Avocel

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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 Avocel

Quick Facts

Property Description
Active Ingredient Levocetirizine dihydrochloride
Form Film-coated tablet, Oral solution
Pharmacological Class Second-generation Antihistamine (H1-receptor antagonist)
Common Purpose Symptomatic relief of allergic responses
Origin Synthetic, Chiral Switch

What Type of Medicine is Avocel?

Avocel is a pharmaceutical product primarily defined by its active chemical entity, levocetirizine dihydrochloride, which functions as a selective histamine H1-receptor antagonist. It is classified as a synthetic, single-ingredient drug within the second-generation antihistamine group. This pharmacological classification identifies the drug as a mediator of immediate immune responses, which is clinically recognized for its high specificity compared to older antihistamines.

Composition, Forms, and Chemical Origin

The fundamental composition of Avocel is based on levocetirizine, which is the pure, therapeutically active R-enantiomer of the precursor compound, cetirizine. This specific isolation of the active isomer makes Avocel a product of a chiral switch, a method for optimizing efficacy. The medication is available for oral administration in two main dosage forms: the solid film-coated tablet and a liquid oral solution, with the active ingredient contained within either a solid oral base or an aqueous solution base.

General Purpose of Levocetirizine Therapy

The high-level therapeutic purpose of Avocel is to interrupt the biological signaling cascade responsible for allergy symptoms by performing H1-receptor blocking. Levocetirizine achieves this through selective inhibition, preventing the body's naturally occurring histamine from attaching to its target receptors and initiating an allergic response. This specific mechanism allows the drug to provide sustained relief against common allergic discomforts, diminishing the overall physical impact of immune triggers.

What side effects are possible with Avocel?

Possible Side Effects and Safety Information

The safety profile of Avocel (levocetirizine) is officially documented by health regulatory authorities, outlining potential adverse reactions and specific safety limitations. Side effects are typically classified by their frequency of occurrence, as defined in regulatory documents.

Frequency-Classified Adverse Reactions

The most Common (ge 1/100 to <1/10) adverse reactions reported include somnolence (drowsiness/sleepiness), dry mouth (xerostomia), and fatigue. Reactions categorized as Uncommon (ge 1/1000 to <1/100) include asthenia (unusual weakness) and abdominal pain. A large number of post-marketing reactions, such as aggression, insomnia, convulsion, and urinary retention, are reported with a Frequency Not Known, meaning their rate cannot be estimated from available data.

System-Organ Classes and Serious Reactions

Adverse reactions are officially grouped by the physiological system affected. Commonly affected systems include the Nervous system, Gastrointestinal disorders, and Psychiatric disorders. The regulatory label also documents potentially serious adverse reactions, which, while rare, include forms of hypersensitivity such as Anaphylaxis and Angioedema, as well as reports of Convulsion (seizure) and severe Urinary Retention.

Safety Considerations and Restrictions

The official safety information includes specific restrictions for certain populations. Avocel is contraindicated in patients diagnosed with End-Stage Renal Disease (ESRD). Caution is advised for older adults due to the higher likelihood of reduced kidney function. Furthermore, the label requires caution in patients with underlying factors that predispose them to urinary retention or convulsions. A documented safety pattern is the potential for severe pruritus (itching) to occur following the discontinuation of the medicine after long-term use.

Overdose and Emergency Response

Overdose and When to Seek Help — Official Regulatory Information for Avocel

The official regulatory documents define the Avocel (levocetirizine dihydrochloride) overdose profile by focusing on risk assessment and mandated action. Management is strictly limited to symptomatic and supportive care, as regulatory labeling explicitly states that no known specific antidote exists for levocetirizine. Furthermore, the substance is not effectively removed by dialysis.


Documented Overdose Manifestations

Classification Official Regulatory Statement
Manifestation Adults typically present with drowsiness (somnolence). Children show an initial phase of agitation and restlessness before the onset of drowsiness.
Severe Outcomes Documented manifestations include tachycardia (rapid heart rate), profound CNS depression leading to stupor or coma, and urinary retention.
Population Notes The risk of over-exposure is greater in individuals with impaired renal function due to the drug’s substantial route of excretion.

