Aldine

Quick links to important sections

Medically reviewed

Marina Burgos

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 Aldine

Property Description
Active Ingredient Levocetirizine dihydrochloride
Form Film-coated tablets, Oral solution/Syrup
Pharmacological Class Second-generation Antihistamine; H1-receptor antagonist
General Purpose Provides systemic relief from allergic discomfort
Origin Synthetic, R-enantiomer derivative of Cetirizine

What Type of Medicine is Aldine?

Aldine is the trade name for a medication containing the active substance Levocetirizine. This drug is classified as a highly selective second-generation antihistamine that operates as an H1-receptor antagonist. It is a synthetic compound that is chemically distinguished as the purified and active R-enantiomer of Cetirizine. This formulation is clinically recognized for its reduced potential for inducing drowsiness compared to older antihistamines. This molecular distinction ensures a targeted therapeutic action that focuses on mitigating the allergic response without pronounced systemic impact on the central nervous system.

Composition and Available Pharmaceutical Forms

The formulation of Aldine contains Levocetirizine dihydrochloride as the sole active substance, establishing it as a single-ingredient product. The drug is designed for oral administration and is typically manufactured in two high-level dosage forms: film-coated tablets and an oral solution or syrup. The availability of these forms makes Aldine suitable for patient groups who may require liquid formulations. Levocetirizine is recognized for its efficacy and safety profile, supporting its classification as a potent antiallergic agent.

What is the General Purpose of Antihistamines like Aldine?

The general purpose of Aldine is to provide systemic relief from allergic discomfort, such as symptoms caused by exposure to seasonal allergens. Its fundamental action as an H1-receptor antagonist is to counter the physiological effects of histamine by blocking its binding to H1-receptors. This mechanism is associated with relief from allergy-related discomfort across multiple body systems. This targeted antiallergic activity addresses symptoms throughout the body, providing comprehensive mitigation of the allergic cascade.

Regulatory References

  1. MedlinePlus

What side effects are possible with Aldine?

Possible Side Effects and Safety Information

The safety profile of levocetirizine, the active substance in Aldine, is officially documented by government regulatory bodies and primarily describes effects on the Nervous System and General Disorders organ classes. The adverse reactions are classified by frequency as observed in clinical trials and post-marketing surveillance.

Documented Adverse Reactions

The most common adverse reactions reported in adults and adolescents include somnolence (drowsiness), fatigue (unusual weakness), dry mouth, and irritation of the nose and throat (nasopharyngitis and pharyngitis). In pediatric populations, common reactions may include fever (pyrexia) and cough.

Post-marketing reports also include adverse reactions where the frequency is generally classified as not known. These involve effects on the Psychiatric System (such as aggression, agitation, depression, and suicidal ideation) and the Nervous System (including convulsions).

Serious Safety Considerations and Constraints

Serious adverse reactions documented in regulatory sources include severe hypersensitivity reactions, such as anaphylaxis, and cases of urinary retention. Use of the drug is contraindicated in individuals with end-stage renal disease or those undergoing dialysis, as levocetirizine is substantially eliminated by the kidneys.

Time-related patterns of risk are also noted. Somnolence and fatigue may be more pronounced at the initiation of treatment. Furthermore, a risk for severe pruritus (itching) has been reported to develop upon discontinuation of the medication after long-term daily use. The official labeling cautions that concurrent use with alcohol or other Central Nervous System (CNS) depressants may result in an additive reduction of mental alertness.

Overdose and Emergency Response

Overdose and When to Seek Help

The official regulatory profile for Aldine (Levocetirizine) overdose defines specific clinical manifestations and strictly mandated emergency actions.

Documented Clinical Manifestations

Overdose presentations are primarily defined by central nervous system (CNS) effects. In adults and adolescents, the principal sign documented in regulatory information is somnolence (drowsiness). The presentation differs in children, where an initial period of agitation or restlessness is documented, followed by somnolence. Reports following ingestion of at least five times the recommended daily dose include more pronounced effects such as stupor and tremor. Cases have also suggested an anticholinergic effect, evidenced by findings like mydriasis and urinary retention.

Official Emergency Actions

It is officially mandated that in the event of any suspected overdose, medical help must be sought right away. Individuals are required to contact a Poison Control Center or emergency medical services immediately. Management is restricted to symptomatic and supportive treatment only. Regulatory documents explicitly state that no specific antidote is known for Levocetirizine, and standard procedures like hemodialysis are not effective in removing the substance. This focus on supportive care and the lack of an antidote defines the official management strategy.

