Levozine

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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 Levozine

What is Levozine? Overview

Property Description
Active ingredient Levocetirizine dihydrochloride
Form Oral tablets and Oral solution
Pharmacological class Histamine H1 receptor antagonist
Common purpose Antiallergic action (blocking histamine effects)
Origin Synthetic (active (R)-enantiomer of Cetirizine)

What Type of Medicine is Levozine?

Levozine is a single-ingredient medicinal product containing Levocetirizine as its active ingredient (as the dihydrochloride salt), and is classified as a potent Histamine H1 receptor antagonist. This precise pharmacological designation confirms that the medicine works to counteract the chemical substance known as histamine.

The drug is categorized as a second-generation antihistamine and is a synthetic compound derived from Cetirizine. Specifically, it is the active (R)-enantiomer, a feature recognized for maximizing receptor efficiency. This targeted approach to composition differentiates it from earlier, less selective compounds in its class.

What is the General Purpose of Levocetirizine?

The general purpose of Levocetirizine is to exert an antiallergic action by interrupting the communication pathway that histamine uses to trigger symptoms. This is achieved through selective H1 blockade, a key physiological action where the active ingredient binds to specific receptors to prevent histamine from activating them.

As a modern, potent H1 antagonist, the medicine achieves rapid and comprehensive receptor occupancy. This establishes its effect by blocking the histamine receptors, which is useful in managing typical allergic discomfort. A defining characteristic of the second-generation classification is that it is typically non-sedating, delivering its antiallergic action while minimally affecting the central nervous system.

In What Forms is Levozine Supplied?

Levozine is administered orally and is supplied in two principal dosage forms: solid oral tablets and a liquid oral solution. Both forms are single-ingredient products. The oral tablets combine Levocetirizine dihydrochloride with solid excipients, while the oral solution uses an aqueous base/vehicle which is often preferred for pediatric patients or individuals who require a liquid preparation. This ensures that the effective antiallergic action is accessible across various patient groups.

Regulatory References

  1. Levocetirizine: MedlinePlus Drug Information

What side effects are possible with Levozine?

Possible Side Effects and Safety Information (Levozine)

This section outlines the officially documented safety information for Levozine (levocetirizine), including adverse reactions, safety restrictions, and population-specific considerations, as mandated by government regulatory agencies.

Adverse Reactions and Frequencies

Adverse reactions are classified by frequency based on clinical trials and postmarketing reports. The most common or expected effects documented include:

Classification Examples (Adult/Adolescent) Examples (Pediatric)
Common (1 in 100 to less than 1 in 10) Somnolence, Fatigue, Dry mouth, Headache. Pyrexia (fever), Vomiting, Diarrhea.
Uncommon (1 in 1,000 to less than 1 in 100) Asthenia, Abdominal pain, Malaise. Abdominal pain, Sleep disorder.

Postmarketing experience also documents events with frequency “Not Known,” including aggression, hallucination, suicidal ideation, and urinary retention.

Serious Adverse Reactions

Although rare, officially documented serious adverse reactions include Hypersensitivity reactions (such as anaphylaxis), Convulsions, and Hepatitis. The risk of new or worsening, widespread Pruritus (itching) has also been reported upon discontinuation of the medicine, particularly following long-term use.

Safety Restrictions and Contraindications

Use of Levozine is contraindicated in patients with known hypersensitivity to levocetirizine, cetirizine, or related piperazine compounds, and in individuals with End-Stage Renal Disease (severe kidney impairment). Caution is required when performing tasks that require full mental alertness, such as driving or operating heavy machinery, due to the risk of somnolence and fatigue. Additionally, caution is advised for patients with predisposing factors for urinary retention and those using alcohol or other central nervous system depressants.

Overdose and Emergency Response

️ Overdose and When to Seek Help

The official regulatory documents for Levozine (levocetirizine dihydrochloride) define the required immediate actions and expected clinical manifestations associated with overdosage.

