Lergium Plus

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Lergium Plus

Method of action: Antitussive, Nasal Preparations

Treatment option: Rhinitis, Hay Fever

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 Lergium Plus

Quick Facts

Property Description
Active ingredient Cetirizine Hydrochloride, Pseudoephedrine Hydrochloride
Form Oral Tablet (Fixed-Dose Combination)
Pharmacological class Antihistamine-Decongestant Combination
Origin Synthetic Compound

Lergium Plus: Classification and Core Identity

Lergium Plus is a Fixed-Dose Combination (FDC) pharmaceutical product, integrating two distinct active ingredients into a single preparation for oral administration. It is fundamentally categorized as an Antihistamine-Decongestant Combination, reflecting its dual mode of therapeutic action. The medicine is a synthetic compound presented in an Oral Tablet dosage form, often formulated for extended release to ensure prolonged systemic effect.

The FDC strategy, combining an antihistamine and a decongestant, is clinically recognized for managing the complex symptoms associated with allergic rhinitis and general upper respiratory congestion. This dual-action approach is supported by the regulatory approval of such combinations, confirming their established efficacy in addressing concurrent symptoms.


Composition: The Dual Active Ingredients

The medication contains two core components, each belonging to a separate pharmacological class. The first component, Cetirizine Hydrochloride, functions as a second-generation H1-receptor antagonist (antihistamine), known for its selective peripheral receptor blockade. This confirms the medication's primary role in specifically targeting the chemical trigger of the allergic response.

The second component is Pseudoephedrine Hydrochloride, a sympathomimetic agent that acts as a nasal decongestant. The combination of these two agents is the defining feature of Lergium Plus, providing a synergistic effect against both immune-mediated symptoms and physical nasal obstruction.


General Purpose and Symptomatic Focus

The overall therapeutic purpose of Lergium Plus is to deliver simultaneous, systemic symptomatic relief for the concurrent discomforts of allergy and upper respiratory congestion. By combining an antihistamine and a decongestant, the product directly addresses the two main issues: mitigating the effects of histamine and actively reducing swelling within the nasal passages.

This comprehensive management approach is typically used for managing the combined symptoms of seasonal allergies, which include itchy, watery eyes alongside persistent nasal stuffiness, by providing relief across the upper respiratory tract.

Regulatory References

  1. Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets - DailyMed

What side effects are possible with Lergium Plus?

Possible Side Effects and Safety Information

The officially documented safety profile for Lergium Plus (Cetirizine and Pseudoephedrine combination) includes adverse reactions categorized by frequency and the organ systems affected, as established in regulatory documents such as the FDA Prescribing Information and EMA Summary of Product Characteristics (SmPC).

Officially Documented Adverse Reactions by System-Organ Class (SOC)

The most frequently reported effects involve the Nervous System (e.g., Somnolence, Dizziness, Insomnia, Fatigue, Headache), reflecting the activity of both active components. Gastrointestinal Disorders (e.g., Dry mouth, Nausea) and Cardiac/Vascular Disorders (e.g., Tachycardia, Palpitation, Hypertension) are also listed in regulatory labeling.

Frequency-Classified Reactions

Classification Examples of Reactions
Common Somnolence, Fatigue, Insomnia, Dry mouth, Headache, Dizziness
Rare Hypersensitivity reactions, Convulsions, Urticaria
Very Rare Anaphylactic shock, Thrombocytopenia, Fixed drug eruption

Serious Adverse Reactions and Constraints

Regulatory documentation highlights severe reactions that are rare but clinically significant, including Anaphylactic Shock and serious cerebrovascular events such as PRES (Posterior Reversible Encephalopathy Syndrome) and RCVS (Reversible Cerebral Vasoconstriction Syndrome).

The medicine is subject to defined contraindications that restrict use, including in patients with severe hypertension, severe coronary artery disease, narrow-angle glaucoma, or concurrent use with a Monoamine Oxidase (MAO) Inhibitor.

Population-Specific Safety Notes

Official labeling includes safety considerations for specific populations: the medicine is not recommended for use in children under 12 years of age or during breastfeeding. Dose adjustments are advised for patients with hepatic impairment and are mandatory for those with severe renal impairment.

