Degraler Plus

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Medically reviewed

Rosario Oropesa

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 Degraler Plus

Quick Facts

Property Description
Active ingredient Levocetirizine dihydrochloride
Form Oral tablet and solution/syrup
Pharmacological class Second-Generation Antihistamine
Common use Relief of allergic symptoms
Origin Synthetic compound (R-enantiomer)

What Type of Medicine is Degraler Plus? (Classification and Identity)

Degraler Plus is a pharmaceutical product whose active component is Levocetirizine dihydrochloride. Levocetirizine is an H1-receptor antagonist, which belongs to the Second-Generation Antihistamines. Chemically, this compound is synthetic and is specifically the R-enantiomer of the older antihistamine, cetirizine. This structural refinement means it is the more potent, active isomer of the racemic mixture, a chemical distinction for providing targeted therapeutic activity.

Composition and Available Forms

The medication contains only Levocetirizine dihydrochloride as the therapeutic agent, making it a single-entity product. It is available for oral administration in multiple dosage forms to suit different patient groups, including film-coated tablets and a liquid oral solution or syrup. This versatility, including a liquid form suitable for the pediatric population, allows the medicine to be absorbed into the bloodstream, where the compound achieves systemic action throughout the body.

What is the General Purpose of Degraler Plus? (High-Level Action)

The overarching purpose of this medication is to provide relief from the symptoms of hypersensitivity by targeting the body's natural allergic response. The active ingredient works by interrupting the action of histamine, a substance the body releases during an allergic reaction, through a process known as histamine H1 blockade. Levocetirizine has a rapid onset of action, which means the medication starts working quickly to provide symptom relief. This efficient histamine blockade is applied in a typical scenario such as reducing discomfort caused by seasonal environmental factors, thereby helping to reduce the physical manifestations of allergic conditions, such as itching and swelling.

Regulatory References

  1. NIH: MedlinePlus

What side effects are possible with Degraler Plus?

Possible side effects and safety information

The official safety documentation for levocetirizine dihydrochloride (Degraler Plus) details potential adverse effects based on clinical trials and postmarketing surveillance, organized by frequency and affected body system.

Frequency-Classified Adverse Reactions

The majority of documented effects are categorized as common. These reactions, which are frequently reported in adults and adolescents, include somnolence (drowsiness), fatigue, dry mouth, nasopharyngitis, and pharyngitis. Reactions classified as uncommon include asthenia (weakness) and abdominal pain. Additional effects, reported during postmarketing use, have included serious reactions such as anaphylaxis, urinary retention, and certain psychiatric disturbances.

System-Organ Class (SOC) Focus Examples from Regulatory Listing
Nervous System Somnolence, fatigue, dizziness, convulsion
Gastrointestinal Dry mouth, diarrhea, vomiting, abdominal pain
Immune System Hypersensitivity, including anaphylaxis
Renal/Urinary Urinary retention

Safety Considerations and Restrictions

The regulatory label includes specific constraints for its use. The medicine is formally contraindicated in patients diagnosed with severe renal impairment (end-stage renal disease), and this prohibition extends to pediatric patients aged 6 months to 11 years with any degree of renal impairment. Safety warnings note that somnolence and related effects are often observed more frequently during the first few hours after administration. Furthermore, the label advises caution for patients with predisposing factors for urinary retention, as the drug may increase this risk. The profile also documents reports of severe pruritus (itching) that may occur within a few days of stopping long-term daily use.

Overdose and Emergency Response

The official regulatory documentation for levocetirizine dihydrochloride (the active ingredient in Degraler Plus) requires users to seek immediate medical attention following any suspected overdose. While symptoms are generally described as mild, they are primarily related to central nervous system (CNS) effects.

The clinical presentation of overdose differs based on age. In adults, the most common manifestation is excessive somnolence (drowsiness). Conversely, young children may initially experience signs of agitation and restlessness before transitioning into a state of drowsiness. Massive overdosage carries the risk of severe CNS depression, and tachycardia (increased heart rate) may occur. Regulatory guidance also notes that CNS effects may be more pronounced in both the elderly and young children.

Management of an overdose is strictly symptomatic and supportive, as there is no specific antidote known for levocetirizine. Emergency response procedures documented in official labels may include the consideration of using activated charcoal or gastric lavage to prevent further absorption, particularly if the ingestion was recent. Hemodialysis is listed as ineffective for removing the drug from the body.

Therapeutic Uses of Degraler Plus

Degraler Plus is used to provide supportive symptomatic relief for groups of symptoms associated with allergic hypersensitivity across multiple clinical domains. The medication is commonly applied in clinical settings for conditions presenting with acute or recurrent episodes of allergic discomfort. These conditions include the symptoms associated with seasonal and perennial allergic rhinitis and the uncomplicated skin manifestations of chronic idiopathic urticaria (hives).

The medication is primarily used for managing symptoms that interfere with daily functioning. This includes addressing the characteristic cluster of sneezing, persistent runny nose, nasal itching, and the external reactions of intense pruritus (itching) and watery, red eyes. The medication assists with managing symptoms related to inflammatory or irritative states, supporting patients during episodes of heightened discomfort associated with allergen exposure.

Quick Fact: Symptom Management
Therapeutic Scope Addresses nasal, ocular, and dermal allergic symptoms.
Supportive Role Supports symptom management during flare-ups and periods of chronic exposure.

Managing Seasonal and Perennial Allergic Rhinitis

This medication is commonly applied in clinical settings marked by the heightened symptoms of allergic rhinitis, often referred to as hay fever or year-around allergies. It plays a role in managing these distressing manifestations, and supports patients during episodes of heightened discomfort associated with allergen exposure.

Addressing Allergic Skin and Ocular Manifestations

Degraler Plus is relevant in contexts marked by increased discomfort involving external allergic reactions, specifically the eyes and skin. It is used for managing symptoms that interfere with daily functioning like intense itching (pruritus) and the appearance of hives (urticaria). Concurrently, it assists with managing the ocular discomfort and contributes to easing the overall symptom load when these acute manifestations interfere with routine activities.

Regulatory References

  1. NIH MedlinePlus overview of Levocetirizine

Eligibility and Restrictions for Use

The eligibility for using Degraler Plus (Levocetirizine dihydrochloride) is strictly defined by regulatory authorities based on age, organ function, and specific medical history. The following summarizes official criteria for use and non-use.

Absolute Contraindications (Must Not Use)

Contraindicated Group Restriction Basis
Hypersensitivity Known allergy to levocetirizine, its ingredients, or cetirizine (the parent compound).
Severe Kidney Disease End-Stage Renal Disease (Creatinine Clearance <10 mL/ min) or patients undergoing hemodialysis.
Pediatric Renal Impairment Children 6 to 11 years of age with any degree of impaired kidney function.

Age-Related Eligibility

The medicine is approved for use in adults and adolescents ge 12 years and in children ge 6 years. Use is also established for infants and children 6 months to 5 years (typically requiring the oral solution/syrup formulation). The safety and efficacy have not been established in infants younger than 6 months of age.

Conditional Use and Special Populations

Certain populations require caution or specific clinical consideration. These include patients with risk factors for urinary retention (e.g., prostatic hyperplasia) or those with epilepsy and a risk of convulsions. For individuals ge 12 years with mild to severe renal impairment (Creatinine Clearance ge 10 mL/ min), use is restricted and requires adjustment. Use during pregnancy and lactation should be based on a clear clinical need, as the drug may be excreted into breast milk.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Pharmacodynamic Interaction Restrictions

Official regulatory information documents a risk of additive central nervous system (CNS) effects when levocetirizine is co-administered with certain substances. The concurrent use of alcohol and other CNS depressants (such as sedatives, tranquilizers, and opioid analgesics) is mandated to be avoided due to the officially described potential for additional reductions in alertness and further impairment of CNS performance.

Pharmacokinetic (Exposure) Alterations

Co-administration with Ritonavir is officially documented to increase the plasma concentration of levocetirizine due to a reduction in its total body clearance. This exposure modification is a key pharmacokinetic consideration. In contrast, levocetirizine demonstrates a low potential for metabolic drug-drug interactions as in vitro data confirm it is not an inhibitor or inducer of major CYP isoenzymes (e.g., 1A2, 2C9, 3A4) at therapeutic concentrations. Studies evaluating co-administration with other medicines, including Azithromycin, Cimetidine, Theophylline, and Ketoconazole, found no clinically significant pharmacokinetic interactions.

