levalbuterol Inhalation Solution, USP?Store unopened Levalbuterol Inhalation Solution, USP vials in the protective foil pouch they come in at 20°-25°C (68°-77°F).Keep Levalbuterol Inhalation Solution, USP away from light and heat.When a Levalbuterol Inhalation Solution, USP foil pouch is opened, use the vials within 2 weeks.When Levalbuterol Inhalation Solution, USP vials are removed from the foil pouch, use them right away or within 1 week.Keep Levalbuterol Inhalation Solution, USP and all medicines out of the reach of children.General information about the safe and effective use of Levalbuterol Inhalation Solution, USP.Medicines are sometimes prescribed for purposes other than those listed in a Patient Information Leaflet. Do not use Levalbuterol Inhalation Solution, USP for a condition for which it was not prescribed. Do not give Levalbuterol Inhalation Solution, USP to other people, even if they have the same symptoms that you have. It may harm them.This Patient Information Leaflet summarizes the most important information about Levalbuterol Inhalation Solution, USP. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Levalbuterol Inhalation Solution, USP that is written for health professionals.To report SUSPECTED ADVERSE REACTIONS, contact Impax Laboratories, Inc.  at 1-855-806-3300 or FDA at 1-800-FDA-1088 or
  • Www.fda.gov/medwatch.
  • What are the ingredients in Levalbuterol Inhalation Solution, USP?Active ingredient: levalbuterol hydrochlorideInactive ingredients: sodium chloride, edetate disodium, sulfuric acid, and water

Instructions For Using Levalbuterol Inhalation Solution, Usp

Levalbuterol Inhalation Solution, USP vial (see
Figure A):
Using your Levalbuterol Inhalation Solution, USP:Read the following Steps before using your Levalbuterol Inhalation Solution, USP. If you have any questions, ask your doctor or pharmacist.
Step 1. Open the foil pouch by tearing the notched edge along the seam of the pouch (
see
Figure B). Remove 1 vial to be used right away. Keep the rest of the unused vials in the foil pouch to protect them from light and heat.
Step 2. Hold the vial in your hands. Make sure your thumb and finger cover the twist-off tabs below the X-top (
see
Figure C).
Step 3. While holding the top firmly between your thumb and finger, twist the body of the vial to open the vial (
see
Figure C).
Step 4. Throw away the top of the vial and squeeze the entire contents of the vial into the nebulizer reservoir (
see
Figure D).
Step 5. Connect the nebulizer reservoir to the mouthpiece (
see
Figure E.1) or face mask (
see
Figure E.2).
      Figure E.1 Figure E.2. Step 6. Connect the nebulizer to the compressor (
see
Figure F).
Step 7. Sit in a comfortable, upright position. Place the mouthpiece in your mouth (
see
Figure G.1) or put on your face mask (
see
Figure G.2). Turn on the compressor.
      Figure G.1 Figure G.2 Step 8. Breathe as calmly, deeply, and evenly as possible until no more mist is seen in the nebulizer reservoir. Your treatment will take about 5 to 15 minutes. When you do not see any mist in the nebulizer reservoir, your treatment is finished.
Step 9. Clean and store your nebulizer. See the manufacturer's instructions that come with your nebulizer for how to clean and store your nebulizer.
This Patient Information Leaflet and Instructions for Use have been approved by the U.S. Food and Drug Administration.Manufactured by:   The Ritedose CorporationColumbia, SC 29203 USA Distributed by:Impax GenericsHayward, CA 94544     To report SUSPECTED ADVERSE REACTIONS, contact Impax Laboratories, Inc. at 1-800-934-6729 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.   2105-01Iss. 07/2017                                                                                                                                                                                                     RPIN0090

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