Therapeutic Uses of Aldine

The medication is commonly used to provide symptomatic relief in two primary categories of conditions characterized by periods of heightened symptoms associated with physical discomfort.


Management of Seasonal and Perennial Allergic Rhinitis

This medication is commonly used in contexts involving Allergic Rhinitis, relevant in both the seasonal type (hay fever) and the perennial (year-round) type. It helps address symptom clusters that may become disruptive, including recurrent sneezing, watery rhinorrhea (runny nose), and distressing itching of the nose and eyes. The primary indications involve conditions like Seasonal Allergic Rhinitis, Perennial Allergic Rhinitis, and Hay Fever. Aldine provides support that helps ease the overall symptom burden, contributing to improved day-to-day comfort during symptomatic periods of heightened allergen exposure.


Supportive Relief for Chronic Urticaria (Hives) and Pruritus

Aldine is applied in conditions marked by recurrent, episodic skin manifestations, specifically the uncomplicated symptoms of Chronic Idiopathic Urticaria (hives). It helps manage the key symptoms of this domain, focusing on easing the symptoms of pruritus (skin itching) and assisting with managing the presence of associated wheals. This offers symptomatic relief that supports patients during difficult episodes by easing distress and assists with maintaining functional stability when symptoms interfere with routine activities and general well-being.


Quick Fact: Relief for Allergic Discomfort Aldine is commonly used to help manage symptoms related to systemic imbalance and irritative states, such as sneezing, itching, and hives (urticaria).

Regulatory References

  1. NIH MedlinePlus overview

Eligibility and Restrictions for Use

Eligibility and Contraindications

The eligibility for using Aldine (Levocetirizine dihydrochloride) is defined by strict regulatory criteria, including age, physiological state, and known hypersensitivity.

Populations Who Must Not Use Aldine (Contraindications)

Use of this medicine is contraindicated in patients with a history of hypersensitivity to Levocetirizine, Cetirizine, Hydroxyzine, or any other piperazine derivatives. It is also contraindicated in adult and adolescent patients (12 years and older) with End-Stage Renal Disease (creatinine clearance le 10 mL/min) or those undergoing hemodialysis.

Children 6 months to 11 years of age with any degree of impaired renal function are also prohibited from using this medicine. Furthermore, the film-coated tablets are not recommended for children under 6 years old as they do not permit the necessary dosage adjustment.

Conditional Use and Special Groups

Population Group Regulatory Status
Infants (< 6 months) Use not established; Contraindicated.
Adults with Renal Impairment Restricted; Requires dose adjustment based on measured kidney function.
Pregnancy Use advised only if clearly needed (Category B).
Lactation/Breastfeeding Not recommended; Expected to be excreted in human milk.

Patients with predisposing factors for urinary retention should use Aldine with caution.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Aldine (levocetirizine) exhibits a defined interaction profile based on additive pharmacodynamic effects and specific pharmacokinetic alterations documented in regulatory labeling.

Documented Interaction Patterns

Interacting Substance/Class Official Interaction Outcome Classification
Alcohol / CNS Depressants Concurrent use must be avoided due to risk of additional impairment of CNS performance and reductions in alertness. Pharmacodynamic
Ritonavir Co-administration leads to a 42% increase in systemic exposure (AUC) and a reduction in clearance of levocetirizine. Pharmacokinetic
Food Delays Tmax and reduces Cmax (peak concentration) by 36%, but does not affect overall exposure (AUC). Pharmacokinetic
CYP Enzymes Levocetirizine is formally documented as not being an inhibitor or inducer of major CYP isoenzymes (e.g., 1A2, 2C9, 3A4). Lack of Metabolic Risk

Other Specific Interaction Findings

No clinically significant interactions were found in studies involving the co-administration of Aldine with Theophylline, Antipyrine, Cimetidine, Erythromycin, Ketoconazole, or Pseudoephedrine.

Population-Based Interaction Note

For the elderly population, total body clearance is reduced by approximately 33% due to age-related changes in renal function, which is the primary elimination route. This mandates consideration of the patient’s renal status to prevent accumulation of the medicine.

Mechanism of Action

How Aldine Works


Targeted H1 Receptor Blockade

Aldine functions primarily as a competitive inverse agonist at the Histamine H1 receptor, the key molecular target that mediates immediate physiological responses. By stabilizing this receptor in an inactive state, the mechanism directly prevents the body's natural Histamine from binding, which in turn restricts Histamine-driven physiological consequences on blood vessels and peripheral nerves. This action modifies the early molecular steps that escalate into systemic physiological outcomes such as increased capillary permeability and nerve excitation.


Non- H1 Inflammatory Pathway Modulation

Beyond its receptor action, Aldine engages mechanisms that modulate the activity of prolonged inflammatory responses. The drug's mechanism also involves inhibiting the migration ( chemotaxis) of specific immune cells, such as Eosinophils, into inflamed tissues. This supplementary action within the Inflammatory Pathway restricts the physiological consequences of excessive mediator activity, which results in modulation of the targeted physiological process.


Highly Peripheral Selectivity

The molecule is designed with physicochemical properties that restrict its passage across the Blood-Brain Barrier (BBB), resulting in highly peripheral selectivity. This targeted mechanism ensures that its effects are exerted primarily on Peripheral H1 receptors, thereby resulting in a focused modulation of the physiological responses mediated by Histamine while restricting engagement with Central Neurotransmitter Pathways.

Dosage and Administration Information

How to Use Aldine: Administration Guidelines

Aldine is intended for oral administration only and is available as a 5 mg film-coated tablet and an oral solution (2.5 mg per 5 mL). The standard regimen for adults and adolescents (ge 12 years) is 5 mg once daily, typically taken in the evening. The maximum recommended daily dose for this age group is strictly 5 mg.

Dosing Across Populations

Age Group Standard Daily Dose Notes on Administration
Adults & Adolescents (ge 12 yrs) 5 mg once daily May be taken with or without food.
Children (6-11 yrs) 2.5 mg once daily Dose must not be exceeded.
Children (6 mos-5 yrs) 1.25 mg once daily Administered as 2.5 mL of the oral solution.

The 5 mg tablets are scored and may be broken to administer the 2.5 mg dose.

Adjustments and Duration

Dosage requires adjustment in adult patients with impaired kidney function, based on their estimated creatinine clearance (CLcr). For patients with mild impairment (CLcr 50-80 mL/min), the dose is reduced to 2.5 mg once daily. Patients with end-stage renal disease (CLcr < 10 mL/min) are not eligible for treatment with this medicine. Conversely, no dose adjustment is required for patients with solely hepatic impairment.

Treatment patterns are generally categorized: for intermittent allergic rhinitis, administration should stop upon symptom resolution and resume if symptoms reappear; for persistent allergic rhinitis and chronic urticaria, continuous use for up to six months is covered by clinical experience. These instructions describe the typical approach for using the medicine.

Recent Clinical Evidence

Research evidence / Overview of studies for Aldine

Evidence for Use in Seasonal and Perennial Allergic Rhinitis

Research exploring the use of Aldine for allergic rhinitis relies extensively on Randomized Controlled Trials (RCTs). These studies were used in research exploring how symptoms change over time and are applied in studies examining patient-reported experiences. Studies monitored patient-reported outcomes describing perceived discomfort such as sneezing, runny nose (rhinorrhea), and itching of the nose and eyes. Research was conducted during periods of increased symptom activity and explored short-term symptom changes.

Findings describe patterns observed in the studies where there was a measured change in key allergy symptom scores compared to a control group receiving an inactive substance. These studies focused primarily on outcomes capturing phases of heightened symptom activity over short and intermediate time intervals. Research provides insight into how symptoms evolved in the observed populations, particularly concerning the irritative states of sneezing, itching, and runny nose. However, data related to nasal congestion were observed in some studies but findings were mixed across the research landscape.


Evidence for Use in Chronic Urticaria (Hives) and Pruritus

Aldine was studied for the management of Chronic Urticaria (hives), a condition characterized by fluctuating or episodic manifestations of the skin. The main research comes from randomized controlled trials where researchers examined outcomes linked to inflammatory or irritative states and patient-reported outcomes describing perceived discomfort.

Trials reported measurements of a change in the Urticaria Activity Score (UAS), which tracks the severity of itching (pruritus) and the appearance of wheals (hives). Studies report how symptoms evolved in the observed populations, with findings describing a pattern of measured change in both the severity of the itching and the appearance of hives over intermediate periods, typically 4 to 6 weeks.


Long-Term Studies and Follow-Up Data

Most pivotal randomized controlled trials focus on short-term periods (two to six weeks). However, research has explored the effects over more extended periods, with some studies observing responses over defined time intervals of up to six months, particularly for persistent allergic rhinitis and chronic urticaria. Despite this, long-term effects are not fully established beyond six months in large, dedicated clinical trials.


Evidence in Special Populations

Aldine was studied in younger populations, with research examining outcomes in children (starting from 6 months of age for the liquid formulation) and adolescents. Data for certain groups remain insufficient, especially regarding the use in older adults (e.g., 65 years and older) and populations with complex or numerous comorbidities, meaning the results apply only to the populations studied in the official research.

Key Studies & References

  1. Levocetirizine Drug Information (Summary of Indications and Active Substance)
  2. Efficacy and safety of levocetirizine in adults and children with allergic rhinitis
  3. Clinical Guidelines on the Management of Allergic Rhinitis (ARIA guidelines - consensus on efficacy of second-generation antihistamines)

Frequently Asked Questions (FAQ)

Common questions about Aldine (FAQ)


Q: How quickly should I expect to see the effects of Aldine?

The active substance in Aldine is quickly absorbed, according to official regulatory documents. The highest concentration of the active substance in the blood is described as being reached approximately 0.9 hour after taking the tablet or about 0.5 hour after taking the oral solution. This rapid absorption pattern is detailed in the drug's official pharmacokinetic data.


Q: Can Aldine be taken with pain relievers like ibuprofen?

Official interaction studies for Aldine primarily focus on other pharmaceutical products. The regulatory documents do not specifically mention studies examining the interaction between Aldine and pain relievers such as ibuprofen. Official interaction documents list specific substances that were studied and found to have no clinically significant interactions with Aldine.


Q: Are there any known interactions between Aldine and birth control pills?

Official regulatory labeling does not specifically document any known pharmacokinetic or pharmacodynamic interactions between Aldine and oral hormonal contraceptives (birth control pills). Interaction summaries typically cover only those substances for which studies have been formally conducted.


Q: Why are there warnings about Aldine and grapefruit?

Official product information on food interactions indicates that while taking Aldine with food can slightly slow absorption, it does not affect the total exposure to the drug. No specific warnings or documented interactions with grapefruit are detailed in the official product labeling.


Q: Does Aldine affect sleep patterns?

Common adverse reactions reported in official summaries include drowsiness (somnolence) and fatigue. In addition to these, post-marketing reports have included effects on sleep, such as difficulty sleeping (insomnia) and nightmares.


Q: What is the description of the withdrawal symptoms, if any, when stopping Aldine?

Regulatory documents describe a risk for severe itching (pruritus) that has been reported upon discontinuation of the medicine. This effect is noted primarily following cessation after long-term, daily administration of the drug.


Q: Does Aldine affect the ability to drive or operate machinery?

Official regulatory warnings advise caution regarding activities that require full mental alertness. This is due to the risk of drowsiness (somnolence) and potential additive impairment when the drug is used concurrently with alcohol or other Central Nervous System (CNS) depressants. Given the common side effect of drowsiness (somnolence), it is generally recommended that individuals assess how the medicine affects their mental alertness before performing tasks that require concentration.


Q: What is the duration of action described for Aldine?

Pharmacological information states the active substance's plasma half-life is about 8 to 9 hours. This value is part of the overall duration and supports the once-daily administration pattern outlined in official documents.


Q: How is the safety profile of Aldine described for elderly patients?

For elderly patients, official information states that the body's clearance of Aldine is reduced by about one-third compared to younger adults. This reduction in clearance is due to the drug being substantially removed by the kidneys, which may operate less efficiently with age.


Q: What is the significance of the half-life mentioned for Aldine in research?

The half-life refers to the time needed for the amount of the active substance in the body to decrease by half. Official pharmacokinetic information states the plasma half-life in adult healthy subjects is approximately 8 to 9 hours.


Q: Is Aldine known to be habit-forming?

Regulatory documents confirm that Aldine is not classified as a controlled substance by official government agencies. The medicine is not described as having an established risk for dependency or abuse.


Q: Can Aldine cause weight gain or loss?

Weight change itself is not listed as a common or serious adverse reaction in the drug's primary safety summaries. However, post-marketing reports have included increased appetite as a possible effect.


Q: Does Aldine interact with common supplements like vitamin D or magnesium?

Regulatory documents include interaction studies with certain prescription and over-the-counter medications. Official labeling does not detail specific interaction studies conducted between Aldine and common dietary supplements like vitamin D or magnesium.


Q: Can Aldine cause problems with vision?

While not reported as a common side effect in clinical trials, post-marketing reports have included ocular (eye-related) side effects. These include visual disturbances and blurred vision.


Q: Is a metallic taste in the mouth a reported side effect of Aldine?

Official summaries of adverse reactions have reported changes in or loss of taste. A specific metallic taste is not commonly or frequently described in the regulatory safety information.


Q: What do studies say about the long-term effectiveness of Aldine?

Research has studied the effects of Aldine over extended periods, with some trials observing responses up to six months for persistent allergic rhinitis and chronic urticaria. Research explored changes in patient-reported allergy and skin symptoms across defined time intervals up to six months.


Q: How long does it takes for Aldine to leave the system?

The active substance is primarily removed from the body through the urine. The plasma half-life is about 8 to 9 hours, and regulatory data confirm that over 85% of the dose is excreted. It is generally understood that it takes multiple half-lives for a substance to be substantially eliminated from the system.


Q: Is Aldine a type of antibiotic?

No, Aldine is not an antibiotic. Official sources classify the active substance in Aldine as a highly selective second-generation antihistamine that works by blocking the H1 -receptor.


Q: How does Aldine compare to similar older medicines?

The official documents describe Aldine as a second-generation antihistamine. This type of formulation is clinically recognized for having a reduced potential for causing drowsiness compared to older, first-generation antihistamines.


Q: Is Aldine considered a 'new' drug?

The active substance in Aldine is established. It has been authorized for use in some regions since at least January 2001, according to official regulatory records.


Q: What should I know about the black box warning associated with Aldine, if applicable?

The official regulatory labeling for Aldine does not contain a 'Boxed Warning,' which is sometimes referred to as a Black Box Warning. However, the label does include serious safety constraints and contraindications related to kidney function and hypersensitivity.


Q: Can Aldine be used for chronic conditions?

Official use instructions categorize treatment for persistent allergic rhinitis and chronic urticaria as continuous use. Clinical experience covers periods up to six months for these conditions.


Q: Does Aldine affect cholesterol levels?

Official adverse reaction lists and safety summaries provided by government regulators do not typically mention any common or serious effects related to cholesterol levels.


Q: What is the relationship between Aldine and the immune system?

Beyond blocking the H1 -receptor, the medicine's mechanism of action involves modulating prolonged inflammatory responses. This includes inhibiting the movement of specific immune cells, such as Eosinophils, into inflamed tissues.


Q: Can Aldine be used alongside herbal remedies?

Official regulatory documents do not provide specific interaction studies for herbal remedies. Interactions summarized in the labeling are typically limited to other pharmaceutical products and select foods/substances like alcohol.


Q: Why is Aldine sometimes prescribed to be taken at night?

The standard regimen for Aldine is typically to take the once-daily dose in the evening. The common side effects of drowsiness (somnolence) and fatigue, which are noted in the official information, are consistent with the typical recommendation to take the once-daily dose in the evening.


Q: Is Aldine described as a common drug for its intended purpose?

Official regulatory summaries classify the active substance in Aldine as a highly selective second-generation antihistamine, indicating its defined use for providing systemic relief from allergic discomfort.

How should Aldine be stored and disposed of?

How to Store and Dispose of Aldine?

The storage and disposal guidelines for Aldine (levocetirizine dihydrochloride) are strictly defined by regulatory authorities to ensure product quality and public safety.


Storage Requirements

Aldine tablets must be stored at Controlled Room Temperature, defined as between 20 C and 25 C (68 F and 77 F). The container must be kept tightly closed and protected from excess heat and moisture.

  • Security: The medicine must be stored out of the sight and reach of children.
  • Integrity: Do not use the product past the expiry date or if the safety seal is torn.

Disposal Instructions

Disposal must follow local regulations. Unused product should not be thrown away via wastewater or household waste unless specialized steps are taken. The preferred method is to utilize community drug take-back programs.

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

Available in countries:

Equivalent of Aldine found in:

A-Z Index: