Pulmodexane

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Pulmodexane

Treatment option: Cough

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 Pulmodexane

Quick Facts

Property Description
Active ingredient Dextromethorphan Hydrobromide
Form Syrup, Oral Solution, Film-coated Tablet
Pharmacological class Antitussive Agent (Cough Suppressant)
Common use Temporary relief of non-productive cough
Origin Synthetic (Levorphanol Derivative)

What is Pulmodexane and What is its Primary Classification?

Pulmodexane is a commercial preparation centered on the single active substance, Dextromethorphan Hydrobromide. It is classified fundamentally as an antitussive agent, which means its primary function is to suppress the body's cough reflex. This active component is synthetic, a methylated, dextrorotatory analogue of levorphanol, and belongs to the class of non-opioid cough suppressants.

Dextromethorphan is in a class of medications called antitussives, used to temporarily relieve cough caused by the common cold or flu. This core function is recognized in reducing the frequency and intensity of coughing.


Composition, Available Forms, and General Purpose

The medication is prepared as a single active ingredient product designed for oral administration. Pulmodexane is commonly available in multiple dosage forms, including syrup and oral solution formulations, as well as solid forms such as film-coated tablets. This range of preparations ensures the active ingredient is delivered effectively, adapting to patient preference, such as the use of syrup for individuals who find tablets difficult to swallow.

The general therapeutic purpose is to provide temporary relief from the impulse to cough. Its action is described as centrally acting: it crosses the blood-brain-barrier and activates sigma opioid receptors on the cough center in the central nervous system, thereby suppressing the cough reflex. Consequently, Pulmodexane is used to manage the bothersome symptom of a persistent, non-productive cough, helping to minimize disruption and discomfort, for instance, managing nighttime coughing.

Regulatory References

  1. MedlinePlus

What side effects are possible with Pulmodexane?

Possible Side Effects and Safety Information

The safety profile of Pulmodexane (Dextromethorphan Hydrobromide) is characterized by a range of officially documented adverse reactions, classified according to their frequency in clinical use. These effects are grouped by the physiological systems they affect, as defined in regulatory labeling.


Frequency and System-Organ Classes

The most common adverse reactions reported include drowsiness (somnolence), dizziness, nausea, and vomiting. These effects are primarily categorized under Nervous System Disorders and Gastrointestinal Disorders in regulatory documents. Less common effects, such as confusion or psychotic states, are also documented, often associated with use at higher-than-recommended doses. Rare events include severe hypersensitivity reactions, such as Angioedema.


Serious Safety Constraints and Special Populations

Official labeling documents two critical safety concerns. The most stringent constraint is the absolute contraindication against concurrent use with, or within 14 days of discontinuing, a Monoamine Oxidase Inhibitor (MAOI). This is due to the documented risk of developing Serotonin Syndrome, a potentially life-threatening reaction. The regulatory profile also notes the risk of abuse and dependence, explicitly associated with prolonged high-dose exposure.

Safety notes for specific populations include that Older Adults may be more susceptible to central nervous system effects. Furthermore, patients with hepatic impairment may experience reduced drug clearance, potentially increasing the risk of adverse reactions, a consideration outlined in official regulatory documents.

Overdose and Emergency Response

Overdose and when to seek help

Overdose with Pulmodexane (Dextromethorphan Hydrobromide) is associated with documented manifestations primarily affecting the central nervous system, cardiovascular, and respiratory systems.

Feature Regulatory Documentation Statement
Documented overdose presentations: Agitation, confusion, somnolence, stupor, nystagmus, dizziness, ataxia, toxic psychosis, nausea, vomiting, dystonia, and hyperthermia.
Dose-related or exposure-related factors: Effects are potentiated by simultaneous ingestion of alcohol and other psychotropic drugs; respiratory arrest risk is heightened in young children.
Emergency-response statements: Seek immediate medical attention or get medical help right away; call a Poison Control Center.

Overdose Classifications

Overdose is classified by regulators as potentially leading to severe or life-threatening outcomes, notably coma, convulsions, respiratory depression, and a specific risk of Serotonin Syndrome and cardiotoxicity (including documented QTc prolongation). Management procedures are defined as symptomatic and supportive treatment, including the potential use of Naloxone to counteract opioid-like central effects and specific interventions like activated charcoal and continuous ECG monitoring.

