Analergin

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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 Analergin

Property Description
Active ingredient Cetirizine Dihydrochloride
Form Oral tablets, Oral syrup
Pharmacological class Second-generation antihistamine (H₁ Antagonist)
Common use Relief of general allergy symptoms
Origin Synthetic derivative of Hydroxyzine

What Type of Medicine is Analergin and What is it Made Of?

Analergin is an established registered medicine containing the active ingredient Cetirizine Dihydrochloride, a compound clinically recognized for its effectiveness against allergic reactions and formally classified as a selective second-generation antihistamine (H₁ Antagonist). This pharmacological group belongs to the synthetic piperazine derivatives, establishing its origin as a key advance over older, more sedating compounds. Cetirizine Dihydrochloride is a racemic compound, available for oral administration in various dosage forms, including film-coated tablets and liquid syrup preparations. These forms accommodate both adults and children from 6 years of age, showcasing a practical differentiation in its intended patient group.

Analergin’s General Purpose and Benefit as an Antiallergy Preparation

The primary purpose of Analergin is to provide efficient relief from the generalized discomfort and irritation associated with allergic conditions. This includes typical scenarios like seasonal sneezing and a runny nose resulting from allergic rhinitis or the persistent itching and swelling of chronic urticaria. Its function relies on the fundamental physiological action of selectively inhibiting the effects of histamine. The use of a second-generation antihistamine is strategically important, as these agents are engineered to have a low central nervous system presence, resulting in minimal sedation—a crucial benefit distinguishing it from older compounds and enabling unimpaired daily activity.

Regulatory References

  1. MedlinePlus Drug Information

What side effects are possible with Analergin?

Possible Side Effects and Safety Information

The safety profile of Analergin (Cetirizine Dihydrochloride) is officially documented by government regulatory agencies, detailing adverse reactions by their frequency and the body system affected.

Documented Adverse Reactions

The most frequently documented effects, classified as Common (up to 1 in 10 people), relate predominantly to the Nervous System and Gastrointestinal Disorders. These include somnolence (drowsiness), headache, fatigue, and dry mouth.

Effects classified as Uncommon (up to 1 in 100) include agitation, pruritus (itching), and rash. Less frequent reactions are classified as Rare or Very Rare.

Classification Examples of Officially Documented Effects
Common Somnolence, headache, fatigue, dry mouth, nausea
Rare Tachycardia, convulsions, oedema, hypersensitivity reactions
Very Rare Thrombocytopenia, syncope, urinary retention

Serious Safety Considerations

Official labels note rare but clinically serious adverse reactions. These include Hypersensitivity reactions, such as anaphylactic shock or angioedema (swelling of the face or throat), and convulsions. The occurrence of somnolence is noted as potentially dose-related.

Population-Specific Constraints

The medicine is officially contraindicated in patients with severe renal impairment (creatinine clearance less than 10 ml/min). Dose adjustments are required for individuals with moderate to severe renal impairment. Regulatory documents also note a higher incidence of rhinitis and pharyngitis in pediatric patients compared to adults.

Overdose and Emergency Response

Overdose with Analergin (Cetirizine Dihydrochloride) is associated with several officially documented clinical manifestations, primarily affecting the central nervous system. These symptoms, which generally follow high dose ingestion, include somnolence, sedation, fatigue, malaise, headache, tremor, and stupor. Other officially reported signs affecting various systems encompass tachycardia (increased heart rate), diarrhoea, pruritus, and urinary retention.

In the event of an overdose, regulatory authorities mandate that patients seek medical help or contact a Poison Control Center right away. Urgent medical assessment is required if a dose greater than the recommended amount has been consumed. Large ingestions are officially associated with a risk of cardiac arrhythmia, necessitating a medical assessment that may include cardiac monitoring and an initial 12 Lead ECG.

The management of Analergin overdose is based entirely on symptomatic or supportive treatment, as official labeling confirms that no known specific antidote exists for cetirizine. Supportive measures like gastric lavage may be considered shortly after ingestion. For children, acute ingestion exceeding three times the maximum daily dose requires professional medical evaluation.