Interactions with Food and Specific Populations

Taking the medication with food does not affect the overall amount of levocetirizine absorbed into the body; however, it may result in a delay in the time to peak plasma concentration. A population-specific caution exists for patients with impaired renal function due to the drug's substantial renal excretion, which increases the risk of adverse reactions and the clinical relevance of exposure-altering interactions.

Mechanism of Action

The active ingredient in Degraler Plus, Levocetirizine, involves a sequence of biological interactions that modulate specific signaling pathways. Its mechanism is highly targeted, operating across three core domains: selective blockade, anti-inflammatory modulation, and focused systemic distribution.

Selective H1 Receptor Antagonism

The drug's primary action is competitive antagonism of the Histamine H1 Receptor (H1R), the main molecular target for histamine released during certain immune responses. By binding to and stabilizing the receptor in an inactive conformation, Levocetirizine prevents endogenous histamine from activating the cell. This molecular blockade affects the H1R on sensory nerves and blood vessel endothelial cells, resulting in altered nerve conduction and changes in vascular permeability (extravasation of fluid).

Modulation of Inflammatory Response

Levocetirizine engages a secondary mechanism that involves direct cellular modulation, independent of H1 blockade. It influences the movement and adhesion of key immune cells, such as eosinophils and neutrophils, which are typically recruited to sites of inflammation. This action on inflammatory cell migration modulates the progression of the biological response pathway, influencing the characteristics of long-term inflammatory signaling.

Focused Peripheral Pharmacological Selectivity

The mechanism is concentrated on peripheral tissues outside the brain due to the drug's interaction with the P-glycoprotein (P-gp) efflux pump at the blood-brain barrier (BBB). This active transport system restricts the molecule's entry into the central nervous system (CNS). The peripheral selectivity concentrates the compound's activity in peripheral tissues where histamine-mediated physiological responses occur, resulting in localized pathway modulation.

Dosage and Administration Information

How to Use Degraler Plus

Degraler Plus (levocetirizine dihydrochloride) is for oral administration and is available in 5 mg film-coated tablets and an oral solution (0.5 mg/mL). The medicine is for a once-daily dosing regimen, which is typically administered in the evening. It may be taken with or without food. Specific usage patterns and adjustments are defined to ensure procedural accuracy.


Standard Dosing and Frequency

The standard recommended dose for adults and adolescents (12 years and older) is 5 mg once daily, which also represents the maximum recommended dose per 24 hours. The labeled dose for children aged 6 to 11 years is 2.5 mg once daily. For patients using the oral solution, it is necessary to use a calibrated measuring device to ensure the correct dose is administered.


Duration and Special Conditions

Usage patterns are classified based on duration: treatment for intermittent allergic symptoms may be stopped when symptoms disappear and restarted upon recurrence. For persistent conditions like chronic idiopathic urticaria, continuous use is supported for periods of up to six months.

Mandatory dose adjustment is required in the presence of renal impairment. For example, patients with moderate renal impairment reduce the frequency to 2.5 mg once every other day. If a dose is missed, standard instructions are to skip the missed dose and resume the next scheduled dose; a double dose must not be taken.


Recent Clinical Evidence

Degraler Plus: Recent Clinical Evidence

This section outlines the structure of the clinical research for Degraler Plus (Levocetirizine), detailing the types of studies conducted and the outcomes monitored, in compliance with scientific review standards.


Evidence for Use in Seasonal Allergic Rhinitis

The primary research for seasonal allergic rhinitis (SAR), or hay fever, has focused on randomized, double-blind, placebo-controlled trials (RCTs). These short-term RCTs explored changes in symptoms compared against an inactive substance. Studies monitored outcomes related to physical discomfort, such as measurements of sneezing and itching. Research observed patterns where measured symptoms evolved over defined time intervals, though reported outcomes varied across some study populations. Long-term effects are not fully established, as follow-up durations were limited, and comparative evidence against all newer antihistamines is lacking.


