Hydroxyzinum Hasco

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Hydroxyzinum Hasco

Medically reviewed

Rosario Oropesa

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 Hydroxyzinum Hasco

Quick Facts

Property Description
Active ingredient Hydroxyzine dihydrochloride
Form Film-coated tablets, Oral solution
Pharmacological class First-generation antihistamine, H1-receptor antagonist
Common use Anti-pruritic, Sedative, Anxiolytic
Origin Synthetic compound (Piperazine derivative)

What Type of Medicine is Hydroxyzinum Hasco? (Defining Identity and Class)

Hydroxyzinum Hasco is a prescription-only medicine containing hydroxyzine dihydrochloride as its sole active ingredient. This substance is a synthetic compound derived from the piperazine chemical structure. Pharmacologically, it is classified as a first-generation antihistamine and a potent, non-selective H1-receptor antagonist. Unlike newer antihistamines, hydroxyzine's structure allows it to readily cross the blood-brain barrier, a property noted for imparting significant activity on the central nervous system. This dual profile fundamentally shapes its therapeutic identity as a drug with both anti-allergic and pronounced sedative effects.

Composition and Available Pharmaceutical Forms

This medication is a single-ingredient product, formulated for oral administration, and is generally provided in two distinct pharmaceutical preparations: film-coated tablets and an oral solution (liquid). Both preparations contain the same active compound. The oral solution is particularly notable as it allows for flexibility in administration, making it a suitable and common choice for the pediatric population. The provision of two distinct forms ensures that the medication is adaptable for various user needs, which is a key factor differentiating it from brands that only offer tablets.

General Purpose and Primary Pharmacological Action

The general purpose of Hydroxyzinum is rooted in its combined H1 histamine blockade and its central sedative effect. The blockade of the H1-receptor provides a mechanism generally useful for the relief of pruritus (itching). This means the medicine helps ease discomfort by countering the action of histamine, which is a major mediator of itching. Furthermore, its ability to reduce CNS activity establishes its identity as an agent useful for promoting a state of reduced tension and calmness. A typical neutral use scenario would involve an individual experiencing skin irritation where the accompanying itchiness is disrupting their sleep.

Regulatory References

  1. MedlinePlus
  2. European Medicines Agency

What side effects are possible with Hydroxyzinum Hasco?

Possible Side Effects and Safety Information

The safety profile of Hydroxyzinum Hasco is organized by the severity and frequency of documented adverse reactions, which include critical restrictions related to heart function.

Serious and Life-Threatening Safety Concerns

The most significant documented risk is the potential for QT interval prolongation and Torsade de pointes, which are alterations in the heart's electrical activity that can lead to life-threatening abnormal heart rhythms and cardiac arrest. Due to this risk, the medicine is contraindicated for individuals with known acquired or congenital QT interval prolongation, existing cardiovascular disease, or significant electrolyte imbalances (such as low potassium or magnesium levels).

It is also contraindicated for use with many other medications known to affect heart rhythm (e.g., certain antibiotics, antifungal medicines, and antiarrhythmics).

Frequency-Classified Adverse Reactions

Adverse reactions are documented by frequency based on clinical data and post-marketing experience:

  • Very Common (may affect more than 1 in 10 people): Sedation, drowsiness.
  • Common (may affect up to 1 in 10 people): Dry mouth, headache, fatigue.
  • Uncommon (may affect up to 1 in 100 people): Dizziness, insomnia, agitation, nausea.
  • Rare (may affect up to 1 in 1,000 people): Convulsions, tremor, disorientation, hallucinations, hypersensitivity reactions, changes in blood pressure, and hepatitis.
  • Very Rare (may affect less than 1 in 10,000 people): Anaphylactic shock, acute generalized exanthematous pustulosis (AGEP).

Population and Cautionary Restrictions

Use is restricted in certain patient groups: the medicine is contraindicated in pregnancy and during breastfeeding. Use in the elderly is not generally recommended due to reduced drug elimination and increased vulnerability to adverse effects, and if unavoidable, a maximum daily dose is mandated. Caution is required in patients with an increased tendency to seizures, glaucoma, bladder outflow obstruction, or conditions like myasthenia gravis.

Overdose and Emergency Response

Overdose Scope

Property Official Regulatory Documentation
Documented Overdose Presentations Hypersedation (most common), stupor, convulsions, nausea, vomiting, dry mouth, blurred vision.
Physiological Systems Affected Central Nervous System (CNS), Cardiovascular System (QT interval prolongation, Torsade de Pointes), and Autonomic functions.
Dose-related or Exposure-related Factors Documented overdose presentations may occur with doses considerably higher than recommended or when the medicine is taken with multiple agents.
Population-specific Overdose Notes Elderly patients are officially noted to be more susceptible to oversedation and confusion following an overdose.
Emergency-response Statements Seek emergency medical attention. Contact the Poison Control Helpline.
When Immediate Medical Help is Required Immediate medical help is required if the person has collapsed, had a seizure, has trouble breathing, or can't be awakened.

Overdose Classifications (High-Level)

Property Official Regulatory Documentation
Severity Classification Manifestations range from hypersedation to severe signs, including convulsions, coma, and dangerous cardiac effects.
Regulatory Basis Information is based on official prescribing documents from regulatory authorities, including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
Overdose-Context Constraints No specific antidote is known. ECG monitoring is recommended for all overdose cases to detect potential cardiac complications.

Resulting Overdose Structure

Official overdose statements:

  • The most common sign of overdose is hypersedation, which can progress to stupor or coma, alongside potential symptoms like seizures, nausea, and vomiting.
  • Severe outcomes include QT interval prolongation and Torsade de Pointes, which are officially noted risks requiring medical intervention.
  • Immediate management includes gastric lavage if vomiting has not occurred spontaneously, followed by general supportive care.
  • Epinephrine must not be used to control hypotension as the drug may officially counteract its pressor action.

Connection to the overall overdose profile (2–4 sentences): Regulatory documents define the Hydroxyzinum Hasco overdose profile based on severe CNS depression and a critical cardiac risk, necessitating immediate contact with emergency services. Due to the lack of a specific antidote, management focuses on supportive treatment and continuous monitoring to manage potential life-threatening cardiac events and maintain vital functions.

Therapeutic Uses of Hydroxyzinum Hasco

What Hydroxyzinum Hasco Treats: Main Uses and Benefits

The primary role of Hydroxyzinum Hasco is to provide symptomatic assistance across therapeutic areas that involve heightened patient distress or functional strain. The medication is used across therapeutic domains where short-term symptom management is generally appropriate. The application of this medicine aligns with established therapeutic uses for this class of medication.

This medicine is commonly used to help manage the intensity of symptoms in three core domains: the relief of pruritus (itching) in allergic skin conditions, the short-term relief of anxiety and tension, and sedation for pre-procedural support.

“The use of this medication is relevant in clinical settings where supportive symptom management is appropriate for conditions marked by periods of increased discomfort or tension.”

For allergic conditions, this use supports the patient during difficult episodes by easing distress and may help improve day-to-day comfort during symptomatic periods. When managing anxiety, it is applied across conditions marked by increased psychological stress, offering symptomatic relief that may assist with managing symptom fluctuations. Furthermore, it is relevant for easing symptoms of increased neurological activity by supporting a state of calmness and is used to help ease apprehension prior to medical or surgical procedures.


Quick Fact: Relief for Pruritus and Anxiety

Domain Symptom/Condition Category Patient Benefit
Dermatological Conditions involving irritative states (Itching) Provides support for easing symptom burden
Psychological States marked by increased tension (Anxiety) Contributes to support for functional strain
Procedural Situations requiring temporary assistance (Sedation) Supports patient during procedural phases

Eligibility and Restrictions for Use

Official regulatory documents define strict population-based criteria for the use of Hydroxyzinum Hasco, primarily due to safety concerns related to cardiac function and reproductive health. Eligibility is determined by absolute prohibitions and conditional restrictions.

Absolute Contraindications (Must Not Use)

  • Cardiovascular: Use is strictly contraindicated in patients with known acquired or congenital QT interval prolongation, pre-existing cardiac disease, significant bradycardia, or specific electrolyte imbalances (like low potassium).
  • Hypersensitivity: Individuals with a history of allergy to hydroxyzine, its active metabolite cetirizine, or other piperazine derivatives are prohibited.
  • Reproductive Status: The medicine is contraindicated for pregnant women (due to inadequate early pregnancy data) and nursing mothers (while breastfeeding).

Conditional and Restricted Populations

Population Eligibility Status
Older Adults (65+) Use requires extreme caution and is restricted due to increased vulnerability to adverse effects and potential for decreased organ function.
Children The medicine is eligible for use in children for certain indications, but regulatory labeling defines a minimum age threshold for initiation.
Comorbidities Use requires caution in patients with decreased hepatic or renal function, and those with conditions sensitive to anticholinergic effects (e.g., glaucoma, urinary retention).

What should I know about interactions with other medicines?

The interaction profile for Hydroxyzinum Hasco is based on documented pharmacokinetic and pharmacodynamic patterns, leading to specific regulatory constraints. Co-administration is formally contraindicated with medicinal products known to prolong the QT interval, such as certain antiarrhythmics, antibiotics (e.g., Erythromycin, Moxifloxacin), and antidepressants (e.g., Citalopram, Fluoxetine), due to the established risk of serious ventricular arrhythmias. This is classified as a prohibition in regulatory documents.

A significant pharmacodynamic interaction involves the potentiation of Central Nervous System (CNS) Depressants (including narcotics and non-narcotic analgesics), which requires consideration for a reduced dosage of the co-administered CNS depressant. The effects of alcohol are also potentiated, and simultaneous use is to be avoided.

Metabolically, the substance is processed via CYP3A4/5 and Alcohol Dehydrogenase. Inhibitors of these enzymes may lead to a pharmacokinetic interaction resulting in an increase in hydroxyzine blood concentrations. For example, the co-administration of Cimetidine has been shown to increase serum concentrations of the active substance. Furthermore, treatment must be stopped for at least 5 days before diagnostic procedures like allergy skin testing or the methacholine bronchial challenge test. In the elderly population, the interaction profile mandates a maximum daily dose restriction of 50 mg.

Mechanism of Action

Hydroxyzinum Hasco's mechanism centers on its interaction with specific central and peripheral receptors. Its primary action is competitive antagonism at the Histamine H1 receptor. By binding to this target, the active substance prevents the binding of endogenous histamine, thereby modifying early molecular steps and reducing histaminergic signaling in affected pathways.

In the central nervous system (CNS), the substance rapidly crosses the blood-brain barrier. Blockade of H1 receptors in subcortical structures, including the reticular formation, contributes to a decrease in overall neuronal excitability. This CNS effect is further modulated by secondary, lower-affinity antagonism at muscarinic cholinergic receptors and specific serotonin ( 5HT2) receptors.

This poly-mechanistic engagement across multiple receptor systems results in a system-level modulation characterized by central nervous system depressant effects and anticholinergic physiological changes.

Dosage and Administration Information

How to Use Hydroxyzinum Hasco

The administration of this medicine is based on clinical guidelines defining the appropriate routes, dosage schedules, and population-specific limits. Hydroxyzine is provided for use via the oral route (tablets, capsules, or syrup) for ongoing management, and as a solution for intramuscular (IM) injection for situations requiring a rapid effect, such as procedural sedation. Intravenous, subcutaneous, and intra-arterial administration are not permitted by product labeling.

Dosage and Frequency Guidelines

Dosage is determined by the specific use and must be individually adjusted to the lowest effective dose. For the relief of symptoms, the medicine is typically administered in divided doses, three or four times daily. For a single-use scenario, such as pre-procedural sedation, a single dose is administered.

Population Group General Dosing Principle Maximum Daily Dose (Example)
Adults Individually adjusted dose, often 25 mg to 100 mg total daily. 100 mg
Older Adults Initiate at half the usual starting dose. 50 mg
Pediatric Patients Calculated based on body weight and administered in divided doses. Up to 2 mg/kg

Administration Specifics

For ongoing use in adults, the effectiveness of the drug has not been established for prolonged treatment, such as beyond four months. When administering the liquid oral form, the container must be shaken vigorously prior to measuring the dose. If the intramuscular route is used, the injection must be given deeply into the muscle, such as the gluteus maximus, and patients should be transitioned to the oral route as soon as practical.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Hydroxyzinum Hasco


Evidence for use in the Symptomatic Treatment of Anxiety in Adults

Research has explored the use of this drug in short-term randomized controlled trials primarily involving adults diagnosed with generalized anxiety disorder (GAD). These studies were designed to observe research exploring short-term symptom changes over defined time intervals, focusing on outcomes that reflect daily functioning and patient-reported outcomes describing perceived discomfort.

Studies conducted during periods of increased symptom activity reported data regarding changes in anxiety symptoms that were measured against changes observed in groups receiving an inactive substance. Studies included comparisons where outcomes were measured against those of other agents being evaluated for this condition. However, the evidence is limited, as the certainty remains low across some outcomes, and follow-up durations were typically short-term, meaning long-term effects are not fully established.


Evidence for use in the Symptomatic Treatment of Pruritus (Itching)

This part outlines research designs, primarily controlled trials, that have examined the measurement of itch severity and related outcomes in conditions linked to inflammatory or irritative states. Studies explored how symptoms evolved in observed populations presenting with conditions characterized by fluctuating manifestations.

Findings describe patterns observed in these studies where patient-reported outcomes describing perceived discomfort and quality of life were measured. Comparative evidence against newer treatments for this condition is limited, and certainty remains low in some settings. Data for certain groups, such as those with specific underlying systemic causes of itching, remain insufficient.


Long-term Studies and Follow-up

The majority of research for this drug was evaluated in short-term to intermediate-term studies, typically lasting only a few weeks to a few months. This means that data are still emerging, and certainty remains low regarding what happens over many months or years of administration. Research focusing on extended use, particularly for anxiety and pruritus, is sparse.

Frequently Asked Questions (FAQ)

Common questions about Hydroxyzinum Hasco (FAQ)

Q: How long does it take for Hydroxyzinum Hasco to start working?

Clinical studies and label information indicate that the onset of effect for the oral form of this medicine is typically observed within 15 to 30 minutes after administration. The drug crosses the blood-brain barrier rapidly, which contributes to its quick action.


Q: What should I do if I miss a dose?

Official dosing guidelines advise that if a dose is missed, it should be taken as soon as possible. However, if the time is already close to the next scheduled dose, the recommendation is to skip the missed dose entirely. The guidance specifies that the dose should not be doubled to compensate for a missed dose.


Q: What should I do if I take too much Hydroxyzinum Hasco (overdose)?

Reported signs of taking too much of this medicine include hypersedation (extreme sleepiness), convulsions, stupor, nausea, and vomiting. Due to the potential for serious effects on the heart's electrical activity, if a suspected overdose occurs, immediate medical attention should be sought.


Q: What other medications should I avoid while taking Hydroxyzinum Hasco?

Regulatory documents indicate this medicine is contraindicated (must not be used) with drugs known to prolong the QT interval—a measure of the heart’s electrical activity. Furthermore, it can potentiate the effects of Central Nervous System (CNS) depressants such as narcotics and non-narcotic pain relievers, which requires consideration for a reduced dosage of the co-administered CNS depressant.


Q: How long can I safely stay on this medicine for anxiety?

Studies and regulatory labeling for the use of this medicine in anxiety have focused on short-term results. The effectiveness of the drug for managing anxiety for long-term use (defined as more than four months) has not been formally established by systematic clinical studies. The usefulness of the drug should be reviewed periodically.


Q: Is Hydroxyzinum Hasco addictive or habit-forming?

According to official drug facts, Hydroxyzine is not considered a controlled substance. It does not carry the same risk of physical addiction or physical dependence that is associated with some other classes of anxiety medications.


Q: Is Hydroxyzinum Hasco a controlled substance?

No, Hydroxyzinum Hasco is not listed as a controlled substance under the U.S. Controlled Substances Act or similar international regulatory schedules. This substance is not categorized under the controlled substance schedules.

How should Hydroxyzinum Hasco be stored and disposed of?

Official Storage and Disposal Requirements

Official labeling mandates that Hydroxyzinum Hasco be stored at Controlled Room Temperature, defined as 20 to 25 C (68 to 77 F), with permitted excursions up to 30 C. The medication must be kept in its original container, tightly closed, and protected away from light, excess heat, and moisture.

Regulatory instructions require the container to have a child-resistant closure and strictly mandate: KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

For disposal, the primary method for unused or expired product is a government-authorized drug take-back program. If this option is unavailable, the medicine should be mixed with an undesirable substance (such as dirt) and sealed in a container for household trash disposal. It must not be poured down the sink or flushed.

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

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