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Hustazol 10%

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Hustazol 10%

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Method of action: Cough And Cold Preparations

Treatment option:

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.

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Overview of Hustazol 10%

Quick Facts

Property Description
Active Ingredient Cloperastine
Form Oral Powder Granules or Tablets
Pharmacological Class Centrally-Acting Antitussive (Cough Suppressant)
General Purpose Relief of Dry, Non-Productive Cough
Origin Synthetic Compound

What Type of Medicine is Hustazol 10%?

Hustazol 10% is a medicinal preparation featuring Cloperastine as its active substance, categorized by the World Health Organization's Anatomical Therapeutic Chemical (ATC) system under the code R05DB21. This places it specifically within the pharmacological class of other cough suppressants, signifying it is a centrally-acting agent designed to manage coughing. Cloperastine is a synthetic compound derived through chemical synthesis. Its mechanism is clinically recognized for acting on the central nervous system to suppress the cough reflex. The substance is functionally distinct from opioid-derived cough suppressants because it achieves its effect without acting on opioid receptors.

Composition and Form of Cloperastine

The preparation Hustazol 10% contains the active ingredient, Cloperastine, typically in the form of a stable salt such as the hydrochloride or fendizoate. The 10% value refers to the concentration of the active component within the final pharmaceutical presentation. This concentration is often associated with the powder or granule form, which offers a flexible oral route of administration. Hustazol 10% is a single-ingredient product, which confirms that the entire therapeutic effect is derived solely from the antitussive properties of Cloperastine. This formulation is frequently marketed for its simple, direct composition, focusing on the active relief of cough symptoms in both adults and children.

What is the General Purpose of Hustazol 10%?

The fundamental purpose of Hustazol 10% is to provide effective relief and control for a dry, irritating, and non-productive cough. The medicine works by influencing the brain's cough center in the medulla, which decreases the hyper-sensitivity that initiates coughing fits. This function is invaluable for patients experiencing a persistent, tiring cough that does not involve the expulsion of phlegm or mucus, a typical use scenario being the management of post-infectious cough. The general therapeutic benefit focuses on suppressing the cough reflex to allow for comfort and rest.

Regulatory References

  1. Japanese Pharmacopoeia Monograph (Cloperastine)
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What side effects are possible with Hustazol 10%?

Possible side effects and safety information

Cloperastine, the active component in Hustazol 10%, has an official safety profile defined by documented adverse reactions and specific regulatory limitations. The majority of undesirable effects listed in official labeling, such as drowsiness, sedation, dry mouth, gastric disturbances, and accommodation disturbances, are formally classified as having a Frequency Not Known, meaning their precise rate of occurrence cannot be estimated from the available data.

Adverse reactions are grouped by the physiological system affected:

  • Nervous System Disorders: Centrally-mediated effects like drowsiness and sedation.
  • Gastrointestinal Disorders: Includes dry mouth and general gastric disturbances.
  • Eye Disorders: Disturbances in visual accommodation.

Documented Serious Reactions and Safety Constraints

While most effects are related to the medicine's pharmacological activity, acute dystonic reactions, characterized by involuntary muscle movements, have been documented, particularly in pediatric patients.

Regulatory documents establish several specific constraints on use. The medicine is formally contraindicated for use in children under 2 years of age. Furthermore, due to the drug's mild anticholinergic properties, caution is advised for older adults and individuals with conditions sensitive to these effects, such as narrow-angle glaucoma or prostatic hypertrophy.

Use is also contraindicated with the concomitant use of Monoamine Oxidase (MAO) inhibitors. The medicine is officially noted to potentially enhance the sedative effects of other Central Nervous System (CNS) depressants.

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Overdose and Emergency Response

Hustazol 10% Overdose and When to Seek Help

The official regulatory documentation for Cloperastine strictly outlines the clinical presentations associated with an overdose and mandates specific emergency actions. The documented manifestations are primarily linked to effects on the central nervous system (CNS) and the manifestation of anticholinergic symptoms.

Documented Clinical Manifestations

The officially recognized signs and symptoms of a Cloperastine overdose include various CNS effects such as drowsiness, states of excitation, hallucinations, and physical signs like ataxia (a lack of motor coordination). A severe outcome explicitly documented within the symptom profile is the potential for convulsions. The overall presentation is characterized by the presence of generalized anticholinergic effects.

Mandated Emergency Action

In the event of any suspected overdose, official government guidance strictly mandates that an individual seek immediate medical attention or contact a certified Poison Control Center right away. Urgent medical care is required due to the potential for severe CNS events and the critical constraint that no specific antidote is known for Cloperastine, according to official labeling.

Official Management Procedures

Treatment detailed in regulatory sources requires symptomatic and maintenance treatment for the patient. Specific procedural steps officially documented for initial management include the performance of gastric lavage using saline serum or the initiation of vomiting to achieve gastrointestinal decontamination.

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Therapeutic Uses of Hustazol 10%

What Hustazol 10% Treats: Main Uses and Benefits

Hustazol 10% is commonly used in situations involving certain distressing symptoms, specifically providing supportive relief for the dry, irritating, and non-productive cough. The therapeutic domain is used for symptoms that create discomfort or tension, focusing on the irritative, dry cough. This compound is classified for its antitussive efficacy.

The medicine helps address symptom clusters that may become intense or disruptive, and is relevant for easing the overall symptom load of this non-functional manifestation. It is commonly used across conditions presenting with acute episodes like those associated with the common cold, bronchitis, and post-infectious states. This supportive treatment is relevant for managing symptoms in both adults and pediatric patient groups.

The primary benefit is that it offers symptomatic relief that may help patients cope more steadily with symptom fluctuations, and contributes to improved comfort during periods of heightened symptoms. The goal is to ease the distressing cough symptoms, supporting general well-being during symptomatic phases.


Quick Fact: Supportive Management for Persistent, Dry Cough

  • Primary Symptom: Irritative, non-productive cough
  • Benefit: May assist with the management of cough frequency and intensity
  • Applicable in: Post-infectious cough, acute bronchitis

Regulatory References

  1. KEGG DRUG database entry for Cloperastine
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Eligibility and Restrictions for Use

Hustazol 10% (Cloperastine) is restricted to specific patient populations as defined by regulatory bodies in official product labeling.

Allowed and Prohibited Age Groups

Use is permitted for adults and children 2 years of age and older. The medication is strictly contraindicated in children under 2 years of age. Older adults must use the medicine with caution and often require medical supervision.

Absolute Contraindications

Patients must not use Hustazol 10% if they have a known hypersensitivity to Cloperastine or any of its components. It is also prohibited for patients concurrently taking Monoamine Oxidase Inhibitors (MAOIs), as well as individuals with specific inherited sugar intolerances like hereditary fructose intolerance.

Conditional and Restricted Use

The medicine should be used with caution by patients who have specific pre-existing conditions, including narrow-angle glaucoma, prostatic hypertrophy, and certain severe cardiovascular diseases (such as hypertension or cardiac arrhythmia). Caution is also required for patients with a chronic cough linked to conditions like asthma or emphysema.

Pregnancy and Lactation Status

Use is generally not recommended for women who are pregnant or breastfeeding due to the lack of established human safety data for these populations.

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What should I know about interactions with other medicines?

Interactions with other medicines and products

This section describes the officially documented interaction patterns for Hustazol 10% (Cloperastine), as defined in government regulatory labeling.

Formally Prohibited Combinations

Co-administration with Monoamine Oxidase Inhibitors (IMAO) is formally prohibited due to the risk of serious interaction and potentiation of effects.

Pharmacodynamic Potentiation

Interactions that produce additive effects are documented, primarily due to Cloperastine’s central and mild antihistaminic properties:

  • Central Depressant Drugs: Concurrent use with substances that depress the central nervous system, such as Opioid Analgesics, Sedatives, Antipsychotics, and Benzodiazepines, may increase the sedative effects of both medicines.
  • Anticholinergic Drugs: Co-administration with drugs possessing anticholinergic effects (e.g., Tricyclic Antidepressants or Neuroleptics) may potentiate the antimuscarinic action.

Physiological Conflict of Function

Official documents warn against combining Hustazol 10% with medicines designed to increase bronchial secretions:

  • Expectorants and Mucolytics: The cough reflex inhibition caused by Cloperastine can lead to a risk of pulmonary obstruction when secretions are made more voluminous or fluid by these medicines.

Interactions with Ingested Substances

  • Alcohol: The ingestion of alcoholic beverages is prohibited during treatment due to the increased risk of sedative effects.
  • Food and non-alcoholic drinks are documented to have no significant effect on the medicine's efficacy.
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Mechanism of Action

Cloperastine modulates the activity of the cough reflex via a dual mechanistic action influencing both central and peripheral pathways.

Central Modulation via Neural Pathway Stabilization

The mechanism begins by targeting the Cough Center in the medulla oblongata of the brainstem. The molecule acts as a blocker of GIRK ion channels and a ligand for the Sigma-1 (sigma1) receptor. This molecular action influences the GABAergic signaling pathway, increasing the influence of inhibitory neurotransmission. This mechanism stabilizes the central neural circuits. The resulting physiological effect is a direct increase in the threshold required for cough motor signal initiation.

Peripheral Desensitization and Airway Modulation

The central action is complemented by activity in the respiratory tract. Cloperastine directly desensitizes afferent sensory nerve endings in the tracheobronchial tree, which reduces the magnitude of irritant signals traveling toward the brainstem. Concurrently, it exerts a mild antagonistic effect at Histamine H1 receptors, which attenuates histamine-mediated airway excitability. These peripheral mechanisms collectively contribute to a decrease in afferent nerve excitability to stimuli.

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Dosage and Administration Information

Official Administration Protocol

Hustazol 10%, containing Cloperastine, is officially intended for oral administration. The usage protocol is defined by a strict three-times-daily (TID) frequency. This structured dosing regimen is designed to be followed across the day to address acute symptoms, typically scheduled for morning, noon, and evening administration.

Dosage and Timing

The required amount of the medicine is standardized based on age. The standard regimen for adults and adolescents over 12 years is based on the equivalent of approximately 35.4 mg of the active ingredient per single dose. To meet administration conditions, the medicine is officially advised to be taken before meals. For any liquid form of the product, official instructions require the container to be shaken thoroughly before the dose is measured. The duration of use is constrained to the period of acute symptomatic relief rather than a long-term plan.

Population-Specific Use

Official administration rules include specific scaling for different age groups. Separate, defined dosage amounts are published for children in the 6-12 year range and the 2-6 year range. A primary administration restriction is that use of the medication is not advised for children under 2 years of age. Furthermore, caution is officially noted when administering the medicine to the older adult population. This framework establishes the necessary constraints for the proper delivery of the medicine.

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Recent Clinical Evidence

Research evidence / Overview of studies for Hustazol 10%

Evidence for Acute Dry, Non-Productive Cough

Research has explored the use of Cloperastine in studies involving acute dry cough, such as those conditions associated with the common cold or acute irritative states of the respiratory tract. These studies, which included both adults and pediatric patient groups, were typically designed as short-term randomized controlled trials (RCTs) or comparative studies. Researchers primarily monitored patient-reported outcomes describing perceived discomfort, specifically measuring changes in the frequency and severity of cough episodes, and assessing the degree of night-time sleep disruption. Studies conducted during periods of increased symptom activity reported measurements of patterns observed in the studies over defined time intervals. Certainty remains low regarding the consistency of outcomes when applied to all specific causes of acute dry cough, and follow-up durations were limited.


Evidence for Persistent or Chronic Dry Cough

The available research also examined Cloperastine's use in conditions characterized by fluctuating or episodic manifestations, specifically in outpatients presenting with persistent or chronic dry cough. The research monitored outcomes reflecting daily functioning, such as the perceived intensity of cough and patient-reported outcomes describing quality of life. Research provides insight into short-term changes observed in research scenarios involving persistent symptoms. It was observed in some studies that findings were mixed across various reports in the evidence base. Sample sizes were modest across a number of the studies conducted, and evidence quality varies across studies.


Long-Term Studies and Follow-Up

The majority of studies conducted for Cloperastine were relevant in trials assessing short-term or episodic symptom patterns, with follow-up durations that were limited. As a result, long-term effects are not fully established. There is limited information for long-term outcomes, and research describing patterns observed in the studies primarily focuses on immediate or short-term changes. More research is ongoing to help clarify what has been observed so far regarding symptom patterns over longer periods.


Key Limitations and Areas of Uncertainty

One key limitation is that evidence quality varies across studies, as the research base includes trials conducted over a long timeframe with differing methodologies. Another complexity is that the evidence base includes data from studies evaluating the Cloperastine racemic mixture alongside its purified isomer, which introduces some uncertainty regarding the precise application of all data to the specific formulation of Hustazol 10%. Comparative evidence remains insufficient for certain specific situations, meaning that certainty remains low for many aspects outside the initial short-term research scenarios.

Key Studies & References Pharmacological and clinical overview of cloperastine in treatment of cough

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Frequently Asked Questions (FAQ)

Common questions about Hustazol 10% (FAQ)


Q: How quickly does Hustazol 10% start working after I take it?

Regulatory information and studies suggest that effects are commonly observed within approximately 30 to 60 minutes after taking the medicine orally. The onset of action for the antitussive effect of Cloperastine is generally considered to be relatively rapid.


Q: How long does the effect of one dose of Hustazol 10% usually last?

Pharmacokinetic data suggests that the cough-suppressing effect of a single dose of Hustazol 10% is typically maintained between 3 and 8 hours. This duration supports the need for repeated administration as directed by a healthcare professional.


Q: What is the difference between Hustazol 10% and other common medicines for the same condition?

Hustazol 10% contains Cloperastine, a centrally-acting antitussive with a mechanism of action distinct from opioid-based cough suppressants. Official regulatory information notes that it is generally not associated with the same dependency concerns as opioid-derived medicines.


Q: Are there any long-term side effects associated with continuous use of Hustazol 10%?

The majority of clinical trials for Cloperastine have focused on short-term or acute use. Consequently, information from official regulatory safety documents regarding the long-term safety and effects of continuous use is considered limited.


Q: What are the typical signs that Hustazol 10% is actually working?

The medicine’s intended therapeutic effect is a reduction in the frequency and severity of the dry, irritating cough. This noticeable change in cough pattern is the expected sign of the medication's efficacy.


Q: What are the rare but serious side effects of Hustazol 10% that I should be aware of?

Official product information notes that, while rare, serious adverse events can occur, such as acute dystonic reactions (involuntary muscle movements) and certain cardiovascular changes. Consulting the full product information is recommended for the complete list of known effects.


Q: Does taking too much Hustazol 10% cause serious harm?

Overdosing on Cloperastine is associated with more severe central nervous system effects, including profound sedation and depression. Official guidance stresses the importance of seeking immediate medical attention if an accidental overdose is suspected.


Q: What happens if I take another medicine that causes drowsiness; can I still use Hustazol 10%?

Official product information warns that Cloperastine may enhance the sedative effects of other central nervous system (CNS) depressant drugs. Concurrent use must be discussed with a healthcare professional to manage potential risks.


Q: Can I use Hustazol 10% if I have narrow-angle glaucoma or prostate issues?

Due to the medicine's mild anticholinergic properties, caution is specifically advised in regulatory documents for individuals with conditions sensitive to these effects, such as narrow-angle glaucoma or prostatic hypertrophy (enlarged prostate).


Q: Does Hustazol 10% interact with common pain relievers like ibuprofen or acetaminophen?

Official drug labeling focuses on interactions with CNS depressants and specific drug classes, and does not typically list interactions with non-opioid, over-the-counter pain relievers such as ibuprofen or acetaminophen. Patients should ensure their healthcare professional is aware of all products they are taking.


Q: Can people with asthma or other breathing issues need to be careful with Hustazol 10%?

Official precautions in the product information state that caution is officially required for patients who have a chronic cough that is associated with conditions like asthma or emphysema.


Q: Are there any major foods or drinks I should avoid while using Hustazol 10%?

Official labeling prohibits the consumption of alcoholic beverages during treatment because this combination can increase the risk of sedative side effects. Food and non-alcoholic drinks are generally documented to have no significant effect on the medicine’s efficacy.


Q: Is it normal to have a slight headache after taking Hustazol 10%?

Headache is included in clinical safety information as one of the possible nervous system effects associated with the use of Cloperastine. Any persistent or severe side effects should be brought to the attention of a healthcare provider.


Q: Is Hustazol 10% available over the counter, or do I need a prescription?

Official drug information sheets suggest that the product is typically a prescription-only medicine. This is indicated by the regulatory requirement that the dosing schedule must be supervised by a doctor.


Q: Does Hustazol 10% interact with herbal supplements or vitamins?

Official regulatory documents advise patients to inform their doctor or pharmacist of all products being used. This includes prescription medicines, over-the-counter drugs, supplements, and vitamins, as there is a potential for interaction.


Q: Is there a generic version of Hustazol 10% available?

Regulatory filings and published studies often include data on bioequivalence. The existence of these studies, comparing generic Cloperastine against the original formulation, suggests that generic forms of the active ingredient are available.


Q: Does Hustazol 10% affect blood pressure?

Clinical safety information indicates that Cloperastine can, in some cases, cause changes in heart rate or blood pressure. This is why caution is advised in regulatory documents for patients with pre-existing severe cardiovascular conditions.


Q: Does sunlight affect the safety or effectiveness of Hustazol 10%?

Official storage instructions require the medicine to be kept securely away from direct sunlight, heat, and moisture. This is a standard measure to maintain the quality, stability, and integrity of the drug product.


Q: Is there a risk of dependency or addiction with Hustazol 10%?

Cloperastine is a synthetic, non-opioid cough suppressant. Official pharmacology information notes that it is distinct from opioid-based cough medicines and is generally not associated with the same risk of dependency or addiction.


Q: Does Hustazol 10% interact with common cold or flu medications?

Cloperastine may interact with certain components of common cold or flu medications, especially those that contain other CNS depressants (like certain antihistamines) or anticholinergic drugs. Combining them may increase the risk of side effects like sedation.


Q: Is it better to take Hustazol 10% with food or on an empty stomach?

Official administration instructions, as defined in regulatory documents, specifically advise that Hustazol 10% should be taken before meals.


Q: Does Hustazol 10% expire, and how should I store it?

The drug product information always includes a defined shelf-life and expiration date, which is typically found on the packaging. Storage instructions require it to be kept away from sunlight, heat, and moisture, and securely out of the reach of children.


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How should Hustazol 10% be stored and disposed of?

Storage and Disposal Requirements

Official labeling for Hustazol 10% (Cloperastine Hydrochloride powder) requires specific environmental protection to maintain the product's integrity.

Classification Official Requirement
Environmental Protection Store away from direct sunlight, heat, and moisture.
Child Safety Keep out of the reach of children.
Disposal of Remainder Discard the remainder; do not store leftover product.

The regulatory documents define the storage conditions as protection from environmental factors, specifically requiring the powder to be kept away from heat, moisture, and direct sunlight. The medicine must be stored securely by being kept out of the reach of children. Regarding disposal, the official instruction is to discard any unused portion immediately, explicitly prohibiting the storage of remnants.

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

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