Overdose and Emergency Response

The official regulatory profile for a Lergium Plus overdose documents manifestations stemming from both its antihistamine (Cetirizine) and decongestant (Pseudoephedrine) components. Officially reported signs of over-ingestion include a combination of Central Nervous System (CNS) effects. These can range from CNS depression, such as drowsiness, sedation, somnolence, and dizziness, to signs of stimulation like restlessness, agitation, and nervousness. High-dose exposure may also be associated with cardiovascular signs, including tachycardia (rapid heartbeat) and other anticholinergic-like effects. Overdose cases in children are specifically noted to often present with symptoms such as drowsiness and irritability.

In all suspected cases of over-ingestion, official regulatory guidance mandates seeking professional medical attention and contacting a Poison Control Center right away. Immediate emergency services must be contacted if the individual exhibits severe manifestations such as a seizure, collapse, trouble breathing, or inability to be awakened. The regulatory profile states that there is no known specific antidote for the cetirizine component, and management is defined as supportive and symptomatic treatment. The official prescribing information further notes that the cetirizine component is not effectively removed by dialysis.

Therapeutic Uses of Lergium Plus

What Lergium Plus Treats: Main Uses and Benefits

The medication is used in situations involving certain distressing symptoms, and may assist with the overall symptom load associated with allergic and congestive conditions. It offers short-term symptomatic assistance, contributing to improved comfort during symptomatic periods. This combination is considered relevant for easing symptoms due to hay fever or other upper respiratory allergies.

This combination may be part of symptomatic management in conditions associated with acute or disruptive episodes, such as seasonal or perennial allergic rhinitis. It helps address symptom clusters that may become intense or disruptive, assisting with the management of itching of the nose and eyes, persistent sneezing, runny nose, nasal congestion, and sinus pressure.

This supportive approach is applied when symptoms create noticeable functional strain. The benefit contributes to symptomatic relief that supports patients during difficult episodes of environmental sensitivity and assists with functional stability.

Quick Fact: Relief for Combined Symptoms
Primary Focus Nasal Obstruction and Histamine Symptoms
Key Benefit Assisting with functional stability
Typical Context Acute allergic episodes with significant congestion

Regulatory References

  1. [DailyMed drug label, managed by the NIH National Institutes of Health

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Lergium Plus — Official Regulatory Information

Category Official Regulatory Statement
Populations for whom use is allowed Adults and Adolescents ge 12 years are the approved population.
Populations for whom use is not recommended Children under 12 years of age are generally not recommended due to the fixed concentration of pseudoephedrine. Breastfeeding women are advised against use, as components pass into breast milk.
Populations for whom use is contraindicated Patients with known hypersensitivity to the active ingredients (Cetirizine, Pseudoephedrine) or related compounds. Patients currently taking, or who have taken, a Monoamine Oxidase Inhibitor (MAOI) within the last 14 days. Individuals with Severe or Uncontrolled Hypertension or Severe Coronary Artery Disease. Patients with Severe Acute or Chronic Kidney Disease/Renal Failure or Narrow-Angle Glaucoma are absolutely prohibited from use.
Condition-specific eligibility rules Use requires caution in individuals with pre-existing conditions such as Diabetes Mellitus, Hyperthyroidism, Heart Disease, or Prostatic Hypertrophy as these conditions may be exacerbated. Caution and potential dose adjustment are also advised for patients with Moderate Renal Impairment or Hepatic Impairment.
Pregnancy eligibility status Official labeling advises to consult a health professional before use during pregnancy.

Connection to the overall eligibility profile:

Regulatory documents strictly define Lergium Plus's use, permitting it primarily for adults and adolescents ge 12 years who are otherwise healthy. Eligibility is principally determined by absolute contraindications that exclude individuals with severe cardiovascular or renal disorders due to risks associated with the pseudoephedrine component. Use is generally prohibited or restricted in populations with compromised organ function or those concurrently taking MAO inhibitors, as explicitly stated in the regulatory label.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documents define the interaction profile of Lergium Plus (Cetirizine/Pseudoephedrine) with specific drug classes and substances, including mandatory prohibitions and exposure modification details.

Interaction Type Interacting Substances/Classes Constraint / Outcome
Contraindicated Combination Monoamine Oxidase Inhibitors (MAOIs) Strictly prohibited due to risk of hypertensive crisis.
Timing-Based Restriction MAOIs (Washout Rule) Must not be used for at least 14 days after stopping MAOI therapy.
Pharmacokinetic Theophylline (400 mg once daily) Causes a documented 16% decrease in the clearance of cetirizine, resulting in increased exposure.
Pharmacodynamic Central Nervous System (CNS) Depressants, Alcohol Potential for additive impairment of mental alertness and performance.
Pharmacodynamic Other Sympathomimetic Agents Not advised; co-administration may cause additive cardiovascular and CNS effects (e.g., increased blood pressure).
Absorption Alteration Antacids (e.g., Kaolin) Antacids may increase the absorption of pseudoephedrine, while Kaolin reduces it.

The regulatory profile identifies several substances that pose a risk of additive effects, including Tricyclic Antidepressants, which may potentiate the pseudoephedrine component. Additionally, the label notes that patients with kidney or liver disease may require dose adjustment, as the elimination of both active components can be reduced, increasing the risk of exposure-related effects.

Mechanism of Action

How Lergium Plus Works

Lergium Plus exerts its activity through targeted modulation of regulatory receptor systems located within neural and peripheral pathways. The drug functions as an allosteric modulator, binding to a distinct site on the receptor. This interaction alters the receptor's conformation and its responsiveness to endogenous chemical mediators, thereby initiating a shift in the signaling dynamics of the targeted pathways.

Following receptor engagement, Lergium Plus intervenes in the subsequent signal transduction cascades. This modification occurs at early molecular steps, resulting in an effective dampening of the intensity and propagation of the internal cell signal. This action consequentially modifies the state of heightened pathway activation.

Ultimately, this focused mechanistic activity influences core regulatory systems that govern physiological stability. The resulting modulation of activity within overactive or dysregulated physiological processes leads to a reduced influence of excessive mediator activity on downstream cellular effects.

Dosage and Administration Information

How to Use Lergium Plus

The general principle for using Lergium Plus, a fixed-dose combination product, is to provide simultaneous systemic relief from allergic and congestive symptoms via the oral route. The medicine is supplied as an extended-release oral tablet, formulated for prolonged action to support a 12-hour dosing interval.

Standard Administration Regimen

For adults and children 12 years of age and older, the standard dosing regimen involves taking one tablet every 12 hours, establishing a twice-daily use pattern. Each tablet typically contains 5 mg of Cetirizine Hydrochloride and 120 mg of Pseudoephedrine Hydrochloride. The total maximum daily dose is therefore two tablets in 24 hours (10 mg Cetirizine / 240 mg Pseudoephedrine).

Practical Usage and Duration

To ensure the controlled release of the active ingredients, the tablet must be swallowed whole with liquid and must not be crushed, broken, or chewed. The medicine may be taken with or without food. The administration is intended for short-term use and should not generally exceed the period of symptoms, with official guidance advising a limit of 2 to 3 weeks.

Population-Specific Dosing Considerations

Official prescribing information outlines necessary dosage modifications for specific patient populations. For patients with moderate hepatic insufficiency, the dose is generally reduced to one tablet daily. Similarly, dose adjustments are required for individuals with renal impairment, with the dosing interval needing to be individualized based on the level of kidney function to avoid accumulation.

Recent Clinical Evidence

Research evidence / Overview of studies for Lergium Plus

Evidence for Symptomatic Relief in Allergic Rhinitis

The research foundation consists primarily of short-term Randomized Controlled Trials (RCTs). These studies were designed as comparisons of symptom measurements over time, evaluating the combination product against an inactive control (placebo) or against the single active ingredients taken alone. These studies were applied in research contexts involving fluctuating or unstable symptoms of allergic rhinitis, a condition characterized by fluctuating or episodic manifestations such as hay fever.

Studies monitored various patient-reported outcomes describing perceived discomfort. Specifically, researchers used scales like the Total Nasal Symptom Score to assess measurements of several key outcomes related to physical discomfort, including nasal congestion, sneezing, runny nose, and itching of the eyes and nose. Research also examined objective metrics, such as nasal airflow measurements. Findings describe patterns observed in the studies related to symptom variability in the observed populations over the short-term.


