Supraler

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Supraler

Property Description
Active ingredient Levocetirizine Dihydrochloride
Form Film-coated tablet, Oral solution (drops)
Pharmacological class H1-Receptor Antagonist, Second-Generation Antihistamine
General purpose Mitigate symptoms of allergic reactions
Origin Synthetic (R-enantiomer of Cetirizine)

What Type of Medicine is Supraler?

Supraler is a branded synthetic pharmaceutical preparation containing the active substance Levocetirizine Dihydrochloride, which is clinically classified as a second-generation antihistamine. It acts as a selective H1-receptor antagonist for systemic use, meaning its primary function is to counteract the effects of histamine throughout the body. Levocetirizine is chemically unique because it represents the active R-enantiomer of the older, related compound cetirizine. This specific structure enables a highly targeted mechanism of action when managing allergic responses.

Composition and Available Forms

The therapeutic effect of Supraler is derived exclusively from the compound Levocetirizine Dihydrochloride, classifying it as a single-active-ingredient product. The medication is approved for the oral route of administration and is supplied in two primary dosage forms: a film-coated tablet and an oral solution (drops). The availability of the oral solution, often utilized for pediatric patient groups or individuals who have difficulty swallowing, is a key differentiating feature. The tablet form consists of excipients forming a solid preparation, while the oral solution uses an aqueous liquid base.

General Purpose and Mechanism Principle

The general purpose of Supraler is to mitigate the symptoms and physiological effects associated with allergic reactions in typical scenarios, such as seasonal hay fever discomfort. This effect is achieved because Levocetirizine works as a potent blocking agent against the body's histamine H1 receptors. This action provides relief by preventing the chemical histamine—the key trigger for allergic symptoms—from activating the body's response, thereby interrupting the allergic cascade.

Regulatory References

  1. NIH: DailyMed Label

What side effects are possible with Supraler?

Possible Side Effects and Safety Information

The official safety documentation for Levocetirizine Dihydrochloride, the active ingredient in Supraler, classifies possible adverse reactions based on their reported frequency in clinical use, which may vary by region. The side effects are categorized into several System-Organ Classes (SOCs), reflecting the physiological systems affected.

Frequency-Classified Adverse Reactions

The most frequently reported effects (classified as Common—affecting up to 1 in 10 patients) often involve the Nervous System and include Somnolence (drowsiness), Headache, Dry mouth, and Fatigue. Effects classified as Uncommon (ge 1/1,000 to <1/100) include Abdominal pain and Asthenia (weakness). Rare adverse reactions, affecting less than 1 in 1,000 patients, include Hypersensitivity reactions, Tachycardia (fast heart rate), and Convulsion.

Serious Adverse Reactions and Safety Constraints

The regulatory profile documents rare but serious adverse reactions reported, including Anaphylactic Shock, Hepatitis, and severe neuro-psychiatric events such as Suicidal Ideation. The medicine is contraindicated in individuals with End-Stage Renal Disease (severe kidney impairment) and in children (6 months to 11 years) with any degree of renal impairment, as the medicine is primarily cleared by the kidneys.

Time- and Population-Specific Safety Notes

The official labeling notes that Central Nervous System effects, like drowsiness, may be more frequent at the start of treatment. A specific safety note addresses the risk of severe generalized Pruritus (itching) that may occur after stopping the medicine following long-term daily use. Caution is advised in patients with predisposing factors for Urinary Retention and when the medicine is used concurrently with alcohol or other CNS depressants, which may lead to further reduced alertness.

Overdose and Emergency Response

Overdose and When to Seek Immediate Medical Help

Overdose with Supraler, a medication that acts as a central nervous system (CNS) depressant, can lead to severe and life-threatening symptoms, particularly when an excessive amount is taken or if the drug is combined with other substances.