Official Overdose Statements

  • Severe CNS effects and life-threatening Serotonin Syndrome risk are explicitly documented manifestations of overdose.
  • Immediate medical attention is required upon suspicion of overdose, mandating hospital monitoring and comprehensive stabilization measures.
  • The official profile highlights the need for specialized care, including breathing support and the use of Benzodiazepines for seizures or hyperthermia management.

The regulatory documents define the overdose profile by listing the expected clinical manifestations and specifying the severe outcomes that necessitate immediate medical attention. This guidance establishes the standard of care based on necessary hospital-level stabilization, monitoring, and supportive intervention.

Therapeutic Uses of Pulmodexane

What Pulmodexane Treats: Main Uses and Benefits

Pulmodexane is commonly used to provide symptomatic relief from the irritating, dry cough that does not produce mucus, primarily in conditions associated with acute or disruptive episodes. The main indications include cough due to the common cold and influenza, or other instances where the cough arises from symptoms related to inflammatory or irritative states. The medication is considered relevant for easing symptoms related to heightened physiological activity.

The therapeutic utility is relevant for easing symptoms that create noticeable physiological strain caused by a persistent cough. By helping to temporarily address symptoms of increased neurological or muscular activity, it assists with moderating the frequency and intensity of coughing fits. This provides support that helps ease the overall symptom burden, particularly in scenarios where coughing significantly disrupts comfort and rest, thereby supporting patients during difficult episodes.


Quick Fact Block

Quick Fact: Relief for Non-Productive Cough The medication is applied across domains where additional symptomatic support is needed to manage a cough that is dry, hacking, and does not bring up phlegm.

Regulatory References

  1. NIH MedlinePlus overview

Eligibility and Restrictions for Use

Who Can and Cannot Use Pulmodexane?

Eligibility for Pulmodexane (Dextromethorphan Hydrobromide) is strictly defined by regulatory authorities based on population characteristics and existing health conditions. Use is permitted for adults and children 12 years and older, with conditional use for specific product forms down to 4 years of age. Use is not established for children under 2 years.

Contraindicated Populations

Pulmodexane must not be used by individuals taking a Monoamine Oxidase Inhibitor (MAOI), or within 14 days of stopping MAOI therapy. It is also contraindicated for patients with known hypersensitivity to any component of the medication, and in regions where it is specified, for patients with respiratory insufficiency or asthma.

Conditional Use and Restrictions

The medicine is not recommended for chronic cough, such as that caused by smoking or emphysema, or for coughs accompanied by excessive phlegm. Caution is required for patients with hepatic impairment and severe renal impairment. Furthermore, use is generally not recommended during pregnancy and lactation, as its safety profile has not been fully established in these groups.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile for Pulmodexane (Dextromethorphan) is primarily defined by mandatory restrictions against co-administration with specific drug classes and substances that affect its clearance or enhance its central nervous system effects. This information is derived from official government regulatory documents.

Formal Contraindications and Restrictions

Pulmodexane must not be taken with Monoamine Oxidase Inhibitors (MAOIs), including Isocarboxazid, Phenelzine, or Methylene Blue. This is a formal contraindication due to the risk of severe reactions. A mandatory separation of at least 14 days is required between discontinuing MAOI therapy and starting Pulmodexane.

Interactions Affecting Exposure

Dextromethorphan is metabolized by the CYP2D6 enzyme. Co-administration with strong CYP2D6 inhibitors, such as Quinidine or Fluoxetine, is documented to cause a clinically significant increase in the plasma concentrations of Dextromethorphan. This interaction profile means individuals who are naturally poor metabolizers of CYP2D6 may be inherently more susceptible to exposure-increasing effects.

Pharmacodynamic Interactions

The medicine should not be combined with substances that cause additive central nervous system (CNS) depressant effects. For instance, co-administration with alcohol or other CNS depressants is officially documented to enhance effects such as drowsiness and dizziness. Combination with other serotonergic agents can also result in an increased risk of Serotonin Syndrome.

Mechanism of Action

Pulmodexane functions as a centralized modulator of neural signaling pathways. Following absorption, the compound and its primary active metabolite, dextrorphan, distribute to the central nervous system. The mechanism is poly-receptor, involving three primary actions.

First, Pulmodexane acts as an uncompetitive antagonist at the N-methyl-D-aspartate (NMDA) receptor complex. This interaction inhibits ion channel opening, resulting in decreased excitatory neurotransmission. Second, the drug acts as a selective agonist at the Sigma-1 receptor, an intracellular chaperone protein that modulates calcium signaling and neuronal excitability. Third, Pulmodexane acts as an inhibitor of the Serotonin Transporter (SERT) and the Norepinephrine Transporter (NET). These combined actions depress the activity within the medullary cough center located in the brainstem, specifically at the synapses of the pulmonary vagal afferent fibers, leading to a modulation of the central cough reflex arc.

Dosage and Administration Information

Official Administration Guidelines

Pulmodexane, containing Dextromethorphan Hydrobromide, is administered strictly through the oral route. Instructions for use define precise dosing intervals and preparation steps based on the medicine's form.

Entity Description
Dosing Schedule (Adults and children 12 years and older) Immediate-Release (IR): 10 mg to 20 mg every 4 hours OR 30 mg every 6 to 8 hours. Extended-Release (ER): 60 mg every 12 hours.
Maximum Daily Dose The total intake for any formulation must not exceed 120 mg in a 24-hour period.
Timing in relation to meals The medicine may be taken with or without food. Taking it alongside food or milk may help mitigate potential gastrointestinal irritation.
Age-Group Rules Use is generally not recommended for children under 4 years of age; specific lower-limit dosing regimens are utilized for children 4 to <12 years.

Procedural Administration Specifics

Standard handling instructions are followed to ensure accurate delivery of the dose. Liquid forms, such as syrups and solutions, require use of a calibrated measuring device (not a household spoon) for precise measurement, and suspensions must be shaken well prior to administration. Solid Extended-Release tablets or capsules must be swallowed whole and should not be crushed, divided, or chewed, as this can affect the intended release pattern.

Because Pulmodexane is taken on an as-needed basis, a missed dose may be administered when remembered, provided the minimum time interval between doses is maintained and the prescribed 24-hour maximum dose is never exceeded. Furthermore, use is discontinued if the cough persists for longer than 7 days.

Recent Clinical Evidence

Pulmodexane: Recent Clinical Evidence

Pulmodexane, containing Dextromethorphan, has been the subject of numerous studies to understand how it was evaluated in the context of acute cough symptoms. This overview summarizes the structure of the evidence base from authoritative sources, without providing clinical advice or making claims about personal outcomes.


Evidence for Use in Acute Non-Productive Cough

The primary evidence base includes Randomized Controlled Trials (RCTs) and Meta-analyses. These studies compared the medicine against a placebo in adults with acute, dry coughs. Researchers examined outcomes like 24-hour total cough counts (measured objectively) and patient-reported outcomes for perceived severity. Studies reported changes in physiological measures, but when researchers examined patient-rated subjective outcomes, the findings were mixed. Reports noted that changes were often similar between the group receiving the medicine and the group receiving placebo. This suggests that research highlights patterns subject to variability across studies.


Long-Term Studies and Follow-Up

The available research provides context primarily for the evaluation of acute or episodic changes. Clinical trials reflect the short-term nature of a cold-related cough, with outcome monitoring often lasting 4 to 5 days. The evidence base does not include studies designed to characterize effects over extended periods for chronic cough conditions.


Evidence in Special Populations

Research primarily focuses on adults, but dedicated research has been conducted on Pediatric Cohorts (children aged 6 to 11 years). Reports noted that the observed changes in subjective outcomes in children were often similar between the study groups. Data for other populations, such as older adults, are more limited.


What Is Still Uncertain About Pulmodexane

The most significant research challenge is the high placebo effect associated with acute cough, which can complicate the ability to discern the true contribution of the medicine. Findings from the research do not determine whether an individual patient will respond similarly to the group patterns observed in clinical trials.

Frequently Asked Questions (FAQ)

Common questions about Pulmodexane (FAQ)


Q: Are people with liver or kidney issues allowed to use Pulmodexane?

According to official product information, caution is advised for individuals with pre-existing liver or kidney conditions. The medicine is generally contraindicated for patients with severe impairment of these organs. In cases of moderate impairment, dosage modification may be considered by a prescriber.


Q: Is Pulmodexane safe to use during pregnancy or while breastfeeding?

Studies and regulatory reviews indicate that the use of this medicine during pregnancy has not been shown to increase the chance of birth defects. When used while breastfeeding, the drug passes into breast milk in small amounts, and side effects in the nursing child are not expected.


Q: Does Pulmodexane interact with alcohol, even in small amounts?

Official documentation notes that combining the medicine with alcohol is generally not recommended. Alcohol is a central nervous system (CNS) depressant and can increase the risk of enhanced CNS depressant effects, suchs as heightened drowsiness and dizziness, which are already associated with the medicine itself.


Q: What happens if I forget to use or take Pulmodexane?

The official administration protocol states that if a dose is missed, it may be taken when remembered. It is noted that the minimum time interval between doses should be maintained and that the maximum prescribed 24-hour dose is not exceeded.


Q: What are the storage guidelines for Pulmodexane?

Regulatory guidelines specify that Pulmodexane should be stored at controlled room temperature, typically between 20 C to 25 C (68 F to 77 F). The product should be protected from light and stored out of the reach of children.


Q: What are the most commonly reported side effects of Pulmodexane?

Official product information lists the most commonly reported side effects. These typically include temporary issues such as drowsiness, dizziness, nausea, vomiting, and abdominal discomfort.


Q: Is it possible to become dependent on Pulmodexane over time?

Regulatory agencies have issued warnings regarding the potential for misuse and abuse of this medicine when taken in doses significantly higher than those recommended on the label. Misuse of the medicine may be associated with serious adverse effects.


Q: Can Pulmodexane make me feel dizzy or light-headed?

Yes, dizziness is listed in official documentation as one of the commonly reported side effects. This effect may also be enhanced if the medicine is combined with other substances that cause central nervous system depression.


Q: What is the half-life of Pulmodexane (how long does it stay in the body)?

According to pharmacokinetic data, the medicine is processed by an enzyme in the body called CYP2D6. Because the rate at which this enzyme works varies significantly between individuals, the amount of time the medicine stays in the body can also vary.


Q: Can Pulmodexane affect my heart rate or blood pressure?

Official reports indicate that at doses significantly higher than those recommended for therapeutic use, cardiovascular adverse effects have been observed. These effects include a rapid heart rate (tachycardia) and increased blood pressure (hypertension).


Q: Are there specific symptoms that signal a rare, serious side effect of Pulmodexane?

Official safety materials indicate that signs of a severe allergic reaction, such as swelling of the face, tongue, or throat, or difficulty breathing, require prompt medical evaluation.


Q: Can Pulmodexane interfere with my sleep pattern?

Official product information includes drowsiness and somnolence (sleepiness) as common side effects. This effect indicates the medicine can potentially interfere with wakefulness and sleep patterns.


Q: Does Pulmodexane commonly cause issues like stomach upset or nausea?

Gastrointestinal upset, including nausea, vomiting, and general abdominal discomfort, is listed in official documentation as a common side effect of the medicine.


Q: If I am allergic to similar drugs, can I still take Pulmodexane?

Official warnings note that the medicine should be avoided by individuals with a known hypersensitivity reaction to Pulmodexane or to any chemically similar drug. This information is a standard part of regulatory contraindications.


Q: Does Pulmodexane contain any common allergens like gluten or lactose?

Official labeling confirms that the inactive ingredients vary by the specific product form (such as liquid or tablet) and manufacturer. Some formulations may contain ingredients like phenylalanine, which is relevant for individuals with phenylketonuria.


Q: Are there any genetic factors that might affect how Pulmodexane works for me?

Yes, official pharmacokinetic data indicates that genetic variations in the CYP2D6 enzyme influence how the body metabolizes and clears the medicine. These differences can affect the resulting concentration of the drug in the bloodstream.


Q: Are there any specific safety warnings listed for Pulmodexane?

Official safety warnings are listed in product information. These include a required separation period when stopping MAOIs and starting Pulmodexane, and warnings about the risk of Serotonin Syndrome if combined with other serotonergic drugs.

How should Pulmodexane be stored and disposed of?

Official Storage Requirements

Pulmodexane must be stored at controlled room temperature, typically 20 C to 25 C (68 F to 77 F), as defined by regulatory labeling. The product requires specific environmental protection: it must be stored away from direct light, moisture, and excess heat. Liquid forms are explicitly prohibited from being frozen. For container integrity, the medicine must be kept in its original container and maintained tightly closed.

Disposal and Child Safety

A mandatory requirement is to keep this medication out of the sight and reach of children and pets. For disposal, unused or expired Pulmodexane must not be flushed down the toilet. The preferred method for discarding the product is utilizing a community drug take-back program. If no take-back program is available, the medicine must be mixed with an unappealing substance, placed in a sealed bag, and then disposed of in the household trash.

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

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