Histrine

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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 Histrine

Quick Facts

Property Description
Active Ingredient Cetirizine Hydrochloride
Form Tablet, Syrup, Oral Solution
Pharmacological Class Second-Generation Antihistamine
General Purpose Antiallergic Relief
Origin Synthetic

Histrine: A Definitive Overview and Pharmacological Identity

Histrine is a recognized brand of medication containing the active pharmacological substance Cetirizine Hydrochloride, which is classified as a second-generation antihistamine. This synthetic compound is administered orally and functions as a highly targeted systemic drug. Chemically, Cetirizine is recognized as the carboxylic acid metabolite of hydroxyzine, confirming its established pharmaceutical origin. Histrine is classified as a single-ingredient product, ensuring the drug's action is focused entirely on its primary therapeutic role without combining it with other active agents. Its positioning often highlights its use across a broad target age range, emphasizing relief for both adults and children.


What is the General Purpose and Classification of Histrine?

The general purpose of Histrine is to provide effective relief from allergic manifestations by functioning as a selective H1-receptor antagonist. This action achieves Histamine antagonism by binding to and blocking the effects of histamine on human peripheral cells. Medications in this class are effective in blocking histamine's effects without severe central nervous system penetration. This means the medicine works specifically on the parts of the body causing the allergy symptoms while minimizing the potential for drowsiness. The drug's primary function is strictly limited to an antiallergic capacity, supporting relief in typical scenarios such as managing symptoms of seasonal allergies.


Available Forms and Administration

Histrine is designed for oral administration, utilizing the gastrointestinal tract, and is marketed in several common pharmaceutical preparations to accommodate different patient populations. The product is readily available as Tablets for easy and precise dosing. Furthermore, liquid forms, including Syrup and Oral Solution, are produced, providing an alternative route for intake, often featuring specific flavors to enhance palatability for pediatric use, or for individuals who find swallowing solid forms challenging.

Regulatory References

  1. MedlinePlus
  2. NIH

What side effects are possible with Histrine?

Histrine: Possible Side Effects and Safety Information

Adverse reactions to Histrine (Cetirizine Hydrochloride) are classified by regulatory authorities based on the frequency observed in clinical studies and post-marketing reports, affecting various System-Organ Classes.

Adverse Reaction Frequencies

Classification Examples of Reactions
Common (Reported frequently) Somnolence (sleepiness), Fatigue, Dry mouth, Headache, Dizziness.
Uncommon Agitation, Paresthesia (abnormal skin sensation), Pruritus (itching), Rash.
Rare Hypersensitivity, Convulsions, Tachycardia (fast heartbeat), Urticaria (hives), and Hepatic function abnormal (elevated liver enzymes).

Serious Adverse Reactions

The regulatory safety profile documents rare but serious adverse reactions, including Anaphylactic shock, which is a severe allergic response, and Thrombocytopenia (low platelet count). Instances of Convulsions and Angioneurotic oedema (deep tissue swelling) are also officially noted in post-marketing data.

Special Safety Considerations

The official labeling includes specific safety considerations for certain patient groups. Individuals with renal impairment or hepatic impairment are advised to use caution, as dose adjustment may be necessary due to the drug's altered clearance. Caution is also recommended in older adults due to the potential risk of developing urinary retention. Furthermore, caution is noted for patients with predisposing factors for urinary retention or in epileptic patients due to the risk of convulsions.

Duration-Related Safety Patterns

A specific safety pattern documented in regulatory reports is the risk of developing severe generalized Pruritus (itching) upon discontinuation of the medicine, especially following long-term daily use.

Overdose and Emergency Response

Histrine Overdose and when to seek help is strictly defined by the regulatory documents outlining documented manifestations and required emergency procedures. Overdose of the active substance, Cetirizine Hydrochloride, is officially recognized to primarily involve central nervous system (CNS) effects.

Overdose Manifestations Severe Outcomes Requiring Urgent Care
Drowsiness (Somnolence) Tachycardia (Elevated Heart Rate)
Restlessness Hallucinations
Irritability Hyperthermia (High Body Temperature)

Common presentations include marked drowsiness, though paradoxical signs like restlessness and irritability are also documented, particularly in children. Severe outcomes requiring urgent attention include signs such as tachycardia, hallucinations, and profound agitation.

Immediate medical attention is required in all instances of suspected overdose. Regulator-mandated action requires contacting emergency services immediately if the individual has collapsed, experienced a seizure, has trouble breathing, or cannot be awakened. The official prescribing information states that no known specific antidote exists. Management is therefore strictly supportive and symptomatic. The substance is also noted in regulatory documentation as not being effectively removed by dialysis.

Therapeutic Uses of Histrine

What Histrine Treats: Main Uses and Benefits

The primary therapeutic role of Histrine is to provide supportive symptomatic relief for conditions associated with heightened physiological activity. This medicine is commonly used to help manage symptoms related to seasonal and perennial allergic rhinitis and chronic hives.


Addressing Symptomatic Discomfort and Acute Episodes

Histrine is applied in clinical settings where short-term symptomatic assistance is needed to address acute episodes and symptom clusters that interfere with daily functioning. This is relevant for managing symptom clusters related to the upper respiratory tract and localized skin irritation. The use is considered relevant in contexts marked by temporary physiological imbalance.

“It provides supportive relief when symptoms intensify and helps patients cope more steadily during difficult episodes.”

Support for Fluctuating Symptom Patterns

The medication is also relevant for managing conditions characterized by periods of heightened symptoms that involve episodic or fluctuating manifestations, especially recurrent skin conditions. By offering supportive relief, Histrine assists with easing the overall symptom load and supports general well-being during symptomatic phases.

Quick Fact: Supportive Management for Key Symptoms
Histrine is considered relevant for use across conditions where functional stability becomes affected, assisting patients when symptoms become more noticeable.

Regulatory References

  1. NIH MedlinePlus Drug Information

Eligibility and Restrictions for Use

Histrine, which contains the active ingredient cetirizine, is generally suitable for most adults and children from a certain age, primarily for the treatment of seasonal or perennial allergies and chronic hives.

Before taking Histrine, it is important to be aware of certain conditions or situations where its use may be contraindicated, require dose adjustment, or warrant professional medical advice.

Who Can Use Histrine?

  • Adults and adolescents with allergic symptoms or chronic hives.
  • Children aged 6 years and older, with lower doses often used for children aged 2 to 5 years (always follow specific product guidelines and pediatrician advice for pediatric dosing).

Who Should Not Use Histrine?

Histrine is contraindicated and should not be used by individuals with:

  • Known allergy or hypersensitivity to cetirizine, hydroxyzine, or any other ingredients in the product formulation.
  • Severe kidney impairment (end-stage renal disease or very low creatinine clearance).

Special caution and potential dose adjustment are required for individuals with:

  • Mild to moderate kidney impairment or liver disease (a lower daily dose is typically recommended).
  • Pregnant or breastfeeding women (consultation with a healthcare provider is essential, as the drug passes into breast milk).
  • Older adults (may be more susceptible to side effects like drowsiness, and kidney function should be considered).

Additionally, alcohol consumption should be avoided while taking Histrine due to the potential for increased drowsiness or central nervous system effects. Individuals should also use caution when performing tasks that require mental alertness, such as driving or operating machinery, until they know how the medication affects them.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory information for Histrine (Cetirizine Hydrochloride) documents specific pharmacodynamic and pharmacokinetic interactions that may alter its effects or systemic exposure. No medicinal product combinations are formally classified as contraindicated.

Documented Pharmacodynamic Interactions

Concurrent use with Alcohol and other CNS Depressants (including sedatives and tranquilizers) is cautioned against due to the risk of additional reductions in alertness and further impairment of CNS performance. This represents an officially recognized additive pharmacodynamic effect. Separately, co-administration with Pitolisant may formally diminish the therapeutic efficacy of Pitolisant.

Documented Pharmacokinetic Interactions

Co-administration with Theophylline (specifically at 400 mg once daily) results in a 16% decrease in the clearance of cetirizine, leading to increased exposure of Histrine. Furthermore, the drug is recognized as a P-glycoprotein (P-gp) substrate, an interaction relevant when co-administered with P-gp inhibitors like Verapamil. Studies confirm that Food intake does not affect the overall extent of exposure (AUC), but the time to reach peak concentration (Tmax) is delayed by approximately 1.7 hours. No clinically significant interactions were observed with common agents like Azithromycin or Erythromycin.

Population-Specific Notes

Patients with Hepatic or Renal Impairment are noted to have decreased drug clearance of cetirizine, which alters systemic exposure and requires consideration.

Mechanism of Action

Histrine is an antagonist (inhibitor) of the Histamine H3 Receptor (H3R) in the central nervous system.

The H3R typically functions as a presynaptic autoreceptor on histaminergic neurons, mediating negative feedback that suppresses histamine release, and as a heteroreceptor on non-histaminergic neurons, modulating the release of other neurotransmitters (e.g., acetylcholine, norepinephrine).

By blocking the H3R, Histrine prevents the receptor's inhibitory action on the histaminergic neuron. This disinhibition facilitates neurotransmission, resulting in increased neuronal histamine release into the synaptic cleft. The elevated histamine, acting on H1 receptors, along with the modulated output of other neurotransmitters, contributes to the upregulation of activity within arousal-promoting neural pathways. The core pharmacodynamic action is the modulation of H3R-mediated neuronal inhibition, with Histrine exhibiting low affinity for H1 and H2 receptors.

Dosage and Administration Information

Official Administration Instructions for Histrine

The Histrine formulation is administered by the oral route (tablet, capsule, or liquid) once daily. It should be taken at approximately the same time each day and may be taken with or without food. Adherence to the prescribed frequency and specific dosage limitations is essential, and patients must not exceed the stated maximum daily amount.

Official Dosing and Administration Rules

Age Group Recommended Dose (Once Daily) Special Condition Rule
Adults (12 years and above) 10 mg 5 mg may be appropriate for milder symptoms.
Children (6 to 11 years) 5 mg to 10 mg Do not exceed 10 mg daily.
Children (2 to 5 years) 2.5 mg to 5 mg May be taken as 2.5 mg once or twice daily.
Patients with Renal Impairment Reduced Dose Dosage must be adjusted by a healthcare provider, typically 5 mg once daily for adults with GFR < 50 mL/min.

Procedural Steps and Missed Doses

Preparation: Liquid formulations (syrup, drops) require careful measurement using only the calibrated dosing device provided. Tablets and capsules should be swallowed whole with fluid; orally disintegrating tablets should be placed directly on the tongue to dissolve and swallowed with saliva.

Missed Dose: If a dose is forgotten, the official instruction is to take it as soon as it is remembered. However, if it is almost time for the next scheduled dose, the missed dose should be skipped entirely. Do not double the dose to catch up.

This protocol ensures consistent daily systemic exposure, with flexibility in relation to meals, while mandating critical dose adjustments to account for age and reduced kidney function.

Recent Clinical Evidence

Research evidence / Overview of Studies for Histrine

The evidence base for Histrine (Cetirizine) is derived primarily from clinical research, including randomized controlled trials and systematic reviews, which describe the structure and outcomes measured, focusing on changes in patient-reported symptoms and disease activity.


Evidence for Allergic Rhinitis (SAR and PAR)

Research exploring how symptoms change over time in Seasonal (SAR) and Perennial (PAR) Allergic Rhinitis has primarily used short-term to medium-term randomized controlled trials (RCTs). Studies were conducted during periods of increased symptom activity and examined outcomes related to physical discomfort, such as changes in the Total Symptom Severity Complex (TSSC). The evidence base includes studies of adults and pediatric patients. While research provides insight into short-term changes, long-term effects on the continuous management of these conditions across multiple seasons are not fully established by randomized efficacy trials.


Evidence for Chronic Hives (Chronic Idiopathic/Spontaneous Urticaria)

The research for Chronic Hives involves controlled studies that examined outcomes linked to irritative states, focusing on reduction in the number and severity of hives (wheal count) and the intensity of itching. Studies monitored symptomatic changes for periods of several months. Research has also explored doses higher than the standard study dose. Findings indicate patterns related to the monitored outcomes for standard dosing. However, the evidence for high-dose strategies in pediatric patients remains insufficient, and the quality of evidence varies across studies.


Evidence Gaps and Follow-up Limitations

The majority of efficacy data for Histrine is relevant in trials assessing short-term or episodic symptom patterns. Follow-up durations were limited in the primary controlled trials, and longer observation periods were mainly designed to gather safety data. Data for certain groups, such as older adults, remain insufficient within the primary efficacy trials. Research describes group patterns, not personal outcomes.

Key Studies & References

  1. The international EAACI/GA²LEN/EuroGuiDerm/APAAACI guideline for the definition, classification, diagnosis, and management of urticaria
  2. Cetirizine for the treatment of allergic diseases in children: A systematic review and meta-analysis
  3. Label: CETIRIZINE HYDROCHLORIDE tablet, film coated - DailyMed - NIH
  4. Cetirizine: MedlinePlus Drug Information

How should Histrine be stored and disposed of?

Official Storage and Handling Requirements

Histrine (cetirizine hydrochloride) must be stored at a Controlled Room Temperature between 20°C and 25°C (68°F and 77°F), as specified in official labeling. The medication must be kept away from excessive heat above 40°C and high humidity to maintain stability. Oral solutions require additional protection from light.

All forms of the medication must be kept in the original container, which should be tightly closed. The labeling explicitly states that the product must be stored out of the reach of children.

Disposal

Official disposal instructions require that any unused or expired Histrine product be disposed of in accordance with local requirements. In the event of an overdose or accidental ingestion, immediate contact with a Poison Control Center is mandatory.

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

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