Comparing the Combination to Single Components in Clinical Trials

The combination drug was studied using active comparisons for outcome measurements against taking only the antihistamine component or only the decongestant component. These trials are relevant in evidence describing how symptoms are measured when different treatment approaches are applied. Findings describe patterns of symptom evolution, specifically for outcomes related to physical discomfort, which were measured during the defined study intervals.

However, the evidence provided is limited to the specific conditions under which these studies were conducted. Comparative evidence with other fixed-dose combination products is also often lacking or highly variable across studies. Research does not determine whether an individual will respond similarly to the group patterns observed in the trials.


Long-Term Studies and Follow-Up Duration

The follow-up durations for the primary efficacy studies were limited. Efficacy in natural-exposure settings was typically observed in studies lasting only 3 to 4 weeks. Because of this design, there is limited information for long-term outcomes describing sustained measurements of relief over an entire allergy season or continuous use beyond one month.


Evidence in Specific Patient Groups

This medicine was evaluated in adolescents and adults, typically studied from the age of 12 and older. The core efficacy research examined study populations including those with allergic rhinitis and co-existing mild-to-moderate asthma.

Populations with Limited Available Data

Data for certain groups remain insufficient. Efficacy evaluations did not include an adequate number of patients aged 65 years and older. As a result, the results apply only to the populations studied, and evidence is limited regarding patterns of response in the geriatric population.


Key Research Gaps and Remaining Uncertainty

The primary limitation is that follow-up durations were limited, with most pivotal trials evaluating outcomes over only a few weeks. Sample sizes were modest in some core studies, and data for certain groups, such as older adults, remain insufficient. Evidence highlights what is known—and what is still uncertain—but the research does not determine whether an individual will respond similarly. Findings describe group patterns, not personal outcomes.

Key Studies & References

  1. FDA Approved Labeling for Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended Release Tablets

Frequently Asked Questions (FAQ)

Common questions about Lergium Plus (FAQ)

Q: Is it safe to take Lergium Plus with my high blood pressure medication?

Official regulatory documents indicate that Lergium Plus is contraindicated (should not be used) if you have severe or uncontrolled high blood pressure. The decongestant component, pseudoephedrine, can increase blood pressure and may cause additive cardiovascular effects when taken with other medications that affect the heart. Because of these factors, you should consult a healthcare professional to review your specific blood pressure medication and medical history.

Q: What are the most common side effects of Lergium Plus?

According to official regulatory documents, the side effects reported most frequently (classified as Common) often involve effects such as somnolence (drowsiness), fatigue, insomnia, headache, and dizziness. Another common physical side effect is dry mouth. If any side effects are persistent or troublesome, it is appropriate to speak with a healthcare professional.

Q: Can I take Lergium Plus if I have a heart condition?

Regulatory information specifies that Lergium Plus should not be used if an individual has severe coronary artery disease. Furthermore, official product labeling advises caution for patients who have other pre-existing heart diseases. Due to the potential effects of the decongestant component on the cardiovascular system, you should consult your healthcare provider to determine if this medicine is appropriate for your specific condition.

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

Official guidance on a missed dose typically indicates to take it as soon as it is remembered. However, if it is almost time for your next scheduled dose, skip the one you missed and continue with your regular dosing schedule. Patients are generally advised not to take two doses simultaneously to compensate for a missed dose.

Q: Can I drive or operate machinery while taking Lergium Plus?

Official product information contains warnings that the medicine may cause side effects such as drowsiness, dizziness, and decreased mental alertness. Due to the potential for these effects, regulatory guidance advises caution regarding driving or operating machinery due to the potential for impairment.

How should Lergium Plus be stored and disposed of?

Lergium Plus tablets must be stored according to official regulatory requirements to maintain product stability.

Required Storage Conditions

Condition Requirement
Temperature Store at Controlled Room Temperature, between 20°C and 25°C (68°F and 77°F).
Protection Keep the container tightly closed and protect the medicine from excess heat and moisture. Storage in the bathroom is prohibited.

Handling and Disposal

The product must be kept out of the sight and reach of children to prevent accidental ingestion.

Official disposal instructions recommend using an authorized drug take-back program for unused or expired tablets. If a take-back program is unavailable, the medicine should be mixed with an undesirable substance (such as used coffee grounds) and sealed in a container before being placed in household trash. Personal information on packaging must be removed or concealed before disposal.

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

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