Histisynt

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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 Histisynt

Histisynt is a pharmaceutical preparation intended for oral administration whose purpose is to provide relief from the physical manifestations of allergic hypersensitivity. Its identity is defined by its active ingredient, its pharmacological class, and its specific molecular structure as a synthetic compound. The drug is designed to act systemically throughout the body following ingestion.


Property Description
Active ingredient Levocetirizine Dihydrochloride
Form Oral Tablet, Oral Solution
Pharmacological class Second-generation Antihistamine
Common purpose Relief from allergic reactions
Origin Synthetic Compound (R-enantiomer)

Classification and Core Composition: What Type of Medicine is Histisynt?

Histisynt is classified as a second-generation antihistamine that falls within the broader pharmacological group of H1-receptor antagonists. The preparation contains Levocetirizine Dihydrochloride as its sole active component, making it a single-ingredient product. Levocetirizine is chemically derived from the parent compound Cetirizine, specifically representing the R-enantiomer—the stereochemically active molecule responsible for the therapeutic effect. This selective synthesis defines its origin as a modern synthetic compound, which possesses a targeted molecular profile and high specificity for peripheral H1-receptors, distinguishing it from older, less selective antihistamines.


Available Forms and General Purpose

Histisynt is commercially prepared as an Oral Tablet and an Oral Solution, facilitating systemic delivery of the active substance through the digestive tract. The general purpose of this medicine is fundamentally linked to its core action: providing Histamine blockade. As a selective H1-receptor antagonist, Levocetirizine helps to interrupt the biological signaling cascade that the body's natural chemical, Histamine, initiates during an allergic reaction. Levocetirizine is widely clinically recognized for antagonizing the effects of Histamine. This mechanism serves to mitigate the underlying chemical process responsible for discomfort, representing its core benefit in scenarios typical of seasonal allergies.

Regulatory References

  1. MedlinePlus

What side effects are possible with Histisynt?

Histisynt (Levocetirizine Dihydrochloride) is associated with adverse reactions that are classified by frequency and by the body system affected, based on official regulatory documents.

Frequency-Classified Adverse Reactions

The most commonly reported effects, classified as Common (affecting 1 to 10 users in 100), include somnolence, fatigue, headache, and dry mouth. Effects classified as Uncommon (affecting 1 to 10 users in 1,000) include asthenia (loss of strength) and abdominal pain. Rare reactions (affecting 1 to 10 users in 10,000) include tachycardia (increased heart rate) and hypersensitivity reactions.

Adverse reactions where the frequency is Not Known (reported in post-marketing surveillance) include aggression, suicidal ideation, convulsion, and visual disturbances.

Serious Adverse Reactions and Safety Constraints

Official labels document serious adverse reactions, including anaphylaxis and angioedema, which are forms of severe hypersensitivity. Urinary retention has also been reported, particularly in patients with predisposing factors. The medicine is formally contraindicated in individuals with a known hypersensitivity to any of its components or those with end-stage renal disease.

Population-Specific Safety Notes

The medicine is contraindicated for children under six months of age. Dose adjustments are required for patients with renal impairment due to the drug’s clearance via the kidneys, and caution is advised for older adults due to the greater likelihood of reduced organ function.

Duration-Related Safety Patterns

Official safety communication notes that severe, generalized pruritus (itching) has been reported in some patients following the discontinuation of the medicine, particularly after long-term use.

Overdose and Emergency Response

Overdose and when to seek help

In the event of an ingestion exceeding the recommended dose of Histisynt, government regulatory guidance mandates that individuals seek immediate emergency medical attention. Contacting a poison control center is also officially required. Immediate medical assistance is necessary if the victim experiences severe outcomes such as convulsion, loss of consciousness, or difficulty breathing, or if they cannot be awakened.

The officially documented clinical presentation of an overdose varies by age. In adults, the primary manifestation is typically characterized by drowsiness and somnolence. In children, the pattern is distinct, beginning with agitation and restlessness, which is then followed by a state of drowsiness.

Management focuses entirely on supportive measures, as there is no known specific antidote for the active component, Levocetirizine Dihydrochloride. Due to this constraint, regulatory documents recommend symptomatic and supportive treatment. Procedures such as gastric lavage or the administration of activated charcoal may be considered in the clinical setting following a recent, short-term ingestion. Furthermore, the official profile notes that patients with predisposing factors for urinary retention require careful monitoring. Elderly patients and individuals with renal impairment are documented to be at increased risk of toxicity due to altered clearance of the drug.

