Cezera

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Cezera

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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 Cezera

What is Cezera?

Cezera is a medicinal product categorized as an antihistamine. It contains the active substance levocetirizine, which is a second-generation H1-receptor antagonist. This medication is primarily used to manage symptoms associated with allergic reactions.

How it Works

When the body encounters an allergen—such as pollen, dust mites, or animal dander—it releases a chemical called histamine. Histamine attaches to receptors in the body, leading to common allergy symptoms. Levocetirizine, the active component in Cezera, works by blocking these histamine receptors. This action helps to prevent or reduce the physiological response to allergens without typically causing significant drowsiness compared to older antihistamines.

Primary Uses

Cezera is utilized for the symptomatic treatment of various allergic conditions, including:

  • Allergic Rhinitis: This includes both seasonal allergic rhinitis (commonly known as hay fever) and perennial allergic rhinitis. It helps alleviate symptoms such as sneezing, runny or itchy nose, and red, itchy, or watery eyes.
  • Urticaria: It is also used to manage the symptoms of chronic hives, specifically helping to reduce the itching and the appearance of skin rashes or wheals.

By targeting the underlying histamine response, Cezera assists in maintaining daily comfort for individuals sensitive to environmental or seasonal triggers.

Regulatory References

  1. Levocetirizine - LiverTox - NCBI Bookshelf - NIH

What side effects are possible with Cezera?

Possible Side Effects and Safety Information

The safety profile of Cezera (levocetirizine) is based on regulatory documentation, including clinical trial data and post-marketing surveillance. This section outlines officially documented adverse reactions and safety considerations.

Adverse Reaction Scope

The most frequently reported adverse reactions are generally mild to moderate and are often related to the Central Nervous System or Gastrointestinal systems. These include somnolence (drowsiness), fatigue, dry mouth, and nasopharyngitis (common cold symptoms).

Frequency Classification Key Adverse Reactions (Examples)
Common (ge 1% to < 10%) Somnolence, Fatigue, Dry Mouth, Nasopharyngitis, Pharyngitis

Serious Adverse Reactions and Safety Restrictions

While uncommon, regulatory sources document the potential for more serious adverse reactions that require medical attention. These include hypersensitivity reactions (e.g., anaphylaxis, angioedema) and urinary retention. Severe, medically significant pruritus (itching) has also been reported in post-marketing surveillance following the discontinuation of the drug after long-term use (months to years).

Population-Specific Safety Considerations

The use of levocetirizine 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 drug's primary route of elimination. Caution is advised in patients with predisposing factors for urinary retention (e.g., prostatic hyperplasia or spinal cord lesions).

Patients should be aware of the potential for somnolence and exercise caution when engaging in activities requiring mental alertness, such as driving or operating heavy machinery.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory profile for Cezera (levocetirizine dihydrochloride) details the documented clinical manifestations of overdose and mandates specific emergency actions.

Documented Manifestations

The presentation of overdose symptoms differs between age groups. In adults, the primary manifestation documented in official labeling is drowsiness, formally termed somnolence. Conversely, pediatric patients typically exhibit a distinct initial pattern of agitation and restlessness preceding the onset of drowsiness. These manifestations primarily reflect effects on the central nervous system.

Emergency Action and Management

It is required that individuals seek emergency medical attention immediately upon suspected overdose. The official regulatory stance on intervention confirms that no known specific antidote to levocetirizine dihydrochloride is available. Consequently, the management protocol consists strictly of providing symptomatic and supportive treatment.

Further procedural limitations are noted: levocetirizine is not effectively removed by dialysis. This means that the procedure is considered ineffective for clearance unless a co-ingested dialyzable agent is present, emphasizing that supportive care defines the required management plan.

Therapeutic Uses of Cezera

Cezera is a second-generation antihistamine used across domains where additional symptomatic support is needed, primarily for managing conditions involving episodic or fluctuating manifestations caused by allergic reactions. The medication may assist with easing the overall symptom load related to systemic imbalance and symptoms that interfere with daily functioning.

The therapeutic domains it is relevant for easing include allergic rhinitis (both seasonal and perennial) and urticaria (hives). Levocetirizine is commonly used across conditions presenting with acute episodes, specifically for managing the symptomatic burden of these conditions.

This medication is applied in clinical settings that involve acute or unstable symptom patterns, and is often used during phases when symptoms become more noticeable. It plays a role in managing symptoms related to inflammatory or irritative states, thereby supporting patients during episodes of heightened discomfort. It assists with maintaining functional stability when symptoms are more noticeable.

“Supportive relief may assist with maintaining functional stability during symptomatic periods.”

Quick Fact: Supports Easing Itching

Eligibility and Restrictions for Use

The eligibility to use Cezera (levocetirizine) is strictly defined by regulatory authorities based on certain health conditions, age, and physiological status.

Contraindicated Populations

Use is strictly contraindicated for patients with a known hypersensitivity to levocetirizine, cetirizine, or any other piperazine derivative. The medicine is also prohibited for adults and adolescents 12 years and older with end-stage renal disease (creatinine clearance CLcr < 10 mL/ min) and for pediatric patients 6 months to 11 years old with impaired renal function.

Age and Restricted Use

Cezera is approved for adults and adolescents 12 years of age and older. Children 6 to 11 years old are eligible, but the tablet formulation is not recommended for children under six due to dosing limitations. Use is generally not established for infants younger than six months. Patients 12 years and older with mild to severe renal impairment require conditional use based on kidney function.

Special Populations

Cezera is not recommended for use during pregnancy or lactation. Additionally, the tablet form is restricted in patients with rare hereditary conditions such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption. Use is generally permitted for patients with solely hepatic impairment.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Cezera (levocetirizine) may interact with other substances by increasing central nervous system (CNS) effects, particularly drowsiness and impairment of performance, or by affecting the concentration of other medicines in the body.

Potential for Increased CNS Effects

Alcohol and CNS Depressants

The most clinically significant documented interaction involves substances that depress the central nervous system. Concurrent use of Cezera with alcohol or other CNS depressants should be avoided. This combination may lead to an additive impairment of central nervous system performance and reduced mental alertness, increasing the risk of somnolence, fatigue, and asthenia.

Patients should be cautious about engaging in activities that require complete mental alertness and motor coordination, such as driving or operating heavy machinery, when using this medication, especially in combination with alcohol or other CNS-affecting products.

Pharmacokinetic Interaction Data

Studies have been conducted to assess the effect of Cezera on the pharmacokinetics of other drugs, and the effect of other drugs on Cezera's levels. The following substances have been tested, demonstrating no clinically relevant change in levocetirizine levels:

  • Antipyrine
  • Azithromycin
  • Cimetidine
  • Erythromycin
  • Ketoconazole
  • Theophylline
  • Pseudoephedrine

In the case of Ritonavir, a co-administration study showed no clinically significant change in Cezera's plasma levels, though the systemic exposure to Ritonavir was decreased by approximately 11%. The overall official interaction profile is defined by a primary caution regarding additive CNS depressant effects rather than broad pharmacokinetic interactions.

Mechanism of Action

Cezera (levocetirizine) functions as a selective inverse agonist at the histamine H1 receptor. This receptor, a G protein-coupled receptor (GPCR), is a primary target in peripheral tissues. By binding to the H1 receptor, Cezera stabilizes the receptor in its inactive conformation, thereby decreasing its constitutive activity. This action reduces the downstream activation of intracellular signaling pathways that are typically triggered by endogenous histamine binding.

The H1 receptor is coupled to Gq/11 proteins. Its inverse agonism leads to a reduced signaling cascade involving the enzyme phospholipase C (PLC) and the subsequent formation of the secondary messengers inositol trisphosphate (IP3) and diacylglycerol (DAG). Reduced IP3 levels translate to diminished release of sequestered calcium ions (Ca^2+) from the endoplasmic reticulum.

At a system level, this inverse agonism modulates the histamine-mediated effects on smooth muscle and endothelial cells. Specifically, the compound limits the H1 receptor-mediated increase in vascular permeability and the contractility of specific smooth muscle tissues.

Dosage and Administration Information

Cezera (levocetirizine) is taken orally once daily, typically in the evening, with or without food.

Official Dosing Rules

The dosage is determined by age and, for adults and adolescents, by kidney function. The dose should not be exceeded to maintain safe systemic exposure. The available forms, such as the 5 mg scored tablet and the oral solution (2.5 mg/5 mL), facilitate accurate dosing.

Age Group Standard Recommended Dose Frequency
Adults & Children 12 Years and Older 5 mg Once daily, in the evening
Children 6 to 11 Years 2.5 mg Once daily, in the evening
Children 6 Months to 5 Years 1.25 mg (Oral solution) Once daily, in the evening

Dose Adjustment for Impaired Renal Function

For patients 12 years and older with impaired kidney function, the dose must be adjusted based on creatinine clearance (CLCR). Use is contraindicated in children 6 months to 11 years with any degree of renal impairment and in patients 12 years and older with end-stage renal disease (CLCR < 10 mL/min) or those undergoing hemodialysis.

Kidney Function (CLCR) Recommended Dose
Mild (50-80 mL/min) 2.5 mg once daily
Moderate (30-50 mL/min) 2.5 mg once every other day
Severe (10-30 mL/min) 2.5 mg twice weekly (once every 3-4 days)

Missed Dose Instructions

If a dose is missed, take the dose as soon as you remember. However, if it is almost time for the next scheduled dose, the missed dose should be skipped to prevent taking two doses close together. Do not double the dose to make up for the missed one.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Cezera

Evidence for Use in Allergic Rhinitis (Seasonal, Perennial, and Persistent)

The evidence related to Cezera (levocetirizine) was evaluated in research exploring allergic rhinitis, which includes common conditions like hay fever. This research is primarily derived from short-term Randomized Controlled Trials (RCTs). These studies were applied in research contexts involving fluctuating or unstable symptoms that characterize seasonal and perennial allergies. Researchers primarily focused on outcomes related to systemic or functional imbalance, such as scores measuring the intensity of sneezing and nasal itching, as well as patient-reported outcomes describing perceived discomfort and effects on daily functioning. The research examined large numbers of Adults and Adolescents, with studies also exploring short-term symptom changes in Children across different age groups. Findings describe patterns observed in the studies where measurements of symptom scores often data show patterns related to differences between the study groups during the observation period.

Evidence for Use in Urticaria (Hives)

Cezera was studied for its role in research exploring symptoms of urticaria, commonly known as hives, particularly the chronic form (chronic spontaneous urticaria). This research explored short-term symptom changes and primarily consisted of short- to intermediate-term (4 to 6 weeks) Randomized Controlled Trials (RCTs). Studies primarily measured outcomes related to physical discomfort, focusing on scores related to the severity of pruritus (itching) and the visible presence of wheals (skin rash). Analysis of the data across multiple studies studies report how symptoms evolved in the observed populations when measurements were taken within the first few weeks of administration. Specific pediatric research was observed in some studies to help establish appropriate exposure levels for Children starting from 6 months of age, data show patterns related to the observed response in this group compared to adults.

What Remains Uncertain and Research Gaps

There is limited information for long-term outcomes regarding the management of chronic urticaria and allergic rhinitis where the study period extended beyond six months. The follow-up durations were limited in many of the core efficacy trials for both indications, and the long-term effects are not fully established regarding the consistency of the observed patterns over many years. The certainty remains low for predicting individual responses, as study results reflect the specific conditions under which they were conducted and findings describe group patterns, not personal outcomes. Furthermore, comparative evidence is lacking in extensive head-to-head trials research has explored Cezera alongside all other second-generation antihistamines across long-term follow-up periods.

Key Studies & References

  1. Levocetirizine: Review of its Use in the Treatment of Seasonal Allergic Rhinitis (includes long-term data limitations)

Frequently Asked Questions (FAQ)

Common questions about Cezera (FAQ)


Q: What types of allergies or conditions is Cezera approved to treat?

A: Official product information indicates that this medicine is used for the relief of symptoms related to seasonal allergic rhinitis (e.g., hay fever), perennial allergic rhinitis (year-round allergies), and the skin symptoms of chronic idiopathic urticaria (hives of unknown cause).


