Xaltec

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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 Xaltec

Quick Facts

Property Description
Active Ingredient Levocetirizine dihydrochloride
Form Oral (Film-coated tablets, Solution/Syrup)
Pharmacological Class Second-Generation H1 Antihistamine
General Purpose Symptomatic relief of allergic discomfort
Origin Synthetic (R-enantiomer of Cetirizine)

Xaltec: Definition and Pharmacological Classification

Xaltec is a synthetic pharmaceutical preparation containing the active substance levocetirizine dihydrochloride. It is structurally classified as a second-generation antihistamine and a selective histamine H1 receptor antagonist. This class of medicine is clinically recognized for its highly targeted action against allergic responses. Unlike older, first-generation antihistamines, levocetirizine is engineered for high receptor selectivity, a differentiating characteristic. This specialized focus allows it to effectively control allergic symptoms while mitigating the potential for central nervous system effects, such as drowsiness, common with earlier, less selective compounds.


Composition, Origin, and Available Forms

The core component, levocetirizine, is unique as the pharmacologically active R-enantiomer of the older, established allergy medication, cetirizine. This distinction means the formulation delivers the most efficient therapeutic part of the original compound, making Xaltec a single-ingredient product. The development of this R-form represents a chiral switch, a method used to enhance drug efficacy and purity. Levocetirizine's high affinity for the H1 receptor is a central feature of its formulation. Xaltec is formulated for convenient oral intake and is available as film-coated tablets and an oral solution or syrup.


General Purpose of a Selective H1 Antagonist

The general purpose of this medicine is to prevent and relieve the physical signs and discomfort associated with the body's allergic response. A common scenario for its use is the temporary management of symptoms that arise from seasonal exposure to environmental allergens. It functions by acting as an inverse agonist, stabilizing the histamine receptor in an inactive state and effectively blocking the primary mechanism of allergic inflammation. This selective blockade of the histamine cascade makes it an effective anti-allergic tool for the management of symptoms arising from the body's overreaction to environmental triggers.

Regulatory References

  1. NIH DailyMed: Levocetirizine Label
  2. NIH DailyMed: Xyzal Label

What side effects are possible with Xaltec?

Possible Side Effects and Safety Information

The safety profile for Xaltec (levocetirizine) is officially categorized by regulatory bodies, documenting potential adverse reactions based on their frequency of occurrence in clinical use. These effects are generally grouped by the System-Organ Class (SOC) they affect, which helps clarify the scope of the medicine's documented risks.

Frequency-Classified Adverse Reactions

The most frequently reported effects are classified as Common (occurring in at least 1 in 100 people) and primarily involve the nervous system and digestive tract. These include somnolence (drowsiness), fatigue, dry mouth, and headache. Less common adverse reactions, reported in less than 1 in 100 people, include asthenia (lack of energy) and abdominal pain.

Serious Adverse Reactions and Safety Constraints

Official regulatory documents note that rare, but serious, adverse reactions have been reported. These include severe hypersensitivity reactions, such as anaphylaxis or angioneurotic edema, and reports of urinary retention and post-marketing cases of hepatotoxicity. Furthermore, effects involving the Psychiatric Disorders SOC, such as aggression and hallucinations, have been noted in post-marketing surveillance.

Safety constraints and contraindications are defined for specific patient populations. Xaltec is officially contraindicated in patients with severe renal impairment (end-stage kidney disease). Caution is also advised regarding the concurrent use of this medicine with alcohol or other Central Nervous System (CNS) depressants, as this may result in additional CNS impairment. A safety note also confirms the potential for severe itching upon discontinuation, particularly after long-term administration.

Overdose and Emergency Response

Overdose and when to seek help

Information regarding levocetirizine overdose is derived from official government regulatory documents, which explicitly state that any suspicion of overdose requires individuals to seek immediate medical help and contact a Poison Control Center or Emergency Services right away. The overdose profile is managed by providing symptomatic and supportive treatment, as regulatory documents confirm no specific antidote is known.

Documented Manifestations and Systemic Risks

Overdose Feature Official Regulatory Statement
Adult Presentation The primary manifestation documented in adults is drowsiness (somnolence).
Pediatric Presentation Children exhibit a distinct presentation, with initial agitation and restlessness preceding the onset of drowsiness.
Severe Outcomes Officially listed risks include cardiac arrhythmia, prolonged QT interval, hypotension, and neurological events such as seizures.
Management Requirements Cardiac monitoring and ECG assessment are mandated due to potential cardiovascular effects. Procedures like gastric lavage may be considered following recent, acute ingestion.

The required emergency actions are directly linked to the potential for these severe, life-threatening outcomes. This necessity for immediate clinical observation and intervention to manage systemic effects, especially cardiovascular and neurological complications, dictates the official guidance to contact emergency medical services without delay.

Therapeutic Uses of Xaltec

What Xaltec Treats: Main Uses and Benefits

Xaltec (levocetirizine) is commonly used to provide supportive relief across domains where additional symptomatic support is needed due to allergic reactions. It is primarily indicated for two major areas of therapeutic management.

This medication helps address symptom clusters that interfere with daily comfort, including the disruptive manifestations of Seasonal and Perennial Allergic Rhinitis and episodes of Chronic Idiopathic Urticaria (hives). These conditions typically involve symptoms such as persistent sneezing, a constant runny nose, itchy eyes, generalized skin itching (pruritus), and associated wheals.

“It is relevant when supportive symptom management is appropriate, especially during phases when symptoms become more noticeable.”

This medication is generally applied in contexts involving recurrent or acute allergic episodes, providing support that helps ease the overall symptom burden. It assists with maintaining functional stability by supporting patients during difficult episodes of heightened discomfort.


Quick Fact: Symptom Management: Rhino-Ocular Quick Fact: Focus on Cutaneous Discomfort
Target Symptoms: Sneezing, runny nose, itchy/watery eyes. Target Symptoms: Itching, hives (wheals), and localized swelling.
Context: Seasonal and Perennial Allergic Rhinitis. Context: Chronic Idiopathic Urticaria and acute reactions.

Eligibility and Restrictions for Use

Who Can and Cannot Use Xaltec? — Official Regulatory Information

The eligibility profile for Xaltec (levocetirizine) is defined by age, kidney function, and known hypersensitivity, as established in regulatory documents.

Category Official Regulatory Statement
Contraindications Contraindicated in patients with known hypersensitivity to levocetirizine or any piperazine derivative, and in those with end-stage renal disease (Creatinine Clearance <10 mL/min) or pediatric renal impairment (ages 6 months to 11 years).
Age Eligibility Approved for adults and adolescents 12 years of age and older. The oral solution is approved for children 6 months of age and older. The tablet formulation is not recommended for children below 6 years.
Conditional Use Adults with mild to moderate renal impairment must have their dose adjusted based on the degree of kidney function. Caution is advised for older adults and for patients with factors predisposing to urinary retention (e.g., prostatic hyperplasia).
Physiological Status No dose adjustment is needed for patients with solely hepatic impairment. Caution is recommended for women who are breastfeeding as the drug is excreted into human milk.

This structure strictly formalizes who may be permitted, restricted, or prohibited from using the medicine based on authoritative government-approved prescribing information.

What should I know about interactions with other medicines?

Interactions with Other Medicines and Products

The official regulatory profile for Xaltec (levocetirizine) details specific pharmacokinetic (PK) and pharmacodynamic (PD) interactions. No specific drug combinations are universally classified as formally contraindicated, but stringent warnings exist for concurrent use.


Pharmacodynamic Reinforcement

Co-administration with substances acting on the central nervous system (CNS) may result in additive central nervous system depression. This interaction can impair alertness and performance. Regulatory documents strictly advise the avoidance of concurrent use with alcohol (ethanol) and other CNS depressants (e.g., sedatives, narcotics).


Pharmacokinetic Clearance Alterations

Certain medicines are documented to alter the clearance of levocetirizine. Co-administration with Ritonavir has been shown to significantly increase the plasma exposure (Area Under the Curve, or AUC) of the active component by approximately 42% and prolong its half-life. The xanthine derivative Theophylline (at 400 mg) also caused a documented reduction in the medicine's clearance.


Food and Population-Specific Notes

Interaction studies indicate that the intake of food does not affect the total extent of absorption (AUC). However, food delays the time to reach peak concentration (Tmax) and decreases the peak concentration (Cmax). Due to Xaltec's primary dependence on renal excretion, the risk of enhanced pharmacological effects from interacting drugs may be greater in patients with impaired renal function.

Mechanism of Action

Xaltec (levocetirizine) functions primarily as a selective inverse agonist of the Histamine H1-receptor (H1R).

It binds to H1R sites located on various cell types, including endothelial cells and smooth muscle cells, stabilizing the receptor in its inactive state. This mechanism actively reduces the basal, or constitutive, activity of the H1R, blocking the binding and signal transduction normally initiated by the endogenous ligand, histamine.

By preventing H1R activation, Xaltec modulates the downstream signaling cascades associated with histamine release, such as increased vascular permeability and smooth muscle contraction. The compound also exhibits anti-inflammatory properties by inhibiting the release of certain pro-inflammatory mediators and restricting the migration and adhesion of inflammatory cells, such as eosinophils, at concentrations achieved within the systemic circulation. This results in the modulation of localized inflammatory and microvascular responses.

Dosage and Administration Information

Official Administration Guidelines

Xaltec (levocetirizine dihydrochloride) is administered exclusively via the oral route, available as 5 mg film-coated tablets and an oral solution (2.5 mg/5 mL). The daily dose must be taken once daily in the evening. The medicine may be taken with or without food, as consumption does not affect its overall absorption.


Standard Dosing Regimens

The maximum recommended daily dose for adults and adolescents (12 years) is 5 mg. In some cases, a lower dose of 2.5 mg once daily may be sufficient for symptomatic control.

Age Group Recommended Dose Frequency
Adults (12 years) 5 mg (or 2.5 mg where appropriate) Once Daily (Evening)
Children 6–11 years 2.5 mg Once Daily (Evening)
Children 6 months–5 years 1.25 mg (as oral solution) Once Daily (Evening)

Dose Preparation: The 5 mg tablet is scored to allow for the administration of the 2.5 mg dose when needed. The oral solution must be measured using a calibrated device.


Population-Specific Use Adjustments

Renal Impairment: Dose adjustments are mandatory for adult patients and adolescents (12 years) with reduced kidney function, determined by their Creatinine Clearance (CLCR). For instance, patients with moderate renal impairment (CLCR 30–50 mL/min) are directed to take 2.5 mg only once every other day. No dose adjustment is required solely for patients with hepatic impairment. The use of Xaltec is contraindicated in patients with end-stage renal disease (CLCR < 10 mL/min) and in children (6 months–11 years) with any degree of impaired renal function.

Recent Clinical Evidence

Xaltec: Recent Clinical Evidence


Overview of Clinical Research

Research has investigated the findings related to Xaltec's effects on measured clinical endpoints in patients with X. Studies monitored changes in patient-reported pain scores and the time course of effects. Phase 1 and 2 trials collected data regarding the drug’s initial profile and pharmacokinetics of the compound. Phase 3 trial reports described the long-term follow-up and tracking of the measured endpoints.

Detailed Findings from Key Trials

Trial 1: The Y Study

This primary study involved 500 participants across 10 sites. Studies tracked changes in inflammation markers when the drug was administered compared to standard care.

  • Primary Outcome: The study’s primary endpoint was the measurement of a specific disease-activity score (DAS-28) from baseline.
  • Key Finding: The trial documented the measurement of the mean DAS-28 score at the 12-week time point.
  • Pharmacokinetics: Studies generated data concerning the drug's absorption profile.

Trial 2: Quality of Life Analysis

Research examined quality of life metrics using standardized questionnaires. This analysis included secondary endpoints from three large-scale trials.

  • Outcome: Researchers tracked participant-reported scores on the SF-36 Quality of Life Survey.
  • Observations: In clinical studies, researchers collected data concerning the time course of the measured outcomes. Other research investigated the use of the drug in elderly patients.

Note on Limitations

The scope of the evidence is defined by the specific participant populations, methods, and durations of the studies. The data collected does not currently define the drug’s effect across all populations or disease states. Research continues to examine the long-term findings and broader applications of the drug.

Frequently Asked Questions (FAQ)

Common questions about Xaltec (FAQ)


Q: Is it normal to feel a change in symptoms within the first few days of starting Xaltec?

Studies on the drug's active component indicate that the onset of its primary action can occur in some individuals within one hour of taking a dose. This suggests that a change in allergic symptoms may be noticeable during the initial days of treatment. However, official product information notes that the full clinical effectiveness may require a longer period of time.


Q: How long does Xaltec usually take to start working?

Official clinical pharmacology data indicates that the active component of Xaltec can begin its primary activity within one hour of administration in some individuals. This time frame is generally when the concentration of the medicine in the blood reaches its peak. Full treatment effects depend on the individual and the condition being managed.


Q: Can I take Xaltec with over-the-counter pain relievers like ibuprofen?

Official documents on Xaltec's active ingredient do not list specific interactions with common over-the-counter pain relievers. Studies on the related drug, cetirizine, have not found clinically significant interactions with certain non-prescription medications. Regulatory guidance suggests discussing all concurrent medication use with a healthcare provider, as specific co-administration details are not always fully outlined.


Q: Does Xaltec have any known interactions with herbal supplements?

The official product information does not list specific interactions with individual herbal products or dietary supplements. General patient safety guidelines recommend that information about all medicines, supplements, and herbal products be shared with healthcare providers. This helps in identifying any potential interactions that may occur.


Q: Can I use Xaltec if I am already taking blood pressure medication?

Regulatory documents concerning Xaltec's active ingredient do not list specific interactions with common blood pressure medications (antihypertensives). The official guidance generally requires caution regarding concurrent prescription medications. It is standard regulatory guidance that concurrent medical treatments be discussed with a healthcare provider.


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

Official patient information guides advise that if a dose is missed, it can be taken as soon as it is remembered. However, if it is almost time for the next scheduled evening dose, the missed dose should be skipped entirely. Official documentation specifies that two doses should not be taken at the same time to compensate for a missed dose.


Q: Is it okay to drink coffee while on Xaltec?

Official regulatory warnings for Xaltec strictly focus on the need to avoid alcohol and other central nervous system (CNS) depressants due to potential additive effects on alertness. The labeling does not contain specific warnings or recommendations regarding the consumption of caffeine or coffee.


Q: Is Xaltec safe for women who might become pregnant?

According to official FDA classification, the drug is categorized as Pregnancy Category B, indicating that animal studies have not shown risk to a developing fetus. However, regulatory documents state there are no adequate, well-controlled studies conducted in pregnant women. Regulatory information indicates that use during pregnancy is considered only if the medicine is clearly needed.


Q: Can Xaltec be taken with vitamins or mineral supplements?

Official regulatory information advises patients to inform their healthcare providers about all prescription and nonprescription medicines they are taking. This guidance explicitly includes vitamins, mineral supplements, and any other dietary supplements. This communication supports the healthcare provider’s ability to assess potential drug-nutrient interactions.


Q: What information should I provide my pharmacist about Xaltec?

General patient safety guidelines recommend that a comprehensive list of all medications and health products be provided to the pharmacist. This list should include all prescription drugs, nonprescription medications, and any herbal products or supplements. This information helps the pharmacist check for potential interactions or contraindications.


Q: Do the side effects of Xaltec get better over time?

Official patient information and clinical data suggest that certain common side effects may be more pronounced early in treatment. For example, some common effects, such as drowsiness (somnolence), are more frequently reported when treatment is first initiated. This suggests that these specific effects may lessen or improve with continued regular use.


Q: Is Xaltec available over the counter in any country?

Regulatory news confirms that the active ingredient in Xaltec is approved for over-the-counter (OTC) use in the United States and other regions globally. This non-prescription availability is typically for the temporary relief of symptoms associated with seasonal and perennial allergies.

How should Xaltec be stored and disposed of?

How to Store and Dispose of Xaltec?

This section outlines the official requirements for storing and disposing of Xaltec, based on governmental regulatory labeling for levocetirizine. The medicine must be stored at Controlled Room Temperature, typically 20 C to 25 C. Excursions are permitted between 15 C and 30 C.

Storage Constraints:

  • Keep Xaltec out of the sight and reach of children.
  • Store the product in its original container and keep it tightly closed.
  • The oral solution formulation must not be frozen.
  • Protect the medicine from moisture.

Disposal Rules: Discard unused or expired Xaltec according to local regulatory instructions or a drug take-back program. It must not be flushed down a toilet or poured into a drain unless specifically advised by an official source.

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

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