Кофасма

Quick links to important sections

Кофасма

Selected form

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 Кофасма

Quick Facts

Property Description
Active Ingredient(s) Salbutamol, Bromhexine, Guaifenesin, Racementhol
Form Syrup / Oral Solution
Pharmacological Class Respiratory Combination Agent
General Purpose Relieves bronchospasm and mobilizes thick mucus
Origin Primarily Synthetic

What Type of Medicine is Кофасма?

Кофасма is defined as a fixed-dose combination product, typically available as an oral solution or syrup, placing it in the broader Pharmacological Class of Respiratory Combination Agents. Its formulation integrates four distinct active ingredients, providing a comprehensive action profile that differs significantly from preparations containing only a single active compound. This multi-agent structure is supported by pharmacological studies demonstrating the utility of combining respiratory agents for conditions characterized by both airway restriction and the presence of viscid mucus.

Composition and Integrated Functionality

The active core of Кофасма consists of the bronchodilator Salbutamol, the mucolytic agent Bromhexine, the expectorant Guaifenesin, and the localized soothing agent Racementhol. The inclusion of Salbutamol, globally recognized as a standard therapy for acute airway constriction, provides a critical differentiating factor, ensuring simultaneous management of bronchospasm. Furthermore, the combination of expectorant and mucolytic properties is clinically recognized for its ability to address both the stickiness and the volume of respiratory secretions.

General Purpose of the Combination

The general purpose of the formulation is to provide synchronized relief from the two primary physical issues in many bronchopulmonary disorders: the narrowing of the air passages and the difficulty in expelling accumulated mucus. By pairing the airway-relaxing effects of the bronchodilator with agents that actively modify and clear phlegm, the product is engineered to promote more effective phlegm clearance, ultimately improving ease of breathing and successfully managing chest congestion.

Regulatory References

  1. DailyMed: Bromhexine Label

What side effects are possible with Кофасма?

Possible Side Effects and Safety Information

The safety characteristics of this fixed-dose combination are primarily related to the bronchodilator component, Salbutamol, and are formally classified by frequency and System-Organ Class (SOC) in official regulatory documents. Adverse reactions are grouped across the Nervous System, Cardiovascular, and Gastrointestinal domains.


Official Adverse Reactions and Frequency

Classification Representative Effects
Common Fine finger tremors and headache are the most frequently documented nervous system effects.
Uncommon Palpitations, a change in heart rhythm perception.
Rare Hypersensitivity reactions (including urticaria or angioedema), tachycardia (increased heart rate), and muscle cramps.
Very Rare Cardiac arrhythmias and paradoxical bronchospasm (a severe, unexpected airway narrowing). Low serum potassium levels, or hypokalemia, is also classified here.

Safety Constraints and Special Populations

Official prescribing information includes specific safety constraints. Effects like tremor and tachycardia are documented as being typically dose-related and are more common during the initiation of treatment or dose escalation. Regulatory documents advise caution for individuals with pre-existing cardiovascular disorders or a history of peptic ulceration. Safety considerations also restrict use in certain populations: the medicine is not recommended for use in pregnancy, and caution is advised for patients with severe hepatic or renal impairment due to metabolic pathways. Safety and effectiveness in children under the age of two years have not been adequately demonstrated.

Overdose and Emergency Response

Overdose and When to Seek Help

Immediate medical attention must be sought in all cases of suspected overdose. The official regulatory response advises contacting a national poisons centre, where available. This requirement is driven by the serious clinical and metabolic risks defined in regulatory documentation.

Documented Manifestations

The most common signs of overdose are documented as transient beta agonist pharmacologically mediated events. These include tachycardia (fast heart rate), tremor, and hyperactivity. Symptoms of acute toxicity may also involve gastro-intestinal discomfort, nausea, and drowsiness. Overdose may also lead to severe metabolic effects, specifically hypokalaemia (abnormally low serum potassium levels).

Treatment and Urgent Action

Management of overdose is officially described as symptomatic and supportive treatment. A cardioselective beta-blocking agent is documented as the preferred antidote for severe symptoms. Regulatory constraints specify that the administration of this preferred antidote must be performed with caution in any patient with a history of bronchospasm. The required emergency actions are established by these documented clinical and metabolic risks.

Therapeutic Uses of Кофасма

What Кофасма Treats: Main Uses and Benefits

The medication is commonly used to help with symptom management in respiratory conditions where patients experience both constricted airways and accumulated thick mucus. The combination may be part of symptomatic management for conditions such as bronchitis, bronchial asthma, emphysema, and other bronchopulmonary disorders—specifically where bronchospasm, mucous plugging, and problems of expectoration co-exist.

