Xyzall

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Medically reviewed

Marina Burgos

Last updated on 22/12/2025

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

Overview of Xyzall

Quick Facts

Property Description
Active ingredient Levocetirizine dihydrochloride
Form Film-coated tablets, Oral solution
Pharmacological class Second-Generation Antihistamine
Common use Relief of allergic symptoms
Origin Synthetic compound

Xyzall is a pharmaceutical product containing the single active substance, Levocetirizine dihydrochloride. This compound is a synthetic chemical entity intended for the management of symptoms associated with allergic conditions. Levocetirizine is chemically the (R)-enantiomer of Cetirizine, representing the purified active form of the compound. The medicine is designed for oral administration and is typically supplied as film-coated tablets or an oral solution.

Classifying Xyzall: A Selective H1-Receptor Antagonist

The medication belongs to the pharmacological class of antihistamines, specifically designated as a second-generation antihistamine. This classification highlights the drug’s mechanism group as a selective peripheral H1-receptor antagonist. Clinical pharmacological studies have confirmed its high affinity for peripheral H1 receptors, which is a key characteristic of its action. Levocetirizine works by blocking the action of histamine, a natural substance in the body that causes allergic symptoms.

General Purpose: Managing Hypersensitivity Reactions

The core purpose of Xyzall is to manage and relieve discomfort caused by histamine-mediated hypersensitivity reactions. By serving as a selective peripheral H1-receptor antagonist, the drug prevents histamine from attaching to its receptors, thereby stopping the subsequent cascade of symptoms. The medical community recognizes this compound's efficacy in managing symptoms typically experienced during seasonal or perennial allergy outbreaks. The drug thus acts as a fundamental tool for controlling the body's physical reaction to common allergens, providing relief for symptoms like itching, sneezing, or nasal discharge.

Regulatory References

  1. Levocetirizine dihydrochloride Label Information
  2. Levocetirizine Drug Information

What side effects are possible with Xyzall?

Possible Side Effects and Safety Information

The safety profile for Levocetirizine dihydrochloride (Xyzall) is structured by officially documented adverse reactions, classified by frequency and affected body systems. The most commonly reported effects in adults and adolescents include somnolence (drowsiness), fatigue, dry mouth, and nasopharyngitis. In children, common reactions may include fever and somnolence.

Adverse Reactions by System-Organ Class

Adverse events are documented across various systems, with notable reactions in the Nervous System Disorders (e.g., dizziness, syncope) and Gastrointestinal Disorders (e.g., abdominal pain). Post-marketing surveillance has also documented effects within Psychiatric Disorders, including reports of aggression, hallucination, depression, and suicidal ideation.


Serious Safety Considerations and Restrictions

Official regulatory sources specify serious adverse reactions that include acute hypersensitivity reactions (e.g., anaphylaxis) and the potential for urinary retention. Caution is advised for patients with predisposing factors for urinary retention, such as prostatic hyperplasia.

Use is contraindicated in patients with End-Stage Renal Disease (severe kidney impairment) and in individuals with known hypersensitivity to levocetirizine or the related compound, cetirizine. Additionally, concurrent use with alcohol or other CNS depressants may result in further reductions in alertness and performance.

Duration-Related Safety Patterns

A specific, duration-related safety pattern is documented: severe generalized itching (pruritus) has been reported following discontinuation after long-term use of the medication.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory documents define the manifestations of Xyzall (Levocetirizine dihydrochloride) overdose based on age, describing primary effects on the central nervous system. The expected presentation in adults who have ingested an excessive amount is documented as profound drowsiness (somnolence). A specific, age-dependent presentation is officially noted for pediatric patients, where the initial clinical manifestations are often agitation and restlessness, which is then followed by a state of drowsiness.


Emergency Actions and Supportive Management

Immediate medical attention must be sought in all cases of suspected overdose. The government-mandated action requires contacting a Poison Control Center immediately for specific guidance on next steps.

Overdose Management & Antidote Status

Domain Regulatory Statement
Antidote Status No specific antidote for Levocetirizine dihydrochloride is officially known.
Management Focus Treatment is directed toward symptomatic and supportive care.
Procedural Note The active substance is not effectively removed from the body by dialysis.

The regulatory profile strictly outlines the required intervention, confirming that the management must be symptomatic and supportive due to the official statement that no specific antidote is known. This profile also explicitly notes that the substance is not considered to be effectively removed by dialysis, defining the constraints for procedural treatment in an overdose scenario.