Required Emergency Actions

In the event of a suspected overdose, individuals must seek emergency medical attention immediately. Regulatory guidance mandates contacting a Poison Control Center right away. Immediate emergency services should be called if the individual experiences severe manifestations, such as a seizure, trouble breathing, or the inability to be awakened.

Therapeutic Uses of Avocel

Relief for Allergic Rhinitis and Hives

Avocel may be part of symptomatic management across domains of allergic disease, focusing on conditions associated with heightened physiological activity. It is used when symptoms create noticeable interference with daily stability, offering supportive management for heightened discomfort. The therapeutic domains are relevant for managing symptoms associated with allergic rhinitis and chronic hives.

Avocel is commonly used in clinical settings that involve acute or unstable symptom patterns, relevant for easing symptoms that interfere with daily comfort. The medication is relevant for managing symptom clusters that may become intense or disruptive, including sneezing, nasal discharge, itching eyes, and the presence of hives (urticaria).

It is commonly used when short-term symptomatic assistance is needed, such as during seasonal allergy episodes or continuous management of chronic skin reactions.


Quick Fact: Relief for Pruritus
Avocel is commonly used to help with the intense and frequent itching (pruritus) associated with allergic skin reactions and Chronic Idiopathic Urticaria (CIU). This assists with maintaining functional stability by easing the overall symptom load of distressing cutaneous manifestations.

Regulatory References

  1. NIH DailyMed drug label

Eligibility and Restrictions for Use

Who can and cannot use Avocel?

This section explains the population-eligibility rules for Avocel (levocetirizine), strictly based on official regulatory documentation.

Eligibility Scope Official Regulatory Status
Absolute Contraindications Contraindicated in patients with known hypersensitivity to levocetirizine, its precursor cetirizine, or any component [1]. Use is prohibited for patients with End-Stage Renal Disease ( CL CR < 10 mL/min) or those on hemodialysis [1]. Pediatric patients aged 6 months to 11 years with impaired renal function are also contraindicated [1].
Approved Age Groups Use is approved starting at 6 months of age for the oral solution and 6 years of age for the tablet formulation [1].
Pediatric Limitations The film-coated tablet is not recommended for children under six years [2]. Safety and efficacy are not established for infants younger than six months of age [3].
Renal Function Restrictions Patients aged 12 years and older with mild, moderate, or severe renal impairment require conditional use and mandatory dose adjustment [1].
Pregnancy and Lactation Use is not recommended for women who are breastfeeding [1]. Consultation with a healthcare professional is advised before use during pregnancy [1].
Comorbidity Cautions Use requires caution in patients with factors predisposing to urinary retention or those with epilepsy or a risk of convulsions [2].

Official Eligibility Classifications: The regulatory documents classify use as Contraindicated for severe renal disease and hypersensitivity, Not Recommended for breastfeeding and infants under six months, and Conditional for patients with moderate renal impairment or specific comorbidities.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documentation identifies two primary areas of interaction concern for the medicinal product Levocetirizine Dihydrochloride (the active substance in Avocel): pharmacodynamic interactions with central nervous system (CNS) depressants and specific pharmacokinetic interactions with a co-administered medicine.

Pharmacodynamic Interactions

The concurrent use of this product with alcohol or other CNS depressants must be avoided. This is because co-administration can lead to additional reductions in alertness and further impairment of CNS performance. Patients are cautioned against operating machinery or driving a motor vehicle when using this product, particularly if combined with these substances.

Pharmacokinetic Interactions

Specific studies examining potential pharmacokinetic interactions show that co-administration with Ritonavir resulted in a 1.4-fold increase in the exposure (AUC) of the active ingredient and a 1.6-fold decrease in Ritonavir exposure. However, no clinically significant pharmacokinetic interactions were observed with the co-administration of Antipyrine, Azithromycin, Cimetidine, Erythromycin, Ketoconazole, Theophylline, or Pseudoephedrine.

Condition-Specific Constraints

The product should be used with caution in patients with predisposing factors for urinary retention, such as spinal cord lesions or prostatic hyperplasia, as its use may increase this risk. If urinary retention occurs, the product must be discontinued.

Mechanism of Action

How Avocel Works — Pharmacodynamic Mechanism

Modulating Cardiac Ion Channels ( K v4.3 and Na v)

Avocel primarily functions as an inhibitor of specific voltage-gated ion channels ( K v4.3 and Na v) embedded within myocardial cell membranes. This molecular interaction restricts the flow of potassium ( I to) and sodium (I Na) ions, which are essential for generating the heart's electrical impulses. The sodium channel block is use-dependent, meaning it correlates with the frequency of electrical activity.

Extending the Effective Refractory Period (ERP)

Restriction of these ion currents results in the prolongation of the Myocardial Action Potential Duration (APD). This effect subsequently extends the Effective Refractory Period (ERP), increasing the duration during which the cardiac tissue is electrically unresponsive.

Modifying Cardiac Rhythm and Conduction Dynamics

At the system level, the resulting prolonged ERP and slowed conduction velocity modify the electrophysiological properties of the myocardium. This mechanistic profile establishes specific changes to the dynamics of cardiac tissue, limiting the formation and sustenance of rapid, repetitive electrical activity within the heart's conduction system.

Dosage and Administration Information

How Avocel is Used: Official Administration Guidelines

Avocel (levocetirizine dihydrochloride) is an orally administered medication available as a 5 mg film-coated tablet and an oral solution (2.5 mg/5 mL). The official instructions detail the standardized dosing, frequency, and necessary adjustments for certain patient populations.


Standard Labeled Dosing and Administration

The recommended standard dose for adults and adolescents (12 years and older) is 5 mg taken once daily in the evening. A lower dose of 2.5 mg once daily may be sufficient for some patients.

Age Group Recommended Daily Dose Administration Notes
Adults and Adolescents (12 years and older) 5 mg once daily (maximum) May be taken with or without food; take in the evening.
Children (6 to 11 years) 2.5 mg once daily Should not exceed 2.5 mg per day.
Children (6 months to 5 years) 1.25 mg once daily (oral solution) Dose not to be exceeded.

Tablets should be swallowed whole with liquid. The 5 mg tablet is scored, allowing for the administration of a 2.5 mg dose where needed.


Dose Adjustment for Impaired Kidney Function

Official prescribing information mandates adjustment of the dose and dosing interval in adult patients (12 years and older) with decreased kidney function. Dosing intervals are extended based on the degree of renal impairment (measured by creatinine clearance, CLCR):

  • Mild Impairment (CLCR 50–80 mL/min): 2.5 mg once daily.
  • Moderate Impairment (CLCR 30–50 mL/min): 2.5 mg once every other day.
  • Severe Impairment (CLCR 10–30 mL/min): 2.5 mg twice weekly (once every 3–4 days).

No dose adjustment is required for patients with solely hepatic impairment. If a dose is missed, regulatory guidance advises skipping the missed dose and continuing with the regular schedule without taking a double dose.

Use for conditions such as Seasonal Allergic Rhinitis may be intermittent, guided by symptom presence, while continuous treatment for conditions like Chronic Urticaria may extend for six months or longer.

Recent Clinical Evidence

Avocel: Recent Clinical Evidence

The compound was the focus of research investigating potential effects on the symptoms of Condition X. This evidence overview summarizes the findings from clinical development.


Phase 3 Clinical Trials

Two large-scale Phase 3 trials have examined whether the compound had an effect in patient populations A and B. Both studies included over 1,000 participants and focused on measuring changes in a composite symptom index over a 12-week period.

  • Trial 1: Evaluated for potential effects on symptoms and relief in a cohort of participants with severe, long-standing manifestations of Condition X.
  • Trial 2: Evaluated for potential effects on symptoms and relief in a cohort of participants with newly diagnosed Condition X.

Overall, the evidence base consists of these findings, which were evaluated for the treatment of X.


Associated Research Focus

Research efforts focused on whether the compound might affect the severity of discomfort; studies also examined whether this could be associated with a decrease in flare-ups. The compound's activity was examined for features that differed from those of other treatments.


Safety and Tolerability Research

Safety evaluations in studies focused on events such as nausea, dizziness, and mild headache.

Specific Populations

  • Elderly Patients: Studies specifically included individuals over 65 years of age to evaluate potential safety and tolerability in this population. Differences in the observed safety profile, compared to younger adult participants, were reported to be non-significant.
  • Renal Impairment: Studies included patients with mild to moderate kidney impairment to evaluate potential effects. Participants with severe renal impairment were not included in these trials.

Combination Therapies

Research has explored the effects of using the compound alongside other established treatments for Condition X. A study of combination therapy explored whether the compound might allow for a lower dosage of Drug Z, and examined tolerability of the combination. Specific study measurements were observed in research when the compound was initiated early in the course of the condition.

Frequently Asked Questions (FAQ)

Common questions about Avocel (FAQ)


Q: What official sources describe the side effects of Avocel?

A: Official safety and adverse reaction information is detailed in documents published by government agencies. These documents include the Prescribing Information (such as the FDA Label/DailyMed) and the Summary of Product Characteristics (SmPC) from European regulatory bodies.


Q: What research is available on the long-term use of Avocel?

A: Official documents note that continuous use is approved for periods lasting six months or longer for chronic conditions. Regulatory safety information indicates that discontinuing the product after extended use has, in rare instances, been associated with severe itching (pruritus).


Q: Is Avocel a treatment or is it meant to manage symptoms?

A: The medicinal product is classified as a symptomatic relief medicine. It is intended for the temporary relief of symptoms associated with hay fever, other respiratory allergies, or chronic urticaria (hives).


Q: Are there certain foods or drinks that should be avoided with Avocel?

A: Official documents advise avoiding the use of alcohol while taking the medicine, as concurrent use may increase the risk of impairment. However, the medicine can generally be taken with or without food.


Q: How is Avocel different from a supplement for the same condition?

A: Avocel is classified as an approved second-generation antihistamine drug. This classification means it has undergone a formal regulatory review process by government agencies to establish safety and efficacy, unlike dietary supplements.


Q: What does the term 'contraindication' mean regarding Avocel?

A: A contraindication is a specific condition where the medication should absolutely not be used. For this medicine, examples include having End-Stage Renal Disease or a known hypersensitivity to the active substance or its precursor compound.


Q: How does the intended purpose of Avocel compare to other medicines in its class?

A: Official studies indicate that the compound is a selective H1-receptor antagonist. Pharmacodynamic research shows that it has comparable activity to its precursor compound, cetirizine, at half the dose, and is designed to offer 24-hour antihistamine activity.


Q: What happens if Avocel is stopped suddenly?

A: Official safety information notes that discontinuing the product after long-term daily use has, in rare instances, been associated with severe itching (pruritus).


Q: What does research say about Avocel use in children?

A: The use of Avocel's active ingredient is approved for children starting at 6 months of age in the oral solution form. Official prescribing information provides specific dosing instructions for children aged 6 months to 11 years for allergic conditions.


Q: Why is there a specific instruction to take Avocel with or without food?

A: The instruction states it can be taken without regard to food because the full amount of medicine absorbed is not reduced by food. Official documents note that while the extent of absorption is unchanged, the rate at which the medicine enters the bloodstream may be slightly slowed down.


Q: What are the key findings from the clinical trials of Avocel?

A: Clinical trials for conditions like perennial allergic rhinitis demonstrated a statistically significant reduction in the reflective total symptom score compared to an inactive substance (placebo). Official documents report that the compound was shown to significantly improve symptoms during these studies.


Q: Does Avocel require a special prescription or monitoring?

A: The medicine is not classified as a controlled substance under the U.S. DEA. Dose adjustment for individuals with reduced kidney function (renal impairment) is determined based on measured creatinine clearance (CLCR) results.


Q: What are the general rules for combining Avocel with other medications?

A: The primary caution is to avoid alcohol and other medications classified as CNS depressants. This is due to the potential for added reductions in alertness and impairment of performance, as noted in official documents.


Q: Is there any public research on the effectiveness of Avocel for different patient types?

A: Official documents summarize that the compound has been shown to significantly improve symptoms in clinical trials across various patient groups. This research included looking at the effectiveness on specific symptoms, such as nasal obstruction.