Therapeutic Uses of Analergin

Main Uses and Benefits of Analergin

Analergin is an antihistamine medication primarily used to manage symptoms associated with allergic reactions. It functions by blocking the action of histamine, a natural substance in the body that triggers allergic symptoms when exposed to allergens.

Seasonal and Perennial Allergic Rhinitis

Analergin is frequently used to alleviate the discomfort caused by allergic rhinitis, commonly known as hay fever. This includes both seasonal allergies, triggered by pollen, and perennial allergies, which occur year-round due to triggers like dust mites, pet dander, or mold. The medication helps address several nasal and ocular symptoms:

  • Nasal Symptoms: It helps reduce sneezing, an itchy or runny nose, and nasal congestion.
  • Ocular Symptoms: It is effective in managing red, itchy, and watery eyes often associated with environmental allergens.

Chronic Idiopathic Urticaria

In addition to respiratory symptoms, Analergin is used to treat chronic idiopathic urticaria, a condition characterized by the regular appearance of hives (urticaria) and skin swelling for which there is no known external cause. The benefits in this context include:

  • Reduction of Hives: It helps decrease the number and size of hives on the skin.
  • Relief from Itching: It provides significant relief from the persistent itching (pruritus) associated with chronic skin reactions.

Mechanism of Action and Patient Benefits

The active ingredient in Analergin provides a non-sedating or minimally sedating effect for many patients compared to first-generation antihistamines. By stabilizing the body's response to allergens, the medication allows individuals to maintain their daily activities with fewer interruptions from allergic symptoms. The primary benefit is the systemic control of the inflammatory response, improving overall comfort during periods of high allergen exposure.

Eligibility and Restrictions for Use

Eligibility Scope: Official Regulatory Information

The eligibility profile for Analergin (cetirizine) is strictly defined by government regulatory documents, outlining populations for whom use is permitted, restricted, or contraindicated.

Contraindicated Populations

  • Patients with a history of hypersensitivity to the active substance cetirizine, the parent compound hydroxyzine, or any piperazine derivatives.
  • Patients with end-stage renal disease or severe renal impairment (typically defined as creatinine clearance below 10 mL/min).

Age-Related Eligibility

  • Use is generally permitted for adults and adolescents (over 12 years of age).
  • Approved for children aged 6 to 12 years using appropriate formulations.
  • The tablet formulation is not recommended for children under 6 years of age, as it prevents the necessary lower dose adjustments.

Condition-Based Restrictions (Conditional Use)

  • Patients with mild to moderate renal impairment require individual dose adjustment, making use conditional on renal function status. Older adults are eligible provided their renal function is normal.
  • Caution is advised for patients with epilepsy, a risk of convulsions, or those with predisposing factors for urinary retention.
  • The medicine is not recommended for use during breastfeeding, as the substance is known to pass into human milk. Caution should be exercised when prescribing to pregnant women.

What should I know about interactions with other medicines?

Analergin Interactions with other medicines and products

The official regulatory profile for Analergin (Cetirizine Dihydrochloride) is defined by documented pharmacodynamic and pharmacokinetic patterns that require specific precautions. The resulting interaction structure focuses on additive CNS effects and alterations to drug clearance in specific contexts.

Interacting Substance/Condition Official Interaction Description
CNS Depressants and Alcohol Co-administration may cause additive effects resulting in additional reductions in alertness and impairment of CNS performance.
Theophylline (400 mg daily) Results in a 16% decrease in the clearance of cetirizine, as observed in pharmacokinetic studies.
Food Does not reduce the extent of absorption (AUC) but officially decreases the rate of absorption (delays Cmax).
Allergy Skin Tests A 3-day wash-out period is required before performing skin tests, as the drug inhibits the necessary response.

Interaction studies with medicines such as ketoconazole, erythromycin, azithromycin, and pseudoephedrine reported no clinically significant pharmacokinetic interactions, consistent with the drug’s low level of first-pass metabolism. Population-specific considerations formally documented in prescribing information relate to impaired organ function: patients with chronic liver diseases demonstrate a 50% increase in half-life and a 40% decrease in clearance of cetirizine. Similarly, substantial renal excretion means that renal impairment requires acknowledgment of potential drug accumulation.

Mechanism of Action

The mechanism of action for Analergin (Cetirizine) is defined by its targeted influence on the pathways and receptors central to certain physiological responses, acting primarily as a selective antagonist.


Targeting the H₁ Receptor to Restrict Vascular Effects

The core mechanism involves the drug acting as a high-affinity and selective antagonist at the peripheral Histamine H1 Receptor ( H1 R). By competitively binding to this molecular target, the molecule prevents histamine from activating the receptor, which halts the signaling cascade that typically leads to increased vascular permeability and smooth muscle contraction. This resulting physiological effect causes the stabilization of the microvasculature state and results in reduced fluid efflux into tissues.


Mechanistic Exclusion at the Blood-Brain Barrier

The drug's structural properties and its interaction with the P-glycoprotein ( P- gp) efflux transporter fundamentally define its spatial mechanism. By acting as a substrate for P- gp, the molecule is actively pumped out of the central nervous system ( CNS), ensuring its activity remains primarily peripheral. This mechanism is a mechanistic factor in the low H1 R occupancy in the CNS.


Secondary Modulation of Inflammatory Cell Kinetics

A secondary domain of action involves the non- H1 R dependent modulation of key inflammatory cells, specifically reducing the chemotaxis (migration) of eosinophils and neutrophils to reaction sites. This cellular modulation is a parallel mechanism to the primary receptor blockade by engaging mechanisms that regulate pro- inflammatory cell recruitment, thereby contributing to the suppression of inflammatory cell recruitment pathways.

Dosage and Administration Information

How Analergin is Used: Official Administration Guidelines

Analergin (Cetirizine Dihydrochloride) is administered primarily via the oral route as tablets, syrup, or solution. For specific clinical indications, a specialized intravenous (IV) injection form is also available.

Standard Regimens and Frequency

The most common dosage for adults and adolescents (12 years and older) is 10 mg taken once daily. This 10 mg dose represents the maximum recommended daily limit. For initial treatment or less severe symptoms, a 5 mg tablet or solution once daily may be appropriate. The medicine may be taken with or without food.

Oral Administration Rules:

Age Group Standard Daily Dose (Oral) Administration Rule
Adults/Adolescents (≥12 yrs) 10 mg once daily Swallow tablets whole with liquid
Children (6–11 yrs) 5 mg or 10 mg once daily Dosing may be divided as 5 mg twice daily in some regions
Children (2–5 yrs) 2.5 mg once daily, max 5 mg Use calibrated device for liquid forms

Special Dosing Adjustments

Official guidelines require dosage adjustments for patients with reduced organ function. For adults with moderate to severe renal impairment, the dose is typically reduced to 5 mg once daily or less frequently, depending on the severity of impairment. Older adults may also require this reduced 5 mg dose, particularly if their kidney function is compromised.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Analergin


Evidence for Use in Allergic Rhinitis (Seasonal and Perennial)

The clinical evaluation of Analergin, whose active ingredient is Cetirizine Dihydrochloride, has focused extensively on its application for use in conditions characterized by fluctuating or episodic manifestations like allergic rhinitis. Research primarily relies on short-term, randomized controlled trials (RCTs). These studies were used in research exploring how symptoms change over time, often comparing the compound to an inactive placebo. Researchers monitored outcomes related to physical discomfort, tracking changes in nasal and eye symptom scores, and also applied in studies examining patient-reported experiences of daily functioning and Quality of Life (QOL).

Findings from these controlled studies describe patterns observed in the short-term treatment of these conditions. Studies reported measurements of changes in symptoms across adults, adolescents, and children. Further research also describes the compound's effect on a biomarker: the suppression of the histamine-induced wheal and flare reaction, a cutaneous outcome linked to inflammatory or irritative states. This high-volume trial data structure contributes to the evidence base for regulatory consideration for use in both seasonal and perennial forms of allergic rhinitis.

Evidence for Use in Chronic Urticaria (Hives)

The active ingredient was studied for its use in conditions like chronic urticaria (hives), which involves persistent skin itching and weals. The research base includes randomized, controlled clinical trials where the compound was evaluated in populations presenting with outcomes related to physical discomfort. Trials examined changes in symptom intensity or variability using standard scales, such as the Urticaria Activity Score (UAS), to monitor changes in pruritus (itching) and the physical size or number of wheals. The available body of controlled clinical trial data contributes to the broader evidence landscape regarding its established role for use in conditions related to the cutaneous manifestations of this chronic condition.

What the Research Evidence Indicates is Still Uncertain

While a high volume of consistent trial data contributes to the evidence base for regulatory consideration, several areas of uncertainty exist. Long-term effects are not fully established regarding the sustained changes in symptom patterns over periods exceeding one year. Comparative evidence is lacking for robust, head-to-head comparisons against all newer generation antihistamines, meaning certainty remains low in some specific comparative analyses. Additionally, research has mainly focused on short-term changes, and the results apply only to the populations studied in the controlled environment.

Frequently Asked Questions (FAQ)

Common questions about Analergin (FAQ)

Q: Does Analergin interact with alcohol?

A: Official product information advises caution regarding alcohol consumption while taking Analergin. According to regulatory sources, it is recommended to avoid alcohol, as it may increase the risk of side effects on the central nervous system, such as drowsiness.

Q: Can Analergin be used during pregnancy?

A: Regulatory documents advise that Analergin is not recommended for use during the first trimester of pregnancy. For the second and third trimesters, official information states that the drug should only be used if a healthcare professional determines the potential benefit outweighs the potential risk to the fetus.

Q: Is Analergin safe for children?

A: According to the official product information, Analergin is not recommended for use in children under 12 years of age. Official information indicates that the appropriateness of this medication for individuals in this age group is typically determined by a healthcare provider.

Q: Can I use Analergin while breastfeeding?

A: Official product information states that Analergin is not recommended for women who are breastfeeding. Regulatory sources explain this is because the active substance in Analergin may pass into human milk.

Q: What is the primary action or function of Analergin in the body?

A: Analergin contains the active ingredient pheniramine maleate. According to regulatory documents, its primary function is to block the action of histamine, a substance the body releases during an allergic reaction, which is intended to relieve symptoms.

Q: What common allergic symptoms does Analergin help treat?

A: Regulatory documents indicate that Analergin is used to address symptoms associated with various allergic conditions. This includes perennial and seasonal allergic rhinitis (hay fever) and symptoms such as chronic allergic conjunctivitis (eye inflammation).

Q: Does Analergin cause drowsiness?

A: Yes, regulatory documents list drowsiness (somnolence) as a very common side effect of Analergin. Because of this potential effect, official product information notes that caution is advised when performing activities that require alertness, such as driving.

Q: Are there any specific activities I should avoid while taking Analergin?

A: The official product information advises caution when engaging in activities that require increased attention and coordination. The regulatory label advises against driving or operating machinery, especially if side effects such as drowsiness or blurred vision occur.

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

A: Regulatory documents advise that if a dose of Analergin is missed, the regulatory instructions typically state that the next dose should be taken at the usual time. Official instructions generally advise against taking a double dose to compensate for a missed one.

Q: What kind of reaction is Analergin used to treat in the eyes?

A: According to the official product information, Analergin is indicated for treating allergic conjunctivitis. This is an inflammation of the lining of the eye, often caused by an allergic reaction, which Analergin is intended to help relieve.

How should Analergin be stored and disposed of?

How to Store and Dispose of Analergin?

Analergin tablets must be stored at Controlled Room Temperature, which is 20 C to 25 C (68 F to 77 F). The medication must be kept away from excess heat and moisture.

Requirement Condition
Container Keep in the original container and maintain it tightly closed.
Light Protect the oral solution (syrup) from light.
Stability Oral solution must be used within 6 months after first opening the bottle.
Safety Store all forms of the medicine out of the sight and reach of children.

For disposal, regulatory instructions state that Analergin should not be thrown into wastewater or general household waste. Users must ask a pharmacist how to dispose of unused or expired medicine to ensure it is handled through appropriate national collection schemes.

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

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