Levostar

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Levostar

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Medically reviewed

Marina Burgos

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Levostar

What is Levostar? The Definitive Overview

Levostar is a pharmaceutical preparation containing the active ingredient Levosalbutamol (also known as Levalbuterol), a synthetic, single-component medicine used to rapidly relax the muscles around the airways. It is fundamentally a Bronchodilator, delivered directly to the lungs via inhalation, and is recognized as the isolated, active form of the ingredient found in traditional salbutamol.

Property Description
Active ingredient Levosalbutamol (The (R)-enantiomer)
Form Inhalation Solution or Aerosol (for nebulizer/MDI)
Pharmacological class Short-Acting beta2-Agonist (SABA)
General purpose Relief from acute airway constriction (bronchospasm)
Origin Synthetic, enantiomerically pure

Definition and Pharmacological Classification

Levosalbutamol is formally classified as a Bronchodilator belonging to the Short-Acting beta2-Agonist (SABA) class. This designation means the medication is specifically engineered to act as a selective beta-2 adrenergic receptor agonist, primarily targeting receptors on the smooth muscle in the lungs to quickly induce relaxation. The effectiveness of this pharmacological class is utilized for providing immediate relief in scenarios involving acute airway narrowing, such as in individuals with reversible obstructive airway disease.

Composition and Form: The Single-Isomer Advantage

The most significant differentiating factor of Levosalbutamol is its composition as an enantiomerically pure substance, containing only the therapeutically active (R)-enantiomer of salbutamol. This isolates the component with beta2-agonist activity, eliminating the largely non-beneficial (S)-enantiomer found in the older racemic mixture of salbutamol. In this unique single-isomer preparation, the (R)-enantiomer performs the primary role in the therapeutic effect. The medication is formulated for Oral Inhalation to deliver the active substance directly to the site of action, commonly supplied as an Inhalation Solution or an Inhalation Aerosol.

General Benefit: Easing Airway Constriction

The general therapeutic purpose of this medication is to provide rapid functional relief from bronchospasm, which involves the sudden tightening of the muscles around the air passages. By acting directly on the receptor sites, the drug initiates the necessary relaxation of bronchial smooth muscle, easing the constriction. This mechanism allows the air passages to widen, which quickly helps to restore adequate airflow for the patient experiencing an acute episode of restricted breathing.

Regulatory References

  1. WHO Essential Medicines List

What side effects are possible with Levostar?

Possible Side Effects and Safety Information

The official safety profile for Levosalbutamol (Levostar) is structured by government regulatory documents, detailing adverse reactions by their expected frequency and the affected System-Organ Class (SOC). These classifications establish the regulatory understanding of the medicine’s risk profile.

Adverse Reaction Classification and Frequency

Adverse reactions are documented across several physiological systems. Nervous System Disorders and Infections and Infestations often contain the most frequently reported effects. Reactions commonly reported in clinical trials include Headache, Pain, Dizziness, Pharyngitis, Vomiting, and Bronchitis.

Less common but officially listed effects related to the heart include Tachycardia (increased heart rate) and Palpitations.

Serious Adverse Reactions

The regulatory label highlights specific, potentially clinically significant adverse reactions. These include Paradoxical Bronchospasm, which is a sudden and potentially life-threatening worsening of breathing that may occur immediately after administration. Immediate Hypersensitivity Reactions such as urticaria, angioedema, and anaphylaxis are also documented as serious events. The official safety documentation notes the potential for Clinically Significant Cardiovascular Effects (e.g., changes in heart rate and blood pressure) which are inherent to the pharmacological class.

Safety Considerations and Limitations

Regulatory documents define specific safety considerations for use in individuals with certain pre-existing conditions. Caution is explicitly advised for patients with cardiovascular disorders (such as coronary insufficiency or hypertension), convulsive disorders, hyperthyroidism, or diabetes mellitus. The beta2-agonist action carries the potential for metabolic effects, including Hypokalemia (decreased serum potassium), which is formally documented as a risk.

Overdose and Emergency Response

Overdose Map: Overdose and when to seek help — Official Regulatory Information for Levostar

Levosalbutamol (Levostar) overdose information is based on the substance's classification as a Short-Acting beta2-Agonist. The official regulatory documents describe the manifestations, severity, and required emergency actions strictly related to an acute excess of this medication.


Overdose Scope

Domain Official Regulatory Statement
Documented overdose presentations Manifestations include tachycardia, palpitations, tremor, nervousness, and headache, consistent with exaggerated beta-adrenergic stimulation.
Physiological systems affected Primary risks involve the cardiovascular and metabolic systems, with documented complications like hypokalemia and metabolic acidosis.
Dose-related or exposure-related factors Overdose occurs when the recommended dose is exceeded; regulatory labeling states that excessive use may be fatal.
Emergency-response statements Users must seek immediate medical attention or contact a poison control center for suspected acute overdose.
When immediate medical help is required Urgent care is required for any sign of acute toxicity, particularly severe symptoms such as chest pain or persistent irregular heartbeat.

