Histax

Quick links to important sections

Medically reviewed

Laura Arias

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Histax

What is Histax?

Histax is a pharmacological treatment classified as an antihistamine. It is primarily used to manage symptoms associated with allergic reactions and certain upper respiratory conditions. The active mechanism involves the modulation of histamine receptors in the body, which helps to reduce the physiological response to allergens.

How It Works

When the body encounters an allergen, such as pollen, dust, or pet dander, the immune system releases a chemical called histamine. Histamine attaches to receptors on cells, causing common allergy symptoms like sneezing, itching, and watery eyes. Histax works by blocking these receptors, preventing histamine from exerting its effects on the body's tissues.

Primary Uses

This medication is typically utilized for the relief of symptoms related to various allergic conditions, including:

  • Allergic Rhinitis: Inflammation of the nasal passages that causes sneezing, congestion, and an itchy or runny nose.
  • Urticaria: Commonly known as hives, characterized by itchy, raised welts on the skin.
  • Allergic Conjunctivitis: Redness, itching, and swelling of the eyes due to allergen exposure.

Characteristics

Histax is designed to provide systemic relief from allergic symptoms. Depending on the specific formulation, it may be categorized as either a first-generation or second-generation antihistamine, which determines its duration of action and the likelihood of associated effects such as drowsiness. It is intended to help individuals manage chronic or seasonal allergies by stabilizing the body's response to environmental triggers.

Regulatory References

  1. NIH Cetirizine LiverTox Entry

What side effects are possible with Histax?

Possible Side Effects and Safety Information

The safety profile of Histax (Cetirizine Hydrochloride) is officially documented by government regulatory bodies like the FDA and EMA, which classify adverse reactions by their likelihood and affected body system. These classifications help define the expected risk profile.


Frequency-Classified Adverse Reactions

The most common adverse reactions, as classified in regulatory documents (occurring in ge 1/100 to < 1/10 of patients), typically include somnolence (drowsiness), headache, fatigue, and dry mouth. Uncommon (ge 1/1,000 to < 1/100) effects include agitation, paresthesia, diarrhea, pruritus, and rash. Effects are grouped by system-organ class, such as Nervous System Disorders (dizziness) and Gastrointestinal Disorders (nausea).

Serious Safety Considerations

Rare (ge 1/10,000 to < 1/1,000) and very rare (< 1/10,000) adverse events are also explicitly documented. These serious adverse reactions include anaphylactic shock (a severe allergic reaction), convulsions, hepatic function abnormality (elevated liver enzymes), and movement disorders. These classifications serve to define the full spectrum of possible risks observed in clinical use.

Population-Specific Notes and Restrictions

Official labeling defines specific safety constraints. Histax is contraindicated in individuals with a known hypersensitivity to the active substance or its related derivatives, and in patients with severe renal impairment (end-stage kidney disease). Regulatory documents also specify that caution and potential dose adjustment are required for older adults and individuals with hepatic impairment, as drug clearance may be reduced in these populations. Time-related patterns are noted, such as somnolence potentially being more prominent at the start of treatment, and the occasional occurrence of pruritus or urticaria upon discontinuation of the medicine.

Overdose and Emergency Response

Histax Overdose and when to seek help

Feature Official Regulatory Statements
Documented Manifestations Clinical signs reported in overdose primarily involve CNS and systemic effects. These include somnolence (drowsiness), confusion, dizziness, diarrhea, malaise, and headache. Systemic effects can include tachycardia (fast heart rate), tremor, and difficulty with urination (urinary retention).
Severe Outcomes Documented severe neurological manifestations reported in overdose cases include convulsions and syncope (fainting).
Population Notes The drug’s elimination half-life is prolonged and total body clearance is reduced in geriatric subjects and in patients with renal impairment, potentially increasing exposure risk during overdose.
Emergency Action Required The regulatory guidance strictly mandates: Get medical help or contact a Poison Control Center right away.