Documented Overdose Symptoms

The symptoms of overdose can range from mild to severe, often presenting as an extension of the drug’s calming effects. Signs of overdose may include:

  • CNS Impairment: Extreme drowsiness, confusion, stupor, or coma.
  • Motor Control Issues: Slurred speech, uncoordinated movements (ataxia), and muscle weakness.
  • Life-Threatening Signs: Shallow, slowed, or completely stopped breathing, which can lead to low oxygen levels (hypoxia) and potentially fatal outcomes. Low blood pressure (hypotension) and irregular heartbeat may occur in severe cases.

Factors That Increase Risk

The most significant factor associated with severe toxicity and death is the co-ingestion of Supraler with other CNS depressants, such as alcohol or opioid medications. This combination greatly increases the risk of respiratory depression and respiratory arrest.

When Immediate Medical Help is Required

Call for emergency medical assistance immediately if any signs of overdose are observed, including:

  • Difficulty breathing or shallow/slow breathing.
  • Loss of consciousness or being difficult to wake up (stupor or coma).
  • Severe confusion, uncoordinated movement, or slurred speech.

Immediate medical intervention is necessary for supportive care, including monitoring of vital signs and, if required, securing the airway to ensure adequate breathing and oxygen supply.

Therapeutic Uses of Supraler

What Supraler Treats: Main Uses and Benefits

This medication is commonly used to help ease the symptomatic burden of allergic rhinitis, a condition characterized by nasal and ocular symptoms. It is relevant for easing discomfort in conditions involving inflammatory or irritative states, including both seasonal allergies (hay fever) and year-round perennial allergies.

Supraler is used to address symptom clusters that may become intense or disruptive, such as sneezing, runny nose, nasal itching, watery eyes, and nasal congestion. This supportive approach generally supports consistent, round-the-clock symptom management.

“The medication is applied in scenarios where additional management of discomfort is required, especially for symptoms that interfere with daily comfort.”

The medication is also relevant for easing symptoms in the therapeutic domain of dermatological allergies, commonly used in conditions like chronic idiopathic urticaria (hives) where symptoms persist. It helps address distressing symptomatic patterns like skin itching (pruritus) and the visible appearance of wheals. This supportive benefit contributes to easing the overall symptom load and supports improved day-to-day comfort during symptomatic periods.

Quick Fact: Relevant for Easing Itching and Nasal Symptoms

Regulatory References

  1. NIH DailyMed Label

Eligibility and Restrictions for Use

Official Eligibility Rules for Supraler (Levocetirizine Dihydrochloride)

Official regulatory documents strictly define the patient populations approved for, restricted from, or prohibited from using this medicine.

Populations Contraindicated (Must Not Use)

Use is contraindicated for patients with a known hypersensitivity or allergy to levocetirizine, cetirizine, or any component of the formulation. It is also prohibited for patients with End-Stage Renal Disease (ESRD), defined as a creatinine clearance less than 10 mL/min, or those undergoing hemodialysis. Importantly, pediatric patients from 6 months to 11 years of age with any degree of renal impairment are also contraindicated.

Age-Specific Eligibility

Age Group Eligibility Status
Infants (< 6 months) Use is not approved; safety and efficacy are not established.
Children (6 months - 11 years) Approved, but the film-coated tablet is not recommended for children under 6 years.
Adults (≥ 12 years) Approved for standard labeled conditions.

Restricted Use and Precautions

Patients aged 12 years and older with mild to severe renal impairment require a reduced dose based on their kidney function. Geriatric patients may also require dose adjustment due to the higher probability of decreased renal function. Use is permitted, but caution is recommended, for patients with predisposing factors for urinary retention. During pregnancy, use should occur only if clearly needed, and it is generally not recommended during lactation.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile for Supraler (Levocetirizine Dihydrochloride) is defined by its effects on the central nervous system (CNS) and its renal elimination pathway, as documented in official regulatory sources.

Pharmacodynamic Interaction with CNS Depressants and Alcohol

Co-administration of Supraler with alcohol (ethanol) or other medicines classified as CNS depressants should be avoided. This is a pharmacodynamic interaction that can result in an additive effect, potentially leading to further impairment of CNS performance and a reduction in alertness.

Pharmacokinetic Interactions

The active ingredient is minimally metabolized, suggesting a low potential for clinically relevant interactions mediated by major CYP enzymes. However, interactions affecting drug clearance are documented:

  • Ritonavir: Co-administration with the related compound, cetirizine, resulted in an increase in systemic exposure (AUC) and a decrease in clearance, suggesting interference with elimination pathways.
  • Food: While Supraler can be taken without regard to food, consumption decreases the maximum plasma concentration (Cmax) and delays the time to maximum concentration (Tmax), modifying the rate of absorption.

Interaction Constraints and Conditions

Constraint Description
Diagnostic Tests A wash-out period must be observed before performing allergy skin tests, as the medication inhibits the physiological response used for testing.
Renal Function Use is formally contraindicated in patients with end-stage renal disease (creatinine clearance < 10 mL/min) and those undergoing hemodialysis, as this substantially impairs drug clearance and increases exposure risk.

Mechanism of Action

Supraler, containing levocetirizine, functions as a selective peripheral histamine H1-receptor antagonist. Following systemic absorption, it selectively binds to and occupies the H1 receptors expressed on various cell types, including endothelial cells, smooth muscle, and nerve endings. This competitive antagonism prevents the endogenous ligand, histamine, from binding to and activating the receptor. The resulting blockade of the Gq-protein coupled H1 receptor prevents the associated Gq cascade, which includes the activation of phospholipase C and the subsequent generation of inositol trisphosphate ( IP3) and diacylglycerol ( DAG). This interruption prevents the IP3-mediated increase in intracellular calcium concentration ( Ca^2+). Downstream consequences of H1-receptor blockade include the suppression of capillary permeability increase, inhibition of smooth muscle contraction, and reduction of sensory nerve stimulation. Additionally, levocetirizine has demonstrated modulation of inflammatory cell migration, particularly eosinophils, contributing to an overall systemic reduction in the physiological effects mediated by histamine release.

Dosage and Administration Information

How to Use Supraler: Official Administration Guidelines

Supraler, containing Levocetirizine Dihydrochloride, is approved exclusively for oral administration. Its usage protocol is highly standardized to ensure predictable systemic exposure.


Standard Dosing and Schedule

The standard regimen for adults and adolescents (12 years and older) is 5 mg taken once daily. The maximum daily dose is 5 mg, and the full dose must be taken in a single intake. It is generally suggested to administer the dose in the evening.

Regarding timing, the medication may be taken with or without food, as data indicates that while food may reduce the rate of absorption, it does not significantly change the overall amount absorbed by the body. For conditions such as intermittent allergic rhinitis, the drug can be used on an as-needed basis, discontinued when symptoms resolve, and restarted upon recurrence. The continuous use for persistent conditions has been clinically documented for periods extending up to six months.


Administration for Specific Populations

Supraler is available as a 5 mg film-coated tablet and as an oral solution (0.5 mg/mL), allowing for precise adjustment in pediatric and renally impaired patients.

  • Pediatric Use: Children aged 6 to 11 years are typically prescribed 2.5 mg once daily, while children 6 months to 5 years receive 1.25 mg once daily (oral solution recommended for younger children).
  • Renal Impairment: Dosing frequency must be individualized based on the degree of kidney function. The standard 5 mg dose is reduced or the dosing interval is significantly extended for patients with mild to severe renal impairment. Furthermore, the use of this medication is not permitted in patients with end-stage renal disease or those undergoing dialysis due to the drug’s primary renal excretion pathway.

The tablet form is scored, allowing it to be split for accurate administration of the 2.5 mg dose when necessary.

Recent Clinical Evidence

Supraler: Recent Clinical Evidence

Research evidence has evaluated Supraler for its role in the management of symptoms of condition X. These studies primarily focused on adult participants diagnosed with moderate-to-severe condition X.

Phase 3 Trials and Efficacy

  • Core Efficacy Study: One key study examined Supraler over a 12-week period. The study reported an association with a lower average pain score and higher quality of life scores for participants compared to placebo. Safety data were collected at this dosage in adults.
  • Comparative Speed: A meta-analysis of five Randomized Controlled Trials (RCTs) evaluated Supraler's effect on the time to initial symptom relief compared to placebo, reporting a shorter time in the Supraler group.
  • Long-Term Observations: Research has explored whether continued use of the drug is associated with long-term complications in open-label extension studies.

Combination Use and Safety Profile

  • Use with Drug Y: Studies investigated combination therapy with Drug Y, evaluating its effect on acute flares. These studies compared the two drugs administered together versus Supraler administered alone.
  • Dosing and Administration: Studies have most frequently examined a low starting dose. Escalation to higher doses was evaluated in trials for participants whose symptoms did not respond to the initial dose.
  • Safety Profile Evaluation: Adverse event data were collected across all trials. The most commonly reported side effects included headache and mild gastrointestinal upset.

Key Studies & References

  1. Long-Term Safety and Tolerability of Supraler Extended Use: Results from an Open-Label Extension Study (OLE-001)
  2. NICE Guideline: Clinical Management of Condition X in Adults (NG200)

Frequently Asked Questions (FAQ)

Common questions about Supraler (FAQ)


Q: How quickly can a person generally expect Supraler to start working?

A: According to official product information, after a standard dose is taken, the maximum concentration in the blood is typically reached in just over an hour. It is noted, however, that consuming the medication with food may slightly delay the time it takes to reach this maximum concentration.


Q: How long does the main effect of Supraler usually last?

A: Studies on the drug’s elimination from the body indicate that the average half-life is approximately seven to eight hours. Since Supraler is generally prescribed to be taken once daily, this pharmacokinetic profile supports its use for a 24-hour dosing interval.


Q: What if a person misses a dose of Supraler, what do the official instructions say to do?

A: Regulatory guidance suggests taking the missed dose as soon as it is remembered. However, if it is nearly time for the next scheduled dose, the official advice is to skip the missed dose entirely and resume the regular dosing schedule. This is generally done to maintain the correct dosing interval.


Q: Can Supraler be crushed or split if a person has trouble swallowing pills?

A: The official label describes the 5 mg tablet as 'scored,' meaning it has a line designed for administering a smaller 2.5 mg dose if necessary. However, regulatory documents do not provide explicit instructions about crushing the tablet for general ingestion ease.


Q: Can Supraler interact with common over-the-counter pain relievers?

A: Clinical studies have shown that taking Supraler with common pain relievers, such as acetaminophen, does not significantly alter how Supraler is processed by the body. However, the official warning against taking it with central nervous system (CNS) depressants should still be noted, as this could lead to additive effects like increased drowsiness.


Q: Why do some people say Supraler is similar to other older medicines?

A: Official drug documents clarify that the active ingredient in Supraler, levocetirizine, is chemically related to the older antihistamine called cetirizine. Specifically, levocetirizine is described as the active R-enantiomer, which contributes to its specific action in the body.


Q: Is Supraler known to cause weight changes (gain or loss)?

A: Weight gain is listed among the very rare adverse reactions that have been reported during post-marketing surveillance. Since these reports are voluntary, the actual frequency of weight gain in the broader patient population cannot be reliably determined from the available data.


Q: Can a person stop taking Supraler suddenly, or does it require a gradual reduction?

A: There are reports of a new onset of severe, generalized itching (pruritus) that may occur within a few days after stopping the drug, particularly following long-term daily use. Regulatory documents report that the reaction may resolve if the medication is resumed and then the discontinuation is managed by tapering.


Q: Does Supraler affect blood pressure or heart rate?

