Стоптуссин

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Стоптуссин

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Method of action: Antitussive, Expectorant, Mucolytic

Treatment option: Cough

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 Стоптуссин

Property Description
Active ingredients Butamirate, Guaifenesin
Form Tablets, Oral drops, Oral solution (Syrup)
Pharmacological class Antitussive Agent, Expectorant
Common use Symptomatic relief of cough and chest congestion
Origin Synthetic (Butamirate), Semi-synthetic derivative (Guaifenesin)

The Dual-Action Nature of Стоптуссин

Стоптуссин is classified as a medicinal product designed for the symptomatic relief of cough, distinguished by its nature as a fixed-dose combination product that targets two distinct aspects of the coughing mechanism. This unique preparation integrates a central antitussive agent with a peripheral expectorant within a single medication. The formulation is used to manage the respiratory discomfort that often accompanies viral and bacterial infections. Its primary purpose is to address the involuntary, irritating cough reflex while simultaneously promoting the physiological clearance of phlegm from the airways.

Composition: Butamirate, Guaifenesin, and Forms

The medication's complementary therapeutic action is provided by its two active ingredients: Butamirate and Guaifenesin, which define its pharmacological class. Butamirate (typically as the citrate salt), a synthetic compound, functions as a central cough suppressant, working to reduce the cough-triggering signal. The secondary component, Guaifenesin (also known as Glyceryl guaiacolate), is a semi-synthetic derivative that serves as the mucoactive agent/expectorant. Within this combination, Guaifenesin helps thin and loosen mucus, which facilitates the body's natural clearance process. The expectorant action supports the flow of respiratory tract secretions, enabling a more productive cough.

Butamirate's classification as a non-narcotic central agent is a key differentiator, as it helps alleviate persistent coughing without the associated dependency risks of opioid-derived antitussives. Стоптуссин is formulated for oral administration and is available in several dosage forms, including tablets, oral drops (a liquid solution), and an oral solution (syrup), offering variations suitable for a wide range of patient preferences.

What side effects are possible with Стоптуссин?

Possible Side Effects and Safety Information

The official regulatory documentation for the combination of Butamirate and Guaifenesin primarily classifies adverse reactions as rare, meaning they are expected to affect a small fraction of individuals. These effects are generally grouped into disorders of the gastrointestinal, nervous, and immune systems.

Documented Adverse Reactions and Frequency

The most frequently classified adverse events are generally categorized as rare (may affect 1 to 10 patients in 10,000). These include dizziness, drowsiness, nausea, diarrhea, and itchy skin rash (urticaria).

Reactions affecting the immune system, such as severe hypersensitivity reactions, including anaphylactic reactions and angioedema (swelling), are considered serious adverse reactions. The frequency of these critical events is typically classified as not known, reflecting reliance on voluntary post-marketing reports.

Contextual Safety Restrictions

The dual action of this medicine imposes specific safety constraints documented in the regulatory labeling. The co-administration of other cough-suppressing medicines must be avoided. This restriction is necessary to prevent the risk of bronchial secretions accumulating in the airways, a consequence of the expectorant component (Guaifenesin) thinning the mucus while the central antitussive component (Butamirate) suppresses the cough reflex.

Furthermore, official safety notes require caution for patients with pre-existing hepatic (liver) or renal (kidney) impairment. Some liquid formulations contain ethanol (alcohol) as an excipient, which is a specific safety consideration for vulnerable populations such as those with liver disease or epilepsy.

Overdose and Emergency Response

Overdose Scope

Property Official Regulatory Statement
Documented overdose presentations Overdose is officially documented to present with gastrointestinal symptoms, including nausea, vomiting, and diarrhea, as well as central nervous system effects such as drowsiness and somnolence [Source 1.1].
Physiological systems affected (as stated in label) Adverse effects associated with overdose are documented to affect the Central Nervous System, the Gastrointestinal System, and the Cardiovascular System, specifically manifesting as hypotension (low blood pressure) [Source 1.1, 3.1].
Dose-related or exposure-related factors (if applicable) In cases of very high, prolonged exposure to the Guaifenesin component, the formation of renal calculi (kidney stones) is a potential severe outcome noted in regulatory information [Source 4.3].
Population-specific overdose notes (if applicable) No specific overdose considerations for pediatrics, hepatic, or renal impairment are explicitly documented within the overdose management sections of official labeling.
Emergency-response statements (as written in official documents) Management is defined as symptomatic and supportive treatment [Source 4.3]. Documented procedural assistance may include the use of activated charcoal and a saline laxative [Source 3.1]. No specific antidote is known for the active ingredients [Source 1.1].
When immediate medical help is required (label-derived phrasing only) Immediate medical attention must be sought in the event of an overdose [Source 1.1]. Patients should contact a poison center right away or seek hospital assistance when more than the recommended dosage has been taken [Source 3.1, 1.2].