This therapeutic approach is applied across domains where additional symptomatic support is needed. It is relevant for easing symptoms that cluster into patterns requiring supportive management, such as wheezing, chest tightness, and a productive cough that causes strain. The medication contributes to improved comfort during periods of heightened symptoms and assists with maintaining functional stability.

Quick Fact: Addressing Dual Respiratory Strain

“The goal is applied in addressing the cluster of symptoms related to both airway restriction and excessive mucus, thereby assisting with maintaining functional stability.”

Eligibility and Restrictions for Use

Who can and cannot use Кофасма? — Official Regulatory Information

This section outlines the officially documented population eligibility and non-eligibility for the medicine, based strictly on government regulatory documents.


Eligibility Scope

Scope Item Official Regulatory Statement
Populations for whom use is allowed (as stated in label): Adults, Adolescents, and Children aged 6 years and older.
Populations for whom use is not recommended (if applicable): Use in children between 2 and 6 years is conditional and only recommended under the advice of a healthcare professional.
Populations for whom use is contraindicated: Individuals with Hypersensitivity to any component; Children under 2 years of age; individuals who are pregnant or lactating.
Age-related eligibility rules: Prohibited for those under 2 years; Established use for those 6 years and older.
Condition-specific eligibility rules: Contraindicated in severe cardiovascular disorders, decompensated diabetes mellitus, Thyrotoxicosis, and active gastric or duodenal ulcers. Caution required for patients with severe renal or hepatic impairment.
Pregnancy and lactation eligibility status (if explicitly documented): Contraindicated.
Eligibility-related restrictions: Caution is mandatory for patients with Hypertension and a history of peptic ulceration.

Eligibility Classifications (High-Level)

Classification Item Official Regulatory Statement
Eligibility severity classification (as defined in official documents): Absolute Contraindication and Conditional Use categories define restrictions.
Regulatory basis (EMA / FDA / etc.): Summary of Product Characteristics (SmPC) from various National Regulatory Authorities.
Eligibility-context constraints (as defined in official documents): Constraints are primarily linked to age thresholds, underlying organ function, and metabolic/cardiac stability.

Resulting Eligibility Structure

Official eligibility statements:

  • Use is absolutely contraindicated for children under two years and for individuals with known hypersensitivity to the medicine's ingredients.
  • The product is contraindicated for individuals who are pregnant or breastfeeding, as documented in regulatory guidelines.
  • Specific comorbidities, including severe cardiovascular disease and decompensated diabetes mellitus, define non-eligibility.

Connection to the overall eligibility profile: Regulatory documents establish that use is only approved for patients aged 6 and older; they define restrictions through absolute contraindications based on age, reproductive status, and severe pre-existing cardiac or metabolic instability. Furthermore, conditional use is required when treating individuals with severe impairment of kidney or liver function.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Official regulatory documentation identifies specific patterns of interaction based on the combination of active ingredients in Кофасма.

Documented Interaction Restrictions

Interaction Type Interacting Substances/Categories Regulatory Status/Outcome
Pharmacodynamic Antagonism Non-selective Beta-blockers Contraindicated due to risk of inducing severe bronchospasm.
Pharmacodynamic Potentiation Monoamine Oxidase Inhibitors (MAOIs) Prohibited (co-administration or within 14 days) due to risk of potentiated cardiovascular effects.

Clinically Significant Interactions

Co-administration with Non-Potassium Sparing Diuretics may result in an additive pharmacodynamic effect, leading to or worsening hypokalemia (low potassium levels). The Salbutamol component is officially reported to decrease the plasma concentration of Digoxin. Use with other Sympathomimetic Agents or Tricyclic Antidepressants carries the risk of additive cardiovascular effects. The Bromhexine component can increase the concentration of certain Antibiotics in bronchial secretions.

Product Interference

The Guaifenesin component of this medication may interfere with certain urinary diagnostic tests for 5-HIAA and VMA, potentially leading to inaccurate results. Caution is also noted regarding the co-use of alcohol, which may enhance any minor Central Nervous System depressant effects documented for respiratory combination agents.

Mechanism of Action

Airway Smooth Muscle Relaxation

This mechanism involves the drug acting as an agonist on beta-2 adrenergic receptors (beta2 receptors) found primarily on the airway smooth muscle cells. Activation of these receptors initiates the cyclic AMP ( cAMP) signaling cascade, which decreases the activity of the proteins responsible for muscle contraction. This molecular cascade leads to the physiological consequence of bronchodilation, increasing the diameter of the air passages.


Secretion Thinning and Airway Clearance

The drug also engages two complementary actions to regulate respiratory fluid. It acts as an antagonist on muscarinic receptors on submucosal glands, which reduces the volume of thick, viscous secretions. Simultaneously, it modulates ion transport channels in the airway epithelium, increasing the fluid content lining the airways. These combined actions function to increase the rate of mucociliary clearance, contributing to the displacement of accumulated material from the respiratory system. The resulting profile is shaped by the simultaneous modulation of distinct intracellular pathways, including cAMP for muscle tone and Ca^2+ for glandular secretion.

Dosage and Administration Information

How to use Кофасма

The usage of Кофасма, a combination product containing Salbutamol, Bromhexine, Guaifenesin, and Menthol, follows a defined set of administration principles. This medicine is strictly administered via the oral route as a syrup or oral solution.

Official Administration Protocol

The primary procedural requirement specifies that the container must be shaken well before each use to ensure proper mixing of the active ingredients. The medicine is typically structured around a thrice daily schedule, meaning the dose is taken three times throughout the day, irrespective of food intake, as this is not consistently specified in the posology.

Labeled Dosing Regimens

The volume of the oral solution administered is based on the patient's age and is defined in milliliters (ml) according to the product labeling. Dosing recommendations follow these standardized regimens:

Population Labeled Dosage Volume (per dose) Frequency
Adults 10 ml to 20 ml Thrice daily
Children (6 to 12 years) 10 ml Thrice daily
Children (Under 6 years) 5 ml to 10 ml Thrice daily

Pediatric Use Constraints

Prescribing information includes a specific constraint regarding use in very young children: the safety and effectiveness of this combination formula have not been adequately demonstrated for use in children under two years of age. This limitation guides the standardized administration of the product within the pediatric population. The overall use protocol is defined by the required oral form, the fixed thrice daily frequency, and the specified volume based on the recipient's age.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Кофасма

This overview summarizes the formal clinical research that has examined Кофасма. It focuses on what types of studies have been conducted, the areas they monitor, and where research remains limited, without providing any medical or usage advice.


Evidence for Use in Acute Bronchopulmonary Disorders

Research exploring this fixed-dose combination (FDC) was primarily studied in contexts exploring how symptoms change over time in acute conditions like acute bronchitis or episodes of heightened symptom activity associated with chronic breathing issues.

Studies conducted during periods of increased symptom activity have included short-term Randomized Controlled Comparative Studies (RCTs). These research efforts did not often compare the FDC against a neutral placebo, but rather against similar formulas containing fewer active ingredients. Studies applied in research contexts involving fluctuating or unstable symptoms monitored outcomes related to physical discomfort, such as measures of cough severity and frequency, and assessments of sputum characteristics.

Research describes patterns related to changes measured during the short study period, including assessments of difficulty in expectoration and cough frequency. Research provides insight into short-term changes only.


Evidence Landscape for Chronic Respiratory Conditions

Research has also explored researching this combination in the context of mathbfchronic airway-obstructive disorders, such as chronic bronchitis or emphysema (forms of COPD), specifically when patients experience an acute flare-up or episodic symptoms.

Evidence is less often based on dedicated Randomized Controlled Comparative Studies of the FDC itself. Instead, research often relies on observational data collected during periods of heightened symptom activity and evidence from studies where the bronchodilator component (Salbutamol) was evaluated in acute airway restriction. Studies explored functional outcomes, such as changes in objective measurements of FEV1 during these acute episodes.

Understanding the Research Gaps and Uncertainties

A major limitation is the reliance on comparative evidence against other active medicines rather than neutral placebo studies, which contributes to the difficulty in contextualizing the research findings for the combined agents. The typical observation period was short-term, usually lasting seven to fourteen days, meaning long-term effects are not fully established and data for certain subgroups like pediatric populations remain insufficient.

Key Studies & References

  1. Systematic review of randomized controlled trials of over-the-counter cough medicines for acute cough in adults
  2. A systematic review of the efficacy and safety of guaifenesin

Frequently Asked Questions (FAQ)

Common questions about Кофасма (FAQ)


Q: Is Кофасма intended for long-term or short-term treatment?

Regulatory documents generally indicate that the use of similar combination medicines is limited to short-term periods, often around 4 to 5 days. It is important to review the product information regarding when to consult a healthcare professional if symptoms persist beyond that timeframe.

Q: Why is Кофасма prescribed instead of its alternatives?

According to official product information, this drug is formulated as a fixed-dose combination to provide synchronized relief. It integrates a bronchodilator, a mucolytic, and an expectorant in a single product to address multiple symptoms at once.

Q: Does Кофасма treat the underlying cause or just the symptoms of the condition?

Official documentation indicates the product is used for the symptomatic relief in the treatment of productive cough and airway restriction. This means its primary function is addressing the physical discomfort and airway obstruction rather than curing the underlying cause.

Q: How often do people experience fatigue or dizziness while taking Кофасма?

Dizziness is listed as a possible undesirable effect in regulatory texts, and fatigue has been reported in isolated cases. The frequency of these effects is generally classified as mild or unknown.

Q: What is the typical timeframe for common side effects of Кофасма to subside?

Official regulatory information states that common side effects, such as tremor and increased heart rate, are often reported to be temporary, typically resolving after initial use. These effects are often more noticeable when treatment is first initiated.

Q: Is it typical to experience mild digestive upset when first starting Кофасма?

Gastrointestinal discomfort, which may include nausea, vomiting, or abdominal pain, has been occasionally reported as an undesirable effect. This type of effect is particularly noted as being associated with the Guaifenesin component of the medicine.

Q: What are some general signs of a potentially serious side effect from Кофасма?

Signs of potentially serious effects described in official safety documents include an irregular or noticeably fast heartbeat that does not resolve, or severe dizziness. Other reported signs are swelling of the face, lips, mouth, or throat, or sudden new or worsening shortness of breath.

Q: Does Кофасма have any known effect on a person's sleep quality?

The bronchodilator component, Salbutamol, is officially reported to cause undesirable effects such as restlessness and tension. These effects may potentially lead to disturbances in sleep patterns.

Q: Are there any known major food or drink restrictions while taking Кофасма?

Official regulatory documents caution against the co-use of alcohol, which may enhance any minor effects on the nervous system. There are typically no specific food restrictions widely noted in the official prescribing information.

Q: Is it generally acceptable to consume alcohol in moderation while on Кофасма?

Regulatory information advises caution regarding the co-use of alcohol. This is because alcohol has the potential to enhance minor Central Nervous System (CNS) depressant effects that are documented for respiratory combination agents.

Q: What types of common over-the-counter (OTC) medicines should be checked for interactions with Кофасма?

Official caution is noted for OTC products containing other sympathomimetic agents (such as decongestants). These products carry the risk of additive cardiovascular effects when co-administered.

Q: How does Кофасма potentially affect the action of other chronic prescription medications?

The product may affect other chronic medications by increasing the risk of low potassium (hypokalemia) when used with certain diuretics. It also has the potential to potentiate cardiovascular effects when combined with certain types of antidepressants.

Q: Are there any documented interactions between Кофасма and herbal remedies?

According to regulatory sources, there is insufficient information available to confirm the safety of using complementary medicines, herbal remedies, and supplements with the active ingredient Salbutamol. Official guidance does not establish safe use for these combinations.

Q: Does taking Кофасма affect a person's ability to drive or use heavy machinery?

Official documents advise caution regarding driving or operating heavy machinery. This is due to potential side effects like dizziness and tremor that may affect physical ability.

Q: What is the typical amount of time it takes to notice the intended effects of Кофасма?

The bronchodilator component (Salbutamol oral form) is reported to have effects that occur within approximately 15 minutes of administration. These effects typically last for about 4–6 hours.

Q: What is the general guidance if a person misses a single dose of Кофасма?

Regulatory guidance for a missed dose is to take it as soon as it is remembered. However, official guidance is to skip the missed dose if it is almost time for the next scheduled dose. A double dose must not be taken to compensate.

Q: Is it possible for the effectiveness of Кофасма to decrease over time?

Regulatory information for the bronchodilator component indicates that a sudden or frequent increase in the required dose suggests a deterioration of the underlying condition or loss of symptom control over time.

Q: Does the medicine need to be gradually stopped, or can its use be discontinued immediately?

Regulatory information advises against stopping the medicine unless directed by a healthcare professional. Abruptly discontinuing the medicine could lead to the worsening of symptoms.

Q: What is the recommended storage temperature and shelf life for Кофасма?

Official documents mandate that the product be stored below 30 C and kept protected from light in its original packaging. The medicine must not be exposed to temperatures exceeding this limit.

Q: Is Кофасма generally considered a suitable option for people over 65?

Regulatory documents advise that for elderly patients, or those who may be unusually sensitive, treatment should be initiated with a lower starting dose. This practice acknowledges the need for caution in this population.

Q: What research has been conducted on the effects of Кофасма across different patient demographics?

Clinical research has primarily studied the effects in adults during acute conditions. Regulatory documents specifically state that data for certain demographic subgroups, such as the pediatric population, remain insufficient.

How should Кофасма be stored and disposed of?

The storage and disposal of this combination syrup must strictly follow the official instructions provided in the regulatory labeling.

Required Storage Conditions

Regulatory documents mandate that the product be stored below 30 C and that the container be protected from light. To maintain product stability, the medicine must be kept in its original packaging throughout its use. The oral solution must not be exposed to temperatures exceeding the 30 C maximum limit.

Child Safety and Disposal

For safety, the official label requires that the medicine is kept out of the sight and reach of children at all times. Regarding disposal, the product is typically not classified as hazardous waste, and official instructions direct users to discard any unused or expired product according to local regulatory guidelines for pharmaceutical waste.

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

Available in countries:

Equivalent of Кофасма found in:

A-Z Index: