Levotriz

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Medically reviewed

Laura Arias

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 Levotriz

Property Description
Active ingredient Levocetirizine (as dihydrochloride)
Form Oral tablets, oral solution/syrup
Pharmacological class Second-Generation Antihistamine
Common use Relieving allergy symptoms, including hives (urticaria) and allergic rhinitis
Origin Synthetic; active R-enantiomer derived from Cetirizine

Classification and Composition

Levotriz is a highly selective synthetic medicinal preparation whose core component is the active ingredient, Levocetirizine. It is definitively classified as a Second-Generation Antihistamine and functions specifically as a potent Histamine H1-receptor Antagonist.

This medication is chemically categorized as one of the Piperazine Derivatives and represents the active R-enantiomer, or active isomer, derived from the older antihistamine, Cetirizine. The isolation of this single active isomer, achieved through a process known as a chiral switch, results in a more targeted pharmacological profile, maximizing effectiveness and generally offering significantly reduced sedation compared to first-generation compounds, a characteristic recognized in its clinical designation.

Forms and General Purpose of Levotriz

Levotriz is primarily available for oral administration in multiple physical forms, including oral solid dosage forms such as film-coated tablets, and as oral liquid solutions, like syrup. Its fundamental purpose is to provide effective relief from the symptoms caused by the body's overreaction to allergens, such as those experienced during a seasonal allergy flare-up.

This medicine achieves this by acting to neutralize the primary chemical trigger of allergic responses. By successfully interrupting the histamine cascade at the H1-receptor level, Levotriz helps to lessen the severity of uncomfortable manifestations like sneezing, eye irritation, a runny nose, and the intense itching and redness associated with chronic hives, or chronic idiopathic urticaria, and seasonal allergic rhinitis. It is indicated for managing the symptoms of chronic idiopathic urticaria, helping to ease discomfort by calming the skin's allergic reaction. While the most common form is a single-ingredient product, Levotriz is also available in fixed-dose combination formulations designed to address complex symptoms that require a simultaneous therapeutic action.

Regulatory References

  1. Levocetirizine: MedlinePlus Drug Information

What side effects are possible with Levotriz?

Possible side effects and safety information

The safety profile for Levotriz (Levocetirizine) is formally documented in government regulatory texts, organizing possible adverse reactions by frequency and affected physiological system.

Frequency-Classified Adverse Reactions

The most frequent reactions observed in clinical studies and documented in official prescribing information are categorized as Common (affecting 1 to 10 users in 100). These typically include Somnolence (drowsiness), Fatigue, Dry mouth, and Headache. Reactions classified as Uncommon include Asthenia (weakness) and Abdominal pain.

Less frequently reported reactions, classified as Rare, include Palpitations (heart flutter), Increased weight, and signs of Abnormal hepatic function.

System-Organ Classes and Serious Reactions

Adverse effects are documented across several body systems, including Nervous system disorders (e.g., somnolence, dizziness), Gastrointestinal disorders (e.g., nausea, dry mouth), and Immune system disorders.

Official labeling documents infrequent but clinically significant events such as severe Hypersensitivity reactions, which can manifest as Anaphylaxis and Angioedema (swelling beneath the skin). Other serious reactions include documented cases of Convulsions and Hepatitis.

Population-Specific Safety Considerations

Levotriz is subject to specific safety limitations. It is Contraindicated in individuals with severe renal impairment, defined by end-stage renal disease (creatinine clearance less than 10 mL/min). Caution is noted for older adults, who may be at an increased risk of sedation, and in patients with conditions predisposing them to Urinary retention.

Adverse effects related to sedation are reported to occur more frequently at the beginning of treatment. Furthermore, pruritus (itching) has been documented following the discontinuation of daily, long-term use of the medicine.

Overdose and Emergency Response

Overdose and when to seek help

Suspected overdose requires individuals to seek emergency medical attention immediately, as officially mandated by regulatory guidance.

Documented Clinical Manifestations

Overdose presentations are primarily associated with the Central Nervous System (CNS) effects. In adults, the most commonly documented sign is severe drowsiness or somnolence. Regulatory documents specify that overdose in children may initially involve symptoms of agitation and restlessness, followed by the characteristic CNS depression, such as drowsiness. Other documented manifestations of overexposure include confusion, dizziness, headache, tremor, and the potential for a severe state known as stupor. Anticholinergic-like signs, including tachycardia (fast heart rate) and urinary retention, are also listed.

Required Emergency Actions

Regulatory labeling confirms that no known specific antidote exists to reverse the effects of an overdose. The mandated management is defined as administering symptomatic and supportive treatment. For cases involving recent, short-term ingestion, the consideration of gastric lavage is described in official procedures. It is also documented that the active ingredient is not effectively removed by haemodialysis. The official guidance uniformly mandates that individuals must seek emergency medical attention to ensure proper clinical monitoring and the immediate administration of supportive care.

Therapeutic Uses of Levotriz

What Levotriz Treats: Main Uses and Benefits

Levotriz (Levocetirizine) is considered relevant in contexts involving distressing symptoms associated with allergic conditions, contributing to easing the overall symptom load for the patient. Its therapeutic applications focus on the management of specific allergic manifestations.

The medication is commonly used across conditions presenting with episodic or fluctuating manifestations, particularly seasonal and perennial allergic rhinitis and the management of chronic idiopathic urticaria (hives). It is applied in addressing challenging symptom clusters that may become intense or disruptive in the upper airways, eyes, and skin.

“The supportive relief provided may help patients cope more steadily with symptom fluctuations and assists with maintaining functional stability.”

Management of Symptom Domains

Levotriz is often applied in clinical settings that involve symptoms that interfere with daily functioning, such as repetitive sneezing, excessive runny nose (rhinorrhea), nasal itching, and associated ocular discomfort. Furthermore, it supports the management of intense generalized skin itching (pruritus) and helps limit the overall impact of recurrent wheals. This provides support that helps ease the overall symptom burden during phases when symptoms become more noticeable.


Quick Fact: Relief for Chronic Skin Symptoms
Levotriz is relevant in scenarios requiring additional management of discomfort associated with conditions involving inflammatory or irritative processes, particularly uncomplicated hives and long-term skin itching.

Eligibility and Restrictions for Use

Eligibility Scope

Populations for whom use is allowed (as stated in label):

  • Adults and adolescents 12 years of age and older.
  • Children 6 to 11 years of age.
  • Younger children 6 months to 5 years of age (typically restricted to the liquid oral solution form).

Populations for whom use is not recommended (if applicable):

  • The film-coated tablet formulation is not recommended for children under 6 years of age (due to the inability to achieve appropriate dose adjustment).
  • Breastfeeding women, as the drug is expected to be excreted into human milk.

Populations for whom use is contraindicated:

  • Patients with a known hypersensitivity or allergy to levocetirizine, its parent compound cetirizine, or any other piperazine derivatives.
  • Adults and adolescents with end-stage renal disease (creatinine clearance less than 10 mL/min) or those undergoing hemodialysis.
  • Pediatric patients 6 months to 11 years of age with impaired renal function.

Condition-Specific Eligibility Rules

  • Renal Impairment: Use in patients 12 years and older with mild, moderate, or severe renal impairment is restricted and requires adjustment based on the degree of kidney function.
  • Comorbidity Caution: Caution is advised for patients with predisposing factors for urinary retention (such as spinal cord lesion or prostatic hyperplasia).
  • Geriatric Status: Older adults (65 years and older) may require an initial assessment of renal function prior to use.
  • Hepatic Impairment: No dose adjustment is generally required for patients with solely hepatic impairment.

Connection to the Overall Eligibility Profile

Official regulatory documents define who can and cannot use Levotriz by classifying specific populations as either approved, conditionally restricted, or strictly contraindicated. Eligibility is governed primarily by age thresholds, the status of the patient's renal function (due to the drug's elimination pathway), and the absence of a known allergic response to the core drug or its chemical relatives. These criteria establish clear boundaries for the medicine's use in standard clinical settings.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documents describe drug interactions for Levotriz (levocetirizine) based on two primary mechanisms: additive central nervous system (CNS) effects and altered plasma exposure of the drug or co-administered agents.

Additive Pharmacodynamic Effects

Concomitant use of Levotriz with alcohol or other CNS depressants (e.g., sedatives, hypnotics, opioid analgesics) should be avoided. This is due to the potential for an additive pharmacodynamic effect that may cause further reductions in alertness and increased impairment of CNS performance. Patients are cautioned about engaging in activities requiring full mental alertness, such as driving or operating machinery, when combining these substances.

Pharmacokinetic Exposure Changes

Studies involving the racemic mixture, cetirizine, have shown that co-administration with certain medications can alter the drug's systemic exposure:

  • Ritonavir: Co-administration resulted in increased plasma AUC and half-life and decreased clearance of cetirizine.
  • Theophylline: Co-administration resulted in a 16% decrease in the clearance of cetirizine. The disposition of theophylline was not altered.

Conversely, Levotriz (as cetirizine) has not demonstrated inhibition of major CYP enzymes (1A2, 2C9, 2C19, 2A1, 2D6, 2E1, or 3A4) in in vitro studies. No clinically significant interactions were observed when cetirizine was co-administered with antipyrine, azithromycin, cimetidine, erythromycin, ketoconazole, or pseudoephedrine.

Population-Specific Notes

Since the drug is substantially excreted by the kidneys, the risk of adverse reactions may be greater in patients with impaired renal function.

Mechanism of Action

How Levotriz Works

Selective Histamine H1-Receptor Antagonism

Levotriz (levocetirizine) functions primarily within the pharmacodynamic domain of selective inverse agonism at the peripheral Histamine H1 receptors . By binding to these receptors, it stabilizes them in an inactive conformation, thereby preventing the binding and activity of the endogenous inflammatory mediator histamine. This action is central to constraining H1-mediated signaling, which modulates subsequent cellular responses such as increased vascular permeability and smooth muscle contraction.

Anti-inflammatory and Cascade Modulation

Beyond direct receptor blockade, Levotriz engages mechanisms that regulate biological signaling pathways associated with cellular inflammation. It inhibits the release of certain pro-inflammatory mediators from mast cells and reduces the movement (chemotaxis) and adhesion of inflammatory cells, such as eosinophils. This secondary pathway modulation supports a constrained state within inflammatory signaling cascades, which contributes to the drug's overall pharmacological activity profile.

Dosage and Administration Information

How to Use Levotriz (Levocetirizine)

The administration of Levocetirizine (often referred to by brand names like Levotriz) focuses on oral intake, specific dosing schedules, and adjustments for age and renal function. This information is provided for educational purposes.

Administration Scope

Feature Official Instruction
Route of Administration Oral only (by mouth).
Timing in Relation to Meals May be taken with or without food.
Optimal Time of Day The dose should preferably be taken in the evening.

Standard Labeled Dosing and Rules

The medicine is typically available as a 5 mg film-coated tablet and an oral solution (0.5 mg/mL). Dosage corresponds to specific daily amounts for each population group.

  • Adults and Adolescents (12 years and older): The standard dose is 5 mg once daily.
  • Children 6 to 11 years: The recommended dose is 2.5 mg once daily.
  • Children 6 months to 5 years: The recommended dose is 1.25 mg once daily (using the oral solution).

Preparation and Special Conditions

Tablets should be swallowed whole with liquid. The dose is adjusted for patients with impaired renal function (based on creatinine clearance), which may involve a reduced frequency, such as every other day or twice weekly. No dose change is required for isolated hepatic impairment. For intermittent use, administration can be stopped and restarted as needed, while long-term use is based on clinical necessity.

Recent Clinical Evidence

Research evidence / Overview of studies for Levotriz


Evidence from Trials for Seasonal and Perennial Allergies (Rhinitis)

Research examining Levotriz (Levocetirizine) related to allergic rhinitis—including seasonal hay fever and year-round, or perennial, allergies—primarily involves short-term Randomized Controlled Trials (RCTs) and systematic reviews. These studies were designed to explore how symptoms change over time during defined time intervals, typically comparing the medication against an inactive placebo or other active treatments. Researchers focused on outcomes related to physical discomfort in the nasal passages and eyes. This includes monitoring changes in Total Symptom Scores (TSS), which is a composite metric used in research to capture the reported intensity of sneezing, runny nose, nasal itching, and eye irritation.

Studies report patterns showing how symptoms evolved in the observed populations during the trials. Studies examine the reported symptom intensity and functional outcomes in the groups observed. Trial populations were primarily adults and adolescents, but separate, targeted research has been conducted during periods of increased symptom activity to study liquid formulations in children as young as one year old.


Evidence from Trials for Chronic Hives (Urticaria)

Levotriz was evaluated in research exploring symptoms of chronic idiopathic urticaria (CIU), a condition where the underlying cause of persistent hives is unknown. The research framework for this use also relies heavily on short-term Randomized Controlled Trials (RCTs) and systematic reviews. These studies focused on outcomes linked to inflammatory or irritative states in the skin. The main outcome measure examined was the Urticaria Activity Score (UAS), which tracks patient-reported metrics of severe pruritus (itching) and the number and size of visible wheals (hives).

