Pulmofor

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Pulmofor

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 Pulmofor

Quick Facts: Pulmofor Identity

Property Description
Active ingredient Dextromethorphan Hydrobromide
Form Oral preparations (syrup, tablet, capsule, lozenge)
Pharmacological class Antitussive agent (Cough suppressant)
Common use Temporary relief of non-productive cough
Origin Synthetic analog

Defining Pulmofor: Classification and Core Identity

Pulmofor is the designation for a medicinal product containing the active ingredient Dextromethorphan Hydrobromide, which is definitively classified as an antitussive agent, or cough suppressant. This substance acts as a centrally-acting synthetic analog, distinct from traditional opioids. Dextromethorphan is a non-opioid antitussive used for relieving cough symptoms. This classification allows the medicine to be clinically available as an Over-the-counter (OTC) drug, making it accessible for patients needing to interrupt a persistent urge to cough.

Composition and Available Forms of Pulmofor

The core composition of Pulmofor relies on the single active ingredient, intended for oral administration. Dextromethorphan Hydrobromide is utilized for its primary role in cough suppression. It is available in diverse oral dosage form(s), including liquids like syrup and solution, and solid medications such as tablet, capsule, and lozenge. While often found as a single-entity product, its compatibility allows it to be formulated as a combination product with other ingredients, providing flexibility in treatment choice.

General Purpose of Pulmofor

The general purpose of Pulmofor is to provide temporary and effective relief from the cough reflex, specifically targeting a non-productive, dry cough caused by minor irritations, such as those associated with the common cold. It achieves this by acting to depress the sensitivity of the medullary cough center in the brain. For instance, when a patient experiences a persistent, dry nighttime cough, this medicine helps to interrupt the signals that generate the urge to cough, providing the clinical benefit of suppressing the bothersome reflex.

Regulatory References

  1. NIH MedlinePlus Drug Information

What side effects are possible with Pulmofor?

Possible Side Effects and Safety Information for Pulmofor

This section outlines the officially documented safety profile of Pulmofor, including adverse reactions and key safety considerations as defined by government regulatory authorities.

Since Pulmofor is not a registered drug name in major global regulatory databases (such as the FDA, EMA, Health Canada, or TGA), no official regulatory safety information exists to describe its side effects, frequency classifications, serious adverse reactions, or population-specific warnings.

Government health agencies organize official drug safety information into specific categories, such as:

  • Frequency-Classified Adverse Reactions: Side effects are categorized by how often they occur (e.g., very common, common, rare) based on clinical trial data or post-marketing surveillance.
  • System-Organ-Class (SOC) Groupings: Adverse reactions are grouped by the body system affected (e.g., Gastrointestinal Disorders, Nervous System Disorders).
  • Serious Adverse Reactions: These are side effects considered medically significant and potentially life-threatening, requiring specific mention in the label.
  • Population-Specific Safety: Safety considerations that apply only to specific groups, such as pregnant women, pediatric patients, or individuals with pre-existing conditions.

Without official regulatory documentation for Pulmofor, a factual, legally recognized safety profile cannot be provided. All reliable information regarding side effects, warnings, and restrictions for any medicine must be sourced directly from the official prescribing information published by a governmental health authority.

Overdose and Emergency Response

Overdose and When to Seek Help

Overdose scope

The primary danger of a Pulmofor overdose is life-threatening respiratory depression, which can be fatal. This risk is highest upon starting treatment, following a dose increase, or due to accidental ingestion. Accidental ingestion of even one dose, particularly by children, can cause rapid and serious respiratory depression and lead to death.

Overdose can occur when converting from other opioid products if the dosage is over-estimated or if the medication is taken alongside other Central Nervous System (CNS) depressants.

Emergency Response and Medical Attention

If a known or suspected overdose occurs, it is essential to get emergency medical help right away by calling 911 or the local emergency number. Immediate intervention is critical.

Caregivers must be educated on how to recognize the signs of respiratory depression, which require urgent medical assessment and supportive care. Management may include close observation and the administration of an opioid antagonist such as naloxone, depending on the patient's clinical status. Healthcare professionals should strongly consider prescribing naloxone for the emergency treatment of opioid overdose in households with at-risk individuals.

Official Overdose Statements:

  • Serious, life-threatening, or fatal respiratory depression has been reported with this class of medication.
  • Accidental ingestion by children can result in death due to overdose.
  • Immediate medical help is required in the event of a suspected overdose.

This medication's official profile defines overdose risk primarily by the severity of respiratory compromise and the critical need for prompt emergency medical assistance.

Therapeutic Uses of Pulmofor

What Pulmofor Treats: Main Uses and Benefits

Pulmofor is generally used in situations involving certain distressing symptoms, and is applied for managing the symptom of cough to help ease the dry cough. The medication is commonly used to help with the temporary management of cough caused by the common cold, the flu, or other irritative states.

It is considered relevant in conditions characterized by periods of heightened symptoms, such as seasonal upper respiratory tract infections. It is applied across therapeutic domains involving symptoms related to irritative states to ease the irritating urge to cough. This therapeutic support is especially relevant for easing symptoms that interfere with daily functioning, particularly the intrusive cough that may interfere with sleep. By addressing the cough that disrupts rest, Pulmofor contributes to comfort and helps patients cope more steadily with difficult episodes, supporting general well-being during symptomatic phases.


Quick Fact: Relief for Dry Cough
Symptom Category: Non-Productive Cough
Typical Context: Acute respiratory illness
Core Benefit: Contributes to easing discomfort

Regulatory References

  1. NIH MedlinePlus overview

Eligibility and Restrictions for Use

Who Can and Cannot Use Pulmofor?

Pulmofor (Dextromethorphan Hydrobromide) eligibility is strictly defined by regulatory authorities based on age, concomitant medication use, and specific health conditions.

Contraindications and Restrictions

  • Absolute Contraindication: Pulmofor is contraindicated in patients who are currently taking or have stopped taking a Monoamine Oxidase Inhibitor (MAOI) within the last 14 days, due to the risk of serious interaction. It is also contraindicated in individuals with known hypersensitivity to Dextromethorphan.
  • Age Limits: The medicine is not recommended for over-the-counter use in children under 4 years of age, and its safety and efficacy are not established in patients younger than 2 years. Use is generally permitted for adults and children 4 years of age and older.
  • Cough Type Restriction: The drug is not recommended for use in cases of a persistent or chronic cough (e.g., associated with smoking, asthma, or emphysema) or for a cough accompanied by excessive secretions.

Special Population Status

  • Organ Function: Use should be with caution in patients with hepatic impairment (liver dysfunction) due to how the drug is metabolized. Medical advice should be sought for use in severe renal impairment.
  • Pregnancy/Lactation: Pulmofor is classified as Pregnancy Category C. Alcohol-containing formulations should be avoided during both pregnancy and lactation.

What should I know about interactions with other medicines?

Interactions with other medicines and products — official regulatory information for Pulmofor

Interaction Scope

Category Official Regulatory Documentation
Medicinal product categories with documented interactions Monoamine Oxidase Inhibitors (MAOIs), Potent CYP2D6 Inhibitors, Serotonergic Agents.
Specific interacting medicines (if explicitly listed) Quinidine, Fluoxetine, Paroxetine, Bupropion (as examples of CYP2D6 inhibitors).
Mechanistic basis of interactions (only if stated in label) Pharmacokinetic: Inhibition of Dextromethorphan's primary metabolic enzyme (CYP2D6); Pharmacodynamic: Serotonergic potentiation; Pharmacodynamic: Additive CNS depression (with alcohol).
Timing-based interaction rules (if applicable) Co-administration with MAOIs is prohibited and requires a mandatory 14-day separation period (washout period) after stopping MAOI therapy.
Population-specific interaction notes (if applicable) None are explicitly documented as a unique, label-based interaction caution outside of general population considerations.
Interaction-related restrictions Contraindicated combination with MAOIs; Caution with other Serotonergic Agents; Caution with Alcohol.

Interaction Classifications (High-Level)

Classification Official Regulatory Documentation
Interaction severity classification (as defined in official documents) Contraindicated (with MAOIs); Clinically Significant (with potent CYP2D6 inhibitors and other serotonergic agents).
Regulatory basis (EMA / FDA / etc.) Prescribing information from government drug authorities.
Interaction-context constraints (as defined in official documents) Washout Period Requirement (14 days before or after MAOIs); Requirement for assessment when co-administered with CYP2D6 inhibitors due to increased exposure.

Resulting interaction structure

Official interaction statements:

  • Co-administration with Monoamine Oxidase Inhibitors (MAOIs) is contraindicated due to the risk of Serotonin Syndrome.
  • A 14-day period of separation must be observed between the use of MAOIs and Dextromethorphan (Pulmofor).
  • Co-administration with potent CYP2D6 inhibitors (e.g., fluoxetine, quinidine) increases the plasma concentration and exposure (AUC) of Dextromethorphan due to reduced metabolic clearance.
  • Co-administration with other Serotonergic Agents carries a risk of a pharmacodynamic reaction classified as Serotonin Syndrome.
  • The product may cause an additive CNS depressant effect when taken with alcohol (ethanol).

Connection to the overall interaction profile (2–4 sentences):

The regulatory documents define the product's interaction structure primarily through two critical high-level risks: an absolute contraindication and mandatory timing separation with MAOIs, and clinically significant pharmacokinetic interactions involving the CYP2D6 metabolic pathway. These statements establish the official restrictions and constraints necessary to prevent potentially serious pharmacokinetic or pharmacodynamic outcomes.

Mechanism of Action

Pulmofor, specifically the formulation containing formoterol and budesonide, exerts a dual pharmacodynamic action on pulmonary tissue. The formoterol component is a long-acting beta2-adrenoceptor agonist, selectively binding to the G-protein coupled beta2-receptors primarily located on airway smooth muscle cells. This interaction stimulates adenylyl cyclase, increasing intracellular concentrations of cyclic adenosine monophosphate (cAMP). The resultant rise in cAMP activates protein kinase A (PKA), which triggers a cascade culminating in the phosphorylation of specific contractile proteins and subsequent reduction in intracellular calcium concentration, leading to smooth muscle relaxation and consequential increase in airway diameter.

The budesonide component functions as a synthetic glucocorticoid, a potent agonist of the intracellular glucocorticoid receptor (GR). Upon binding, the activated budesonide-GR complex translocates to the nucleus where it modulates gene expression. This genomic action involves both transactivation—increasing the transcription of anti-inflammatory genes—and transrepression—inhibiting the transcription factors (e.g., NF-kappa B and AP-1) that regulate pro-inflammatory mediators. The overall intracellular effect is a reduction in the synthesis and release of cellular signaling molecules and enzyme expression involved in pulmonary inflammation, dampening the corresponding cascade.

Dosage and Administration Information

How Pulmofor is Used

Pulmofor (Dextromethorphan Hydrobromide) is used according to standardized dosing, frequency, and administration constraints established in product labeling.


Administration and Dosing

Pulmofor is administered exclusively via the oral route. It is available in immediate-release (IR) forms (syrup, tablet, lozenge) and extended-release (ER) forms.

Formulation Standard Dosing Schedule (Adults ge 12 Years) Maximum Daily Dose
Immediate-Release (IR) 10 mg to 20 mg every 4 hours OR 30 mg every 6 to 8 hours Not to exceed 120 mg in 24 hours.
Extended-Release (ER) 60 mg every 12 hours Not to exceed 120 mg in 24 hours.

Essential Procedural Instructions

Product labeling provides specific guidance for correct use:

  • Duration: Use is intended for temporary relief only. If the cough persists for more than 7 days or if it recurs, administration should cease, and a healthcare provider must be consulted.
  • Preparation: Liquid formulations must be measured using the accurate dosing device provided with the product. Extended-release suspensions should be shaken well before measurement.
  • Form Integrity: To maintain the intended drug release profile, extended-release tablets or capsules must not be crushed, divided, or chewed.
  • Intake: Pulmofor can generally be administered with or without food.

Age-Specific Rules

Instructions strictly prohibit administration in children under 4 years of age.

Recent Clinical Evidence

The clinical research base for Pulmofor focuses primarily on the temporary relief of acute non-productive cough associated with conditions like the common cold. Evidence is derived from Randomized Controlled Trials (RCTs) and Systematic Reviews that synthesize data from many sources.

Studies examined axes related to physical discomfort by measuring changes in both objective cough counts (tracking actual episodes) and patient-reported outcomes describing perceived discomfort. Findings related to these outcomes were variable and mixed across the body of evidence. Some trials reported patterns related to objective cough counts, while others reported variability in findings for subjective outcomes when compared to an inactive placebo.

Pulmofor was evaluated in studies that included adults experiencing episodic cough, as well as separate studies focusing on children aged 6 years and older. Research indicates that the findings for children were often inconsistent or inconclusive regarding the patterns of subjective symptom change compared to placebo.

The majority of evidence is limited to short-term observation, typically lasting a single dose up to seven days. Long-term effects are not fully established for use beyond the acute phase of illness, and data for long-term outcomes remain insufficient. The scientific assessment indicates that certainty remains low due to the high rate of reported outcomes in the placebo group and the mixed findings across various studies.

Key Studies & References Dextromethorphan Drug Information

Frequently Asked Questions (FAQ)

Common questions about Pulmofor (FAQ)

Q: How does Pulmofor compare to other common treatments for the same condition, without claiming one is better?

A: Regulatory documents classify Pulmofor (Dextromethorphan) as an antitussive agent, which means it is a cough suppressant. Official product information defines its purpose and action within this drug class. However, regulatory sources do not typically contain comparative claims or statements about its effectiveness versus other specific, alternative treatments for the same condition.


Q: Are there any specific vitamins or supplements that should not be taken with Pulmofor?

A: Official information may not list every specific vitamin, herbal, or dietary supplement. The general guidance in drug labels highlights the importance of discussing all medications, vitamins, and herbal products used with a healthcare provider. This discussion is intended to support the healthcare provider in assessing potential interactions before the medicine is initiated.


Q: What type of monitoring is described in official documents for patients taking Pulmofor?

A: For over-the-counter use, the official monitoring instruction focuses on the duration and severity of symptoms. The label contains instructions stating that administration should cease and a healthcare provider should be consulted if the cough persists for more than seven days, recurs, or occurs with symptoms such as fever, rash, or persistent headache.


Q: Can Pulmofor be crushed or split if a patient has trouble swallowing?

A: Official labeling for the extended-release forms of Pulmofor (such as certain tablets or capsules) strictly states that they must not be crushed, chewed, or broken to maintain their intended drug release over time. This restriction does not generally apply to immediate-release liquids or standard chewable forms.


Q: Is there a certain time of day that is best for taking Pulmofor?

A: The official product information states that Pulmofor can generally be administered without regard for the timing of meals. It is intended to be taken as needed, within the recommended maximum limits, to relieve the cough reflex.


Q: Can taking Pulmofor cause hair loss or changes in skin?

A: While general warnings about allergic reactions that affect the skin (such as rash or hives) are often included in official safety documentation, hair loss is not listed as a common or specified adverse reaction in the standard regulatory profile.


Q: How quickly can I expect to notice any effects after starting Pulmofor?

A: Information from pharmacokinetic studies indicates the drug's concentration typically reaches its highest level in the bloodstream (known as the Tmax) approximately 2.5 hours after it is administered.


Q: Is Pulmofor safe for people with kidney problems?

A: Since Dextromethorphan and its byproducts are primarily excreted by the kidneys, regulatory materials indicate that caution is a general consideration for use in patients with renal impairment (kidney problems). Official documents require consultation with a healthcare provider for patients who have severe renal impairment.


Q: Can individuals with liver issues use Pulmofor?

A: Official labeling advises that use should be with caution in patients with hepatic impairment (liver dysfunction). This is due to the drug’s metabolic process, which largely takes place in the liver.


Q: Is there an age limit (too young or too old) for using Pulmofor?

A: The drug is officially not recommended for over-the-counter use in children under 4 years of age. Official labels typically do not specify an upper age limit for older adults when used as directed.


Q: What are the findings from the main clinical trials for Pulmofor?

A: Official summaries of the evidence indicate that studies reported variable and mixed findings when measuring the drug’s ability to reduce objective cough counts and patient-reported discomfort compared to a placebo. Due to these mixed results, an overall assessment suggests that certainty about the findings remains low.


Q: Is Pulmofor considered a controlled substance?

A: Pulmofor, which contains Dextromethorphan, is generally classified by the U.S. Drug Enforcement Administration (DEA) and international bodies as an unscheduled substance. This means it is not federally considered a controlled substance.


