Cinfatos Expectorante

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Cinfatos Expectorante

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Method of action: Antitussive

Treatment option:

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Overview of Cinfatos Expectorante

Property Description
Active ingredient Dextromethorphan Hydrobromide, Guaifenesin
Form Solución Oral (Syrup)
Pharmacological class Antitussive and Expectorant Combination
Common use Symptomatic management of cough with phlegm
Origin Synthetic

What Type of Medicine is Cinfatos Expectorante?

Cinfatos Expectorante is a recognized brand of combination medicine administered via the oral route, typically supplied as a Solución Oral (syrup) formulation by the Cinfa laboratory. It is classified within the pharmacological group of combinations of cough suppressants and expectorants, indicating a dual mechanism of action. This classification signifies that the product is formulated to address two distinct, yet often related, respiratory symptoms: a persistent, irritating cough and the presence of accumulated thick mucus.

This integrated approach defines the medicine's identity, providing a unified therapeutic strategy for managing both irritation and chest congestion.


The Composition of Dextromethorphan and Guaifenesin

The therapeutic action of Cinfatos Expectorante is derived from its two key active ingredients: Dextromethorphan Hydrobromide and Guaifenesin. Both are synthetic compounds used for managing cough symptoms. The formulation is specifically positioned for use in adults and adolescents, and its syrup format often includes specific flavorings designed for patient compliance. Dextromethorphan Hydrobromide functions as the antitussive component, while Guaifenesin serves as the expectorant, a pairing designed to provide complementary effects on respiratory symptoms.


What is the General Therapeutic Purpose of the Dual Formula?

The general therapeutic purpose is the simultaneous symptomatic management of respiratory discomfort when a cough is accompanied by excessive mucus production. The Dextromethorphan component works to reduce the frequency of the cough, offering relief from irritation. Concurrently, the Guaifenesin acts as a mucoactive agent to thin and loosen tenacious bronchial secretions. This strategy ensures the medicine is designed to both calm the cough and enhance the body's natural ability to clear the congested airways through more productive expectoration.

Regulatory References

  1. AEMPS Technical Data Sheet (Ficha Técnica)
  2. MedlinePlus Dextromethorphan Information
  3. NIH StatPearls Dextromethorphan/Guaifenesin
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What side effects are possible with Cinfatos Expectorante?

Possible side effects and safety information

Regulatory documents classify the adverse reactions associated with Dextromethorphan and Guaifenesin based on frequency and the physiological system affected. The most frequently documented adverse reactions typically involve the nervous system and the gastrointestinal tract.


Adverse Reactions and System-Organ Classes

The following are officially documented adverse reactions, grouped by the affected organ system as classified in regulatory safety profiles:

System-Organ Class Common Adverse Reactions Uncommon / Not Known Adverse Reactions
Nervous System Dizziness, Drowsiness, Headache Confusion, Restlessness
Gastrointestinal Nausea, Vomiting, Abdominal Discomfort Diarrhea
Immune System Rash, Urticaria (Hives)

Serious Safety Considerations

The official safety documentation highlights the potential for severe allergic reactions, including anaphylaxis and angioedema (swelling of the face, tongue, or throat), which are classified as serious adverse reactions. A critical safety constraint is the explicit prohibition of concurrent use with, or within 14 days of stopping, Monoamine Oxidase Inhibitors (MAOIs), as this combination carries the risk of a severe drug reaction known as Serotonin Syndrome.


Population and Regulatory Constraints

Safety constraints noted in official labeling include the general restriction of these products to adolescents and adults, with specific age restrictions applicable. Caution is advised for patients with pre-existing conditions such as chronic bronchitis or asthma. For individuals with Phenylketonuria (PKU), a note regarding the presence of phenylalanine sources (e.g., aspartame) in certain syrup formulations is included as a safety consideration.

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Overdose and Emergency Response

Overdose and when to Seek Help: Official Regulatory Profile

Official regulatory documents emphasize that an overdose of Dextromethorphan and Guaifenesin requires immediate medical intervention due to the potential for serious toxicity from the cough suppressant component.