Q: Does Cezera work for both seasonal and year-round allergies?

A: Yes, the medicine is indicated by regulatory bodies for use in both seasonal allergic rhinitis and perennial allergic rhinitis. This means it is used for symptoms that occur during specific seasons as well as those that persist throughout the year.


Q: How long does it typically take to feel the effect of Cezera after taking it?

A: According to pharmacokinetics data, the active ingredient in the bloodstream usually reaches its maximum concentration in adults in approximately 0.9 hours after an oral dose is taken. This time point is typically associated with the beginning of the maximum concentration of the drug.


Q: How long does the effect of one dose of Cezera last?

A: The standard recommendation is to take the dose once daily in the evening. This dosing schedule indicates the intended period of action is designed to cover approximately 24 hours.


Q: Can Cezera be taken long-term for chronic conditions?

A: The medicine is indicated for persistent conditions, such as chronic idiopathic urticaria and perennial allergic rhinitis, which often involve extended use. Regulatory documents note specific safety information, such as reports of severe itching (pruritus) following discontinuation after extended use.


Q: What is the difference between Cezera (levocetirizine) and cetirizine?

A: Levocetirizine is described in official documentation as the pharmacologically active R-enantiomer (a specific component) of the parent drug, cetirizine. This molecular difference is intended to allow the drug to achieve its therapeutic effect at the prescribed dose.


Q: Is Cezera available over-the-counter (OTC) or only by prescription?

A: In some regions, levocetirizine is marketed in both prescription and over-the-counter (OTC) formulations and strengths. The specific availability depends on the product and local regulations.


Q: Does taking Cezera at night help reduce daytime drowsiness?

A: The recommended dose is generally to be taken once daily in the evening. The evening timing of the dose may be used to align with the potential for somnolence (drowsiness), a common side effect.


Q: Is Cezera used for treating symptoms related to insect bites or stings?

A: The drug is indicated for symptoms related to urticaria (hives). Since insect bites often cause histamine-mediated symptoms like hives, the drug's mechanism of action addresses these symptoms, but official indications do not explicitly list insect bites or stings as a separate condition.


Q: Are there studies on the use of Cezera in managing chronic idiopathic urticaria (CIU)?

A: Yes, regulatory documents explicitly indicate that the medicine is approved for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria (CIU), which is hives of unknown cause.


Q: Can Cezera be used to treat symptoms of a common cold, even if they mimic allergies?

A: Official indications state the medicine is for symptoms resulting from hay fever or other respiratory allergies. It is not indicated for the treatment of the common cold.


Q: Why does Cezera sometimes cause sleepiness or drowsiness in some people?

A: Somnolence (drowsiness), fatigue, and asthenia are listed as reported side effects. Although the medicine is designed as a second-generation type to minimize these central nervous system (CNS) effects, some individuals may still experience them.


Q: Can Cezera affect the ability to drive or operate machinery?

A: Official warnings advise patients to avoid engaging in hazardous occupations that require complete mental alertness and motor coordination, such as driving or operating heavy machinery, until they know how the medicine affects them, due to the potential for somnolence.


Q: What is the risk of severe itching (pruritus) after stopping long-term use of Cezera?

A: New-onset pruritus (severe itching) has been reported in post-marketing surveillance. Post-marketing surveillance reports indicate this generally occurred following the discontinuation of the medicine after long-term use, spanning months to years.


Q: What are the possible side effects of Cezera specifically in young children?

A: Official clinical trial data shows that in children 1 to 5 years of age, common adverse reactions included pyrexia (fever), diarrhea, and vomiting. In infants 6 to 11 months, common reactions were reported as diarrhea and constipation.


Q: Can Cezera cause problems with urination, such as difficulty or inability to empty the bladder?

A: Urinary retention (difficulty or inability to empty the bladder) is a reported adverse reaction. Official warnings note that caution is advised for patients with predisposing factors for this condition, such as prostatic hyperplasia (enlarged prostate).


Q: Is there a risk of weight gain associated with taking Cezera?

A: Weight gain has been reported in post-marketing surveillance. The frequency and direct link of this effect are not established as common in the core regulatory label.


Q: Are headaches a potential side effect of Cezera?

A: Yes, official adverse reactions data list headache as a common side effect reported in clinical trials.


Q: Does Cezera cause changes in appetite or lead to feeling more hungry?

A: Increased appetite has been listed in post-marketing reports. The frequency of this effect is not established in the core regulatory label.


Q: Is a sore throat or cold-like symptoms a reported side effect of Cezera?

A: Yes, official clinical trial experience lists nasopharyngitis and pharyngitis (sore throat) as common adverse reactions in subjects 12 years of age and older.


Q: Is there any evidence about Cezera affecting mental alertness or concentration?

A: The drug is associated with a risk of somnolence and impairment of central nervous system performance. Patients are cautioned about tasks requiring complete mental alertness.


Q: Does Cezera affect blood pressure or heart rhythm?

A: Post-marketing surveillance has documented reports of palpitations and tachycardia (fast heart rate). The frequency and direct link of these effects are not established in the core regulatory label.


Q: Is it common for children to have diarrhea or vomiting while taking Cezera?

A: Yes. Official clinical trial experience shows that in children 1 to 5 years of age, diarrhea and vomiting are listed as common adverse reactions (rate ge 2% and > placebo).


Q: Is there a chance of experiencing blurred vision while on Cezera?

A: Blurred vision has been documented in post-marketing surveillance. This effect is considered very rare.


Q: Is Cezera safe to take during pregnancy?

A: Levocetirizine is classified as Pregnancy Category B. This means that animal studies did not indicate harm to the fetus, but no adequate and well-controlled studies have been conducted in pregnant women.


Q: Is Cezera safe to use while breastfeeding or nursing?

A: Official information indicates that levocetirizine is expected to be excreted in human milk. The decision to nurse while using the medicine involves considering the potential benefit to the mother against the potential risk of adverse effects to the infant.


Q: Is Cezera appropriate for use by older adults (e.g., those 65 and older)?

A: Yes, but official information states that in older adults, the dose should be adjusted based on renal function. This is because adults in this age group are more likely to have decreased kidney function, which affects how the drug is cleared from the body.


Q: Can Cezera be taken with common over-the-counter painkillers like paracetamol or ibuprofen?

A: Pharmacokinetic studies of levocetirizine and other common medicines, such as paracetamol (acetaminophen), generally showed no known clinically significant interactions. However, co-administration of any medicines should be discussed with a healthcare professional.


Q: Can the medication impact the results of allergy skin tests?

A: Yes. Since the medicine works by blocking histamine, it can suppress the wheal-and-flare reaction (the bump and redness) caused by an allergy skin test. Official guidance often includes recommendations to stop taking antihistamines for a specified period before allergy skin testing.


Q: Does Cezera interact with common medications for anxiety or sleep?

A: Regulatory warnings state that patients must avoid concurrent use with central nervous system depressants. This includes many medications prescribed for anxiety or sleep, as the combination may cause additional reductions in alertness and impairment.


Q: How does Cezera compare to older (first-generation) antihistamines regarding sedation?

A: Cezera is classified as a second-generation antihistamine. This class of drugs is generally designed to be less sedating than older, first-generation antihistamines because it typically has limited ability to cross the blood-brain barrier.

How should Cezera be stored and disposed of?

How to Store and Dispose of Cezera (Levocetirizine)

Official regulatory labeling dictates strict conditions for storing and disposing of Cezera tablets to maintain product stability and safety.

Storage Requirements

Condition Requirement (Official Labeling)
Temperature Store at Controlled Room Temperature, between 20 C and 25 C (68 F and 77 F).
Protection Keep the product from freezing and protect from excess heat, moisture, and direct light.
Container Preserve in the original, well-closed container to maintain integrity.
Child Safety Must be kept out of the sight and reach of children at all times.

️ Disposal Instructions

Disposal of unused or expired Cezera must comply with official pharmaceutical waste rules. The medicine must not be thrown away via household trash or flushed down the toilet (wastewater). Patients are instructed to return the product to a drug take-back program or consult a pharmacist for guidance on authorized disposal methods.

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

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