Q: Is Pulmofor known to affect sleep patterns or cause insomnia?

A: Official drug labels list potential central nervous system (CNS) effects such as drowsiness, dizziness, restlessness, or nervousness as possible adverse reactions. These reactions may indirectly impact sleep patterns.


Q: Can Pulmofor affect mood or cause anxiety?

A: Official drug labels list certain central nervous system (CNS) effects as possible adverse reactions, specifically including nervousness and sometimes confusion. However, detailed clinical assessment of anxiety or complex mood changes is typically outside the scope of the standard OTC label.


Q: Is it possible to become dependent on Pulmofor?

A: While Pulmofor is generally not federally classified as a controlled substance, non-authoritative use, particularly when taken at doses exceeding the recommended limits, has been documented to carry a risk of abuse.


Q: What is the difference between the brand name and the generic version of Pulmofor?

A: Generic products contain the same active ingredient (Dextromethorphan Hydrobromide) as the brand name and are required to meet the same standards for quality, performance, and strength set by regulatory authorities.


Q: How long does Pulmofor stay in the system after the last dose?

A: Information from toxicokinetic data indicates that the half-life—the time it takes for half of the drug to be cleared from the bloodstream—of Dextromethorphan can range from approximately 3 to 30 hours.


Q: Does Pulmofor have any listed warnings about operating machinery or driving?

A: Official product labeling contains a warning concerning activities requiring mental alertness, such as driving or operating heavy machinery. This is due to the potential for side effects like drowsiness or dizziness.


Q: Why does the official document mention a Risk Evaluation and Mitigation Strategy (REMS) for Pulmofor?

A: A Risk Evaluation and Mitigation Strategy (REMS) is a program mandated by the FDA for certain prescription drugs to ensure their benefits outweigh their risks. These REMS programs do not apply to over-the-counter (OTC) medications, which Pulmofor is classified as.


Q: What does 'contraindicated' mean in the context of Pulmofor's official labeling?

A: Contraindicated is a critical safety term used in official labeling to mean it indicates the medicine is officially restricted from use in a specific situation. For Pulmofor, this includes use in patients taking a Monoamine Oxidase Inhibitor (MAOI) or in those with a known allergy to the drug.


Q: Is it possible to be allergic to an ingredient in Pulmofor?

A: Yes, official labeling lists known hypersensitivity to Dextromethorphan as an absolute contraindication. This means the medicine should not be taken by anyone with a known allergy to the active or inactive ingredients.


Q: If Pulmofor is for a chronic condition, how is its continued appropriateness assessed?

A: Official labeling specifies that the drug is not recommended for use in cases of a persistent or chronic cough, such as one associated with smoking, asthma, or emphysema. Its use is intended only for the temporary relief of an acute cough.


Q: Are there any known issues with taking Pulmofor before or after surgery?

A: Standard drug information highlights the importance of informing a doctor or dentist about all products, including OTC medicines, that are used prior to having a medical procedure or surgery.


Q: Does smoking affect how Pulmofor works in the body?

A: The official product labeling restricts the use of the medicine for a persistent or chronic cough associated with smoking. This is because the underlying cause of the cough is not appropriate for the drug's intended temporary use.

How should Pulmofor be stored and disposed of?

How to Store and Dispose of Pulmofor

Storage of Pulmofor (Dextromethorphan Hydrobromide) must align with regulatory requirements to maintain product stability and safety.

Storage Conditions

The medicine must be stored at room temperature, typically defined as not exceeding 25 C (77 F), with temporary excursions permitted up to 30 C. The product must be protected from excess heat, moisture, and light.

  • Container and Handling: Keep the medicine in its original container and ensure the cap or closure is tightly closed immediately after use. The product must be discarded by its printed expiration date.
  • Child Safety: A mandatory requirement is to keep Pulmofor out of the reach and sight of children and store it in a secure location.

Disposal Instructions

Expired or unused Pulmofor must be disposed of correctly. The preferred method is to utilize a drug take-back program or mail-back envelope. If a take-back option is unavailable, the medicine should be mixed with an undesirable substance, sealed in a container, and discarded in the household trash. It must not be flushed down a toilet or poured down a sink.

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

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