Overdose Classifications (High-Level)

Classification Type Official Regulatory Statement
Severity classification Overdose is classified as potentially severe or life-threatening, with cardiac arrest being a documented severe outcome.
Regulatory basis Information is drawn from official sources like FDA Prescribing Information and international Summary of Product Characteristics (SmPC).
Overdose-context constraints Management requires symptomatic and supportive treatment, continuous cardiac monitoring, and testing of serum potassium levels.

Resulting overdose structure

Official overdose statements:

  • Acute toxicity presents as exaggerated beta-adrenergic effects (tachycardia, tremor) and may lead to hypokalemia and metabolic acidosis.
  • The potential for life-threatening outcomes, including cardiac arrest, necessitates that users seek immediate medical attention.
  • Management involves symptomatic and supportive treatment, along with monitoring of cardiac function and serum potassium levels.

Therapeutic Uses of Levostar

What Levostar Treats: Main Uses and Benefits

Levostar (Levosalbutamol) is a short-term supportive medication generally used to address symptoms and acute episodes across several respiratory domains. It is primarily indicated for the treatment or prevention of bronchospasm in patients with reversible obstructive airway disease. It is applied across domains where additional symptomatic support is needed when breathing difficulties arise.

The medication is commonly used across conditions presenting with acute episodes, including Asthma and Chronic Obstructive Pulmonary Disease (COPD). It helps address symptom clusters that may become intense or disruptive, such as wheezing, chest tightness, and acute shortness of breath. It is also often applied to prevent the onset of exercise-induced bronchospasm.

“This supportive medication is applied across domains where additional symptomatic support is needed when breathing difficulties arise.”

The general benefit is providing support that helps ease the overall symptom burden of these acute episodes. It is utilized during phases where the patient experiences heightened discomfort, offering relief that may help patients cope more steadily with difficult episodes and assists with comfort during symptomatic periods.


Quick Fact: Relief for Acute Airflow Restriction

Regulatory References

  1. DailyMed Full Prescribing Information for Levalbuterol

Eligibility and Restrictions for Use

Who can and cannot use Levostar? Official Regulatory Information

The eligibility for Levostar (Levosalbutamol) is strictly defined by regulatory documents, focusing on patient age, known drug component allergies, and certain pre-existing medical conditions.

Contraindications (Must NOT Use)

Classification Prohibited Patient Group
Absolute Contraindication Patients with a history of hypersensitivity to levalbuterol, racemic albuterol, or any other component of the product formulation.

Age-Related Eligibility

The medicine is indicated for use in adults and adolescents geq 12 years of age. For children, eligibility is determined by the specific formulation used:

  • Inhalation Aerosol (MDI): Indicated for children 4 years of age and older.
  • Inhalation Solution (Nebulizer): Indicated for children 6 years of age and older.
  • Use is not established in children below these respective minimum ages.

Condition-Specific Restrictions (Use with Caution)

Official labeling requires caution when the medicine is used in patients with certain conditions, including:

  • Cardiovascular disorders (e.g., coronary insufficiency, hypertension, arrhythmias).
  • Metabolic and Endocrine disorders (e.g., diabetes mellitus, hyperthyroidism).
  • Convulsive disorders.
  • Renal impairment (due to potential for decreased drug clearance).

Pregnancy and Lactation Eligibility

  • Pregnancy: Use should occur only if the potential benefit justifies the potential risk to the fetus.
  • Lactation: A decision must be made to discontinue nursing or discontinue the drug, taking into account the drug's importance to the mother.

What should I know about interactions with other medicines?

The official interaction profile for Levostar (Levosalbutamol) primarily details pharmacodynamic interactions and specific substance-related constraints derived from its classification as a beta-agonist.

Interaction-Related Restrictions

Classification Substance / Group Constraint/Interaction Pattern
Contraindicated Monoamine Oxidase Inhibitors (MAOIs), Linezolid Contraindicated due to risk of severe cardiovascular potentiation (e.g., acute hypertensive episodes).
Antagonism Risk Non-selective Beta-blockers May block the expected bronchodilatory effects and may precipitate bronchospasm.

Timing-Based Rule: The official documentation requires that administration of Levostar be avoided for 14 days (two weeks) following the discontinuation of MAOIs or Tricyclic Antidepressants (TCAs).

Other Documented Interactions:

  • Tricyclic Antidepressants (TCAs) and Other Adrenergic Drugs may potentiate the effect on the cardiovascular system, increasing the risk of cardiovascular adverse effects.
  • Non-potassium-sparing Diuretics carry an additive risk of hypokalemia (low serum potassium) and may worsen associated electrocardiographic changes.
  • Digoxin levels may be decreased by co-administration of Levostar, a documented pharmacokinetic effect on the co-administered drug. The label does not detail specific interactions with food, alcohol, or herbal products.

Mechanism of Action

Levostar, which contains levosalbutamol as the active R-enantiomer, functions as a selective beta2-adrenergic receptor agonist. Its primary targets are the beta2-adrenergic receptors found predominantly on the smooth muscle of the airways, extending from the trachea to the terminal bronchioles.

Binding of levosalbutamol to the beta2-receptor activates the associated Gs protein, leading to the stimulation of the enzyme adenylate cyclase. This enzymatic action catalyzes the conversion of adenosine triphosphate (ATP) into cyclic adenosine monophosphate (cAMP), resulting in an elevation of intracellular cAMP concentration.

Increased cAMP levels subsequently activate Protein Kinase A (PKA). PKA phosphorylates specific intracellular proteins, which causes two critical intracellular consequences: inhibition of myosin light-chain kinase (MLCK) phosphorylation and a decrease in intracellular ionic calcium ( Ca^2+) concentration. The reduction of intracellular Ca^2+ and the deactivation of the contractile machinery facilitate the relaxation of the airway smooth muscle. This ultimately results in system-level bronchodilation, increasing the diameter of the air passages.

Dosage and Administration Information

How to Use Levostar

Levostar (levosalbutamol/levalbuterol) administration is defined by its product labeling, which specifies its use as a supportive medication delivered exclusively via oral inhalation.


Official Administration and Dosage Patterns

The medicine is supplied as an Inhalation Solution for use with a jet nebulizer and as an Inhalation Aerosol for a Metered-Dose Inhaler (MDI), with specific dosing patterns defined for each form.

Formulation Population Standard Dose Frequency
Inhalation Solution Adults/Adolescents (ge 12 years) 0.63 mg or 1.25 mg Three times daily (every 6 to 8 hours)
Inhalation Aerosol Adults/Children (ge 4 years) 90 mcg (2 inhalations) Every 4 to 6 hours, as needed

These scheduled doses and intervals are fixed, and the recommended dose should not be exceeded. The dose for older adults may begin at 0.63 mg for the nebulizer solution, while safety and efficacy have not been established for children under 4 years (MDI) or under 6 years (nebulizer solution).


Preparation and Procedural Requirements

Correct administration depends on proper device usage. The Inhalation Aerosol is primed with four test sprays before the first use, or if it has not been used for more than three days, to ensure the dose is accurately delivered. Furthermore, the MDI actuator requires regular cleaning with warm water to prevent clogs. The solution intended for nebulization is typically used undiluted with a standard jet nebulizer.

This structured protocol establishes a precise, device-dependent framework for use, ensuring the medicine is utilized according to its intended design and delivery method.

Recent Clinical Evidence

The research structure for Levostar is based on controlled clinical trials and systematic reviews, primarily focusing on its use in acute asthma exacerbations and Chronic Obstructive Pulmonary Disease (COPD). In the context of acute asthma, studies monitored outcomes describing episodic or acute changes in the body, such as changes in airflow measurements in both adults and children. Comparative trials exploring the single-isomer drug against the older racemic mixture reported outcomes on physical discomfort and pulmonary function, but findings were mixed across different systematic reviews.

Research related to COPD examined the short-term physiological change on airflow and resource utilization in adults with moderate-to-severe disease. This evidence focuses mainly on the acute response during a flare-up, with observational studies reporting varying patterns related to resource use. For the prevention of Exercise-Induced Bronchospasm (EIB), research was structured as controlled challenge trials. These studies reported patterns related to functional pulmonary measurements taken after the challenge within the immediate follow-up period (typically six hours or less), demonstrating the research is limited to acute scenarios.

A central feature of the overall research landscape is the limited nature of long-term evidence. Data regarding the long-term functional measurements monitored over extended periods are less common than short-term trials, and long-term data are not fully established for chronic use. Additionally, limited information is available for certain specific population groups, such as older adults with multiple long-term health issues or very young children, and comparative evidence is lacking consensus across several endpoints. Research contributes context, but data are not fully established regarding sustained changes in the underlying disease context.

Key Studies & References

  1. Trough Bronchoprotection Conferred by Levosalbutamol and Racemic Salbutamol (NAI009)

Frequently Asked Questions (FAQ)

Common questions about Levostar (FAQ)


Q: Is Levostar a generic medication or a brand name?

Levostar is a brand name medication. Its active ingredient is levosalbutamol, which is also known by its generic name, levalbuterol. Official drug listings confirm this status.

Q: Can Levostar cause problems with sleep or insomnia?

Yes, official product information indicates that trouble sleeping, known as insomnia, has been reported as an adverse reaction in clinical studies for Levostar. This may be related to the stimulating effects on the central nervous system associated with this class of medication.

Q: Why do some people report feeling anxious while taking Levostar?

Official product information states that feelings of anxiety and nervousness have been reported in clinical studies. This reporting is consistent with the stimulating effects that this class of medication can have on the central nervous system.

Q: What should be done if a dose of Levostar is missed?

The official labeling does not contain specific instructions on what to do if a single dose is missed. Instead, the official documentation states that the dose or frequency of use should not be increased without first consulting a physician.

Q: Does Levostar interact with caffeine or energy drinks?

Official information indicates that Levostar is an adrenergic drug, meaning it can stimulate the central nervous system. Combining it with other stimulants, like those found in caffeine, may enhance effects suchs as increased heart rate and blood pressure. Regulatory warnings indicate that caution and monitoring may be warranted when these substances are used together.

Q: Can Levostar be taken with everyday foods or specific meals?

According to the official product labeling, there are no specific food interactions detailed for Levostar. General administration guidelines provided by a healthcare provider should be followed.

Q: Are there any known interactions between Levostar and herbal supplements?

The regulatory label does not list specific interactions with herbal supplements. However, because some herbal products may affect the body in ways similar to medication, patients are generally advised to inform their healthcare provider about all supplements they are taking.

Q: Is it safe to consume alcohol while using Levostar?

Levostar is not known to interact directly with alcohol, and the official label does not contain a specific restriction. Nevertheless, alcohol consumption may sometimes worsen the underlying symptoms of obstructive airway disease that the medication is intended to treat.

Q: How quickly should I expect Levostar to start working?

Studies and official information indicate that the quick-relief effect of Levostar generally begins rapidly after administration. Depending on the specific device used, the onset can start within 5 to 17 minutes.

Q: How long does the effect of one dose of Levostar last in the body?

As a Short-Acting beta2-Agonist (SABA), the bronchodilatory effects of one dose typically last for a few hours. Official information suggests the effects generally last approximately 3 to 6 hours for the Inhalation Aerosol and 5 to 8 hours for the Inhalation Solution.

Q: Is Levostar designed for short-term use only?

Levostar is primarily indicated for the acute treatment of sudden airway tightening (bronchospasm). While its use can be continued as needed to control recurring acute episodes, official documents indicate that it is not a substitute for long-term, daily maintenance control medications.

Q: Are there special considerations for Levostar use in people with kidney or liver issues?

Caution is officially advised for patients who have renal impairment (kidney issues) because this may potentially slow down how the body clears the drug. The regulatory label does not specifically detail precautions or dosage adjustments for patients with liver impairment.

Q: Can Levostar affect blood sugar levels?

Yes, official warnings note that Levostar may cause clinically significant changes in blood glucose (sugar) levels. For this reason, caution is specifically advised for use in patients who have diabetes mellitus.

Q: What happens in the body when Levostar is being processed?

Levostar functions by binding to specific receptors in the lungs to relax the airways. Once its therapeutic effect is complete, the active ingredient is mainly processed and excreted by the body through the kidneys in the urine over time.

Q: Is it true that Levostar is only for very serious conditions?

Levostar is indicated for the quick relief of restricted breathing caused by bronchospasm in conditions like asthma and COPD. It is used to manage acute events that are functionally significant, meaning they directly impact the ability to breathe adequately.

Q: Can Levostar interfere with other non-prescription vitamins or mineral supplements?

Levostar belongs to a class of drugs that carries a risk of hypokalemia, which is low serum potassium. Official product information notes that patients are typically advised to inform their healthcare provider about all supplements, including minerals like potassium, as the combined effects may potentially be additive.

How should Levostar be stored and disposed of?

Official Storage and Disposal Requirements for Levostar

Levostar (Levosalbutamol) inhalation solution must be stored strictly according to its official labeling to ensure product stability.

Storage Conditions

Condition Requirement
Temperature Store at controlled room temperature, between 20 C and 25 C (68 F and 77 F).
Prohibited Do not refrigerate or freeze the inhalation solution.
Protection Keep the product protected from heat and direct light.
Packaging Store ampules in the original foil pouch; unused ampules removed from the pouch must be used within one week.
Child Safety Keep out of the reach and sight of children.

Disposal

Expired or unused Levostar must be disposed of according to local requirements and pharmacist guidance. The aerosol canister must never be thrown into a fire or incinerator.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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