Documented Overdose Manifestations

Category Official Regulatory Documentation Statement
Documented overdose presentations Overdose manifestations primarily include CNS effects (e.g., drowsiness, dizziness, confusion, unsteadiness, hallucinations), gastrointestinal effects (nausea, vomiting), and signs of excitation (e.g., muscle twitches, rapid heartbeat).
Physiological systems affected Central Nervous System (CNS), Respiratory System, and Cardiovascular System (evidenced by tachycardia and blood pressure changes).
Severe outcomes Documented life-threatening risks include respiratory depression (especially in young children), seizures, coma, and the potentially fatal condition, Serotonin Syndrome.
Emergency-response statements Regulatory guidance mandates: Seek professional assistance immediately and Call a Poison Control Center right away.

Management and Urgent Help Requirements

Category Official Regulatory Documentation Statement
Immediate medical help required Immediate medical attention is required for any suspected overdose or accidental poisoning, particularly if the person has collapsed, has a seizure, or is experiencing difficulty breathing.
Supportive management Treatment in a professional setting is symptomatic and supportive, including monitoring of vital signs and, if warranted, administration of activated charcoal. Naloxone may be used to reverse Dextromethorphan-induced CNS or respiratory depression.

The regulatory guidance defines the overdose profile primarily through the risk of CNS toxicity and the potential for life-threatening systemic outcomes like respiratory depression and Serotonin Syndrome. This elevated risk is the sole basis for the official mandate that immediate medical help must be sought for all suspected overdoses, regardless of the severity of initial symptoms.

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Therapeutic Uses of Cinfatos Expectorante

What Cinfatos Expectorante Treats: Main Uses and Benefits

This medication is applied across domains where additional symptomatic support is needed for acute episodes of respiratory conditions. It is commonly used to help manage disruptive symptoms associated with the common cold, flu, or acute bronchitis.

The core benefit is addressing the specific symptom cluster of an irritating, persistent cough combined with excessive, thick mucus or phlegm. It helps manage symptoms that create noticeable physiological strain, making it relevant for contexts involving heightened systemic burden.

The combination is relevant for managing symptoms that interfere with daily comfort, particularly in situations where patients experience irritating coughs and thick mucus. It is commonly used when short-term symptomatic assistance is needed during phases of increased distress or discomfort. This supports the patient during difficult episodes by easing distress.


Quick Fact: Relief for Productive Cough and Congestion

Cinfatos Expectorante is applied in scenarios requiring simultaneous assistance for both cough frequency (irritation) and the difficulty of clearing accumulated phlegm.

Regulatory References

  1. DailyMed/NIH National Library of Medicine
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Eligibility and Restrictions for Use

Cinfatos Expectorante is intended for use by adults and adolescents from 12 years of age and children aged 6 to 11 years. Eligibility for use is strictly defined by regulatory documents, which list several groups for whom the medicine is contraindicated and therefore must not be used.

Groups Who Must Not Use This Medicine (Contraindicated)

  • Age: Children under 2 years of age.
  • Hypersensitivity: Patients with known allergy or hypersensitivity to the active ingredients (dextromethorphan, guaifenesin) or any excipients.
  • Conditions: Patients with asthmatic cough, productive cough, respiratory failure, high blood pressure, liver disease, diabetes, or atopic dermatitis.
  • Clinical Status: Sedated, debilitated, or bedridden patients.
  • Medication Conflicts: Individuals taking or having recently taken (within 14 days) Monoamine Oxidase Inhibitors (MAOI), Selective Serotonin Reuptake Inhibitors (SSRI) antidepressants, Bupropion, Linezolid, Procarbazine, or Selegiline.

Restricted or Limited Use

  • Children 2 to 6 years: Use is restricted and must be only under medical supervision.
  • Severe Impairment: Patients with severe renal or hepatic insufficiency must not use this medicine unless they are under medical supervision.
  • Pregnancy/Lactation: Use is contraindicated during the first trimester of pregnancy and restricted during the remainder of pregnancy and breast-feeding, requiring medical consultation.
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What should I know about interactions with other medicines?

Interactions with other medicines and products

Cinfatos Expectorante contains Dextromethorphan, an ingredient whose interaction profile, as defined by regulatory documents, centers on two main areas: serotonin-modulating drugs and cytochrome P450 enzyme inhibitors.

Interaction Domain Key Constraint & Timing Rule
Monoamine Oxidase Inhibitors (MAOIs) & Serotonergic Agents Strict Avoidance. Must not be used concurrently or within two weeks of stopping MAOIs or related medicines (e.g., Bupropion, Linezolid, Selegiline, Procarbazine, and SSRIs).
Central Nervous System (CNS) Depressants Avoidance. Must not be combined with alcohol or alcoholic beverages due to the risk of potentiating CNS depressive effects.
Enzyme-Inhibiting Beverages Avoidance. Grapefruit juice and bitter orange juice must not be consumed concurrently, as they may inhibit the CYP2D6 and CYP3A4 enzymes, potentially increasing the systemic concentration of Dextromethorphan.
Other Cough Suppressants Avoidance. Use in parallel with other antitussive/cough suppressant drugs is restricted.

This profile dictates clear limitations on co-administration, classifying the use with MAOIs and related serotonergic medicines as a high-risk interaction that requires a mandatory two-week waiting period. The restrictions also extend to dietary elements (grapefruit/bitter orange juice) and general depressants (alcohol) that can alter drug levels or pharmacodynamic effect. Furthermore, official labeling requires a dose reduction for patients with hepatic insufficiency due to the altered metabolism of the active ingredients.

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Mechanism of Action

Central Nervous System Cough Reflex Damping

The antitussive component, Dextromethorphan, acts on the medulla oblongata, the brainstem region that houses the central cough center. It engages mechanisms involving sigma1 receptors and potentially NMDA receptors to modify the reflex arc. This binding interaction increases the activation threshold required to trigger the reflex, thereby decreasing the sensitivity of the central pathway. This modification influences the frequency of efferent signaling from the CNS.


Autonomic Regulation of Secretion Viscosity

The expectorant component, Guaifenesin, operates through an indirect peripheral mechanism by stimulating vagal receptors in the gastric mucosa. This stimulation initiates a gastro-pulmonary reflex that increases efferent parasympathetic signaling to the respiratory tract. This heightened signaling results in greater respiratory tract fluid production and a subsequent reduction in mucus viscosity.


Integrated Modulation of Airway Clearance

This medication modifies the cough reflex and the properties of respiratory secretions through two distinct, coupled pathways. The physiological result is a combination of decreased central reflex sensitivity and increased mucociliary transport efficiency. This combined action supports the expulsion of bronchial secretions while contributing to the modulation of an overactive physiological cough response.

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Dosage and Administration Information

How to Use Cinfatos Expectorante: Administration Guidelines

Administration of Cinfatos Expectorante follows a protocol that specifies the route, dosage, frequency, and duration of use.


Administration Scope

Property Instruction
Route of Administration The solution is administered via the oral route.
Dosing Schedule (Adults/Adolescents 12 years and older) 5 mL or 10 mL per dose. The maximum allowed is 60 mL per 24 hours.
Frequency and Timing Dosing occurs every 4 to 6 hours, as needed, not to exceed 6 doses in 24 hours.
Timing in Relation to Meals Can be taken with or without food.
Preparation Requirements Use the measuring cup provided with the bottle for accurate volume measurement.
Missed-Dose Rules If a dose is forgotten, the next dose should be taken at the usual time; the next dose must not be doubled.

Age-Group and Population-Specific Rules

Administration rules vary by age and physiological status:

  • Children (6 to 12 years): The standard dose is 2.5 mL or 5 mL per intake, with a maximum limit of 30 mL per 24 hours.
  • Hepatic Impairment: The dose must be reduced to half the standard recommended amount, and the frequency must not exceed 4 daily doses.
  • Children < 2 years: Use of the product is contraindicated, and children 2 to 6 years require medical supervision for administration.

Course Duration and Restrictions

Treatment should be maintained for the shortest possible time to control symptoms. If symptoms persist or worsen after 7 days of treatment, a medical evaluation is required. The solution must not be taken with grapefruit juice, bitter orange juice, or alcoholic beverages.

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Recent Clinical Evidence

Research Evidence / Overview of Studies for Cinfatos Expectorante

The clinical evaluation of Cinfatos Expectorante, which combines Dextromethorphan and Guaifenesin, is based on research exploring how these ingredients affect the symptoms of a cough with mucus. The evidence largely consists of clinical trials and systematic reviews, which were studied for their potential role in managing the two primary symptoms simultaneously: reducing the urge to cough and assisting with the clearance of thick secretions. The findings from this research provide context for how these types of medicines are used in periods of heightened symptom activity.


Evidence for Acute Cough with Phlegm

Studies designed to assess the active ingredients typically involve short-term Randomized Controlled Trials (RCTs), where groups receiving the active ingredients are compared against groups receiving a placebo (an inactive substance). These trials are applied in studies examining patient-reported experiences of cough symptoms linked to conditions such as the common cold. Researchers have focused on whether the combination was associated with changes in outcomes related to physical discomfort arising from a persistent, irritating cough that occurs alongside mucus production.


What the Research Highlights as Uncertain

The research exploring this medicine has several acknowledged limitations that evidence highlights what is known — and what is still uncertain. Foremost, findings were mixed across various studies, especially when comparing the medicine to a placebo, a factor that often results in low certainty for symptomatic treatments. The interpretation of these findings is also complicated by the high rate of spontaneous symptom resolution—where the cough naturally clears on its own—which is a known challenge in trial design related to acute cough.

Study durations for acute conditions are generally short-term (4 to 7 days), meaning long-term effects are not fully established. Additionally, data for certain groups remain insufficient, as the research base is centered primarily on studies involving adults and adolescents, with limited information available for specific subgroups such as younger children.

Key Studies & References GUAIFENESIN AND DEXTROMETHORPHAN HBR tablet, extended release - DailyMed (Authoritative Drug Label)

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Frequently Asked Questions (FAQ)

Common questions about Cinfatos Expectorante (FAQ)


Q: What are the symptoms of a Cinfatos Expectorante overdose?

A: According to official product safety information, symptoms of an overdose may include severe dizziness, blurred vision, confusion, or difficulty urinating. More serious signs can involve shakiness, unsteady walking, and severe excitement, nervousness, or restlessness. Official safety information advises seeking immediate medical attention if an overdose is suspected.


Q: Is Cinfatos Expectorante the same as plain Cinfatos (Dextromethorphan-only)?

A: No, Cinfatos Expectorante is not the same as a single-ingredient product. This medicine is a combination formula that contains two active ingredients: dextromethorphan hydrobromide, which works as a cough suppressant, and guaifenesin, which is an expectorant. The dual action is formulated to help with both reducing the urge to cough and assisting with the presence of excess mucus.


Q: How long can I use Cinfatos Expectorante after opening the bottle or sachets?

A: Official pharmaceutical advice states that once the bottle is opened, the product maintains its stability for a maximum of four weeks. The product should not be used if it has been open for longer than this period.


Q: Is there clinical evidence supporting the effectiveness of the Dextromethorphan/Guaifenesin combination?

A: Official documentation confirms the medicine's approval for its intended use—to help relieve cough and clear phlegm. Research indicates its mechanism is designed to facilitate the expulsion of mucus and modulate the cough reflex.


Q: Does Cinfatos Expectorante contain colorings, flavorings, or other non-active ingredients I should know about?

A: Yes, regulatory documents list several excipients, or non-active ingredients, used in the syrup formulation. These can include flavorings, sweeteners such as Sorbitol and Sodium saccharin, and preservatives such as Sodium benzoate.


Q: Is Cinfatos Expectorante safe for diabetic patients because of its sweeteners?

A: The official product information lists the presence of the excipient Sorbitol. The use of Cinfatos Expectorante is contraindicated for individuals with diabetes, as noted on the regulatory label.


Q: Is there a different dose of Cinfatos Expectorante for the elderly?

A: Official prescribing information states that for adults and adolescents starting from 12 years of age, including the elderly population, no specific dosage adjustment is required.


Q: Can Cinfatos Expectorante cause tremor or shaking?

A: While tremor or shaking is not listed as a common side effect in the official product documents, the active ingredient dextromethorphan, especially at high doses, has been associated with central nervous system effects such as agitation or tremor (shaking). If concerning or severe symptoms are experienced, consultation with a healthcare professional is recommended.

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How should Cinfatos Expectorante be stored and disposed of?

How to Store and Dispose of Cinfatos Expectorante?

Official regulations govern the storage and disposal of Cinfatos Expectorante (Dextromethorphan/Guaifenesin Oral Solution) to ensure both product stability and public safety.

Requirement Area Official Instructions
Temperature & Protection Store at controlled room temperature (typically 20 C to 25 C). Do not refrigerate, freeze, or expose to excessive heat.
Container Rules Keep the medicine in its original container and ensure the bottle is tightly closed when not in use.
Child Safety Keep this medicine out of the sight and reach of children.
Disposal Protocol Do not dispose of unused or expired medicine in household trash or pour it down the sink or toilet. Dispose of the product through an authorized medicine take-back program or official collection point.

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

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