Management and Official Context

The official overdose protocol confirms that there is no known specific antidote to cetirizine. Treatment is therefore focused on administering symptomatic or supportive care. In accordance with regulatory guidelines, a healthcare professional may consider gastric lavage shortly after ingestion to aid in decontamination. The documentation also states that the medicine is not effectively removed by dialysis. These official statements define the need for urgent medical support, as management relies entirely on life-support measures and observation.

Therapeutic Uses of Histax

Histax may be part of symptomatic management, supporting the easing of symptom load related to allergic conditions. It is commonly used in contexts involving inflammatory or irritative processes.

The medication is considered relevant in conditions presenting with episodic or fluctuating manifestations, including Seasonal Allergic Rhinitis (hay fever), Perennial Allergic Rhinitis (year-round allergies), Allergic Conjunctivitis (eye irritation), and Chronic Idiopathic Urticaria (hives).

Histax supports managing symptom intensity in situations where symptoms interfere with daily functioning and create noticeable physiological strain. It is applied in addressing symptom clusters related to respiratory distress (sneezing, runny nose), ocular symptoms (itchy, watery eyes), and cutaneous discomfort (pruritus/itching).

Quick Facts

Property Description
Primary Therapeutic Domains Allergic Rhinitis, Urticaria
Symptom Focus Easing itching (pruritus), sneezing, rhinorrhea
Typical Use Context Seasonal flare-ups and chronic management
Patient Benefit Supports general well-being and comfort

Regulatory References

  1. DailyMed (NIH) Drug Labeling

Eligibility and Restrictions for Use

Histax (Cetirizine Hydrochloride) eligibility is strictly defined by regulatory documents based on age, physiological status, and underlying conditions.

Eligibility Scope

Category Official Regulatory Statement
Populations for whom use is allowed Adults and adolescents ge 12 years are eligible. Use is approved for children ge 6 years (tablets/general use), with certain liquid formulations approved for children ge 6 months for specific indications.
Populations for whom use is contraindicated Patients with known hypersensitivity to cetirizine, its parent compound hydroxyzine, or any piperazine derivatives must not use the medicine. It is also contraindicated in patients with severe renal impairment (Creatinine Clearance <10 mL/min).
Age-related eligibility rules The tablet formulation is not recommended for children under 6 years. Older adults with normal kidney function require no initial adjustment, but regulatory labeling advises seeking medical consultation due to potential age-related decline in renal function.
Condition-specific eligibility rules Use is subject to caution in patients with predisposing factors for urinary retention (e.g., prostatic hyperplasia) or those with epilepsy/risk of convulsions. Patients with renal or hepatic impairment may require conditional use.
Pregnancy and lactation eligibility status Use should be avoided during pregnancy unless necessary and after medical consultation. Use is not recommended during breastfeeding as the substance passes into breast milk.

Eligibility Classifications (High-Level)

Category Official Regulatory Wording
Eligibility severity classification Contraindicated (for hypersensitivity/severe renal impairment), Not Recommended (for breastfeeding), Caution (for urinary retention risk).
Regulatory basis Based on Prescribing Information and Summary of Product Characteristics (SmPC).

Resulting Eligibility Structure

Official eligibility statements:

  • Use is absolutely prohibited for patients with a documented hypersensitivity to the drug or severe renal impairment.
  • Adults and children over 6 months are generally eligible, with restrictions based on age, formulation, and indication.
  • The label advises against use in nursing mothers and for pregnant women unless medically necessary.

Connection to the overall eligibility profile (2–4 sentences): The regulatory documents establish strict eligibility requirements, primarily classifying patient populations as allowed, restricted, or contraindicated. Eligibility is defined by assessing age, history of hypersensitivity, renal function, and reproductive status. This structure ensures that use is limited to patient groups for whom official safety and efficacy data is established and acceptable.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section summarizes the officially documented interaction patterns for Histax (Cetirizine Hydrochloride) as stated in government regulatory documents.


Documented Interaction Patterns

Classification Interacting Substance/Condition Official Regulatory Description
Pharmacodynamic Alcohol, other CNS Depressants Concurrent use may cause additional reductions in alertness and further impairment of performance, defined as an additive effect.
Pharmacokinetic Theophylline (400 mg dose) Co-administration resulted in a 16% decrease in the clearance of Histax.
Drug-Food Food The rate of absorption is decreased (delayed time to maximum concentration), though the extent of absorption (AUC) remains unchanged.