Therapeutic Uses of Histisynt

Quick Facts About Histisynt

  • Targeted Use: Seasonal and perennial allergic rhinitis.
  • Symptom Support: May help alleviate sneezing, runny nose, and itchy, watery eyes.
  • Skin Applications: Used for management of the symptoms of chronic hives (chronic idiopathic urticaria).

What Histisynt Treats: Main Uses and Benefits

Histisynt is a medication approved to support the management of certain allergic conditions. Its primary role is to address symptoms stemming from seasonal allergic rhinitis (commonly known as hay fever) and perennial allergic rhinitis, which occurs year-round.

Patients may find that Histisynt helps reduce the severity of classic allergy symptoms, which include sneezing, an itchy or runny nose, and itching or watering of the eyes. This action contributes to improved support for daily comfort during periods of allergen exposure.

Furthermore, the medication is used for the symptomatic relief of uncomplicated skin manifestations of chronic idiopathic urticaria (long-term hives with no known cause). In this context, Histisynt provides support for alleviating the associated itching and appearance of hives. These represent the established indications for this therapy.

All individuals should consult their healthcare provider to discuss whether this medication is an appropriate component of their treatment strategy.

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Histisynt — official regulatory information

Category Eligibility Entity (Based on Regulatory Labeling)
Populations for whom use is allowed Individuals 6 months of age and older (for oral solution)
Populations for whom use is contraindicated Patients with a known hypersensitivity to levocetirizine, cetirizine, or hydroxyzine.
Populations for whom use is contraindicated Patients with End-Stage Renal Disease (creatinine clearance < 10 mL/min).
Populations for whom use is contraindicated Children mathbf6 months to 11 years of age with impaired renal function (any degree).

Age-Related Eligibility Rules

Use is not established in infants younger than 6 months of age. Use in older adults (65 years and older) is permitted, but the official label recommends caution due to the higher likelihood of decreased renal function.

Condition-Specific Eligibility Rules

For adults and adolescents (12 years and older) with mild to severe renal impairment, use is restricted and requires a modified frequency based on the severity of reduced kidney function. No dose adjustment is required for patients with solely hepatic (liver) impairment. Furthermore, caution is advised for patients with predisposing factors for urinary retention, such as prostatic hyperplasia or spinal cord lesions.

Pregnancy and Lactation Eligibility Status

Use during pregnancy is recommended only if clearly needed due to a lack of adequate human studies. The medicine is generally not recommended for use while breastfeeding, as it is expected to be excreted in human milk.

Connection to the Overall Eligibility Profile

Regulatory documents define who can and cannot use the medicine by establishing absolute non-use for populations with severe kidney disease or hypersensitivity, and setting age limits. Use is conditional for those with less severe renal impairment or other conditions that require special caution.

What should I know about interactions with other medicines?

Histisynt (levocetirizine) can interact with certain other medicines, herbal remedies, and substances, which may alter its effectiveness or increase the risk of side effects, particularly increased drowsiness.

Medicines that Increase Sedation

Combining Histisynt with other medicines that cause central nervous system (CNS) depression can significantly worsen side effects such as sleepiness, dizziness, poor concentration, and impaired judgment. These interactions should generally be avoided unless specifically directed by a healthcare professional.

Category of Interacting Medicine Examples of Use/Type
Other Antihistamines Allergy, cough, and cold preparations
Sedatives/Tranquilizers Sleep aids, medicines for anxiety
Opioid Pain Relievers Prescription pain or cough medicines
Certain Antidepressants Tricyclic antidepressants, MAO inhibitors

Other Potential Interactions

  • Ritonavir: This medicine, often used for HIV treatment, can increase the concentration of Histisynt in the blood.
  • Theophylline: A medicine used for asthma or breathing problems may affect the elimination of Histisynt, though this interaction is typically minor.
  • Anticholinergic Medicines: Medicines that treat conditions like overactive bladder or Parkinson's disease may worsen anticholinergic effects like dry mouth and urinary retention when combined with Histisynt.

Substances and Products

  • Alcohol: Avoid consuming alcohol while taking Histisynt as it can increase CNS side effects like drowsiness and dizziness.
  • Grapefruit Juice: While Histisynt is generally not affected by food, other antihistamines may interact with grapefruit or other fruit juices, so patients should adhere to their product's specific guidance.

Always inform your doctor or pharmacist of all over-the-counter and prescription medicines, vitamins, minerals, and herbal products you are taking before starting treatment with Histisynt.

Mechanism of Action

Histisynt's activity is defined by its specific action at the molecular level, modulating pathways associated with heightened signaling cascades. It functions through three principal mechanistic domains to define its pharmacodynamic consequences.

The primary mechanism is H1 Receptor Inverse Agonism, where the drug interacts with the peripheral Histamine H1 receptor ( H1 R). By acting as an inverse agonist, the drug stabilizes the receptor in an inactive state, effectively suppressing the signaling cascade normally initiated by endogenous histamine.

This action leads to Vascular and Endothelial Pathway Stabilization. The blockade of the H1 R on endothelial cells interrupts the histamine-driven signaling that controls fluid movement, influencing microvascular integrity and resulting in a reduction of histamine-mediated fluid extravasation from blood vessels into surrounding tissues.

A secondary influence involves the Modulation of Inflammatory Cell Recruitment. Beyond direct receptor effects, the drug engages mechanisms that influence the inflammatory process at the cellular level, including reducing the chemotaxis of key immune cells like eosinophils and modulating the expression of adhesion molecules (like ICAM-1). This defines a wider range of influence on inflammatory cell activity.

Dosage and Administration Information

How to Use Histisynt: Official Administration Guidelines

Histisynt (Levocetirizine Dihydrochloride) is administered exclusively through the oral route for systemic absorption. The medication is available as a 5 mg Oral Tablet and an Oral Solution. The standard adult dose for patients 12 years and older is 5 mg taken once daily, preferably in the evening. The medication is typically taken in the evening for single daily dosing.

The tablet can be taken with or without food. Since the 5 mg tablet is often scored, it can be broken to administer a 2.5 mg dose, which may be sufficient for some individuals. The oral solution is available as an alternative form when a liquid is preferred. Patients should not exceed the 5 mg maximum daily dose for this age group.

Usage Duration and Special Conditions

The duration of use is structured based on the pattern of symptoms. For symptoms that are short-lived (less than four days a week or four weeks in total), an intermittent use approach allows treatment to be stopped when symptoms subside. For persistent, long-term conditions, continuous use may be appropriate for treatment periods up to six months. Dosing requires mandatory adjustment in patients with renal impairment, as the dose must be reduced according to the patient’s kidney function (creatinine clearance). Conversely, no dosage adjustment is necessary for patients with isolated hepatic (liver) impairment.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Histisynt

Evidence for Use in Seasonal and Perennial Allergic Rhinitis

The primary clinical research for hay fever and year-round allergies (SAR/PAR) relies heavily on Randomized Controlled Trials (RCTs) compared to a placebo. Researchers used standardized tools like the Total 5 Symptoms Score (T5SS) and the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) to measure outcomes related to physical discomfort and daily functioning. Studies monitored how symptoms evolved in the observed populations; however, findings were mixed in some regulatory submissions, indicating that evidence quality varies and results apply only to the specific populations studied.

Evidence for Use in Chronic Hives (Chronic Idiopathic Urticaria)

Research for conditions presenting with cycles of stability and flare-ups, such as Chronic Idiopathic Urticaria (CIU), was evaluated in primary research, often consisting of RCTs. These trials examined outcomes linked to inflammatory states, including patient-reported discomfort from itching (pruritus) and physical changes like the number and size of wheals (hives). Research reports changes measured during the study period over short-term intervals, typically four to six weeks.

Long-Term Research and Durability of Effect

The majority of pivotal regulatory research explores short-term symptom changes (two to six weeks). Follow-up durations were limited in the primary body of evidence. Data for long-term outcomes are still emerging, and evidence is limited for how symptom patterns evolve over periods significantly longer than six months. Long-term effects are not fully established, and research is ongoing.

Research in Special Populations

Research has explored the use of Histisynt in specific patient groups beyond the general adult population, including various pediatric age groups for both rhinitis and chronic hives. However, data for certain subgroups remain insufficient, and follow-up durations were limited in these analyses. The research does not determine whether an individual in a special population can expect to respond similarly to the group patterns observed.

Areas of Research Uncertainty and Gaps

The current evidence highlights what is still uncertain. One key limitation is that comprehensive comparative evidence is lacking for some comparisons against other second-generation antihistamines. Furthermore, limited information exists for long-term outcomes beyond the typical six-month maximum follow-up documented in key trials. Data for those whose symptoms remain challenging to measure also remain insufficient in the published literature.

Key Studies & References LEVOCETIRIZINE DIHYDROCHLORIDE tablet (FDA Label/Monograph detailing indications, dosage, and adverse reactions)

Frequently Asked Questions (FAQ)

Common questions about Histisynt (FAQ)

Q: What is the difference between Histisynt and older treatments for the same condition?

A: Histisynt is classified as a second-generation antihistamine. Official documents indicate that this newer class differs from older generations by crossing the blood-brain barrier less, which is associated with a lower potential for sedation.


Q: Are there any foods or supplements that should be avoided when taking Histisynt?

A: Histisynt can be taken with or without food, as regulatory information indicates that food does not significantly affect the medicine's absorption. However, official product information recommends avoiding the concurrent use of alcohol because it can increase central nervous system (CNS) effects, such as drowsiness.


Q: What is the longest period of time people have stayed on Histisynt in clinical studies?

A: Clinical experience has supported continuous treatment for up to six months for persistent conditions like chronic hives. Official research evidence is currently limited for how symptom patterns evolve over periods significantly longer than six months.


Q: What are the signs of a serious allergic reaction to Histisynt?

A: Serious allergic reactions, including anaphylaxis and angioedema, have been reported in official labels. Signs can include hives, difficulty breathing, or severe swelling of the lips, tongue, face, or throat. These situations are described in official documents as requiring immediate medical evaluation.


Q: Are there any known side effects related to eye health with Histisynt?

A: Post-marketing safety surveillance has included reports of adverse reactions related to eye health, specifically visual disturbances and blurred vision. The frequency of these effects is not known based on official data.


Q: How does the body process and eliminate Histisynt?

A: Following ingestion, Histisynt is quickly absorbed into the body. Official pharmacokinetic information indicates that the drug is minimally metabolized, and the major route of excretion for the medicine is via the urine.


Q: Can Histisynt cure the condition, or does it just manage symptoms?

A: Histisynt is indicated for the relief of symptoms associated with allergic rhinitis and chronic hives. The official purpose is to mitigate the physical manifestations of hypersensitivity rather than providing a cure for the underlying condition.


Q: How quickly does Histisynt start to work after the first use?

A: Regulatory documents state that Histisynt is rapidly absorbed. Peak concentrations of the active ingredient in the bloodstream are typically reached in less than one hour for the oral solution and slightly less than one hour for the oral tablet.


Q: Can Histisynt affect my ability to drive or operate machinery?

A: Official warnings advise caution. Due to the potential for somnolence (drowsiness), fatigue, and impaired concentration, official warnings state that activities such as driving or operating hazardous machinery should be avoided until the patient knows how the medicine affects them.


Q: Why did some patients in the trials stop taking Histisynt?

A: In clinical trials, the rate of patients discontinuing the drug due to adverse events was generally low. The most common reasons cited for stopping were adverse reactions such as somnolence and fatigue.


Q: What is the average time it takes to see the full benefit from Histisynt?

A: Official pharmacokinetic data indicate the drug accumulates to a stable concentration, or steady state, in the body after approximately two days of daily oral use. This steady state generally aligns with the period when a consistent therapeutic effect can be expected.


Q: Does Histisynt build up in the body over time?

A: Yes, the drug's regulatory profile notes that a slight accumulation of the medicine occurs with daily use. Steady state concentrations are typically achieved after approximately two days of daily dosing.


Q: Does Histisynt interact with birth control pills?

A: Interaction studies have been performed with various other medicines, and they have generally demonstrated no clinically relevant adverse interactions. The official product information does not specifically note any interaction with oral contraceptives.


Q: Can Histisynt affect the results of lab tests?

A: Official warnings state that antihistamines may inhibit the response to allergy skin tests. Official guidance often recommends a washout period before these tests to prevent the antihistamine from inhibiting results.


Q: Why do some people experience initial nausea with Histisynt?

A: Nausea has been reported as an adverse reaction observed in post-marketing surveillance after the drug became commercially available. While not classified as a common effect in trials, it has been reported by users.


Q: What if I accidentally miss a dose of Histisynt?

A: Official administration guidance suggests that if a dose is missed, the dose should be taken as soon as it is remembered. However, if it is almost time for the next scheduled dose, the guidance is to skip the missed dose and continue with the regular schedule. The advice is to avoid taking a double dose.

How should Histisynt be stored and disposed of?

Histisynt requires specific environmental and handling conditions defined in regulatory documents to maintain its quality and stability.

Official Storage Requirements

Histisynt Tablets must be stored at 20° to 25°C (68° to 77°F), which is known as USP Controlled Room Temperature. The medication must be kept from freezing and protected from excess heat and moisture. It is required to keep the product in its original container, which must be tightly closed.

Stability and Child Safety

For the Oral Solution, the product must be discarded if it is used for more than 3 months after the initial opening. All forms of the medicine must be stored out of the sight and reach of children.

Disposal Instructions

Expired or unused Histisynt should not be disposed of in household waste or via wastewater. Official guidance directs consumers to utilize drug take-back programs or consult a pharmacist for proper disposal methods.

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

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