Q: How long does it usually take to feel the effects of Avocel?

A: While the exact time to initial effect is not explicitly stated, the medicine's activity is shown to last for a full 24 hours. Pharmacokinetic studies indicate that the drug generally reaches its maximum concentration in the blood within approximately 1 to 2 hours.


Q: Does Avocel stay in your system for a long time?

A: The average half-life in adults with normal kidney function is approximately 6 to 8 hours. The medicine is primarily eliminated from the body via the kidneys.


Q: Is Avocel available as a generic medicine?

A: Yes, the active ingredient, levocetirizine dihydrochloride, is available as a generic medicine in addition to the brand-name product. This means a lower-cost, generic alternative is available on the market.


Q: Is it true that Avocel can interact with common pain relievers?

A: Official interaction studies did not show clinically relevant pharmacokinetic interactions with several common agents tested in studies, including Antipyrine. Official information generally advises caution when combining any medication with known CNS depressants.


Q: Is Avocel considered a controlled substance?

A: No, the medicine is not classified as a controlled substance under the U.S. Drug Enforcement Administration (DEA) scheduling.


Q: What is the risk classification of Avocel during pregnancy?

A: The medicine was previously classified by the U.S. FDA as Pregnancy Category B. This classification means animal studies failed to show a risk to the fetus, but there are no adequate controlled studies in pregnant women.


Q: Do people need regular lab tests while taking Avocel?

A: No routine lab tests are universally required. The dose for individuals aged 12 years and older with decreased kidney function is determined based on measured creatinine clearance (CLCR) results.


Q: Where can I find the full official safety information for Avocel online?

A: The complete official safety and prescribing information is available online through government databases. These include DailyMed (NIH/FDA) in the U.S. and the Summary of Product Characteristics (SmPC) published by the European Medicines Agency (EMA).


Q: What are the reported effects of Avocel on liver function?

A: Adverse reactions in official documents reported with a 'Frequency Not Known' include potential liver-related issues. These include reports of hepatitis and abnormal liver function tests.


Q: Does Avocel have a black box warning in the US?

A: No, the medicine does not have a Black Box Warning, which is the U.S. FDA’s strongest safety warning. This type of warning is reserved for drugs with serious or life-threatening risks.


Q: Are there official descriptions of drug interactions with herbal products?

A: Official regulatory documents generally do not provide specific interaction information for herbal products or supplements with the active ingredient.


Q: Is Avocel known to cause weight changes?

A: Adverse reactions reported in official documents with a 'Frequency Not Known' include reports of both increased appetite and weight increased.


Q: What does the official patient information leaflet say about overdose?

A: Official prescribing information contains a section detailing symptoms of overdosage and provides advice on supportive measures. This information helps healthcare providers manage potential overexposure to the medicine.


Q: Does Avocel have any known effect on fertility?

A: Official regulatory documents indicate that there are no clinical data available regarding the potential effects of the active ingredient on human fertility.


Q: Why is Avocel sometimes prescribed for condition X if it is mainly approved for condition Y?

A: The active ingredient in Avocel is officially indicated for conditions such as chronic idiopathic urticaria (a form of hives) and perennial allergic rhinitis. Regulatory research has also focused on its potential effects in Condition X.

How should Avocel be stored and disposed of?

How to Store and Dispose of Avocel (Levocetirizine Dihydrochloride)

The official regulatory documents specify precise conditions for the storage and disposal of Avocel to maintain product stability and ensure household safety.

Storage Requirements

Item Official Requirement
Temperature Store at controlled room temperature, 20 C to 25 C (68 F to 77 F).
Protection Keep in the original container, tightly closed, and protect from excessive moisture.
Prohibited Area Do not store in the bathroom.
Child Safety Keep out of the sight and reach of children.

Disposal Instructions

Disposal of any unused or expired Avocel must be managed according to local requirements. The regulatory labeling explicitly states that the medicine must not be disposed of in wastewater, such as by flushing down the toilet or pouring down a sink. Instead, follow established local guidelines for the proper discard of pharmaceuticals.

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

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