Overdose Classifications (High-Level)

Property Official Regulatory Statement
Severity classification (as defined in official documents) Overdose manifestations are severe enough to require urgent medical help and appropriate monitoring of the patient's condition [Source 1.1, 3.1].
Regulatory basis (EMA / FDA / etc.) Based on official governmental prescribing information for the active components (Butamirate and Guaifenesin) [Source 1.1, 4.3].
Overdose-context constraints (as defined in official documents) Overdose symptoms are described as the combined known toxicological effects of the two active components [Source 1.1, 4.3].

Resulting Overdose Structure

Official overdose statements:

  • Overdose presents with documented signs of central and gastrointestinal distress, including somnolence, vomiting, and diarrhea [Source 1.1].
  • A known potential cardiovascular manifestation of overdose is hypotension (low blood pressure) [Source 3.1].
  • Immediate medical attention must be sought if an overdose is suspected, including contacting emergency services or a national poison control center [Source 1.1].
  • Management of overdose is limited to symptomatic and supportive treatment, as regulatory documents state that no specific antidote is known [Source 4.3, 1.1].
  • The potential for renal calculi is officially noted in situations involving prolonged excess of Guaifenesin [Source 4.3].

Connection to the overall overdose profile:

Regulatory documents define the overdose profile by listing specific documented clinical signs, including CNS depression and hypotension, which establish the basis for required emergency action. This profile dictates that immediate medical help must be sought for any suspected overdose, with management consisting strictly of supportive care due to the absence of a known specific antidote documented in the official labeling.

Therapeutic Uses of Стоптуссин

What Стоптуссин Treats: Main Uses and Benefits

Стоптуссин is commonly used to help with symptomatic relief for the dual discomfort of cough and chest congestion arising from acute respiratory illnesses. It is commonly applied in scenarios where symptoms interfere with daily functioning and create noticeable physiological strain. Medications in this class are applied to help relieve chest congestion and clear airways.

It is applied in acute conditions such as bronchitis, tracheitis, or the common cold, where patients experience a disruptive cough that is difficult to control. The combination product may assist with the reduction of the frequency and intensity of persistent, dry, or paroxysmal coughing episodes. This action contributes to improved comfort and minimizes the impact of coughing episodes on rest and sleep.

This combination is applied across domains where additional symptomatic support is needed for mixed symptom patterns, including the cough reflex and tenacious secretions.

In conjunction with cough suppression, the medication is considered relevant for managing symptoms of chest congestion marked by thickened mucus and phlegm buildup. This use assists with maintaining functional stability by helping to thin and loosen the tenacious secretions, thus promoting a more effective and productive cough. This action supports patients during episodes of heightened discomfort by easing the overall congestion burden.


Quick Fact: Relief for Heightened Symptoms

The medication is commonly used across conditions characterized by periods of heightened symptoms that involve both an irritable cough and thick, difficult-to-clear mucus.

Regulatory References

  1. NIH MedlinePlus overview of expectorants

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Стоптуссин — Official Regulatory Information

The eligibility profile for Стоптуссин (Butamirate/Guaifenesin) is strictly defined by regulatory documentation, establishing who is permitted or restricted from using the medicine.


Eligibility scope
Populations for whom use is allowed: Adults and adolescents from 12 years of age (tablets/solution); children from 6 months of age (liquid drops/solution).
Populations for whom use is contraindicated: Patients with known hypersensitivity to Butamirate or Guaifenesin; children under 12 years (tablets) or under 6 months (liquid); patients with hereditary glucose-galactose malabsorption.
Populations for whom use is not recommended: Pregnant individuals during the first trimester.

Condition-Specific Eligibility Rules
Pregnancy and Lactation: Use is not recommended during the first trimester. During the second and third trimesters, and while breastfeeding, use is generally permitted only in unavoidable cases after careful assessment.
Comorbidities: Caution is advised for patients with alcoholism, liver disease, or epilepsy when using liquid formulations containing ethanol. Caution is also advised for diabetics due to sugar content in liquid forms.
Restrictions: Must not be used simultaneously with other cough suppressants or cold medicines containing similar ingredients.

Connection to the overall eligibility profile

Official regulatory documents strictly define who can and cannot use the medicine by establishing absolute contraindications based on age, hypersensitivity, and excipient-related metabolic disorders. Eligibility is further structured by conditional limitations concerning organ function and reproductive status, clarifying that for these groups, use is only permitted under specific, labeled constraints.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The official regulatory profile for Стоптуссин defines specific interaction risks across pharmacodynamic, pharmacokinetic, and procedural domains.

Interaction Scope

Detail Statement (Based on Regulatory Labeling)
Medicinal product categories with documented interactions: Expectorant/Mucolytic Agents; Strong enzyme inhibitors; Medicinal products with a narrow therapeutic index; CNS Depressants.
Mechanistic basis of interactions: Pharmacodynamic (Inhibition of the cough reflex); Pharmacokinetic (Possible risk of increased exposure via enzyme inhibition).
Population-specific interaction notes: Patients with renal and/or liver disease may be at greater risk for adverse effects due to drug and metabolite accumulation.
Interaction-related restrictions: Concomitant use with Expectorant/Mucolytic Agents must be avoided. Co-use with strong enzyme inhibitors and narrow therapeutic index drugs is not recommended.

Official Interaction Statements

  • Concomitant use of Expectorant/Mucolytic Agents is officially restricted and must be avoided due to the central component's inhibition of the cough reflex, which may lead to the accumulation of mucus in the respiratory tract.
  • Co-administration with strong enzyme inhibitors is not recommended due to the possible risk of increased systemic exposure of Butamirate.
  • The use of Central Nervous System (CNS) Depressants, including alcohol, may result in an enhancement of sedative effects.
  • The Guaifenesin component may interfere with specific laboratory tests, causing falsely elevated results for 5-HIAA and VMA. Food does not affect Guaifenesin absorption.

The overall interaction structure is defined by official constraints on co-administration based on conflict (expectorants) and altered systemic exposure risk (enzyme inhibitors). Procedural constraints also apply to certain diagnostic testing due to the analytical interference documented for the expectorant component.

Mechanism of Action

Central Neural Inhibition of the Cough Reflex

The central inhibitory mechanism involves Butamirate directly engaging the Cough Center in the medulla oblongata of the brainstem . This interaction modulates the neural reflex arc by decreasing its sensitivity and excitability to afferent inputs. By acting on this regulatory system, the mechanism influences the downstream consequences of elevated reflex activity, resulting in a functional shift that leads to a reduced frequency and intensity of neural cough signaling.


Peripheral Modulation of Secretion Dynamics

The complementary expectorant action is driven by Guaifenesin, which initiates a reflex via gastric vagal receptors, resulting in increased water secretion into the respiratory tract. This physiological response thins the secretions by reducing their viscosity and adhesiveness. This enhanced hydration, combined with the peripheral effect of Butamirate modulating bronchial smooth muscle tone to reduce airway resistance, enhances the functional capacity of mucociliary transport and secretion clearance.


Coordinated Dual-Action Mechanism

This fixed-dose combination leverages a coordinated dual-action to manage both the neural signal and the physical characteristics of secretions. Butamirate addresses the excessive central reflex drive, while Guaifenesin ensures that essential airway secretions are thinned and mobilized. This synergy functionally coordinates the inhibition of the central signal with the mobilization of secretions, mitigating the potential for secretion retention that may follow isolated central suppression.

Dosage and Administration Information

How to Use Стоптуссин: Official Administration Guidelines

Administration of Стоптуссин (Butamirate/Guaifenesin combination) is governed by official prescribing instructions that detail the proper administration route, dosing, frequency, and duration of use. The medication is designated for oral administration in all its approved forms, including tablets, oral drops, and oral solution (syrup).


Labeled Dosing and Frequency

Official dosing for the liquid form is typically based on body weight to ensure appropriate delivery of the active ingredients. The medication must be taken multiple times daily. Prescribing specifications indicate that an interval of at least 4 to 6 hours must be maintained between individual doses.

Patient Body Weight Dosing Frequency
Adults (40 kg and up) 3 to 4 times daily

Administration Conditions and Constraints

The prescribing instructions require that the dose must be administered after meals. When taking the liquid form, the patient must use the provided measuring cup or dosing pipette to ensure accurate measurement and should swallow the dose with an ample amount of liquid (such as water or tea).

Pediatric and Course Duration Rules

Стоптуссин is authorized for use in pediatric patients starting from 6 months of age, with specific dosing regimens calculated strictly by weight tier. A key procedural constraint established by product guidelines is the duration of self-treatment. The medicine should not be used for more than 7 consecutive days without medical re-evaluation, thereby defining its intended short-term usage pattern.

Recent Clinical Evidence

Research evidence / Overview of studies for Стоптуссин

Research Evidence for Relief of Dry, Irritable Cough

Studies explored the antitussive component in a number of randomized controlled trials (RCTs) and other comparative studies. These investigations explored the component in relation to symptoms characteristic of acute respiratory disorders and certain chronic conditions. The studies primarily focused on outcomes related to physical discomfort, specifically measuring changes in the frequency and intensity of coughing episodes over short-term observation periods. Researchers also utilized specialized challenge tests to monitor how the component was observed in affecting the body's cough reflex sensitivity.

The findings describe patterns observed in the studies that measured patient-reported cough severity and frequency. However, when researchers examined the cough reflex in laboratory settings using healthy volunteers, the findings were mixed; some studies reported observed patterns related to reflex activity while others data show patterns related to no significant difference compared to control groups (such as placebo) in healthy volunteer cohorts. Evidence contributes to understanding short-term changes in patients experiencing conditions characterized by fluctuating or episodic manifestations of cough.

Studies on Relief from Chest Congestion and Thick Mucus

The research base for the expectorant component was explored in systematic reviews and short-term randomized controlled trials. These studies were conducted during periods of increased symptom activity where patients were experiencing symptoms linked to acute upper respiratory tract infections or stable chronic bronchitis. The outcomes monitored included patient-reported outcomes describing perceived discomfort, such as the subjective ease of expectoration, and objective measures, such as assessments of sputum viscosity and volume.

When researchers summarized the trials, the findings were mixed regarding measured outcomes related to cough frequency and the subjective experience of clearing phlegm. Some studies reported measured changes related to sputum thickness over short periods, which contributes to the broader evidence landscape. Because the evidence quality varies across studies, the certainty remains low for some of the key functional outcomes.

Research Evidence on the Fixed-Dose Combination

Clinical research for the fixed-dose combination of the antitussive and the expectorant was studied for overall symptom management in patients presenting with a mixed pattern of cough and congestion. The evidence relevant in trials assessing the combination research describes the combined endpoints used for regulatory approval of the product. Published information available data show patterns related to extrapolation from the known properties and monotherapy studies of the two individual active components.

High-quality randomized controlled trials (RCTs) are lacking that directly investigate the comparative efficacy of this particular fixed-dose medication. Research examining the simultaneous use of the two components remains limited.

Key Studies & References

  1. Over-the-counter (OTC) medications for acute cough in children and adults: a systematic review of the efficacy and safety
  2. Guaifenesin MedlinePlus Drug Information (Expectorant Overview)

Frequently Asked Questions (FAQ)

Common questions about Стоптуссин (FAQ)

Q: Is Стоптуссин the same as other cough suppressants?

Official information describes this medicine as a dual-action product. It combines a non-narcotic central cough suppressant, Butamirate, with an expectorant, Guaifenesin. This formulation is described as designed to both reduce the intensity of the cough reflex and help thin and loosen secretions in the airways.


Q: Is it safe to take Стоптуссин before driving or operating machinery?

Regulatory documents advise caution regarding activities that require mental alertness. This is due to the possible adverse effects of drowsiness or somnolence (a sleepy state) which are listed in the safety information. Official information indicates that activities requiring mental alertness, such as driving or operating heavy machinery, should be avoided if drowsiness or somnolence is experienced.


Q: Are there long-term safety data available for Стоптуссин?

According to official regulatory guidance, the use of antitussive medicines is intended for the short-term management of symptoms. The medication is generally not intended for use for prolonged periods. The label specifies a duration constraint on self-treatment before re-evaluation.


Q: What is the general expectation for cough relief after starting Стоптуссин?

Studies and product information indicate that the active component Butamirate citrate is rapidly absorbed by the body. The time to onset of action for the Butamirate component is noted in official documents as potentially being within 30 minutes of the first administration. This timeframe provides a general indication of when the central cough-suppressing effect may begin.


Q: Is Стоптуссин a long-acting or short-acting medicine?

The active component Butamirate has an elimination half-life of approximately 13 hours. Standard formulations require administration multiple times daily to maintain symptomatic effect, consistent with the reported half-life. Therefore, the medicine is intended to be taken periodically to maintain the symptomatic effect.


Q: Is Стоптуссин available without a prescription?

The Guaifenesin component is widely available over-the-counter (OTC) in many regions. The specific regulatory status of the combination product (Butamirate/Guaifenesin) varies across different international jurisdictions. However, in many areas where it is approved, the combination product is frequently made available without a prescription.


Q: Can I take Стоптуссин if I have asthma or other breathing problems?

Official safety documents state that caution is advised for patients with pre-existing breathing conditions. This includes chronic obstructive pulmonary disease (COPD) and asthma. These documents clarify that use requires consideration due to these conditions.


Q: What happens if I miss a dose of Стоптуссин?

As the medicine is intended for symptomatic relief, use is typically limited to when needed. Official guidance in the product labeling includes a specific warning against taking a double dose to compensate for a missed one. The prescribed interval between administrations is defined in the instructions.


Q: Can Стоптуссин be used by elderly people?

General information regarding the Guaifenesin component suggests that this ingredient is not expected to cause different side effects or problems in older people than it does in younger adults. Usage is typically guided by general adult dosing principles listed in the official patient information.


Q: Does Stoртуссин interact with common pain relievers like ibuprofen?

Official regulatory documents define specific interaction risks across various drug categories. However, there are no known specific interactions listed between the components Butamirate/Guaifenesin and common non-steroidal anti-inflammatory drugs (NSAIDs) like ibuprofen.


Q: What interactions does Stoртуссин have with herbal supplements?

Official product information does not list specific, identified interactions with herbal supplements. However, the general warning text includes the necessity of disclosing all herbal products being taken to a healthcare provider.


Q: What should I do if I experience an unusual side effect while taking Стоптуссин?

Official patient information provides guidance on when to seek assistance. The information specifies that contact with a healthcare provider is warranted if the cough lasts longer than seven days, returns, or if unusual symptoms such as a fever, rash, or persistent headache develop.


Q: Is Стоптуссин sold under different names in other countries?

Yes, the core active ingredient, Butamirate, is marketed internationally under various trade names. Examples of these alternative names, depending on the country, include Sinecod, Codesin, and Pertix.


Q: What information do official labels provide about overdosage?

Official documents list potential symptoms of overdose, which can include somnolence (drowsiness), nausea, vomiting, dizziness, and low blood pressure. If an overdose is suspected, official guidance states that treatment is supportive and necessitates the involvement of immediate medical care.


Q: Can I crush or chew the Стоптуссин tablets?

For certain tablet forms of the active ingredients, such as extended-release formulations, official instructions explicitly advise against chewing, cutting, or crushing them. Altering the physical form may affect how the medicine is absorbed and functions in the body.

How should Стоптуссин be stored and disposed of?

Official Storage and Disposal Requirements

The storage of Stoptussin (Butamirate/Guaifenesin) must strictly follow the conditions defined in the regulatory labeling to maintain product stability and efficacy.

Storage Conditions

  • Temperature: Store the medicinal product at a temperature up to 25°C.
  • Protection: The product must be protected from cold and frost.
  • Child Safety: Keep the medicine out of the sight and reach of children.
  • Stability: Stoptussin oral drops must be discarded 28 days after first opening the bottle, regardless of the remaining volume.

Disposal Instructions

Official instructions mandate that medicines must not be thrown away via wastewater or household waste. Unused or expired Stoptussin must be disposed of according to local regulations, and the user is directed to ask a pharmacist for guidance on proper disposal.

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

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