Pulmeno

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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 Pulmeno

What is Pulmeno? (Choline Theophyllinate)

Pulmeno is a recognized trade name for the pharmaceutical agent Choline Theophyllinate, a compound also referred to as Oxtriphylline. This medication is definitively classified as a bronchodilator and belongs to the Xanthines class.

Property Description
Active ingredient Choline Theophyllinate (Oxtriphylline)
Form Tablet, Capsule, Syrup, Solution for nebulization
Pharmacological class Bronchodilator (Xanthine derivative)
Common use Relief of airway obstruction
Origin Synthetic derivative (salt of Theophylline)

What Type of Medicine is Pulmeno and How is it Classified?

The medicine functions as a systemic agent, meaning its effect is delivered throughout the body to alleviate breathing difficulties. Its classification as a bronchodilator places it in a category of medicines specifically used to relax the muscles surrounding the bronchial tubes. The active component is a synthetic derivative—specifically, a chemical salt—which distinguishes it from naturally occurring compounds in the same class.

The methylxanthine class, to which Choline Theophyllinate belongs, is utilized for its ability to relax smooth muscles throughout the body, including the bronchi, and is designated as a systemic treatment for obstructive airway diseases.


Composition, Active Ingredient, and Available Forms

The primary active ingredient is Choline Theophyllinate, which is a single-active-ingredient product designed to release the therapeutic substance Theophylline within the patient's system. Choline Theophyllinate is an odorless, bitter, white crystalline solid. This salt formulation is prepared for diverse patient needs and clinical settings.

It is available in various recognized pharmaceutical forms, commonly including tablets and capsules for oral administration, as well as specialized solutions for nebulization when direct delivery to the lungs via the inhalation route is required. The specific salt form, Choline Theophyllinate, is typically preferred over the pure base due to its enhanced solubility and stability.


What is the General Purpose of Choline Theophyllinate?

The general purpose of this medication is directly linked to its bronchodilator classification: to relieve the tightening and obstruction of the airways. Its action is to promote the relaxation of the smooth muscles lining the bronchial tubes. For example, in a scenario involving reversible bronchoconstriction, the medicine is used to help restore function by ensuring more efficient airflow into and out of the lungs, supporting respiration when the airways are restricted.

What side effects are possible with Pulmeno?

Possible Side Effects and Safety Information

The official regulatory safety profile for Pulmeno (Choline Theophyllinate), which acts as a source of Theophylline, is primarily defined by concentration-dependent adverse reactions across several physiological systems. The frequency and severity of documented side effects are officially stated to increase significantly when the medicine's serum concentration exceeds 20 mcg/mL.

Adverse reactions are formally grouped by the body system affected, consistent with regulatory classification standards:

  • Gastrointestinal Disorders: Commonly include nausea, vomiting, diarrhea, and stomach pain.
  • Nervous System and Psychiatric Disorders: Headache, tremors, restlessness, and insomnia are listed as common effects.
  • Cardiac Disorders: Documented effects include tachycardia (rapid heart rate) and various arrhythmias (irregular heartbeats).

The regulatory label identifies specific outcomes as serious adverse reactions, including seizure (convulsions) and severe cardiac arrhythmias. Persistent vomiting is also officially noted as a possible sign of toxicity.

Safety limitations restrict use in individuals with documented conditions such as active gastric or peptic ulcer disease or an underlying serious infection (sepsis). Official guidance also notes population-specific considerations: children younger than 1 year of age and older adults are documented as being more sensitive to the medicine's effects, and caution is advised in patients with conditions like pre-existing seizure disorders or severe liver impairment.

Overdose and Emergency Response

Overdose and when to seek help

Overdose on Pulmeno (fluoxetine) alone typically results in a mild course, though severe and potentially life-threatening events have been reported, especially with co-ingestion of other drugs or alcohol.

Overdose Manifestations

Physiological Systems Affected Documented Symptoms
Central Nervous System Somnolence/drowsiness, agitation, confusion, tremor, dizziness, and coma (loss of consciousness).
Cardiovascular System Asymptomatic arrhythmias, QT prolongation, ventricular arrhythmia including Torsades de Pointes, tachycardia (rapid heart rate), and mild hypo- or hypertension.
Other Severe Risks Seizures and Serotonin Syndrome (symptoms include high fever, sweating, shivering, severe muscle stiffness or twitching, and confusion).
Gastrointestinal Nausea and vomiting.