Evidence for Persistent Allergic Rhinitis and Hives

Research for Perennial (Year-Round) Allergic Rhinitis (PAR) and Chronic Idiopathic Urticaria (CIU) or hives included controlled trials applied in research contexts involving fluctuating symptoms. Studies monitored patient-reported outcomes capturing phases of heightened symptom activity, such as itch severity and the presentation of hives. Data describe patterns related to how symptoms evolved over intermediate-term durations (up to several months). For these chronic conditions, evidence is limited regarding long-term maintenance outcomes exceeding six months.


ightarrow Focus on Study Durations and Key Age Groups

The core evidence for this medicine's indications was primarily derived from studies with short-term (two to four weeks) to intermediate-term (up to three to six months) follow-up durations. Research provides insight into short-term changes but does not fully establish the long-term consistency of the observed patterns, meaning the results reflect the specific, limited time intervals under which they were conducted. The active substance was evaluated in studies across a wide range of ages, including adults, adolescents, and pediatric populations (down to six months). Results apply only to the populations studied, and data for groups with specific comorbidities remain insufficient.


ightarrow What Research Gaps and Uncertainties Remain

A key research limitation is that comparative evidence against all other second-generation antihistamines is lacking in large-scale studies. The research describes how symptoms were measured in the observed populations, but certainty remains low regarding outcomes in patients whose condition had been unresponsive to previous antihistamine therapies. Findings describe group patterns, and research does not determine whether an individual will respond similarly.

Frequently Asked Questions (FAQ)

Common questions about Degraler Plus (FAQ)


Q: What is the typical time frame for the drug to start relieving symptoms?

Studies and official information indicate that a decrease in nasal symptoms may occur as soon as 1 hour after taking the medication, compared to a placebo. The medication is generally recognized for its rapid onset of action in relieving allergy symptoms.


Q: Is it normal to feel drowsy or sleepy when taking Degraler Plus?

Official safety data lists somnolence (drowsiness) and fatigue as common adverse reactions in adults and adolescents. Somnolence is often observed more frequently during the first few hours after administration. Due to this potential effect, caution is generally advised when engaging in activities that require full attention until an individual knows how the medication affects them.


Q: Are there any known interactions between Degraler Plus and alcohol?

Yes. Regulatory documents state that the concurrent use of alcohol is mandated to be avoided. This restriction is due to the potential for additive central nervous system (CNS) effects, which can lead to further impairment of alertness and performance.


Q: Can certain foods or juices affect how Degraler Plus works in the body?

Official information indicates that taking the medication with food does not change the overall amount of the drug absorbed into the body. However, food may result in a delay in the time to peak concentration of the drug in the bloodstream. Regulatory documents do not specifically describe interactions with common fruit juices.


Q: Does Degraler Plus interact with any medications used to treat depression or anxiety?

Regulatory documents warn against the concurrent use of other CNS depressants. This group of medicines includes certain substances used for depression or anxiety, as they carry the potential for additive effects that could increase impairment of alertness and performance.


Q: Can the medication cause lightheadedness or dizziness when standing up?

Official safety documents list dizziness as a reported adverse reaction. While the regulatory label does not specifically reference positional dizziness (lightheadedness upon standing), the potential for dizziness is a documented safety factor associated with this medication.


Q: What is the scientific basis for combining the two active ingredients in Degraler Plus?

Official drug identification documents state that the active component is Levocetirizine dihydrochloride, which is a single-entity product, not a combination. It is the more potent, active isomer (a specific chemical form) of the older antihistamine, cetirizine. This structural refinement is what provides its highly targeted therapeutic activity.


Q: What is the main difference between Degraler Plus and other common allergy medicines?

Degraler Plus's active ingredient, Levocetirizine, is officially classified as a Second-Generation Antihistamine. These medications are recognized for crossing the blood-brain barrier (the boundary between the blood and the brain) to a significantly smaller extent than older, first-generation antihistamines, which may be associated with reduced sedation.


Q: Can Degraler Plus cause a feeling of nervousness or anxiety?

The official safety profile for the medication has documented certain psychiatric disturbances based on postmarketing reports, which can include symptoms like agitation or anxiety in some cases. While regulatory documents do not list 'nervousness' or 'anxiety' as common side effects, this class of reactions has been noted.


Q: Can Degraler Plus be used for non-allergy related nasal stuffiness?

Official documents list the medicine's approved uses as the symptomatic treatment of allergic conditions, specifically seasonal and persistent allergic rhinitis (hay fever/allergies) and chronic idiopathic urticaria (hives). Regulatory sources do not list non-allergy related nasal stuffiness as an approved use.


Q: Is it common for Degraler Plus to cause dry mouth or dry eyes?

The official safety documentation lists dry mouth as a common adverse reaction for this medication. However, dry eyes are not explicitly listed among the most common adverse effects in regulatory documents.


Q: Are there specific side effects that should prompt me to contact a healthcare provider quickly?

Official safety documents list serious reactions reported postmarketing, such as anaphylaxis (a severe allergic reaction) and urinary retention. Severe reactions, such as signs of an allergic reaction or difficulty/inability to urinate, are often cited in patient counseling information as conditions that may warrant immediate medical attention.


Q: Does the medication's effectiveness decrease over time with regular use?

Official warnings note that severe pruritus (itching) may occur within a few days of stopping the medication after long-term daily use. The regulatory text does not address the topic of tolerance or a decrease in drug effectiveness (tachyphylaxis) during continuous use.


Q: Are there any official warnings about driving or operating machinery while taking Degraler Plus?

Yes, the regulatory label advises caution for patients when driving a motor vehicle or operating machinery. This is important until they know how the drug affects them, as the documented effects of drowsiness and fatigue may potentially impair reactions.


Q: Is there a risk of taking too much of an active ingredient when using Degraler Plus?

The official label specifies a maximum recommended dose per 24 hours. Exceeding the recommended dosage is advised against, and supportive care is documented as the general approach in case of an accidental overdose. This class of drug generally has a lower risk of serious events in overdose compared to older antihistamines.


Q: Does having kidney problems affect how Degraler Plus is used?

Yes. Mandatory dose adjustment is officially required in the presence of renal impairment (kidney problems). Furthermore, the drug is officially contraindicated (must not be used) in patients with severe renal impairment (end-stage renal disease) and in certain pediatric populations with any degree of impaired kidney function.


Q: Why is it important to check if Degraler Plus contains acetaminophen or another pain reliever?

It is important to check the active ingredients of all co-administered products because using multiple combination medicines could lead to accidentally exceeding the maximum safe dose for a single component, such as acetaminophen. Regulatory guidance advises reading all labels to prevent this type of accidental overdose.


Q: What are the official clinical expectations for symptom improvement with Degraler Plus?

The medicine is approved to provide relief from the symptoms of allergic rhinitis (hay fever) and chronic idiopathic urticaria (hives). Clinical trials summarized in regulatory documents showed patterns of symptom evolution and improvement over defined short-term to intermediate-term follow-up intervals. These results reflect the observed outcomes in the studied patient populations.


Q: Is there a known link between Degraler Plus and changes in heart rate?

The regulatory label does not list changes in heart rate (like tachycardia) as a common adverse event for levocetirizine. However, regulatory reviews often note that while its risk is low, massive overdoses of the second-generation antihistamine class may be associated with some cardiovascular effects.


Q: Does Degraler Plus carry any specific warnings for people with liver disease?

Official regulatory documents state that no dose adjustment is needed in patients who have solely hepatic impairment (liver problems). However, a dose adjustment is required if a patient has both liver and kidney impairment.


How should Degraler Plus be stored and disposed of?

Storage and Handling Requirements

Official labeling for Degraler Plus (levocetirizine) mandates specific conditions to maintain product stability and safety.

Condition Requirement
Temperature Store at controlled room temperature, typically 20 C to 25 C (or below 30 C in some regions).
Protection Keep in a dry place and protect from light.
Packaging Must be stored in the original container and should not be used if the safety seal is torn.
Child Safety Store strictly out of the sight and reach of children.

Disposal Instructions

There are no special requirements for disposal beyond following local guidelines. Unused or expired medication must be discarded according to local regulations for pharmaceutical waste.

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

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