Population-Specific Pharmacokinetic Notes

Official documents note that a prolonged half-life and reduced clearance occur in specific patient populations, which formally affects the pharmacokinetic context for potential interactions:

  • In geriatric patients, the elimination half-life is prolonged by 50%, and apparent total body clearance is 40% lower.
  • In patients with hepatic impairment, the half-life is increased by 50%, and clearance is decreased by 40%.

Regulatory studies of co-administration with pseudoephedrine, ketoconazole, erythromycin, and azithromycin showed no clinically relevant interactions. Histax is also recognized as a P-glycoprotein substrate.

Mechanism of Action

Core Mechanism: Epigenetic Modulation via HDAC Inhibition

Histax functions as an inhibitor of Histone Deacetylase (HDAC) enzymes, which are key regulators of gene activity. This interaction results in the molecular consequence of hyperacetylation—the increased presence of acetyl groups on both histone and non-histone proteins. The hyperacetylation of histone proteins leads to a physical change in the cell's nucleus by relaxing the tightly wound chromatin structure . This structural modification allows the cell's transcriptional machinery to access specific DNA sequences, which in turn alters the expression of numerous genes.

This cascade induces the expression of genes associated with cell cycle arrest and differentiation. By altering the genetic landscape, Histax influences the cellular signaling pathways that govern survival and proliferation. The mechanism alters the internal balance of a cell by reducing rapid, uncontrolled division and increasing regulated stasis and death, resulting in the reduction of viability and proliferation rate in susceptible cells.

Dosage and Administration Information

How to Use Histax

Histax (Cetirizine Hydrochloride) administration follows instructions detailing the route, dosage, and frequency of use.


Administration and Dosing Standards

Histax is primarily administered via the oral route, available in forms such as tablets (typically 5 mg and 10 mg strengths), capsules, and oral solutions. An intravenous (IV) injectable solution (10 mg / mL) is also used in specific acute clinical settings, such as acute urticaria.

For routine use, the established adult dosing regimen is typically 10 mg once daily. Dosing may be initiated at 5 mg and adjusted based on the required level of symptom management, but the standard maximum oral dose is 10 mg per day. The IV form is administered as a single 10 mg dose.


Administration Context and Adjustments

Contextual Factor Official Instruction
Dosing Frequency Administered once daily (qDay).
Intake Conditions May be taken with or without food; food may slightly delay the rate of absorption but does not impact the total absorbed amount.
Renal Impairment Dose reduction is required. For adults with reduced kidney function, dosing is typically reduced to 5 mg once daily or 5 mg every two days, depending on the severity of impairment.
IV Procedure The injectable solution is administered as an intravenous push over a defined period, generally 1 to 2 minutes.

These instructions define the standardized oral and intravenous protocols. The primary once-daily regimen is the foundation of Histax use, and the dose reduction for renal impairment is necessary to maintain appropriate usage across different patient populations.

Recent Clinical Evidence

Histax: Recent Clinical Evidence

Overview of Clinical Trials

Histax was evaluated in several pivotal clinical trials involving participants with moderate to severe plaque psoriasis. These studies investigated the drug's effect on primary clinical endpoints, notably skin clearance as measured by the Psoriasis Area and Severity Index (PASI 75 and PASI 90). Research explored whether the treatment might be associated with a change in the severity and extent of psoriatic plaques. In the pivotal Phase 3 trials, the findings of the trials aligned with pre-specified criteria.

Efficacy and Maintenance Studies

A major Phase 3 program examined the drug's performance against placebo over a 16-week induction period. Trial results reported a distinction in the proportion of participants achieving skin clearance compared to placebo. Subsequent maintenance studies spanning up to 52 weeks assessed the long-term findings related to safety and continued response. The study data primarily involved adult participants; long-term studies further investigated whether the drug was associated with a reduction of symptoms that was maintained over the study period. Studies did not include direct head-to-head comparisons against older biologic treatments.

