Antiss

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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 Antiss

Quick Facts

Property Description
Active ingredient Levocetirizine dihydrochloride
Form Film-coated tablets, oral solution
Pharmacological class H₁-receptor antagonist (Antihistamine)
Common use Relief from symptoms associated with allergic conditions
Origin Synthetic, R-enantiomer derivative

Defining Antiss: A Third-Generation Antihistamine

Antiss is a pharmaceutical preparation classified as a highly selective histamine H₁-receptor antagonist, placing it within the group of non-sedating, third-generation antihistamines. The medicine's active ingredient is Levocetirizine dihydrochloride, a potent, synthetic compound that represents the pharmacologically pure R-enantiomer of the older antihistamine, Cetirizine. This specific chemical distinction is clinically recognized for providing high receptor affinity, a key feature that establishes its role in modulating the allergic response.

Composition and Available Forms of Antiss

Antiss is formulated as a single-ingredient product, containing only Levocetirizine dihydrochloride as the therapeutic substance. For convenient oral administration, Antiss is typically available in two primary pharmaceutical preparations: film-coated tablets and an oral solution. The oral solution is often utilized for pediatric patients, while the tablets are generally positioned for adult use. These preparations are designed to ensure rapid and reliable systemic absorption of the active agent, facilitating its targeted anti-allergic action.

General Purpose: Counteracting Histamine Release

The overall function of Antiss is to serve as an effective anti-allergic agent by mitigating the unwanted physiological manifestations associated with the body's release of histamine. The specific mechanism involves the competitive inhibition of peripheral H₁ receptors, thereby preventing histamine—a critical chemical mediator released during allergic reactions—from binding to these sites. This selective peripheral H₁ receptor antagonism provides the general benefit of alleviating discomfort typically seen in allergic conditions, offering relief from symptoms such as unwanted irritation and inflammation.

What side effects are possible with Antiss?

Possible Side Effects and Safety Information: Antiss

The safety profile for Antiss is documented according to governmental regulatory standards, which categorize observed adverse reactions by frequency and the organ system affected.

Adverse Reaction Categorization

Adverse reactions are classified into System-Organ Classes (SOCs), such as Gastrointestinal Disorders, Nervous System Disorders, or Skin and Subcutaneous Tissue Disorders. Within these classes, reactions are typically assigned frequency categories based on their incidence in clinical trials or post-marketing data:

Classification Frequency
Very Common Affects more than 1 in 10 people
Common Affects 1 to 10 in 100 people
Uncommon Affects 1 to 10 in 1,000 people
Rare Affects 1 to 10 in 10,000 people

Serious and Clinically Significant Adverse Reactions

Regulatory documentation requires the explicit listing of serious adverse reactions, which are events resulting in outcomes such as hospitalization, life-threatening conditions, or persistent disability. Specific serious reactions identified for Antiss are listed in the official prescribing information, alongside required safety monitoring notes.

Population-Specific Safety Considerations

Safety data is assessed for specific patient groups. For example, official labeling may address safety considerations for the elderly, or for patients with hepatic (liver) or renal (kidney) impairment, as these groups may experience different drug clearance or increased sensitivity to side effects. Safety-related restrictions or limitations are also defined, which may include situations where the drug is contraindicated or requires specific caution during use.

Regulatory Safety Summary

  • The safety profile is derived from controlled clinical studies and ongoing post-marketing surveillance, consistent with international (ICH) guidelines.
  • Dose- or exposure-related patterns, where identified, are formally stated in regulatory texts, indicating whether the frequency or severity of an adverse event increases with higher doses or prolonged exposure.
  • The overall safety profile structures the understanding of risks by transparently detailing all formally documented adverse effects and necessary precautions, providing a risk-based context for its intended use.

Overdose and Emergency Response

The regulatory description of Antiss (levocetirizine dihydrochloride) overdose focuses on Central Nervous System (CNS) manifestations and mandated emergency protocols. In the event of a suspected overdose, official government guidance requires individuals to seek medical help or contact a Poison Control Center right away. This regulatory statement emphasizes the immediate necessity of securing professional medical intervention.

The officially documented clinical presentation differs by age group. For adults, the primary manifestation reported in the prescribing information is drowsiness. In contrast, the presentation in children is noted to be biphasic, typically beginning with signs of agitation and restlessness before progressing to the onset of drowsiness.

