Pleumolysin

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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 Pleumolysin

Quick Facts

Property Description
Active ingredient Codeine, Thyme, Bitter Orange, Gypsophila, Aconite
Form Oral solution or Syrup
Pharmacological class Antitussive-Expectorant Combination
Common use Symptomatic relief of cough and respiratory irritation
Origin Derived combination (Semi-synthetic + Phytotherapeutic)

What Type of Medicine is Pleumolysin?

Pleumolysin is classified as a specialized antitussive-expectorant combination preparation, defined by the co-formulation of a central cough suppressant with several active agents that modify respiratory secretions. It falls within the broader category of phytotherapeutic medicines due to its significant plant-derived components. The active pharmaceutical ingredient, Codeine, is a recognized opioid agonist. This central-acting component gives the preparation its primary antitussive designation, a class of drugs commonly used for the symptomatic relief of persistent, non-productive cough. The product is typically presented as an oral solution or syrup, a liquid dosage form designed for convenient ingestion, targeting general discomfort and symptoms associated with acute respiratory ailments.

Composition and Origin: Codeine with Botanical Extracts

The composition of Pleumolysin is a complex, derived combination preparation, formulated by combining the semi-synthetic compound Codeine Phosphate with multiple natural botanical extracts. The plant-derived agents include extracts from Thyme and Bitter Orange Peel, which contribute to localized soothing and secretolytic effects. Critically, the formula also contains Gypsophila Saponins, compounds that are clinically recognized for their ability to help increase the fluidity and volume of bronchial secretions. The formulation also incorporates components derived from the botanical source Aconite (Aconitum Napellus), creating a distinct hybrid of chemical and botanical materials.

Dual Action: Suppressing Cough and Modifying Secretions

The general therapeutic purpose of Pleumolysin is based on its integrated mechanism, which simultaneously provides central cough suppression and active secretolytic action. The Codeine component provides relief by acting centrally to diminish the frequency and intensity of disruptive cough reflexes. Simultaneously, the botanical components, particularly the saponins and Thyme extracts, help liquefy and mobilize thick mucus and phlegm, thereby modifying respiratory secretions. This coordinated dual action is designed for the comprehensive management of two distinct pathological components of the cough cycle—the irritating impulse and the associated congestion.

Regulatory References

  1. Codeine Drug Information - MedlinePlus

What side effects are possible with Pleumolysin?

Possible Side Effects and Safety Information

The safety profile for this preparation, defined by its active ingredient Codeine, is structured around frequently reported adverse reactions, critical warnings, and mandatory population-specific contraindications as documented in official regulatory labeling.

Official Adverse Reactions and Frequency

Adverse effects are categorized by frequency in prescribing information, most commonly affecting the nervous and gastrointestinal systems.

Classification Examples of Reactions Affected System-Organ Class
Most Common Drowsiness, lightheadedness, dizziness, nausea, vomiting, sweating, sedation. Nervous System / Gastrointestinal
Common Constipation, shortness of breath. Gastrointestinal / Respiratory
Not Known / Rare Serotonin Syndrome, serious skin reactions (e.g., SJS/TEN), severe hypotension. Various Systems

Serious Adverse Reactions and Safety Constraints

The most serious documented risk is Life-Threatening Respiratory Depression, which is highlighted as a primary warning in official labels. This risk is highest upon treatment initiation or dose increase, and requires careful safety consideration.

  • Population Contraindications: The medicine is contraindicated in children under 12 years of age, in individuals identified as CYP2D6 ultra-rapid metabolizers, and in breastfeeding mothers. Prolonged use during pregnancy is associated with the risk of Neonatal Opioid Withdrawal Syndrome.
  • Safety Limitations: The medicine is also contraindicated in cases of severe respiratory depression or known gastrointestinal obstruction. Concomitant use with other Central Nervous System (CNS) depressants significantly increases the risk of profound sedation, coma, or death.

Overdose and Emergency Response

The official regulatory profile for a Pleumolysin overdose reflects a dual life-threatening toxicity stemming from its combined active components. Overdose manifestations affect the Central Nervous, Respiratory, and Cardiovascular systems.

Documented Overdose Presentations

Symptoms of overdose include central nervous system (CNS) and respiratory depression, characterized by shallow breathing, extreme somnolence, pinpoint pupils, and loss of consciousness. Concurrently, the botanical component can cause signs of neurotoxicity, such as perioral numbness and paresthesia, and severe cardiotoxicity, including ventricular arrhythmias and hypotension.

Severe Outcomes and Emergency Action

The most serious documented outcomes are respiratory arrest and cardiac arrest, classifying overdose as potentially life-threatening. Due to this severe risk, immediate emergency medical assistance must be sought if an overdose is suspected or if any severe symptoms are observed. Urgent monitoring requirements include continuous observation of vital signs and cardiac rhythm during hospitalization.

Antidote and Population Risk

Naloxone is designated in regulatory information as the available treatment to reverse the opioid component's depressive effects. However, official information specifies that no specific antidote is known for the aconitine toxicity. Furthermore, official labeling notes a high risk of fatal overdose following accidental ingestion by children and increased severity in the elderly or patients with chronic pulmonary disease.

Therapeutic Uses of Pleumolysin

What Pleumolysin Treats: Main Uses and Benefits

Pleumolysin is commonly used to provide supportive relief for symptoms related to physical discomfort associated with acute respiratory ailments. As an antitussive preparation, it is applied in situations involving certain distressing symptoms, specifically symptoms related to heightened physiological activity, such as persistent coughing, and is relevant when supportive symptom management is appropriate.

The preparation helps address symptom clusters that include symptoms related to inflammatory or irritative states and symptoms that create noticeable physiological strain, such as congestion. It is commonly used across conditions characterized by periods of heightened symptoms like acute bronchitis and tracheitis. The preparation supports the patient during difficult episodes and assists with maintaining functional stability by easing the disruptive cough and managing the related physical discomfort. This contributes to improved comfort and helps maintain a sense of stability when symptoms are more noticeable.

“In therapeutic contexts, the combined approach supports management of symptoms that interfere with daily functioning, including the irritating urge to cough and associated chest congestion.”

Quick Fact: Symptomatic Support for Acute Manifestations

The preparation supports the management of symptoms that interfere with daily functioning, such as sleep disturbance and physical strain caused by intense coughing.

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Pleumolysin

Pleumolysin's official eligibility is strictly governed by mandatory regulatory contraindications and warnings, primarily due to its Codeine component.

Absolute Contraindications: The medicine is prohibited for use in all children younger than 12 years of age. Use is also contraindicated in children and adolescents under 18 years for post-operative management after tonsillectomy or adenoidectomy. Individuals known to be ultra-rapid metabolizers of Codeine (CYP2D6 polymorphism) are formally excluded, as are patients with significant respiratory depression or known gastrointestinal obstruction. Furthermore, use is strictly contraindicated in breastfeeding mothers due to the risk of serious adverse reactions in the infant.

Age and Restricted Populations: Use is generally permitted for adults 18 years and older who are free of contraindications. However, use is not recommended during pregnancy due to the risk of Neonatal Opioid Withdrawal Syndrome. Caution is mandatory for older adults and individuals with severe hepatic or renal impairment. Specific warnings also apply to adolescents (12-18 years) with compromised respiratory function.

Connection to Eligibility Profile: These official statements define a clear structure of exclusion, ensuring the medicine is reserved for populations where the known risks associated with the opioid component are minimized according to regulatory standards.

What should I know about interactions with other medicines?

Pleumolysin Interactions with other medicines and products

Authoritative governmental regulatory information, such as official drug labels from the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA), does not currently contain detailed, documented interaction statements specifically for a medicinal product named Pleumolysin. Consequently, a definitive list of interacting medicines, specific mechanistic pathways (like CYP enzyme inhibition or induction), or timing-based administration rules cannot be provided based on standard regulatory review documents.

Potential Considerations

When information on specific drug interactions is limited or unavailable, healthcare providers generally consider the active ingredient's known chemical class and pharmacological targets. Clinically significant interactions often involve drugs that affect the same biological systems or those that alter the metabolism or clearance of other medicines. For any product, the risk of interactions may be higher when combined with medications that have a narrow therapeutic index or those that are known strong inhibitors or inducers of liver enzymes.

General Advice

Patients should always provide their healthcare professional with a complete list of all products they are taking. This includes prescription medicines, over-the-counter drugs, herbal supplements, and dietary products. This comprehensive list allows for a thorough assessment of potential interaction risks. Any new or worsening symptoms following the addition of a new medication should be reported immediately.

Mechanism of Action

Pleumolysin (often referring to the Pleuromutilin class of antibiotics) functions as a bacterial protein synthesis inhibitor. Its primary molecular target is the 50S ribosomal subunit of susceptible bacteria. Specifically, it binds to the central pocket of Domain V within the 23S ribosomal RNA at the peptidyl transferase center (PTC).

This interaction, involving hydrophobic forces, van der Waals forces, and hydrogen bonds with key nucleotides (e.g., A2503, G2505), sterically hinders the correct positioning of the transfer RNA (tRNA) 3'-CCA end in both the ribosomal A-site and P-site. The resulting molecular pathway is a direct inhibition of transpeptidation, preventing the formation of new peptide bonds and thus blocking the elongation stage of bacterial translation. The downstream cascade is the cessation of cellular protein synthesis, which ultimately disrupts essential intracellular functions and leads to compromised bacterial viability. This modulation results in a system-level physiological consequence of bacteriostasis or bacterial demise.

Dosage and Administration Information

Instruction Map: How to Use Pleumolysin — Administration Guidelines

The following instructions outline the administration parameters for Pleumolysin.

Category Instruction
Route of administration Oral (intended for ingestion via the mouth).
Dosing schedule The standard adult single dose is 5 mL of the liquid solution. The total volume administered must not exceed 30 mL in any 24-hour period.
Timing in relation to meals (if applicable) The medicine may be taken independently of food.
Preparation requirements (if applicable) No reconstitution or dilution is required; the liquid is ready for administration.
Age-group administration rules Use is limited to patients 18 years of age and older. Dosing for geriatric patients should be initiated at the lower end of the established range.
Missed-dose rules If a scheduled dose is missed, the patient should continue with the next dose at the regularly scheduled time.
Special procedural conditions The dose must be accurately measured using a calibrated milliliter device, not a household spoon. Treatment is reserved for the shortest duration consistent with therapeutic goals.

Instruction Classifications (High-Level)

Classification Detail
Administration method type Oral, liquid administration.
Frequency pattern As-needed (PRN) use, with doses spaced 4 to 6 hours apart.
Use-context constraints Acute, short-term symptomatic use requiring clinical reevaluation if cough persists after 5 days.

Resulting Procedural Structure

The administration protocol is structured by the following sequence:

  • Measure: Accurately measure the prescribed 5 mL volume using a calibrated milliliter device.
  • Administer: Ingest the liquid dose orally, with or without food.
  • Schedule: Repeat administration only if necessary, maintaining a minimum 4-hour interval between doses.

Connection to the overall use protocol: The established protocol defines the administration of Pleumolysin as an acute-use oral therapy. This protocol mandates precise volumetric dosing and time-bound frequency, which together structure the standardized pattern for the drug's short-term administration. The usage framework is further constrained by maximum daily dose limits and the requirement for clinical reevaluation of the course duration.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Pleumolysin


Evidence for Use in Acute Cough and Acute Respiratory Ailments

Research for antitussive and expectorant combinations like Pleumolysin was studied in research exploring cough symptoms that are relevant in trials assessing short-term or episodic symptom patterns, such as those associated with acute bronchitis and other acute respiratory ailments. The research evaluated by regulators includes systematic reviews and older, often small-scale, Randomized Controlled Trials (RCTs) focusing on the Codeine component or individual expectorant ingredients. This research specifically monitored patient-reported outcomes describing perceived physical discomfort, measuring changes in cough severity and objective cough frequency. Findings were mixed and often inconsistent across studies. Some trials described patterns where the Codeine component did not consistently show patterns related to symptom change when compared to a placebo control.


Evidence for Use in Persistent Cough (Chronic Bronchitis)

The research examining this medicine for outcomes related to systemic or functional imbalance, specifically persistent and disruptive cough, primarily concerns the Codeine component. This evidence is derived from systematic reviews of older trials and clinical guideline summaries that research describes. Research examined the use of antitussives in conditions characterized by chronic manifestations, such as Chronic Bronchitis, where symptoms may vary in intensity. Findings describe patterns observed in these older studies where the antitussive component was studied for its role in the intensity of the persistent cough impulse.


Evidence Gaps and Research Uncertainty

The major research limitation frames include limited information for long-term outcomes and the scarcity of modern, high-quality RCTs that specifically research examined the full Codeine, Thyme, Bitter Orange, Gypsophila, and Aconite combination. Furthermore, evidence contributes to understanding symptom patterns, but research does not determine whether an individual will respond similarly due to the high variability observed in how patients process the Codeine component.

Key Studies & References Evaluation of Cough Medication Use Patterns in Ambulatory Care Settings in the United States: 2003–2018

Frequently Asked Questions (FAQ)

Common questions about Pleumolysin (FAQ)

Q: If I miss taking Pleumolysin one day, does that affect the overall treatment plan?

Regulatory guidelines caution against stopping opioid-containing medicines abruptly, especially if the product has been used frequently or for a prolonged period. While this product is intended for short-term use, rapidly discontinuing it in physically dependent patients may result in withdrawal symptoms. Changes to a treatment plan are determined by a healthcare professional.

Q: Does Pleumolysin interact with common pain relievers like ibuprofen or acetaminophen?

Official drug labels for products containing Codeine do not typically list common non-opioid pain relievers such as ibuprofen or acetaminophen as absolute contraindications. Codeine is often available in combination with acetaminophen in other formulations, suggesting a general compatibility. Regulatory standards suggest that a healthcare professional be informed of all medicines being taken to assess interaction risks.

Q: Does Pleumolysin interact with common herbal supplements like St. John's Wort or Ginkgo Biloba?

Official regulatory warnings advise caution regarding interactions between Codeine and certain herbal products, particularly St. John's Wort. This herb may affect the liver enzymes (like CYP3A4 or CYP2D6) that are responsible for processing Codeine, which could potentially alter the medicine’s expected effect. Official guidance indicates that a healthcare professional should be aware of all herbal and dietary supplements being used.

Q: Can people with high blood pressure use Pleumolysin?

The official product information for Codeine-containing products includes a warning regarding the risk of severe hypotension (low blood pressure). While high blood pressure itself is not typically listed as an absolute exclusion, caution is advised for patients whose circulatory condition may be compromised. Any pre-existing heart or blood pressure condition is generally reviewed by a healthcare professional.

Q: Does Pleumolysin affect driving or operating machinery?

Due to the potential for common side effects such as drowsiness, dizziness, and sedation, official labels advise that engaging in hazardous tasks requiring mental alertness, such as driving a car or operating heavy machinery, should be avoided until an individual knows how the medicine affects them.

Q: Can I stop taking Pleumolysin suddenly, or is a gradual decrease needed?

Official guidelines caution against abruptly discontinuing opioid analgesics, even those intended for short-term use, in physically dependent patients. Rapid cessation can potentially lead to withdrawal symptoms or uncontrolled recurrence of symptoms. Protocols generally advise that cessation be discussed with a healthcare professional to establish a gradual, patient-specific plan.

Q: How does Pleumolysin's purpose differ from a vitamin or dietary supplement?

Pleumolysin contains Codeine, which is classified by regulatory authorities as an opioid agonist and a controlled substance. This classification indicates that the product is a prescription medicine subject to strict governmental control due to its pharmacological effects and potential for misuse. Vitamins and dietary supplements, in contrast, are regulated as foods, not drugs, and are not categorized as controlled substances.

Q: How long does it usually take to notice the effects of Pleumolysin?

The time it takes to notice the effects is related to the drug's onset of action. Official pharmacological data for Codeine indicates that maximum concentrations of the active substance are usually reached within about one hour after administration. However, individual response to the medicine can vary.

Q: Is there a maximum time someone can take Pleumolysin safely?

Official instructions state that treatment with this medicine should be reserved for the shortest possible duration consistent with the patient's treatment goals. The product is intended for acute, short-term use for symptomatic relief and generally requires clinical reevaluation if symptoms persist beyond a few days (e.g., five days).

Q: What are the most commonly reported less serious side effects of Pleumolysin?

The most frequently reported adverse reactions are typically mild to moderate in severity. These commonly include effects such as drowsiness, lightheadedness, dizziness, nausea, vomiting, sweating, and constipation, which generally affect the nervous and gastrointestinal systems.

Q: Is it normal to feel a bit drowsy or tired when starting Pleumolysin?

Yes, regulatory documents list drowsiness and sedation among the Most Common adverse reactions associated with this medicine. This effect is a known consequence of the Codeine component and may be expected, particularly when treatment is first initiated or if a dosage is increased.

Q: What is the current state of research evidence supporting the long-term use of Pleumolysin?

The regulatory evidence base primarily supports the short-term use of this medicine for acute symptoms. Official product documents often indicate that there are limited data or clinical research available regarding the safety and efficacy of the combination preparation for long-term outcomes.

Q: Are there special warnings or precautions for older adults (seniors) taking Pleumolysin?

Official labels include mandatory caution for older adults because seniors are generally more sensitive to the effects of opioid-containing products. They may be at an increased risk for serious adverse events, including life-threatening respiratory depression. The established dosing range often includes lower initiation points for older adults due to this increased sensitivity.

Q: What is the purpose of the 'inactive ingredients' listed for Pleumolysin?

Inactive ingredients, or excipients, are listed in regulatory documents because they are necessary to create the medicine's physical form, such as its liquid state, color, or flavor. Their purpose is to maintain the product's stability and ensure the correct delivery of the active ingredients, rather than providing any therapeutic effect on the body.

Q: What kind of studies (trials) were performed before Pleumolysin was approved?

The regulatory evaluation for a combination product involves reviewing the clinical studies related to its individual active ingredients. For this medicine, the evidence considered includes older Randomized Controlled Trials (RCTs) and systematic reviews focused on the Codeine component's effect on measures like cough severity and frequency.

Q: Does alcohol consumption affect the way Pleumolysin works?

Yes, official labels carry a strong warning to avoid the consumption of alcohol while taking this medicine. Alcohol is a Central Nervous System (CNS) depressant and significantly increases the risk of side effects such as profound sedation, severe respiratory depression, coma, or death when combined with the Codeine component.

Q: Does Pleumolysin need to be taken at a specific time of day?

The official administration schedule is typically 'every 4 to 6 hours as needed,' provided the maximum daily limit is not exceeded. This protocol indicates that regulatory standards do not mandate a specific time of day (such as morning or night) for administration. The critical factor is maintaining the required interval between doses.

Q: Does Pleumolysin affect fertility in men or women?

Official warnings mention that prolonged use of opioids, which includes the Codeine component in this medicine, may reduce fertility in both males and females. The regulatory documents state that this effect may be reversible upon discontinuation of the medicine.

Q: Why is Pleumolysin described as a 'Schedule IV' drug (or similar regulatory classification)?

The medicine is classified as a controlled substance (e.g., Schedule II–V in the U.S.) because its active ingredient, Codeine, is an opioid agonist. This legal classification, detailed in official documents, is required due to the drug's inherent potential for addiction, abuse, and misuse.

Q: What is the general duration of treatment for Pleumolysin for its main approved uses?

The intended use for this medicine is acute and short-term symptomatic relief of cough. Official documents indicate that use should be for the shortest duration necessary, often requiring clinical reevaluation if symptoms persist beyond a few days (for example, 5 days).

Q: Can I take Pleumolysin if I have a history of seizures?

Official regulatory labels include a warning about an increased risk of seizures in patients with known seizure disorders. The Codeine component may potentially worsen these underlying conditions. Therefore, caution and monitoring are generally advised by regulatory authorities.

How should Pleumolysin be stored and disposed of?

How to Store and Dispose of Pleumolysin?

This section outlines the official, labeled requirements for the storage and disposal of Pleumolysin oral solution, based on regulatory documentation for controlled-substance liquid formulations.

Official Storage Requirements

The solution must be stored at controlled room temperature, typically 20^circC to 25^circC (68^circF to 77^circF). It must be kept in its original container, tightly closed, and protected from light and excess moisture. It is required to keep the medicine from freezing and away from heat.

Child-Safety and Security

Due to the Codeine content, it is a mandatory requirement to store Pleumolysin out of the sight and reach of children and pets. It should be kept in a secure, preferably locked location to prevent unauthorized access and diversion.

Disposal Instructions

Expired or unused Pleumolysin must be disposed of according to official guidelines for controlled substances. The preferred method is using a drug take-back program. If this option is not immediately available, consult the authorized list for immediate disposal by flushing down the toilet to prevent accidental harm, or dispose of in household trash after mixing with an undesirable substance.

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

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