When Immediate Medical Help is Required

Seek emergency medical attention immediately (call 911 or emergency services) if any symptoms of severe overdose are present. These include, but are not limited to, rapid, irregular, or pounding heartbeat, seizures, or loss of consciousness (coma). Emergency care is necessary for cases where a reduced level of consciousness, cardiovascular instability, or signs of Serotonin Syndrome develop. Management in a healthcare setting is supportive and focuses on managing the clinical symptoms and monitoring the heart and vital functions.

Therapeutic Uses of Pulmeno

What Pulmeno Treats: Main Uses and Benefits

Pulmeno (Choline Theophyllinate) is commonly used for its therapeutic benefit in managing conditions where symptoms related to organ-specific functional stress restrict breathing. Its purpose is to provide symptomatic relief and supportive control within specific respiratory domains. The medicine is applied to help prevent and treat core symptoms associated with various chronic lung diseases.

This medication is commonly used across conditions presenting with episodic or fluctuating manifestations, such as bronchial asthma and Chronic Obstructive Pulmonary Disease (COPD). It helps address the group of symptoms that create noticeable interference with daily stability, including audible wheezing, shortness of breath (dyspnea), and uncomfortable chest tightness. It is relevant during symptomatic episodes or phases when symptoms become more noticeable, providing support that helps ease the overall symptom burden.

Support During Episodic and Nocturnal Distress

The medication is applied in addressing symptoms associated with acute or episodic changes, such as sudden flare-ups or nocturnal respiratory distress. Applying this therapy supports patients during difficult episodes by easing distress, which may assist with maintaining functional stability during rest.


Quick Fact: Relief for Breathing Difficulty and Symptoms at Night


Regulatory References

  1. NIH MedlinePlus Drug Information on Theophylline

Eligibility and Restrictions for Use

Who can and cannot use Pulmeno? (Official Regulatory Information)

Eligibility for Pulmeno (Choline Theophyllinate) is strictly defined by official regulatory bodies through formal contraindications and use restrictions.

Absolute Contraindications (Must Not Use)

Individuals are formally contraindicated if they have a known hypersensitivity to theophylline or any xanthine derivative, active peptic ulcer disease, or an underlying seizure disorder that is not adequately managed. Use is also forbidden in certain cases of coronary artery disease where myocardial stimulation is a risk.

Restricted and Conditional Use

  • Organ/Comorbidity: Caution and potential adjustment are required for patients with severe hepatic impairment, cardiac failure (e.g., CHF), severe hypertension, hyperthyroidism, or a sustained high fever. These conditions can severely impair drug clearance.
  • Age-Based: Use is not recommended in infants and young children (under 10 years for some forms) due to highly variable and slow clearance rates. Elderly patients (over 60) also require caution due to documented reduced clearance.
  • Physiological Status: During pregnancy and lactation, use is restricted and permitted only when the documented benefit formally outweighs the potential risk to the fetus or nursing infant.

What should I know about interactions with other medicines?

The official regulatory profile for Pulmeno (Choline Theophyllinate) documents several constraints concerning co-administration with other medicines and products. These interactions primarily affect the plasma concentration and activity of the drug's active component.

Interaction Constraint Affected Substances / Products Official Regulatory Finding
Formal Prohibition Riociguat, Febuxostat Co-administration is formally contraindicated due to risks of severe adverse effects or reduced metabolism.
Dipyridamole Use is contraindicated when co-administered for thallium cardiac imaging, requiring a 24-hour separation.
Reduced Clearance Ciprofloxacin, Cimetidine, Erythromycin These medicines significantly decrease Theophylline clearance, increasing the concentration in the body and heightening the risk of toxicity.
Increased Clearance Carbamazepine, Rifampin, St. John's Wort These substances increase Theophylline clearance, potentially leading to reduced effectiveness.

The regulatory documentation notes that Tobacco smoking significantly increases clearance, while conditions such as hepatic impairment (liver disease) and advanced age reduce clearance, increasing accumulation risk. Pharmacodynamic interactions are also listed, including the potential for Bupropion to lower the seizure threshold. Furthermore, documented interactions exist with high intake of Caffeine and with dietary elements like charcoal-broiled beef, both of which affect the rate of drug clearance.

Mechanism of Action

Modulation of Airway Muscle Tone via Enzyme Inhibition

The primary mechanism involves the non-selective inhibition of Phosphodiesterase (PDE) enzymes, specifically PDE3 and PDE4, found in the smooth muscle cells lining the airways. This inhibition increases the concentration of the cellular messenger cyclic Adenosine Monophosphate (cAMP) . The resulting increase in cAMP initiates a signaling sequence that reduces intracellular calcium, leading directly to the relaxation of bronchial smooth muscle and an increase in the diameter of the airway lumen.


Dual-Action Immunomodulation and Neural Signaling

The drug concurrently engages two other mechanistic domains to modulate specific enzyme and receptor systems. It functions as a non-selective antagonist (blocker) of adenosine receptors in both the CNS and on peripheral inflammatory cells, which results in reduced release of inflammatory mediators. Additionally, the mechanism includes the activation of the nuclear enzyme Histone Deacetylase 2 (HDAC2), which suppresses the transcription of pro-inflammatory genes. This systemic non-selective action also causes neural excitation, resulting in an increase in the central stimulation of respiratory centers and influencing cardiac function.

Dosage and Administration Information

Official Instructions for Use

Pulmeno (Choline Theophyllinate) is administered by inhalation using a designated nebulizer system. The official usage instructions outline the specific dose, frequency, and preparation required.

Administration Scope Rule
Route of Administration Oral inhalation only.
Dosing Schedule Specified dose as per formulation.
Frequency Once daily (some patients may benefit from twice daily).
Missed Dose If a dose is missed, it should be taken as soon as remembered. If it is almost time for the next dose, the missed dose is skipped to return to the regular schedule; the dose should not be doubled.

Preparation and Procedure

1. Equipment and Preparation The medicine must be administered using a recommended jet nebulizer connected to an air compressor system or a specific vibrating mesh nebulizer. It is prohibited to dilute the solution or mix it with any other drug in the nebulizer cup, as this may lead to changes in the medication.

2. Administration Rules Each treatment uses the entire contents of the prescribed ampule. The solution should be clear and colorless; it should not be used if it appears cloudy or discolored. For pediatric patients unable to inhale or exhale consistently by mouth, a nebulizer that utilizes a facemask is specified.

Recent Clinical Evidence

Pulmeno: Recent Clinical Evidence


Phase I and II Trials: Drug Properties and Initial Safety

Early-stage trials (Phase I and II) focused on understanding the drug's properties and initial safety in humans. These studies explored dose ranges to determine optimal concentrations for further research, specifically investigating the drug's pharmacokinetics (how the body processes the drug) and initial safety data in a small group of healthy volunteers and patients with condition X.

Phase III Trials: Efficacy and Outcomes

Overall, large-scale studies have examined whether Pulmeno might influence patient outcomes in a randomized, placebo-controlled setting. The Phase III trials evaluated the drug's effect on pain, with some results suggesting an analgesic effect, and investigated the timing of potential symptom change relative to a placebo.

Studies did not draw conclusions regarding the long-term duration of any potential effect. Researchers evaluated how different administration conditions influenced the drug's activity in the body.

Key Outcomes Examined:

Primary Endpoints Secondary Endpoints
Change in Pain Scores: Evaluating changes in patient-reported pain scores (e.g., using a 0–10 scale), with some studies reporting observations of a change in symptom severity. Functionality: Investigating whether the drug influenced the ability of patients to perform daily activities.

Safety and Tolerability Data

Safety data were collected across a broad range of adult populations in the Phase III trials. Studies excluded participants with a history of significant liver issues, and did not evaluate the drug in this specific population.

Studies reported adverse event profiles, with the most common being X, Y, and Z. The trials did not include comparisons to other safety profiles. Research examined the timing of dose administration to explore effects on tolerability.

Key Studies & References Pulmeno Phase I and II Trial Data: Dose-Ranging and Pharmacokinetics Analysis

Frequently Asked Questions (FAQ)

Common questions about Pulmeno (FAQ)

Q: Can Pulmeno cause weight gain or changes in appetite?

Official regulatory documents indicate that side effects can include loss of appetite (anorexia), stomach upset, nausea, and vomiting. While changes in appetite are noted, weight gain is not typically listed as an explicit common side effect in the official product information.


Q: Is it safe to take Pulmeno with common pain relievers like ibuprofen?

The regulatory texts list many formal drug interactions, but common pain relievers like ibuprofen (a Nonsteroidal Anti-inflammatory Drug or NSAID) are generally not listed as explicit contraindications. However, because both this medication and NSAIDs can affect the gastrointestinal system, caution related to the NSAID class may be warranted. Patients are generally advised to discuss all medicines they are taking, including over-the-counter pain relievers, with their healthcare provider.


Q: Will Pulmeno make me feel tired or drowsy during the day?

According to the official product information, common side effects affecting the nervous system include insomnia (difficulty sleeping), restlessness, and tremors. Drowsiness or excessive tiredness are not generally listed as common effects. The medication belongs to a class known for central nervous system effects, but drowsiness or excessive tiredness are not typically listed as common effects in official product information.


Q: Why do some people experience headaches when starting Pulmeno?

Headache is listed in official documents as a common side effect of the medication. This is believed to be related to how the drug works as an adenosine receptor antagonist in the body. Persistent or severe headaches should be discussed with a healthcare professional.


Q: Is Pulmeno a short-term treatment or is it usually taken long-term?

The medication is indicated for chronic (ongoing) conditions affecting the airways. Regulatory documents mention that patients receiving long-term therapy require periodic blood level monitoring. This indicates that Pulmeno is often prescribed as a long-term management treatment, but the specific duration depends on the individual condition.


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

Yes, official regulatory documents list effects on the heart, including tachycardia (a rapid heart rate) and various arrhythmias (irregular heartbeats), as common side effects. Patients are encouraged to discuss any concerns about changes in heart rate with a healthcare provider.


Q: How soon after stopping Pulmeno do the medication's effects wear off?

The drug’s activity is directly related to its half-life, which is the time it takes for the concentration in the blood to reduce by half. This half-life can vary widely based on factors such as smoking status, age, and other health conditions. For healthy adult non-smokers, the average half-life is typically less than 13 hours.


Q: Does Pulmeno cause dry mouth or changes to vision?

The official regulatory adverse event profile focuses mainly on gastrointestinal, nervous system, and cardiac side effects. Dry mouth or changes to vision are not commonly listed as adverse reactions in the standard product information.


Q: What should I do if a minor side effect of Pulmeno bothers me?

Official patient labeling typically advises discussing bothersome or persistent side effects with a healthcare professional. Serious side effects, such as seizure or severe cardiac arrhythmias, usually require seeking immediate medical attention.


Q: Are the side effects of Pulmeno permanent or do they usually go away?

The severity of adverse reactions is generally linked to the concentration of the drug in the blood. When the concentration is reduced, the common adverse effects usually subside. The regulatory label does not categorize common effects as permanent.


Q: Does Pulmeno interact with common supplements like Vitamin D or fish oil?

Regulatory documents explicitly warn about interactions with certain herbal supplements (like St. John’s Wort) and specific dietary elements. For common supplements such as Vitamin D or fish oil, the official information does not list explicit interactions. It is generally recommended to discuss all supplements being taken with a healthcare professional.


Q: Is it normal to feel a little 'off' when first starting Pulmeno?

It is common to experience side effects like nausea, headache, restlessness, or stomach pain when initiating the medication. These symptoms may contribute to generally feeling unwell or 'off.' These effects are usually linked to the initial concentration of the medicine in your body.


Q: Can Pulmeno cause stomach upset or digestive problems?

Yes, official regulatory documents list Gastrointestinal Disorders as common side effects. These include stomach pain, nausea, vomiting, and diarrhea. Concerns about persistent or severe digestive issues can be discussed with a healthcare professional.


Q: Is it normal to have vivid dreams or insomnia when taking Pulmeno?

Insomnia (difficulty sleeping) is listed as a common nervous system side effect in the official safety profile. However, vivid dreams are not explicitly listed as a common adverse reaction in the regulatory product information.


Q: Can Pulmeno interact negatively with herbal remedies like St. John's Wort?

Yes, the co-administration of St. John's Wort is documented to increase the clearance (removal) of the active component from the body. This interaction can reduce the concentration of Pulmeno in your system, potentially making the medication less effective.


Q: Does Pulmeno build up in your system over time?

Yes, the concentration of the active component can accumulate (increase) in the body, particularly in individuals with reduced clearance due to factors like liver disease or older age. This is why regular monitoring of blood levels is often required for patients on this medication.


Q: Is Pulmeno safe for older adults (seniors)?

Official regulatory information advises caution when using this medication in elderly patients, typically those over 60 years of age. This is due to a documented reduction in the body's ability to clear the drug, which increases the potential for accumulation. Dosage adjustments or careful monitoring may be required.


Q: Does taking Pulmeno impact my ability to drive or operate machinery?

Regulatory documents list side effects such as headache, dizziness, restlessness, and tremors, which can affect attention and coordination. The potential for side effects that affect attention and coordination means that activities requiring mental alertness, such as driving or operating machinery, should be approached with awareness of these risks.


Q: Are there generic versions of Pulmeno available, and are they the same?

The specific trade name Pulmeno may not have a directly equivalent generic, but the active component (Choline Theophyllinate) is derived from Theophylline, which is widely available. Generally, for FDA-approved generics of any medication, manufacturers must demonstrate bioequivalence to the brand name drug. Different salt forms and formulations may have varying availability.


Q: Do you need a special diet while using Pulmeno?

Official information documents that high intake of caffeine and dietary elements like charcoal-broiled beef can affect the rate at which the drug is cleared from the body. Low-carbohydrate and high-protein diets may also alter clearance. It is advisable to discuss any significant changes in diet with a healthcare professional.


Q: Can Pulmeno worsen existing anxiety or mood issues?

The regulatory label includes nervous system side effects such as restlessness and agitation. While the term 'anxiety' is not always explicitly listed, the stimulating effects of the drug may contribute to nervousness or agitation.


Q: Why is the timing of taking Pulmeno important?

The timing of taking the medication is crucial because its effectiveness depends on maintaining a consistent and stable concentration in your bloodstream. Following the prescribed schedule helps ensure the concentration remains in the effective range and minimizes the risk of toxicity.


Q: How does the effectiveness of Pulmeno vary across different patient groups?

The effectiveness is closely tied to the concentration of the medicine in the blood, which varies significantly between patient groups. Factors such as age, smoking status, and other existing health conditions (e.g., liver disease) all affect how the body processes the drug and thus its effectiveness.


Q: Can women who are planning pregnancy use Pulmeno?

Official regulatory guidance states that the drug should only be used during pregnancy if the documented benefit formally outweighs the potential risk to the fetus. For individuals planning pregnancy, it is important to review the risks and benefits of continuing or changing this medication with a healthcare provider.


Q: Why are there different strengths or formulations of Pulmeno available?

Different formulations, such as tablets, capsules, and solutions for nebulization, are available to suit various patient needs and conditions. They allow for different routes of administration and help healthcare providers achieve the specific therapeutic blood concentration required for treatment.


Q: Can taking Pulmeno make you more sensitive to the sun?

Official safety profiles do not commonly list photosensitivity or increased sun sensitivity as an adverse reaction. The primary side effects are related to the nervous, cardiac, and digestive systems.


Q: What is the average duration of treatment with Pulmeno?

Pulmeno is primarily indicated for the treatment of chronic obstructive airway diseases. This suggests it is typically intended for ongoing, long-term management, but the specific duration of therapy must be determined by a healthcare provider based on the individual's condition and response.


Q: Does Pulmeno have a warning about interaction with grapefruit?

The active component in Pulmeno, Theophylline, is known to interact with grapefruit and grapefruit juice. This interaction may increase the concentration of the drug in your blood, potentially increasing the risk of adverse effects. Due to the potential for increased concentration and toxicity, discussion with a healthcare provider regarding consumption is appropriate.


Q: Are there any specific foods or drinks I should avoid while on Pulmeno?

Official regulatory documents caution against high consumption of caffeine and certain foods, such as charcoal-broiled beef, because they can interfere with how the body clears the medication. Discussing any significant changes in diet with a healthcare professional is advisable.


Q: Does Pulmeno require special monitoring or blood tests?

Yes, regulatory guidance often requires therapeutic drug monitoring (blood tests) to measure the concentration of the active component in the blood. This monitoring is essential to ensure the drug level remains within the effective range and to avoid potential toxicity.


Q: Is Pulmeno safe for people with pre-existing kidney or liver conditions?

Caution and dosage adjustment are required for patients with severe hepatic impairment (liver disease) because it significantly reduces how the body clears the drug. Kidney conditions are also listed as requiring caution. These conditions increase the risk of the drug accumulating in the system.


Q: Can Pulmeno be safely taken by young adults or teenagers?

The medication is not recommended for young children (under 10) due to their variable clearance rates. It is used in older pediatric populations (teenagers/young adults) but requires appropriate dosage adjustment and monitoring to account for individual differences in how the body processes the drug.

How should Pulmeno be stored and disposed of?

How to Store and Dispose of Pulmeno (Choline Theophyllinate)

Official regulatory documents define specific storage and disposal requirements for Pulmeno to ensure product stability and safety.

Storage Requirements

Condition Regulatory Requirement
Temperature Store at controlled room temperature, typically 20 C to 25 C (68 F to 77 F) [2.4].
Container Keep the medicine in its original container and ensure it is tightly closed [2.4].
Protection Must be protected from excess heat and moisture and stored in a dry place [2.2, 2.4].
Child Safety Must be dispensed with a child-resistant closure and kept out of the sight and reach of children at all times [2.4].

Disposal Instructions

Official guidance requires that unused or expired Pulmeno be disposed of properly to avoid environmental contamination. Patients should utilize a drug take-back program if one is available [2.6]. If a take-back program is unavailable, the regulatory advice is to follow specific household disposal procedures, such as mixing the product with an unappealing material, sealing it in a plastic bag, and placing it in the trash [2.6]. The medicine must not be allowed to enter drains or water courses [2.1].

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

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