Safety and Tolerability Profile

The assessments of safety were conducted in trials lasting up to 52 weeks. A key finding related to safety included observations of a slight increased chance of infection, and this was monitored throughout the study period. Safety monitoring in all studies included routine laboratory tests, which evaluated for changes in liver enzymes, neutrophil counts, and other key markers.

Frequently Asked Questions (FAQ)

Common questions about Histax (FAQ)


Q: What is the main purpose of the medicine Histax?

Histax is approved by regulatory bodies to temporarily relieve symptoms associated with upper respiratory allergies, including hay fever. These symptoms typically include a runny nose, sneezing, and itching of the eyes, nose, or throat.


Q: Is Histax an antihistamine? If so, what generation is it?

Official sources classify Histax as an antihistamine. It is described as a newer-generation antihistamine with properties that generally result in less sedation compared to older allergy medicines.


Q: How long does it typically take for Histax to start relieving symptoms?

According to studies, the effects of Histax are reported to typically begin approximately 20 to 60 minutes after taking the medicine.


Q: How long do the effects of Histax last?

Official pharmacokinetics data indicates that the effects of Histax are generally reported to persist for at least 24 hours.


Q: Can Histax be used for both seasonal and year-round allergies?

Regulatory indications confirm that Histax is used for temporary relief of symptoms caused by hay fever (seasonal) or other upper respiratory allergies. This includes common triggers that can cause symptoms throughout the year.


Q: Is Histax approved to treat hives or other chronic skin itching?

Official indications state that Histax is approved for the treatment of chronic urticaria, which is commonly known as hives. It is indicated for use in patients starting at 6 months of age.


Q: What are the most common side effects associated with Histax?

The official product information reports that the most common side effects include drowsiness (somnolence), fatigue, dry mouth, and dizziness. These effects were reported by 2% or more of patients in clinical trials.


Q: Will Histax cause drowsiness or affect concentration?

Drowsiness may occur with Histax use. Official labeling describes that due caution should be exercised when driving or operating machinery, due to the potential for impaired alertness.


Q: Is Histax safe to use with alcohol?

Official warnings state that alcoholic drinks may increase the effect of drowsiness. For this reason, official labeling recommends avoiding the concurrent use of alcohol.


Q: What are the over-the-counter medicines that interact with Histax?

Official warnings describe the need for people to consult a health professional before use if they are taking tranquilizers or sedatives. These types of medicines may increase drowsiness when taken with Histax.


Q: Can Histax be taken with common pain relievers like ibuprofen?

Official drug interaction studies have examined the potential for Histax to interact with common non-prescription pain relievers. These studies have not found any clinically significant drug interactions.


Q: Are there any specific foods or drinks to avoid while taking Histax, such as grapefruit juice?

Regulatory data indicates that food does not significantly impact the total amount of the drug absorbed by the body. Therefore, official labeling has not identified any specific food or drink restrictions while using Histax.


Q: Is Histax generally considered safe for older adults?

Official guidelines describe the need for adults 65 years and over to consult a health professional about the appropriate dosing. This consultation is recommended because dosage adjustments may be necessary for some individuals.


Q: Are there any age restrictions for people who want to use Histax?

The oral dosage forms of Histax are officially indicated for use in children 6 years of age and older. Dosing for children younger than 6 years requires specific professional guidance.


Q: Can people with kidney problems or liver disease safely use Histax?

Official warnings describe the need for people with liver or kidney disease to consult a doctor before use. This consultation is recommended because a different dose may be necessary in these situations.


Q: What conditions make a person ineligible to take Histax?

Official warnings describe that Histax is contraindicated for use by a person who has had a previous allergic reaction to this product, any of its ingredients, or to the related antihistamine hydroxyzine.


Q: Is there information on the safety of Histax during pregnancy?

Official guidance describes the need for consultation with a health professional regarding the use of Histax during pregnancy.


Q: Is Histax transferred through breast milk?

Official labeling describes that use while breast-feeding is not generally recommended in the regulatory instructions.


Q: Are there any serious but rare side effects I should be aware of?