Therapeutic Uses of Xyzall

What Xyzall Treats: Main Uses and Benefits

Xyzall is used to help with the symptomatic management of various allergic conditions. It is applicable within settings that involve acute or disruptive symptom patterns, often utilized during phases when symptoms become more noticeable and interfere with daily comfort.

The medication is applied in addressing symptoms related to allergic rhinitis, which includes both seasonal (hay fever) and perennial forms, as well as for the symptomatic management of chronic idiopathic urticaria (hives). This use is relevant across domains where additional symptomatic support is required.

Supportive Management of Nasal and Ocular Symptoms

The medication helps address symptom clusters that may become intense or disruptive, such as excessive sneezing, profuse rhinorrhea (runny nose), uncomfortable nasal congestion, and itchy, watery eyes. This support contributes to easing the overall symptom load, helping to maintain a sense of stability when symptoms are more noticeable.

“This medication is applied in scenarios where additional management of discomfort is required, especially when acute manifestations interfere with function.”

Symptomatic Support for Skin Irritation

Xyzall is also relevant for managing symptoms that interfere with daily comfort, including the pervasive pruritus (itching) associated with chronic idiopathic urticaria. In these conditions, it may assist with easing the disruptive physical manifestations of hives, providing supportive relief when symptoms interfere with routine activities and helping to improve day-to-day comfort.


Quick Fact: Therapeutic Focus on Pruritus and Wheals

Property Description
Associated with Symptoms related to heightened physiological activity
General Benefit Easing overall symptom load
Chronic Condition Chronic Idiopathic Urticaria (Hives)
Acute Condition Seasonal Allergic Rhinitis (Hay Fever)

Eligibility and Restrictions for Use

Official Eligibility and Restriction Profile

The eligibility for Xyzall (levocetirizine) use is strictly defined by regulatory authorities based on age, organ function, and allergy history.

Category Regulatory Status Statement
Contraindicated Populations Patients with known hypersensitivity to levocetirizine, cetirizine, or other piperazine derivatives. Patients with end-stage renal disease (creatinine clearance < 10 mL/min) or those undergoing hemodialysis. Pediatric patients aged 6 months to 11 years with any degree of impaired renal function.
Age-Related Eligibility Use is approved for adults and children 6 years of age and older (tablets) or 6 months of age and older (oral solution). Use is not established for infants younger than 6 months of age.
Condition-Specific Rules Patients with mild to severe renal impairment require adjustment to the dosing frequency, as the drug is substantially excreted by the kidneys. No dose adjustment is required for patients with solely hepatic impairment. Caution is advised for those with predisposing factors for urinary retention.
Pregnancy and Lactation Use during pregnancy may be considered if clearly needed. The medication is not recommended during lactation because it is expected to be excreted into human breast milk.

Connection to the overall eligibility profile

Official regulatory documents classify patient groups through absolute contraindications, primarily based on severe organ dysfunction (renal) and known allergies to the compound. Eligibility for use is established according to minimum age, while specific conditions like mild renal impairment or risk factors for urinary retention lead to explicit warnings or requirements for dosage modification.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section describes documented interaction patterns for Levocetirizine as noted in official regulatory information.


Additive Central Nervous System Effects

Co-administration with substances that depress the central nervous system, including alcohol (ethanol) and other CNS depressants (such as sedatives or tranquilizers), may result in an additive pharmacodynamic interaction. This documented effect is the potential additive impairment of mental alertness and a corresponding decline in performance. Official labeling advises precaution with the concurrent intake of alcohol.


Pharmacokinetic Clearance Alteration

Regulatory studies using the parent racemate, Cetirizine, indicate that certain medications can alter the drug's clearance. Co-administration with Ritonavir resulted in a significant increase in the plasma Area Under the Curve (AUC) of the racemate, signifying reduced clearance. A small decrease in the racemate’s clearance was also documented when co-administered with Theophylline (400 mg once a day). The official profile also includes the finding of no clinically relevant adverse interactions with several agents tested, including Pseudoephedrine and Erythromycin.


Interaction-Related Restrictions

Levocetirizine is primarily excreted unchanged by the kidneys. Individuals with severe renal impairment (Creatinine clearance less than 10 ml/min) are classified as contraindicated due to the high risk of drug accumulation and compromised clearance. Additionally, the drug is officially documented as unlikely to produce pharmacokinetic interactions through the inhibition or induction of major CYP metabolic enzymes due to its low overall human metabolism (less than 14% of the dose).