Studies describe patterns where complete symptom control was not uniformly achieved at the dose level used in the pivotal trials in every observed individual. Research explores various dosing regimens, but data are still emerging regarding the long-term patterns and safety of these higher-dose approaches. Long-term outcomes from controlled trials extending beyond a few weeks remains uncharacterized in the core evidence base.


Areas of Research Uncertainty and Study Gaps

Comparative evidence is limited, as research against every other widely available second-generation antihistamine across all endpoints has not been published, meaning evidence quality varies across studies depending on the specific comparison made. The results apply only to the populations studied, and specific subgroup findings are uncertain when moving beyond the age groups explicitly included in the pivotal trials. The research provides context but not individual predictions for patient response.

Key Studies & References

  1. Public Assessment Report (PAR) for Levocetirizine Dihydrochloride 5 mg film-coated Tablets (EMA/Decentralised Procedure)

Frequently Asked Questions (FAQ)

Common questions about Levotriz (FAQ)

Q: What is the usual duration of a Levotriz treatment course?

A: Studies and official information indicate that the length of a Levotriz treatment course can vary significantly based on the condition being treated. For chronic conditions like perennial allergic rhinitis or chronic hives, clinical trials have assessed the medicine for durations ranging from 2 weeks up to 6 months. The total length of treatment is ultimately determined by the patient's clinical necessity.

Q: Is it safe to drive after taking Levotriz?

A: Regulatory documents advise that caution is necessary regarding activities that require full mental alertness. This is because drowsiness and fatigue are possible adverse effects of the medicine. Warnings note that engaging in activities requiring complete mental alertness, such as driving or operating machinery, may be impaired due to possible effects like sedation.

Q: What should I do if I miss a dose of Levotriz?

A: Patient information indicates that if a dose is missed, it can be taken as soon as it is remembered. If it is nearly time for the next scheduled dose, the missed dose should generally be skipped to resume the regular schedule. The guidance is clear that a double dose should not be taken to compensate for a missed dose.

Q: Does Levotriz contain any gluten or common allergens?

A: Official product labeling lists all inactive ingredients in Levotriz formulations for safety review. For example, the film-coated tablet formulation contains the excipient lactose monohydrate. While information regarding gluten content is generally not specified in the main label sections, reviewing the full list of ingredients in the official prescribing information may be necessary for those with known sensitivities.

Q: Can I crush or chew the Levotriz tablet instead of swallowing it whole?

A: The official instructions for administration state that the Levotriz tablet should be swallowed whole with liquid. These instructions are provided to ensure the medicine's correct pharmacological function. The label does not provide instruction for crushing or chewing the tablet.

Q: How quickly does Levotriz start working to relieve symptoms?

A: Studies on the drug’s pharmacokinetics (how the body handles the medicine) show that levocetirizine is rapidly absorbed after oral intake. In adults, the concentration of the medicine in the blood typically peaks in approximately 0.9 hour after taking the oral tablet.

Q: Is Levotriz safe to take during pregnancy?

A: Official regulatory information advises that consultation with a health professional is necessary before use if you are pregnant. The medicine is advised to be used during pregnancy only if clearly needed, as there are no large, well-controlled studies documenting its safety in pregnant women.

Q: Where can I dispose of my expired Levotriz medication?

A: For environmental safety, regulatory guidelines recommend that you do not flush expired or unused Levotriz down the toilet or pour it down a drain. Common recommendations for disposal include using a drug take-back program or an authorized collector. If these are unavailable, the medicine can be mixed with an undesirable substance (like coffee grounds or kitty litter) and placed in a sealed container before disposal in household trash.

How should Levotriz be stored and disposed of?

How to Store and Dispose of Levotriz (Levocetirizine)

The official storage and disposal requirements for Levotriz are defined by regulatory authorities to maintain product stability and safety.

Storage Requirement Rule Defined by Regulatory Labeling
Temperature Store at controlled room temperature, typically between 20 and 25 C (68 and 77 F).
Environment Keep away from excess heat and moisture. Do not freeze.
Packaging Must remain in its tightly closed original container. Do not use if seals are broken or blisters are torn.
Safety Keep out of the sight and reach of children.

For disposal, do not throw away unused or expired Levotriz into wastewater or household waste. Consult a pharmacist or healthcare professional for instructions on appropriate disposal methods, which helps protect the environment.

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

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