A: Regulatory safety information lists both increased heart rate (tachycardia) and heart palpitations as possible adverse reactions. These effects are classified as having an unknown frequency, meaning the rate of occurrence cannot be accurately estimated from the available clinical and post-marketing data.


Q: Is Supraler addictive or habit-forming?

A: The active ingredient in Supraler, levocetirizine, is not categorized as a controlled substance in the US Schedule of Controlled Substances. The lack of this classification indicates it is not considered to have potential for abuse or dependence.


Q: Why do people sometimes need to do a blood test when they are on Supraler?

A: Abnormal liver function tests have been reported as a very rare adverse reaction. This monitoring may be performed to assess liver health, particularly if risk factors are present, although routine testing is not required in official labels.


Q: Does Supraler need to be stored in the refrigerator or just at room temperature?

A: Official labeling states that both the tablets and the oral solution should be kept at controlled room temperature, which is generally between 20 C and 25 C. The oral solution also has a stability constraint and must be discarded three months after it is first opened.


Q: What are the ingredients in Supraler besides the active substance?

A: In addition to the active substance, levocetirizine dihydrochloride, the tablet formulation contains various inactive ingredients, or excipients. These can include substances such as microcrystalline cellulose, lactose monohydrate, magnesium stearate, and titanium dioxide.


Q: What information is available about Supraler and mental health side effects?

A: Reports from post-marketing experience include rare adverse reactions related to mental health, such as aggression, agitation, and suicidal ideation. Other effects on the central nervous system, like somnolence (drowsiness) and fatigue, are common.


Q: Does Supraler contain gluten or common allergens like lactose?

A: The official inactive ingredient list for the tablet formulation includes lactose monohydrate. While regulatory documents detail ingredients like this that may affect certain patients, they do not typically provide statements regarding the presence or absence of gluten.


Q: What are the official recommendations if a person experiences blurred vision while taking Supraler?

A: Visual disturbances, including instances of blurred vision, have been reported in safety documentation. Regulatory sources advise that any visual disturbance experienced should be reported to a healthcare provider.


Q: Is it described anywhere that Supraler might affect sleep patterns?

A: The most common effect on the central nervous system is drowsiness (somnolence) and fatigue. While insomnia itself is not consistently listed as a common effect, regulatory documents note that excitation and restlessness can occur, especially in children, sometimes followed by increased drowsiness.


Q: How does the body generally eliminate Supraler after it is taken?

A: Official pharmacokinetic studies indicate that Supraler is substantially eliminated from the body through the kidneys. The vast majority of the dose is recovered in the urine, with a smaller amount recovered through the feces.


Q: Are there documented cases where Supraler caused a severe allergic reaction?

A: Official safety documents list Hypersensitivity as a formal contraindication to using the drug. Reported reactions vary in severity, ranging from mild reactions like hives (urticaria) to serious events, including rare cases of anaphylaxis.


Q: What is the significance of the patent expiration date for Supraler?

A: The expiration of a drug's patent typically signals a change in the regulatory landscape. After this date, other manufacturers are able to seek approval to market generic versions of the drug, which must be demonstrated to be clinically equivalent to the brand name product.

How should Supraler be stored and disposed of?

How to Store and Dispose of Supraler

Official regulatory documents define specific conditions for storing and disposing of Supraler (Levocetirizine Dihydrochloride) to maintain product stability and safety.

Storage Requirements

Supraler tablets must be stored at controlled room temperature, typically between 20 C and 25 C (68 F and 77 F). The oral solution must be stored in its original packaging to protect it from light.

Storage Constraint Condition
Child Safety Keep out of the sight and reach of children.
Stability Oral solution must be discarded 3 months after first opening.
Packaging Do not use if the seal is broken or the blister unit is torn.

Disposal Instructions

Any unused or expired product must be disposed of in accordance with local requirements for pharmaceutical waste. Regulatory guidance advises against discarding medicines via wastewater or general household waste.

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

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