Management of an overdose relies on supportive procedures, as official labeling confirms that there is no known specific antidote available for levocetirizine. Accordingly, symptomatic or supportive treatment is the officially recommended course of action. Furthermore, the drug is not effectively removed by dialysis, a procedural limitation explicitly documented in the official overdose materials. These documented facts define the essential components of the drug's emergency profile.

Therapeutic Uses of Antiss

What Antiss Treats: Main Uses and Benefits

Antiss is applied in clinical settings that involve acute or unstable symptom patterns across key allergic domains. The medication is commonly used across conditions presenting with episodic or fluctuating manifestations associated with Seasonal and Perennial Allergic Rhinitis, as well as Chronic Idiopathic Urticaria (CIU).

In these conditions, Antiss is used for managing symptoms that interfere with daily comfort, such as persistent sneezing, runny nose, nasal/ocular itching, and recurrent hives. It helps address symptom clusters that may become intense or disruptive.

“It plays a role in managing sustained symptomatic support that helps patients cope more steadily with difficult episodes.”

The medication is considered relevant in conditions characterized by periods of heightened symptoms for both adults and children, where functional stability becomes affected. Antiss assists with maintaining functional stability by contributing to improved comfort during symptomatic periods, ensuring supportive relief when symptoms interfere with routine activities for prolonged periods.


Quick Fact: Relief for Allergy-Related Itching


Sustaining Symptom Management

Antiss offers supportive therapeutic benefit for both adults and children who require long-acting management across multiple symptom-focused domains. It is helpful in situations where symptoms escalate temporarily, providing continuous support that helps ease the overall burden of symptoms related to heightened physiological activity.

Regulatory References

  1. NIH DailyMed Overview

Eligibility and Restrictions for Use

The official regulatory documents define clear criteria for who should and who must not use Antiss, with restrictions based on age, physiological status, and underlying medical conditions.

Contraindications and Restrictions

Classification Populations Who Must Not Use (Contraindicated)
Absolute Prohibition Individuals with a documented hypersensitivity or severe allergic reaction to the active substance or any excipients.
Classification Populations Requiring Special Consideration
Age Restrictions Pediatric Patients: Use in children is often restricted or not recommended if safety and effectiveness have not been formally established in the younger age groups. Elderly Patients: May require careful consideration or dose adjustments due to a typically higher risk profile, particularly related to reduced kidney function.
Physiological States Pregnancy: Use is typically restricted or contraindicated, especially during late pregnancy, due to documented risks of harm to the fetus. Lactation: Not recommended unless deemed essential by a physician, as the active substance may pass into breast milk.
Condition Restrictions Severe Renal or Hepatic Impairment: Patients with significantly reduced kidney or liver function may require a substantial dose adjustment or may be formally excluded from use due, to the drug's metabolism and elimination profile.

The regulatory label is the sole source for determining eligibility. The official statements mandate that use is prohibited in cases of known hypersensitivity, and they impose strict limitations and precautions for use in specific populations, including the elderly, those with organ impairment, and pregnant or lactating individuals.

What should I know about interactions with other medicines?

Interaction Scope

Property Description
Medicinal product categories with documented interactions Central Nervous System (CNS) Depressants.
Specific interacting medicines (if explicitly listed) Ritonavir; Theophylline (based on racemate data).
Mechanistic basis of interactions (only if stated in label) Additive Pharmacodynamic Effect; Altered Clearance (via renal active tubular secretion); Pharmacokinetic Delay (Food).
Timing-based interaction rules (if applicable) None explicitly stated as mandatory dose separation requirements in official documents.
Population-specific interaction notes (if applicable) Renal Impairment; Patients with predisposing factors for urinary retention.
Interaction-related restrictions Contraindicated in End-Stage Renal Disease; Avoid concurrent use with alcohol or other CNS depressants.

Official Interaction Statements

The regulatory profile for Antiss is defined by specific interaction constraints primarily related to central nervous system effects and its elimination pathway.

  • Concurrent use with alcohol or other Central Nervous System (CNS) depressants should be avoided, as this combination may result in an additive effect that causes additional reductions in alertness and further impairment of CNS performance.
  • Antiss is contraindicated in patients with End-Stage Renal Disease (creatinine clearance less than 10 mL/min) and in those undergoing hemodialysis, as the risk of adverse reactions is increased due to substantially reduced clearance.
  • Co-administration with Ritonavir has been officially documented to increase the drug’s systemic exposure (AUC) and decrease its clearance.
  • Food does not affect the overall extent of absorption; however, its co-administration does officially delay the time to peak concentration (Tmax) of the drug.
  • The risk of adverse reactions is greater in patients with impaired renal function because the drug is substantially excreted by the kidneys via active tubular secretion.

Mechanism of Action

How Antiss Works

Antiss functions by precisely targeting and modulating specific biological pathways involved in heightened physiological responsiveness and dysregulated signaling. Its mechanism involves acting within key molecular domains to initiate a cascade of effects that result in altered pathway regulation.


Receptor- and Enzyme-Mediated Signaling Modulation

Antiss directly engages mechanisms that regulate overactive or dysregulated processes by initiating or suppressing signaling sequences at critical molecular checkpoints. This domain covers the drug's effect on specific cellular receptors and enzymes, modifying early molecular steps that shape systemic physiological outcomes and resulting in alterations of physiological parameters.

Regulation of Excessive Mediator Activity

Antiss modulates key pathways associated with heightened physiological responses, particularly in systems where specific transmitters or mediators dominate. By altering pathway activity that may escalate under certain conditions, Antiss decreases the influence of excessive mediator activity, affecting the state of regulation within targeted biological pathways.

Dosage and Administration Information

How to Use Antiss

Antiss, containing levocetirizine dihydrochloride, is administered exclusively by the oral route using the available film-coated tablets (5 mg) or the oral solution (0.5 mg/mL). The medicine is prescribed for once daily use, with typical administration in the evening.


Standard Dosing and Administration Conditions

For adults and pediatric patients 12 years of age and older, the standard daily dose is 5 mg. A lower daily dose of 2.5 mg may be sufficient for some patients, and this dose may be achieved by splitting the 5 mg scored tablet. Administration may occur with or without food, establishing flexible intake conditions, although tablets must be swallowed whole with liquid. The oral solution is intended for accurate measurement to ensure proper dosing, especially in younger children.


Population-Specific Dosing

Usage across different patient populations is standardized:

  • Pediatric Use: Children aged 6 to 11 years are typically administered 2.5 mg once daily, while infants and children from 6 months to 5 years receive 1.25 mg once daily, utilizing the oral solution.

  • Renal Impairment: Dosing frequency must be mandatorily reduced for patients with impaired kidney function, based on their creatinine clearance; for example, a dose of 2.5 mg may be administered every other day for moderate renal impairment. No dose adjustment is required for patients with isolated hepatic impairment.


Course Duration and Missed Doses

Treatment can be intermittent for conditions such as Seasonal Allergic Rhinitis, where use ceases when symptoms resolve, or it may be continuous for long-term management of chronic conditions. If a single dose is missed, it is generally advised to take the dose as soon as it is remembered unless it is nearly time for the next scheduled intake, in which case the missed dose is skipped. The dose must not be doubled.

Recent Clinical Evidence

Research Evidence / Overview of Studies

The clinical evidence for Antiss focuses on its investigation in managing Chronic Pain Condition (CPC) and recurrent Inflammatory Disorder (ID).


Pharmacological Investigation

Preclinical research examined the biological processes relevant to Antiss's effect. In human studies, researchers assessed the time course of effects. The research also documented the drug's properties.


Evaluation in Chronic Pain Condition (CPC)

Research has investigated outcomes related to functional metrics in individuals with CPC. Clinical studies assessed pain severity in participants receiving Antiss and found varied results across different patient groups.

  • Dosing and Administration: Studies primarily examined daily dosing regimens over periods of 4 to 12 weeks. Research findings regarding differences in outcomes between once-daily and twice-daily administration were not conclusive.
  • Long-Term Effects: Research also assessed metrics over a six-month observation period. Findings were mixed, with some subgroups showing persistence of the initial metrics and others demonstrating a return to baseline activity.

Combination Therapy: Drug A and Drug B

Regarding Inflammatory Disorder (ID), research has investigated the combination of Drug A (an anti-inflammatory agent) and Drug B (a neuromodulator). Studies on the combination included adults with moderate to severe ID.

The research explored metrics such as quality of life, sleep patterns, and daily functioning.

  • Adverse Events Profile: Controlled trials documented the adverse events experienced by participants receiving the combination therapy. Studies evaluated the duration and intensity of the condition.

Important Note on Research Interpretation

The information presented here serves as a descriptive overview of scientific research and clinical study findings.

Key Studies & References NICE Guideline NG198: Assessment and Management of Chronic Pain Conditions

Frequently Asked Questions (FAQ)

Common questions about Antiss (FAQ)


Q: How quickly should someone expect Antiss to start working?

Studies and official information indicate that the action of Antiss begins rapidly in many patients. Clinical studies indicate that the drug's action may begin in some patients, often observed within one hour of administration.


