Levosan

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Levosan

Quick Facts

Property Description
Active Ingredient Levocetirizine
Form Oral Tablet or Syrup/Solution
Pharmacological Class Antihistamine (H1-Receptor Antagonist)
Common Use Relief of general allergy symptoms
Origin Synthetic

What Type of Medicine is Levosan?

Levosan is an anti-allergic medication whose active component is the substance Levocetirizine. It is classified as a second-generation antihistamine, a category of medicine known formally as a Histamine H1-Receptor Antagonist, which is clinically recognized for easing the discomfort associated with allergies. This class of drugs is used to relieve common symptoms like itching, sneezing, and watery eyes caused by the body's reaction to allergens.

What is Levosan Made Of and How is it Formulated?

The essential component of this medicine is the single active ingredient, Levocetirizine. This compound is synthetic, having been developed as the highly active enantiomer (pure form) of the older antihistamine, Cetirizine. Levosan is typically manufactured as a single active ingredient product for oral use, meaning it is taken by mouth. It is commonly available in two distinct formats: a tablet and a syrup/oral solution, providing flexible administration options for different patients.

How Does Levosan Compare to Older Allergy Drugs?

Levosan is part of the modern, selective generation of antihistamines. Levocetirizine is less likely to cross the blood-brain barrier than older agents. This pharmacological property means that Levosan works to relieve allergic discomfort while exhibiting a lower potential for causing significant drowsiness compared to some first-generation antihistamines. The drug is thus frequently chosen for daily use during allergy seasons.

Regulatory References

  1. MedlinePlus: Levocetirizine Drug Information

What side effects are possible with Levosan?

Possible Side Effects and Safety Information

The safety profile of Levosan (Levocetirizine) outlines possible adverse reactions categorized by their reported frequency in official regulatory documents. These classifications include effects on various organ systems.


Frequency-Classified Adverse Reactions

The most frequently reported effects in regulatory studies are classified as Common (affecting 1 to 10 users in 100). These reactions typically involve the nervous and gastrointestinal systems, and include Somnolence (drowsiness or sleepiness), Fatigue, and Dry Mouth. Effects classified as Uncommon (affecting 1 to 10 users in 1,000) include Abdominal Pain and general lack of energy (Asthenia).

Reactions classified as Not Known are based on post-marketing surveillance and cannot be reliably estimated. These serious effects include Anaphylaxis (severe allergic reaction), Convulsion (seizure), and certain psychiatric disturbances such as Suicidal Ideation.


System-Organ Class Involvement

Adverse reactions are organized by the physiological systems they affect. Systems involved include Nervous System Disorders (e.g., somnolence, dizziness), Gastrointestinal Disorders (e.g., dry mouth, nausea), and Psychiatric Disorders (e.g., aggression, insomnia).


Safety Constraints and Special Populations

Official labeling contains specific constraints. The medicine is Contraindicated in individuals with severe renal impairment (end-stage kidney disease). Caution is advised for older adults due to the greater likelihood of reduced kidney function. The label also notes that severe, widespread itching (Rebound Pruritus) has been reported upon discontinuation following long-term daily use. Additionally, caution is advised for patients with pre-existing conditions that increase the risk of Urinary Retention.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory documentation describes Levosan (Levocetirizine) overdose primarily through effects on the Central Nervous System (CNS). The documented clinical manifestations differ based on age. Overdose in adults is generally characterized by pronounced drowsiness (somnolence). In children, the symptoms typically present in a two-stage pattern, beginning with agitation and restlessness, followed by a subsequent state of drowsiness. Overdose may also be associated with conditions such as urinary retention.

If any level of overdose is suspected, official guidance strictly mandates that individuals seek immediate medical attention and/or contact a Poison Control Center immediately.

Management procedures are strictly defined as symptomatic and supportive treatment, as regulatory data confirms there is no known specific antidote available to reverse the effects of Levocetirizine. Procedural interventions may involve the consideration of gastric lavage following the short-term ingestion of a toxic quantity. A key consideration noted in official documents for managing severe cases is that the active substance is not effectively removed by haemodialysis, meaning this procedure is ineffective unless other dialyzable agents were also ingested.

Therapeutic Uses of Levosan

What Levosan Treats: Main Uses and Benefits

Levosan is commonly used to help manage the symptomatic discomfort associated with a few key allergic domains. The medication is applied across contexts where additional symptomatic support is needed to address symptoms that interfere with daily functioning. This may include conditions presenting with systemic or localized discomfort, particularly seasonal and perennial allergic rhinitis and the uncomplicated skin manifestations of chronic idiopathic urticaria (hives).

The medicine is relevant for easing symptom clusters that may become intense or disruptive, such as a runny nose, sneezing, itchy eyes, and skin itching. The medication assists with maintaining functional stability when symptoms create noticeable physiological strain. It supports patients during difficult episodes by easing distress.

Quick Fact: Targeted for Itching Symptoms

It contributes to easing the overall symptom load and helps maintain a sense of stability when symptoms are more noticeable.

Regulatory References

  1. DailyMed/NIH official drug label

Eligibility and Restrictions for Use

This section outlines the official population-eligibility rules for Levosan (Levocetirizine), strictly based on governmental regulatory labeling.

Contraindicated Populations (Must Not Use)

Use is contraindicated in patients with a known hypersensitivity to levocetirizine, cetirizine, or hydroxyzine. Absolute exclusion applies to patients with end-stage renal disease (creatinine clearance < 10 mL/min) and those undergoing hemodialysis.

Age-Specific Eligibility

Age Group Eligibility Status (Regulatory)
Infants (< 6 months) Safety and efficacy not established [1.1, 1.3].
Children (6 months to 11 years) Approved for use (liquid formulation is recommended for children under 6) [1.5].
Adults and Adolescents (ge 12 years) Standard approved population [1.5].
Older Adults Caution is advised due to potential age-related decline in renal function [1.1].

Condition-Based Restrictions

Eligibility is restricted for patients with impaired kidney function. All pediatric patients (6 months to 11 years) with any degree of renal impairment are contraindicated [1.5]. Adults and adolescents with mild to severe renal impairment are eligible but require a change in use frequency [1.5]. Patients with predisposing factors for urinary retention (e.g., prostatic hyperplasia) should use with caution [1.1]. For pregnancy, use is advised only if clearly needed; caution is recommended during lactation as the substance may be excreted in human milk [2.2].

What should I know about interactions with other medicines?

Levosan Interactions with Other Medicines and Products

Official regulatory information for Levosan (Levocetirizine) outlines specific interactions related to pharmacodynamic effects and altered drug exposure, derived from studies on Levocetirizine and its parent drug, Cetirizine.


Pharmacodynamic and CNS Restrictions

Concurrent use with alcohol (Ethanol) or other Central Nervous System (CNS) depressants should be avoided. This combination may lead to additional reductions in alertness and further CNS performance impairment, as documented by regulatory authorities.

Pharmacokinetic Alterations

Levosan is considered unlikely to produce significant metabolic interactions due to its low involvement with major CYP enzyme systems.

  • Ritonavir: Co-administration with the racemate, Cetirizine, resulted in an increase in plasma exposure ( AUC) by approximately 42% and a decrease in its clearance.
  • Theophylline: Co-administration with the racemate, Cetirizine (400 mg once daily), caused a small (sim 16%) decrease in Cetirizine clearance.

Food and Population Constraints

While the extent of absorption is not reduced by food, the official label notes that the rate of absorption is decreased.

Due to Levosan's substantial elimination via the kidneys, its use is contraindicated in patients with end-stage renal disease ( CL CR < 10 mL/min) and in certain pediatric patients with impaired renal function. Regulatory information mandates that individuals with moderate to severe renal impairment require considerations for dose adjustment.

Mechanism of Action

Dual Antagonism of Allergic Mediators

Levosan works by engaging a dual-pathway mechanism that targets two distinct receptor systems: the Histamine H1 receptor and the Cysteinyl Leukotriene Receptor 1 ( CysLT1). The mechanism involves the antagonism of both receptors, preventing the binding of their respective inflammatory mediators. The mechanism acts in systems where histamine mediates immediate responses and leukotrienes mediate prolonged effects on inflammation and airway smooth muscle.


Modification of Inflammatory Cascades and Signaling

By intervening early in these signaling sequences, the mechanism modifies the inflammatory cascade at multiple levels. Blocking H1 receptors limits signaling that influences vascular permeability and sensory nerve stimulation. Blocking CysLT1 receptors limits signaling that influences the contraction of airway smooth muscle and the recruitment of inflammatory cells. The dual interaction modifies the signaling within these targeted pathways, influencing physiological processes characterized by heightened activity.


Alteration of Airway Tone and Vascular Fluid Regulation

The resulting physiological effects are the direct consequences of modifying these cascades. The mechanism results in the alteration of airway tone through reduced bronchial smooth muscle contraction and the modification of vascular integrity via a decrease in fluid extravasation into tissues. These shifts in pathway activity induce observable physiological alterations, influencing the biological processes involving inflammation and tissue fluid regulation.

Dosage and Administration Information

How to Use Levosan: Official Administration Guidelines

Levosan (Levocetirizine) is a medication used according to standardized instructions. These instructions define the approved route, official dosing, frequency, and conditions for use.


Official Administration Scope

Levosan is available in two main formats: a film-coated tablet (typically 5 mg and often scored) and an oral solution (0.5 mg/mL). The only approved route of administration is oral (by mouth).

Instruction Category Official Guideline
Standard Adult Dose 5 mg once daily. Maximum dose is 5 mg per 24 hours.
Dosing Frequency and Timing Once daily (QD), preferably taken in the evening (QDPM).
Contextual Instructions May be taken with or without food as a single daily intake.

Population-Specific Dosing

The dosage for Levosan is structured by age group, and adjustments are required based on kidney function. Pediatric dosing is lower than the standard adult dose of 5 mg.

  • Pediatric Dosing: Children aged 6 to 11 years are typically prescribed 2.5 mg once daily. Children aged 6 months to 5 years receive 1.25 mg once daily.
  • Renal Impairment: For adults and adolescents 12 years with reduced kidney function (renal impairment), the dose and frequency must be adjusted based on creatinine clearance (e.g., 2.5 mg once daily or once every other day). No dose adjustment is generally required for isolated hepatic (liver) impairment.

Procedural Notes

The tablet must be swallowed whole with liquid, though scored tablets may be broken to provide a 2.5 mg dose. Treatment duration varies; for intermittent allergic rhinitis, use can be stopped when symptoms resolve and restarted when they recur. Continuous use for conditions like chronic urticaria is supported by clinical experience for up to six months.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Levosan

Treatment of Allergic Rhinitis (Hay Fever and Year-Round Allergies)

The majority of studies on Levosan for allergies focus on its use in treating allergic rhinitis, which includes both seasonal allergies (like hay fever) and perennial allergies that last year-round. These studies are often designed as randomized controlled trials (RCTs) to compare the drug's effects against a placebo or another medication.

Research has explored whether Levosan may affect common symptoms such as sneezing, runny nose, congestion, and itchy/watery eyes. Findings from these controlled studies generally reported that symptom scores were lower in the group that received Levosan compared to those who received a placebo. In some head-to-head comparisons with other similar medications, the research suggested that the symptom scores were similar between the groups studied.

Research is ongoing to better understand its effects across all patient groups and for long-term use. The consistency or volume of evidence reporting changes in nasal congestion appears less extensive than the evidence for changes in sneezing and watery eyes.


Treatment of Hives (Urticaria) and Chronic Idiopathic Urticaria

Research has also investigated the use of Levosan in treating hives (urticaria), especially the long-lasting type for which a clear cause cannot be found (chronic idiopathic urticaria). These trials evaluate whether Levosan may affect the itchiness and the number and size of the hives.

The findings suggest that patients who received Levosan reported less severe itching and fewer visible hives compared to control groups. Research found that participants receiving Levosan often reported improvements in their quality of life measures related to the condition. This condition is one of the primary areas where Levosan has been widely studied.

A remaining area of uncertainty involves the optimal length of treatment. The evidence base for very long-term use (over many months or years), particularly in patients whose hives are difficult to control, remains less robust.


Studies in Pediatric Populations (Children)

Studies specifically focused on children have been conducted to see if the findings from adult studies apply to younger patients. The results of these pediatric studies suggest that the patterns of reported symptom scores were similar to those found in adult studies for perennial allergic rhinitis and chronic hives.

A key gap in the research involves the need for longer studies to track factors like growth and development over many years. While initial findings suggest an effect, a complete picture requires more extensive data to fully understand the long-term patterns of observed effects across the entire pediatric age range.

Frequently Asked Questions (FAQ)

Common questions about Levosan (FAQ)

Q: How long does it typically take before I start to feel any effects from Levosan?

A: According to official clinical data, the drug reaches its maximum concentration in the body approximately one hour after a single dose. This concentration is often used as a measure for the onset of its effects.

Q: If I miss a dose of Levosan, what is the generally accepted advice?

A: If a dose is missed, official patient guidance recommends taking it as soon as it is remembered. However, if it is nearly time for your next scheduled dose, the guidance recommends skipping the missed dose and resuming the regular schedule. The official information also specifies not to take two doses simultaneously.

Q: I heard Levosan can affect blood pressure; is that a known side effect?

A: Official product information does not list changes in blood pressure, such as hypotension, among the common or uncommon adverse reactions reported in controlled studies.

Q: Is Levosan considered a controlled substance?

A: Regulatory information from official sources confirms that Levosan is not classified as a controlled substance under U.S. federal regulations.

Q: Can Levosan interact negatively with common over-the-counter pain relievers?

A: Official documents indicate that this medicine is unlikely to cause a significant pharmacokinetic interaction with other medications, including most over-the-counter (OTC) pain relievers. This is because the drug has low involvement with the major pathways that process many other medicines in the body.

Q: Is Levosan only available by prescription?

A: Levosan is available to the public in two different formats. It is sold as an over-the-counter (OTC) product in many jurisdictions, but certain formulations or strengths may still require a prescription (Rx) in some areas.

Q: What happens if I forget to take Levosan for several days?

A: Official guidance for a missed dose generally applies to a single day. Instructions for forgetting the medicine for several days are not specifically addressed, but official patient information typically advises that the medicine user should resume the usual single daily dose and avoid taking more than that amount.

Q: Is it common for people to experience changes in appetite while on Levosan?

A: Changes in appetite are not listed as a commonly or uncommonly reported side effect in the official product information for Levosan.

Q: Are there any specific blood tests required before starting Levosan?

A: Official labeling does not contain a requirement for specific blood tests before starting treatment. However, because kidney function is a factor in determining the appropriate dosage, regulatory documents note that renal status is a consideration.

Q: Does Levosan interact with birth control pills?

A: According to regulatory data on drug interactions, there is no reported pharmacokinetic interaction between Levosan and hormonal contraceptives, such as birth control pills.

Q: Does Levosan make you gain or lose weight?

A: Weight gain or weight loss are not listed among the commonly or uncommonly reported adverse reactions in the official product information for Levosan.

Q: What is the estimated elimination half-life of Levosan?

A: Official clinical data provides the estimated elimination half-life (t1/2) of the active ingredient in healthy adults as approximately 7 to 10 hours. The half-life is the time it takes for half of the dose to be eliminated from the body.

Q: Does Levosan cause dependency or addiction?

A: Regulatory documents on drug abuse and dependence do not list Levosan as having an abuse potential or causing dependency or addiction.

Q: Is it normal to feel slightly nauseous when first starting Levosan?

A: Nausea has been listed in post-marketing surveillance reports, but it is not classified as a common or uncommon side effect in the official controlled study data. Common side effects affect a larger proportion of users.

Q: Is Levosan a cure for the condition it treats, or just a management tool?

A: Levosan is officially indicated for the relief and treatment of symptoms related to conditions like allergic rhinitis and chronic hives. The official product information does not describe the medicine as a cure for the underlying condition, but rather a tool for symptom management.

Q: What does 'contraindicated' mean in relation to Levosan?

A: The official term 'contraindicated' is used in regulatory documents to signify that the medication is advised to be avoided if a patient has a certain condition or characteristic, such as severe kidney disease. This classification means that official data indicates the risks would strongly outweigh any potential benefit for that specific population.

Q: What kind of studies have been done on Levosan for long-term safety?

A: Regulatory studies supporting the drug's approval examined safety across durations ranging from weeks to a few months. For chronic conditions, longer-term trials, sometimes lasting up to six months, have also been conducted, providing safety information.

Q: Does Levosan have an effect on mental clarity or concentration?

A: Official documents caution that the medicine may cause effects such as somnolence (drowsiness) and fatigue. Since these are central nervous system ( CNS) effects, they may impact a person's overall alertness and performance.

Q: Does taking Levosan affect driving or operating machinery?

A: Regulatory documents contain an explicit caution statement regarding activities that require full mental alertness, such as driving or operating hazardous machinery. This warning is noted to be particularly relevant when treatment is initiated or when the dosage is changed.

Q: Are there specific symptoms that require immediately contacting a healthcare provider while on Levosan?

A: Official information lists rare, serious adverse reactions observed in post-marketing surveillance, such as anaphylaxis (a severe allergic reaction) and convulsion (seizure). Such serious events are listed in the regulatory documents as conditions that warrant immediate consultation with a healthcare provider.

Q: What are the known long-term effects of Levosan according to official data?

A: Regulatory data supports the use of this medicine for chronic conditions for periods up to six months. In general, the observed long-term effects are consistent with the known short-term safety profile, though official warnings include the potential for severe itching, known as rebound pruritus, upon suddenly stopping after prolonged use.

Q: What is the difference between an 'interaction' and a 'contraindication'?

A: In official documents, an interaction describes when the effects of the medicine are altered by another substance, like food or another drug. A contraindication, however, is an absolute condition or pre-existing factor in a patient that requires the medicine to be avoided entirely.

Q: How does the body generally process Levosan?

A: Official data indicates that the drug is rapidly absorbed after being taken by mouth. It undergoes a low level of metabolism (chemical change) in the liver and is primarily eliminated from the body unchanged via the kidneys.

Q: Are there specific demographic groups where Levosan is studied less?

A: Official research documents indicate that the volume of evidence is less extensive for certain demographic groups. This includes children under six months of age, as well as very long-term use across all patient populations.

Q: How long does Levosan typically stay in the system after the last dose?

A: Based on the estimated half-life (the time taken for half the drug to be eliminated) of 7 to 10 hours, the medicine is typically considered to be largely cleared from the body within 4 to 5 half-lives, which is approximately 2 to 3 days after the final dose.

Q: Can I take herbal remedies or supplements with Levosan?

A: Official documents do not list specific interactions with herbal remedies or supplements. However, the medicine has a low involvement with the major drug metabolism pathways in the liver, which suggests a low potential for pharmacokinetic interactions with many substances.

How should Levosan be stored and disposed of?

Storage Conditions for Levosan

Levosan (levocetirizine) must be stored at Controlled Room Temperature, specifically between 20 C and 25 C (68 F and 77 F). The medication must be protected from freezing, excess heat, and moisture. It is required to keep the product in the original container and ensure the container is tightly closed at all times.

For safety, Levosan must be kept out of the sight and reach of children.


Official Disposal Rules

Unused or expired Levosan should be disposed of according to local regulations and official guidance. It is important to note that this medicine is not recommended for flushing down the toilet. If a drug take-back program is unavailable, official guidance suggests mixing the medicine with an undesirable substance before discarding it in the household trash.

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

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