Element Official Regulatory Statement
Overdose Manifestations The documented presentation in adults is principally drowsiness (somnolence). In children, the onset of overdose may be characterized by initial agitation and restlessness before progressing to sedation.
Emergency Actions Upon suspected overdosage, the required action is to seek immediate medical attention or contact a Poison Control Center right away for guidance.
Antidote Status No known specific antidote for Levocetirizine is listed in the official prescribing information from government authorities.
Supportive Management Treatment is generally recommended as symptomatic and supportive. Standard emergency procedures, such as gastric lavage, may be considered following a recent ingestion.
Treatment Constraint Levocetirizine is not effectively removed by dialysis, and the regulatory label notes that dialysis will be ineffective unless another dialyzable substance was co-ingested.

The regulatory profile establishes that overdosage management relies entirely on symptomatic and supportive treatment given the explicit statement of no known specific antidote. The CNS symptom clusters, which are distinct for adults and children, serve as the key clinical indicators requiring urgent external medical assessment, which is mandated by official regulatory instructions.

Therapeutic Uses of Levozine

What Levozine Treats: Main Uses and Benefits

Levozine is commonly used to help with certain symptomatic manifestations in clinical settings where short-term assistance is needed. The medication is applied across domains where additional symptomatic support is needed.


The primary therapeutic applications involve managing symptoms associated with acute or episodic changes and supporting conditions involving inflammatory or irritative processes. This addresses symptoms related to physical discomfort and heightened physiological activity.

“This use supports patients during episodes of heightened discomfort and may assist with maintaining functional stability.”

By easing the overall symptom load, Levozine may contribute to improved day-to-day comfort during periods of heightened symptoms, supporting patients in coping more steadily with symptom fluctuations.


Quick Fact: Relief for Symptoms That Create Noticeable Physiological Strain

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

Levozine eligibility is determined by specific population restrictions and absolute contraindications documented in regulatory labeling.

Contraindicated Populations

Use is contraindicated (prohibited) for individuals with a known hypersensitivity to levocetirizine, cetirizine, or any other piperazine derivative. The medicine is also contraindicated in patients with end-stage renal disease (creatinine clearance less than 10 mL/min). This prohibition extends to pediatric patients 6 months to 11 years of age who have impaired renal function.

Age and Condition Eligibility

Population Group Regulatory Eligibility Status (FDA/EMA)
Adults and Adolescents ( ge 12 years) Use is established under standard conditions.
Children 6 months to 11 years Approved for use; formulation is restricted by age. Safety and efficacy are not established in infants under 6 months.
Renal Impairment Use is restricted and requires dose adjustment for mild to severe impairment in patients ge 12 years.
Pregnancy/Lactation Pregnancy: Use may be considered only if necessary. Lactation: Use is generally not recommended.

Patients with factors predisposing to urinary retention are advised to consult a healthcare professional before use. No dose adjustment is typically required for patients with solely hepatic impairment.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section summarizes officially documented interactions and constraints related to the co-administration of Levozine (Levocetirizine).

Classification Official Regulatory Documentation
Interacting Substances Alcohol, other Central Nervous System (CNS) Depressants
Documented Pharmacokinetic Changes Ritonavir, Theophylline (effects noted for the racemate, Cetirizine)
Interaction-Related Restrictions Contraindicated in specific populations with severe renal impairment

Official Interaction Statements:

  • Alcohol and other CNS Depressants should be avoided because co-administration leads to additional reductions in alertness and additional impairment of CNS performance. This is classified as a pharmacodynamic interaction.
  • Co-administration with the antiretroviral medicine Ritonavir resulted in increased plasma exposure (AUC) and decreased clearance of the racemate compound, Cetirizine, in studies.
  • A multiple dose study involving Theophylline also showed a minor decrease in the clearance of the racemate compound, Cetirizine.
  • Food consumption delays the time to maximum concentration (Tmax) and lowers the maximum concentration (Cmax), but official data confirms it does not affect the total extent of exposure (AUC).
  • The medicine is contraindicated in patients with End-Stage Renal Disease (creatinine clearance < 10 mL/min) and in pediatric patients with impaired renal function due to the risk of increased systemic exposure.

These documented constraints define the product's interaction profile, requiring the avoidance of substances that cause additive CNS impairment and imposing population-specific restrictions due to the medicine's predominant renal elimination.

Mechanism of Action

Primary Action: Inverse Agonism at the H1 Receptor

Levozine's mechanism begins at the Histamine H1 Receptor (hH1R), where it acts as an inverse agonist with high affinity. This action stabilizes the receptor in an inactive state, effectively preventing the body's natural signaling molecule, histamine, from initiating its signaling cascade. Because the drug is peripherally selective, concentrating its effect away from the central nervous system, this primary mechanism leads to rapid and sustained occupancy and stabilization of the inactive H1 receptor in the body's tissues.


️ Modulating Vascular and Cellular Responses

The molecular blockade of the H1 receptor alters two key physiological responses: vascular permeability and inflammatory cell recruitment. By inhibiting the histamine signal, Levozine reduces the leakage of fluid from small blood vessels, resulting in a decrease in local vascular permeability. It also exerts secondary, non-H1 mediated influence by modulating the movement and adhesion of key inflammatory cells, such as eosinophils, leading to the attenuation of cellular processes involved in sustained inflammation.

Dosage and Administration Information

How to Use Levozine

The following instructions summarize the standardized administration guidelines for Levozine, including approved dosing, frequency, and special conditions for use.

Administration and Dosing

Levozine is administered orally and is typically taken once daily. The tablet or oral solution can be taken with or without food. The specific dose depends on the patient's age and kidney function.

Age Group Recommended Daily Dose Conditions for Use
Adults and Adolescents (12 years and older) 5 mg Standard oral use
Children (6 to 11 years) 2.5 mg Do not exceed 2.5 mg once daily
Patients with Moderate-to-Severe Kidney Impairment (CrCl 10 to 49 mL/min) 5 mg Take every other day

Procedural Rules

Age-Specific Use: Levozine is not recommended for children under 6 years of age. For children 6 to 11 years, the maximum daily dose is 2.5 mg.

Missed Dose: If a dose is missed, it should be taken as soon as it is remembered. However, if it is almost time for the next scheduled dose, the missed dose should be skipped, and the patient should continue with the regular dosing schedule. Two doses should not be taken at the same time.

Special Condition: A reduction in dose frequency is required for patients with compromised kidney function (renal impairment) to prevent the accumulation of the drug in the body, as specified in the dosing table.

Recent Clinical Evidence

The research base for Levozine primarily focuses on conditions characterized by fluctuating or episodic manifestations, such as allergic rhinitis and chronic idiopathic urticaria (CIU).


Evidence for Primary Indications

For allergic rhinitis (seasonal and perennial), research includes numerous Randomized Controlled Trials (RCTs) and meta-analyses that examined how symptoms change over time. Studies report data show patterns related to symptom scores (TSS) and patient-reported Health-Related Quality of Life (QoL) metrics across active treatment and comparison groups.

Similarly, for CIU, research explored Multi-center, Double-Blind, Placebo-Controlled trials. These studies monitored outcomes linked to inflammatory or irritative states by tracking the Urticaria Activity Score (UAS), which includes daily measurement of itching (pruritus) and wheals. Trial reports described observations in these measurements across the studied groups.


Evidence in Special Populations and Uncertainties

Levozine was evaluated in special populations, including children and infants. For children aged 6 and older, evidence is often based on extensions of adult trials. However, for the youngest age cohorts (e.g., infants 6 to 24 months), evidence for conditions like recurrent cough is derived from smaller, specialized Clinical Studies monitoring acute changes over periods up to 90 days.

This evidence base highlights limitations, particularly concerning follow-up duration. While some trials monitored persistent symptoms for six months, data for long-term outcomes are not well established beyond these intermediate observation periods. This limitation is pronounced for the youngest pediatric patients, where data for certain groups remain insufficient, and the overall evidence quality varies.

Frequently Asked Questions (FAQ)

Common questions about Levozine (FAQ)

Q: Is Levozine the same type of medicine as [similar drug name]?

A: Official drug information describes Levozine as a second-generation H1 receptor antagonist, a type of medicine commonly known as an antihistamine. It is specifically identified as the active (R)-enantiomer of the compound Cetirizine. This molecular difference is a key characteristic distinguishing it from related compounds.

Q: Is Levozine considered a strong medication?

A: Regulatory documents classify the active ingredient, levocetirizine, as a potent and selective H1 receptor antagonist with a high affinity for the receptor. The term 'potent' in this context refers to its high effectiveness in binding to the receptor.

Q: How does Levozine compare to over-the-counter options for the same condition?

A: While many antihistamines are available for purchase without a prescription, Levozine is often classified as a prescription-only medicine in many regulatory regions. Like many non-prescription options, it is a second-generation H1 antagonist, indicating it works primarily to block the effects of histamine in the body.

Q: Are there any specific foods I should avoid while on Levozine?

A: According to the official product information, there are no specific foods that must be avoided while using Levozine. Taking the medicine with food may delay the time at which the maximum concentration of the drug is reached in the body. However, regulatory data confirms that consuming food does not change the total amount of medicine absorbed.

Q: Can Levozine affect my mood or energy level?

A: Yes, the official adverse reactions list includes common effects such as fatigue and somnolence (drowsiness), which affect energy levels. Additionally, postmarketing experience has included reports of mood changes, such as aggression and hallucination, although the frequency of these events is not established.

Q: What are the long-term safety concerns for people who use Levozine?

A: Official research evidence indicates that data for outcomes beyond intermediate observation periods, such as six months, are limited. Regulatory documents also report that new or worsening widespread pruritus (itching) has been reported in some individuals upon discontinuation of the medicine after long-term use.

Q: Is Levozine used for anything besides its main listed purpose?

A: The official indications for Levozine include conditions such as allergic rhinitis (seasonal and perennial) and chronic idiopathic urticaria (hives). Its use is limited to the conditions for which official indications have been established by regulatory authorities.

Q: What common supplements might interact with Levozine?

A: Regulatory documents require the specific listing of any known interactions, which include avoiding co-administration with alcohol and other central nervous system (CNS) depressants. Supplements, including herbal remedies, are not typically listed in the official interaction tables unless a specific effect has been documented.

Q: What should I do if a side effect seems serious?

A: Official drug information documents specify serious adverse reactions, such as Hypersensitivity (severe allergic reaction), Convulsions, and Hepatitis. Official documentation requires seeking immediate medical attention or contacting a healthcare provider for any serious or potentially life-threatening adverse reactions.

Q: What does the official drug information say about the duration of treatment with Levozine?

A: Clinical studies for Levozine have often covered treatment periods of up to six months for persistent symptoms. Official regulatory texts do not specify a single, universal maximum duration; the duration of treatment is guided by the patient's specific condition and clinical need.

Q: How is Levozine different from other drugs in its class?

A: Levozine is differentiated by being the active (R)-enantiomer of the drug Cetirizine, a distinct molecular form. It is categorized as a second-generation H1 antagonist and is noted for its ability to selectively target the receptors outside of the central nervous system.

Q: Is there a maximum time I should take Levozine?

A: Official clinical studies have monitored symptoms for periods up to six months. Regulatory documents do not define a single, universal maximum duration for use; the length of time the medicine is used is typically determined by the nature of the condition and the patient’s clinical need.

Q: Is it okay to stop taking Levozine suddenly?

A: Official regulatory documents report that abruptly stopping the medicine, particularly after long-term use, has been associated with the development of new or worsening widespread pruritus (itching). This risk is listed in the official safety information.

Q: What is the 'How it works' explanation for Levozine in simple terms?

A: The medicine works by targeting the Histamine H1 receptor, acting to stabilize this receptor in an inactive state. This process prevents the body's natural histamine from binding and starting its signaling cascade. This mechanism of action is intended to reduce the physical manifestations, or symptoms, of the allergic condition.

Q: Is Levozine associated with any warnings about organ damage?

A: Official safety documents report that Hepatitis (liver inflammation) is an adverse reaction that has been reported, although its frequency is not established. Furthermore, the medicine is contraindicated (prohibited) for patients who have End-Stage Renal Disease (severe kidney impairment) due to the risk of accumulation.

Q: Can Levozine cause stomach upset or nausea?

A: Adverse events documented in official sources include gastrointestinal effects such as vomiting, diarrhea, and abdominal pain, which are listed as common or uncommon. Specific mention of nausea is sometimes included in the documentation of gastrointestinal side effects.

Q: What are the common reasons people discontinue Levozine?

A: Official documents list common adverse events such as somnolence and fatigue, which are typical patient-reported reasons for discontinuing a medicine. The official safety information also notes the risk of pruritus (itching) upon discontinuation following long-term use.

Q: Does Levozine treat the cause or just the symptoms of the condition?

A: The medicine functions by targeting the H1 receptor, which is the pathway used by histamine, a key chemical involved in allergic reactions. By counteracting the effects of this chemical mediator, Levozine reduces the physical manifestations, or symptoms, of the allergic condition.

Q: Can I take other prescription medications while using Levozine?

A: Regulatory documents specifically list known interactions with certain prescription medications like Ritonavir and Theophylline, as well as drug classes like CNS depressants. The inclusion of specific interactions in the label emphasizes the importance of checking all co-administered prescription medications.

Q: How quickly can I expect to notice any effects from Levozine?

A: Official pharmacokinetic studies often detail the Time to maximum concentration (Tmax), which is the point at which the medicine reaches its highest level in the bloodstream. This measurement, often reported in terms of hours, is the time at which the highest blood concentration is reached.

Q: How long does Levozine stay in my system?

A: Official pharmacokinetic data for the medicine includes the Plasma elimination half-life (t1/2), which is a measure of the time it takes for the concentration of the drug in the body to be reduced by half. This measurement is used to determine how long the medicine remains in the system.

Q: Is Levozine safe for older adults (seniors)?

A: Official labeling includes specific guidance for use in older adults (seniors). It indicates that dosage selection should be approached cautiously, often because older adults may experience reduced kidney function. Dose adjustment is required for patients with compromised kidney function.

Q: Does Levozine require regular blood tests or monitoring?

A: Official regulatory documents specify if any routine laboratory monitoring is required due to safety concerns. If a patient has impaired kidney function, dose frequency reduction is required, which necessitates monitoring of kidney function.

Q: Can Levozine affect my ability to get pregnant?

A: Official regulatory documents contain a section addressing the effects on fertility and reproductive potential. This section typically states whether there is available data regarding the medicine's effect on the ability to become pregnant, based on human or animal studies.

How should Levozine be stored and disposed of?

How to Store and Dispose of Levozine?

Official regulatory documents detail specific storage and disposal requirements for Levozine (levocetirizine dihydrochloride) to ensure its quality and safety.

Storage Requirements

The tablets must be stored at Controlled Room Temperature, defined as between 20 C and 25 C (68 F and 77 F), with permitted temperature excursions up to 30 C. It is mandatory that the medicine is kept out of the sight and reach of children.

Disposal Instructions

Disposal of unused or expired Levozine must follow local regulatory requirements. Products should not be thrown into household wastewater. If a drug take-back program is unavailable, non-flushable medicines should be prepared for household trash by mixing them with an undesirable substance and sealing the mixture in a container.

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

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