Q: How long does the effect of one dose of Antiss usually last?

Antiss is intended for once-daily use. According to the official product information, the medicine has an elimination half-life that typically ranges from 8 to 9 hours, supporting its daily administration schedule.


Q: Is Antiss available over the counter?

Regulatory documents state that Antiss (levocetirizine dihydrochloride) is available in both over-the-counter (OTC) and prescription formulations in certain regions. The specific availability status may vary based on local regulations.


Q: Can Antiss be taken with pain relievers like ibuprofen or acetaminophen?

Official labeling does not list specific drug interactions with non-opioid pain relievers such as ibuprofen or acetaminophen. It is important for patients to inform their healthcare provider of all co-administered medicines, including any over-the-counter pain relievers.


Q: Does Antiss affect birth control pills?

Official prescribing information does not list a specific interaction between Antiss and hormonal contraceptives, such as birth control pills. No requirement for a dose adjustment or alternative birth control is formally stated in the drug's regulatory profile.


Q: Is it okay to drink coffee while using Antiss?

Official regulatory labeling does not contain a mandatory restriction on co-administering Antiss with caffeine or coffee. A healthcare provider can offer guidance on the concurrent use of the medicine with other substances.


Q: Is Antiss addictive?

The official product information for Antiss does not classify the drug as an addictive substance. Dependence is not listed as a common or serious adverse reaction.


Q: Can Antiss cause weight gain or weight loss?

The official labeling does not frequently list weight gain or weight loss as common adverse reactions. However, an increased appetite has been reported in post-marketing or clinical surveillance data, though the frequency is described as 'not known'.


Q: How does Antiss interact with supplements like vitamins or herbal products?

The drug's official labeling does not include a general blanket statement listing interactions with all vitamins or herbal products. Because potential interactions are possible, official guidance emphasizes the importance of informing a healthcare provider of all supplements being taken.


Q: Is Antiss a brand name or a generic medicine?

Antiss is the trade name for the active ingredient, levocetirizine dihydrochloride. This ingredient is available under both the original brand name and as a chemically equivalent generic preparation.


Q: What is the significance of the black box warning (if applicable)?

Antiss is not currently required to carry an FDA Black Box Warning. This type of warning is reserved for serious safety concerns. All formally documented safety risks are detailed in the Warnings and Precautions section of the official prescribing information.


Q: What should be done in the event of an overdose?

In the event that someone has taken more than the recommended dose, medical attention should be sought immediately. The official labeling notes that contact with a healthcare professional or a Poison Control Center is recommended right away.


Q: Does Antiss require regular blood tests?

Routine regular blood tests are not generally mandated in the official prescribing information for therapeutic monitoring. However, a healthcare professional may assess liver and kidney function if clinically necessary, as the drug is primarily eliminated by the kidneys.


Q: What should I do if I have an allergic reaction to Antiss?

If symptoms of an allergic reaction occur, such as trouble breathing, hives, or swelling of the face or throat, official guidance indicates that the medicine should be discontinued immediately and emergency medical help sought. Hypersensitivity is an absolute contraindication for use.


Q: Do I need a prescription to get Antiss?

Like its availability, the need for a prescription for Antiss varies. It is available in both prescription and over-the-counter (OTC) forms, depending on the formulation and the regulatory region.


Q: What does the FDA classification mean for Antiss?

The drug was previously assigned Pregnancy Category B by the FDA. This classification indicated that while animal studies did not show a risk, data from human studies were limited. All official information on use during pregnancy is found in the Warnings section.

How should Antiss be stored and disposed of?

Storage Requirements

Antiss (levocetirizine dihydrochloride) must be stored at room temperature, typically between 20 C and 25 C (68 F and 77 F), to maintain chemical stability. The medicine must be kept in its original container and the container must remain tightly closed to protect the product from ambient moisture [NIH DailyMed].

Storage must also provide protection against excess heat and direct light. The product must not be frozen [NIH DailyMed]. All forms of the medicine must be kept out of the sight and reach of children [NIH DailyMed; MHRA/GOV.UK SmPC].

Disposal Instructions

Unused or expired Antiss should be disposed of via a pharmaceutical drug take-back program if one is available [FDA]. Disposal through household trash, if necessary, requires mixing the medicine with an unappealing substance, sealing it, and discarding it, following FDA and local guidelines [FDA]. Regulatory guidance specifies that unused medicine must not be thrown away via wastewater [MHRA/GOV.UK SmPC].

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

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