Mechanism of Action

Levocetirizine, the active ingredient in Xyzall, acts through two primary mechanistic domains to influence activity within specific inflammatory signaling pathways.


Selective H1 Receptor Antagonism

This domain involves levocetirizine's action as a selective Histamine H1 receptor antagonist. By binding to and stabilizing the inactive conformation of the H1 receptors on effector cells, the molecule inhibits the activity of the endogenous mediator histamine. This action is a key molecular step that inhibits the downstream signaling initiated by histamine release, influencing the regulation of physiological processes, including vascular permeability.


Modulation of Inflammatory Mediator Pathways

Levocetirizine engages mechanisms that influence inflammatory processes beyond the direct action of histamine. The drug modifies early molecular steps in specific signaling sequences through the inhibition of various secondary mediators released from cells like eosinophils and epithelial cells. This action influences signaling pathway homeostasis by modulating mediator activity within targeted systems.

Dosage and Administration Information

Administration Overview

Xyzall (levocetirizine) is an antihistamine available in various oral forms, including tablets and oral solutions. Proper administration ensures the medication is absorbed effectively to manage symptoms associated with seasonal or perennial allergic rhinitis and uncomplicated skin manifestations of chronic idiopathic urticaria.

Oral Tablets

Tablets are designed to be swallowed whole. They may be taken with or without food, as the presence of food does not significantly decrease the overall absorption of the medication, though it may slightly delay the time it takes to reach peak concentration in the bloodstream. Consistency in how the medication is taken—either always with food or always without—can help maintain stable levels in the body.

Oral Solution

The liquid form of the medication is intended for those who have difficulty swallowing tablets or for specific age groups where precise volumetric measurement is necessary. When using the oral solution, it is important to use a calibrated measuring device, such as an oral syringe or a medicine cup, rather than a household teaspoon, to ensure an accurate volume is dispensed.

Timing and Routine

This medication is typically taken once daily. Many individuals choose to take the dose in the evening, as antihistamines can occasionally cause drowsiness in some users. Maintaining a regular schedule by taking the dose at the same time each day helps in managing allergy symptoms continuously throughout a 24-hour period.

Recent Clinical Evidence

Xyzall (Levocetirizine): Recent Clinical Evidence

The clinical development program for levocetirizine has primarily focused on establishing its role in managing symptoms of seasonal allergic rhinitis (SAR), perennial allergic rhinitis (PAR), and chronic idiopathic urticaria (CIU) across adult and pediatric populations.


Efficacy Studies

Allergic Rhinitis: Randomized, controlled trials lasting up to six months have investigated the compound's effect on symptom scores for allergic rhinitis. Studies explored potential associations between treatment and improvements in sneezing, rhinorrhea (runny nose), and ocular symptoms (itchy, watery eyes). In trials focused on PAR, which is a long-term condition, the investigational regimen was associated with improvements in health-related quality of life metrics compared to placebo.

Chronic Urticaria (Hives): Placebo-controlled studies in patients diagnosed with CIU examined whether the treatment was associated with a reduction in the mean total symptom score, including the number and size of wheals (hives) and the severity of pruritus (itching). The reduction in symptoms was observed during the active treatment phase.


Safety and Tolerability

The studies collected data on adverse events over periods typically ranging from one week to six months. In adolescents and adults (12 years and older), the adverse events reported most commonly and more frequently than in the placebo groups included somnolence, fatigue, and dry mouth. The events were generally reported as mild to moderate in intensity.

In children aged 6 to 12 years, the most commonly reported events included pyrexia (fever) and somnolence. The drug is primarily excreted by the kidneys, and clinical protocols involve close monitoring or dosage adjustments for individuals with existing renal impairment.

Key Studies & References

  1. The international EAACI/GA²LEN/EuroGuiDerm/APAAACI guideline for the definition, classification, diagnosis, and management of urticaria

Frequently Asked Questions (FAQ)

Common questions about Xyzall (FAQ)

Q: How quickly does Xyzall start to work?

A: Studies and official information indicate that the active ingredient, levocetirizine, acts relatively quickly after ingestion. Clinical data suggests symptom relief may begin to be experienced within one hour of administration, according to official regulatory summaries.


Q: Is Xyzall considered a steroid?

A: No, Xyzall is not a steroid. According to official classifications, it is categorized as a second-generation antihistamine and a selective peripheral H1-receptor antagonist. Its function is to block the action of histamine, a substance released during allergic reactions, rather than affecting inflammatory pathways like a corticosteroid.


Q: Can I take Xyzall if I have high blood pressure?

A: Levocetirizine is not typically associated with the cardiovascular concerns of some other cold and allergy medications, such as decongestants. Official regulatory guidelines do not list high blood pressure as a contraindication. However, the decision to use this medication must be made in consultation with a healthcare professional.


Q: Does Xyzall cause weight gain or changes in appetite?

A: Official post-marketing surveillance documents list increased appetite as an adverse reaction. The frequency of this event is categorized as unknown because it cannot be reliably estimated from the available data. These are distinct from the more commonly reported adverse events, such as somnolence and dry mouth.


Q: Is Xyzall available without a prescription?

A: In the United States, levocetirizine, the active component of Xyzall, is approved and available as an over-the-counter (OTC) medication. This may vary depending on the country or specific product strength. The current regulatory status for a specific product version can be verified on its packaging.


Q: What are the ingredients in Xyzall?

A: The single active ingredient is Levocetirizine dihydrochloride. The full official prescribing information lists the entire composition of the product, including all inactive ingredients (excipients). These components may differ between the tablet and the oral solution forms.


Q: Are there specific studies about Xyzall use in older adults?

A: Regulatory documents recommend that dose adjustments be considered for elderly patients who have moderate to severe renal impairment (reduced kidney function), indicating a specific area of concern. Official documentation does not typically detail separate, dedicated clinical trials focused solely on the geriatric population.


Q: Does Xyzall affect sleep patterns?

A: While somnolence (drowsiness) is a commonly reported side effect, clinical studies comparing levocetirizine to placebo have not shown any significant negative effects on overall cognitive function or general sleep-wake cycles. This is why the medication is often recommended for evening use.


Q: Are there generic versions of Xyzall available?

A: Yes, levocetirizine is widely available as a generic medication. The US Food and Drug Administration (FDA) and other health authorities have approved multiple generic versions of both the tablets and the oral solution forms.


Q: Can Xyzall be used to treat a common cold?

A: The official uses (indications) for Xyzall are confined to the relief of symptoms related to hay fever, other respiratory allergies, and chronic idiopathic urticaria (hives). The drug's approved uses are limited to allergic conditions.


Q: How long can I expect to take Xyzall before my symptoms improve?

A: Clinical data indicates that significant improvements in some allergy symptoms may be experienced within the first two hours of drug intake. For benefits concerning symptoms like nasal congestion, consistent use over a period of a few days may be associated with maximum relief.


Q: What are the long-term safety considerations for Xyzall?

A: Long-term toxicity studies have been reviewed by regulatory bodies and have provided the necessary data to support its approval for long-term use in chronic conditions, such as perennial allergic rhinitis. The safety profile includes a noted risk of severe itching following discontinuation after long-term use.


Q: What is the typical time frame of research evidence available for Xyzall?

A: The active substance was brought to market in Europe and approved by the US FDA for prescription use in 2007. This initial approval date gives context to the span of the clinical research program supporting the current approved uses.


Q: Is Xyzall linked to any heart-related side effects?

A: Levocetirizine is a second-generation antihistamine and is not typically associated with the cardiotoxicity risks sometimes seen with first-generation antihistamines. Official documentation does, however, include a warning regarding the potential for QTc prolongation when used with specific combined drug therapies.


Q: Does Xyzall relieve sinus pressure?

A: While the official regulatory label does not explicitly mention the relief of sinus pressure, clinical studies have shown that levocetirizine is effective for symptom relief in allergic rhinitis, which includes helping with nasal congestion and improved airflow.

How should Xyzall be stored and disposed of?

Storage and Disposal Requirements for Xyzal (Levocetirizine Dihydrochloride)

The storage and disposal requirements for Xyzal are mandated by regulatory authorities to ensure product stability and safety.

Storage Conditions

Xyzal products must be stored at Controlled Room Temperature, which is defined as 20 C to 25 C (68 F to 77 F), with permitted fluctuations. The medicine must be kept in its original container and protected from light and excessive humidity. A mandatory safety instruction requires Xyzal to be stored out of the reach and sight of children at all times.

Disposal Instructions

Unused or expired Xyzal should be disposed of using a community drug take-back program. If a take-back program is not available, federal guidelines recommend mixing the medicine with an unappealing substance, such as used coffee grounds or kitty litter, placing the mixture in a sealed container, and discarding it in the household trash.

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

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