Official warnings describe the action to take, which involves stopping use of the product and seeking medical help right away if a severe allergic reaction occurs.


Q: Can taking Histax for a long period cause long-term health issues?

The FDA has issued a safety communication regarding a rare risk concerning the occurrence of severe itching (pruritus) that can happen a few days after stopping daily use, especially after several months or years.


Q: Does Histax affect or interfere with birth control pills?

Official drug interaction studies have examined potential interference with hormonal medicines. These studies have not identified any clinically significant interaction between Histax and oral contraceptives.


Q: What is the active ingredient in Histax, and is a generic version available?

The active ingredient in the medicine is Cetirizine Hydrochloride. A generic version is available under the approval status of an Abbreviated New Drug Application (ANDA).


Q: Can Histax be used for a reaction to a pet?

Histax is indicated for symptoms due to upper respiratory allergies, which broadly includes common triggers like pet dander. It is approved to help temporarily relieve these associated symptoms.


Q: Can Histax cause a dry mouth or change your taste sensation?

Dry mouth is listed in official documents as one of the common adverse reactions. A change in taste sensation, known as dysgeusia, is listed among the less common side effects reported.


Q: Does Histax affect blood pressure or heart rate?

Official post-marketing reports have included rare occurrences of cardiovascular changes. These include increases in heart rate (tachycardia) and elevated blood pressure (hypertension).


Q: Is it safe to stop taking Histax suddenly after using it daily for a long time?

The FDA has warned about the rare risk of severe itching (pruritus) that can occur a few days after stopping daily use. This is primarily seen after taking the medicine daily for a long period.


Q: What should I do if I think I'm having an allergic reaction to Histax itself?

Official warnings describe the action to take, which involves seeking medical help right away if a person suspects they are experiencing an allergic reaction to the product. Use of the medicine may need to be stopped immediately.


Q: Is Histax specifically for nasal symptoms (runny nose, sneezing) or a broader range of allergy symptoms?

The official indications confirm Histax is approved for a broad range of allergy symptoms. This includes relief of both nasal symptoms (like runny nose) and non-nasal symptoms (like itchy, watery eyes or an itchy throat).


Q: How does Histax compare to a first-generation antihistamine in terms of side effects?

Official information describes Histax as an antihistamine with properties that generally result in less sedation. This is a characteristic that differentiates it from older allergy medicines.


Q: Is there a risk of overdose with Histax, and what are the symptoms?

Official warnings describe the necessary action in the case of a suspected overdose, which involves contacting a Poison Control Center or seeking medical help right away. Symptoms reported may include extreme sleepiness, confusion, or a rapid heartbeat.


Q: Does Histax contain lactose or other ingredients that might be a concern for some users?

The inactive ingredients section for the Histax tablet form lists lactose monohydrate as an excipient (non-active ingredient). This information is provided in the official regulatory documents.


Q: How should I properly store Histax tablets or liquid?

Official product information describes the required storage conditions, stating that tablets are intended to be stored between 20 C and 25 C (68 F and 77 F). Furthermore, the medicine is intended to be kept away from excess heat and moisture.


Q: Is there a specific time of day that is better for taking Histax?

Histax is intended to be taken once daily. Some patient guidance suggests taking it in the morning, however, the determination of the best schedule for individual needs requires discussion with a health professional.

How should Histax be stored and disposed of?

How to Store and Dispose of Histax

Storage Requirements

Histax (Cetirizine Hydrochloride) must be stored at Controlled Room Temperature, which ranges from 20 C to 25 C (68 F to 77 F). The product should be kept in the container it came in, with the lid tightly closed, and must be protected from excessive heat and moisture.

To ensure safety, the medication must be stored out of the sight and reach of children in a secure location. Do not use the medication if the packaging seals are broken or the container is damaged.

Disposal Instructions

Unused or expired Histax must be disposed of safely in accordance with local regulations. To prevent harm to the environment and others, do not dispose of the medication by pouring it down a drain or flushing it down a toilet, unless otherwise instructed by an official medicine take-back program.

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

Available in countries:

Equivalent of Histax found in:

A-Z Index: