Dilatair

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Dilatair

Method of action: Bronchodilator

Treatment option:

Medically reviewed

Laura Arias

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 Dilatair

Property Description
Active Ingredient Doxofylline
Form Oral tablet, Capsule
Pharmacological Class Bronchodilator, Xanthine derivative
General Purpose To manage airflow restriction in the lungs
Origin Synthetic derivative

What Type of Medicine is Dilatair (Doxofylline)?

Dilatair is the specific trade name for the drug whose active ingredient is Doxofylline, a substance precisely classified as a bronchodilator within the Xanthine derivative pharmacological class. This compound is manufactured as a prescription-only (Rx) medication. Doxofylline is identified by the ATC code R03DA11.


Composition, Origin, and Available Forms

The Doxofylline molecule is a synthetic compound derived from the oxopurine class, known globally under alternative brand names such as Ansimar and Doxobid. Its structure is chemically defined as a methylxanthine derivative that features a unique dioxolane group at position 7. Pharmacologically, Doxofylline is characterized by a lower affinity for adenosine receptors compared to Theophylline, which contributes to its distinct pharmacological profile. The preparation is a single-compound drug, most commonly supplied as an oral tablet for oral administration, making it a straightforward formulation for chronic therapy.


General Purpose and High-Level Action

The general therapeutic purpose of Dilatair is to relieve the restricted airflow symptoms that characterize chronic respiratory conditions, such as the persistent airway narrowing experienced by adult patients with Chronic Bronchitis. The medication achieves this through its primary physiological action of promoting smooth muscle relaxation in the bronchial passages. By facilitating this dilation, the drug fundamentally helps to widen the airways, which is the key mechanism for easing the mechanical obstruction to breathing. This function maintains open passages and is a cornerstone in the long-term, systemic management of these conditions.

What side effects are possible with Dilatair?

Possible Side Effects and Safety Information

The safety profile of Dilatair (Doxofylline) is officially classified within the therapeutic category of xanthine derivatives. Adverse reactions are primarily grouped by the physiological systems they affect, focusing on the gastrointestinal, nervous, and cardiovascular systems.

Documented Adverse Reactions

Adverse reactions that may occur following xanthine administration include gastrointestinal disturbances (such as nausea, vomiting, abdominal pain, and epigastric distress), nervous system effects (including headache, insomnia, and irritability), and cardiac disorders (such as tachycardia, palpitation, and extrasystole).

Serious Safety Considerations

In the context of potential overdose or high plasma levels, regulatory documents specify the risk of severe arrhythmias and seizure. These events are noted as potential first signs of intoxication.

Safety Restrictions and Special Populations

Official labeling contains explicit constraints to ensure safety. Dilatair should not be administered concurrently with other xanthine derivatives, including products containing caffeine, due to the risk of increased blood concentration. A potential toxic synergism with ephedrine is also documented.

Specific caution is required for special populations. This includes older adults and patients with pre-existing conditions like liver disease, renal disease, and heart disease, as drug clearance may be slowed in these groups, leading to persistently higher blood levels. The medication is formally contraindicated in patients with acute myocardial infarction, hypotension, and is not to be used by lactating women.

Overdose and Emergency Response

Overdose Map: Overdose and when to seek help — Official Regulatory Information for Dilatair

Property Official Regulatory Statement
Documented overdose presentations Overdose is formally documented to involve manifestations such as severe arrhythmias and seizure, which may serve as the first signs of intoxication. Other effects can include nausea, vomiting, epigastric pain, headache, tachycardia, and tachypnea.
Physiological systems affected (as stated in label) Central Nervous System and Cardiovascular System, where severe complications like cardiovascular collapse are a recognized risk.
Dose-related or exposure-related factors (if applicable) The risk of severe manifestations is associated with potential oral overdose of xanthine derivatives.
Population-specific overdose notes (if applicable) Prescribing information notes that caution is recommended in the elderly and patients with hepatic dysfunction or heart failure due to factors that may prolong drug plasma levels and increase risk.
Emergency-response statements (as written in official documents) Management must include instituting symptomatic and supportive treatment, with a focus on symptomatic relief of cardio circulatory shock. In non-seizing patients, procedures like gastric emptying, followed by activated charcoal, are indicated. If seizures occur, maintaining an adequate airway is required.
When immediate medical help is required (label-derived phrasing only) Seek medical attention immediately upon suspicion of overdosage or at the first sign of an adverse reaction.

Overdose Classifications (High-Level)

Classification Official Regulatory Statement
Severity classification (as defined in official documents) Potential for severe cardiac rhythm disturbances and tonic-clonic seizure, which can be life-threatening.
Regulatory basis (EMA / FDA / etc.) Information derived from Summary of Product Characteristics (SmPC) and national Prescribing Information documents.
Overdose-context constraints (as defined in official documents) No specific antidote is known; therefore, management must be supportive and focused on symptoms.

Resulting Overdose Structure

Official overdose statements:

  • Overdosage is associated with the risk of severe cardiac arrhythmias and seizures, which are documented as major signs of intoxication.
  • Regulatory documents explicitly state that no specific antidote is available for Doxofylline.
  • Management is limited to symptomatic and supportive treatment and may involve procedures like gastric emptying or airway maintenance, depending on the patient's presentation.
  • Immediate medical attention is required, and patients are mandated to seek medical attention immediately at the first sign of an adverse event.

Connection to the overall overdose profile (2–4 sentences): The official regulatory profile defines Dilatair overdose by the potential for high-risk outcomes, specifically severe CNS and cardiac toxicity. Due to the explicit constraint that no specific antidote is available, the regulatory guidance mandates immediate and aggressive symptomatic and supportive treatment to manage complications like cardiovascular collapse. This critical lack of a specific intervention reinforces the requirement to seek medical attention immediately upon suspicion of an overdose.

Therapeutic Uses of Dilatair

What Dilatair Treats: Main Uses and Benefits

Dilatair is commonly used to provide symptomatic support in conditions that affect the respiratory system, primarily addressing the symptoms associated with chronic obstructive airway diseases. The medication helps address symptoms that often create noticeable physiological strain and may interfere with daily functioning. Doxofylline (the active ingredient in Dilatair) is commonly used for managing bronchial asthma and Chronic Obstructive Pulmonary Disease (COPD).

Managing Symptoms of Obstructive Airway Diseases

This therapeutic domain is applied across conditions characterized by periods of heightened symptoms, such as chronic bronchial asthma and COPD. Dilatair is considered relevant in contexts marked by increased discomfort where short-term symptomatic assistance is appropriate. The use of Dilatair generally helps address symptom clusters that may become intense or disruptive, provides support during episodes of heightened discomfort and contributes to easing discomfort during symptomatic periods.

Easing Respiratory and Physical Strain

Dilatair is relevant for easing symptoms like wheezing, chest tightness, and the sensation of breathlessness. It is applied in scenarios where additional management of discomfort is required, especially when symptoms become more disruptive during flare-ups. This supportive therapeutic approach may assist with maintaining functional stability and offers symptomatic relief that may help patients cope more steadily with symptom fluctuations, helping to ease the overall symptom load.


Quick Fact: Supportive Relief for Respiratory Strain

Dilatair is used for managing respiratory-related strain and helps address groups of symptoms that may appear suddenly or intensify over time, providing support during episodes of heightened discomfort.

Regulatory References

  1. Philippines FDA Verification Portal Product Information Sheet

Eligibility and Restrictions for Use

Who Can and Cannot Use Dilatair?

The eligibility for using Dilatair (Doxofylline) is strictly defined by regulatory guidelines based on population health status and age.

Absolute Prohibitions (Contraindications)

Dilatair must not be used in individuals with:

  • Known hypersensitivity to Doxofylline or any other methylxanthine derivative.
  • Acute myocardial infarction.
  • Hypotension (abnormally low blood pressure).
  • Lactating women (nursing mothers).

Age and Restricted Use

Population Group Eligibility Status Restriction Note
Adults Approved Use is documented as acceptable under standard conditions.
Children Approved (>6 years) Approved for children above 6 years of age. Use is restricted in younger children.
The Elderly Restricted Requires caution, particularly with co-existing cardiac or hepatic conditions.
Pregnant Women Restricted Safety is not established; use only if clearly needed.

Condition-Specific Limitations

Use requires caution in patients with conditions like hepatic dysfunction (liver disease), renal disease, peptic ulceration, heart failure, or epilepsy. These conditions classify use as restricted, necessitating careful evaluation as defined by official labeling.

What should I know about interactions with other medicines?

The official regulatory profile for Dilatair is structured around defined constraints concerning co-administration with other substances and the modification of its clearance rate, which occurs primarily through hepatic metabolism.

Prohibited Combinations and Pharmacodynamic Risk

Regulatory labeling classifies the combination of Dilatair with other Xanthine derivatives as formally contraindicated due to the risk of additive toxic effects. This restriction also extends to beverages and food containing caffeine (methylxanthines). Furthermore, toxic synergism has been documented for xanthines when co-administered with Ephedrine.

Exposure-Altering Interactions

Co-administration with agents documented to decrease hepatic clearance, such as Macrolide Antibiotics (e.g., Erythromycin), H2 Receptor Antagonists (e.g., Cimetidine), Allopurinol, or the anti-flu vaccine, may lead to an increase in blood levels. Conversely, Phenytoin and other Anticonvulsants, as well as Cigarette Smoking, are documented to increase clearance, which may result in reduced drug exposure.

Population-Specific Constraints

Regulatory documents note that clearance is considerably slower in patients with conditions like Congestive Heart Failure and may be prolonged in those with Liver Disease. This patient status influences the significance of all clearance-reducing interactions. Dilatair is also formally contraindicated in lactating women.

Mechanism of Action

How Dilatair Works: Pharmacodynamic Mechanism

The physiological action of Dilatair (Doxofylline) is primarily mediated by the inhibition of specific phosphodiesterase (PDE) enzymes, notably suggested to be the PDE2A isoform, within bronchial tissues.

This enzymatic block reduces the hydrolysis of cyclic adenosine monophosphate (cAMP), leading to an increase in the intracellular concentration of this secondary messenger. The resulting cAMP accumulation activates Protein Kinase A, initiating a molecular cascade that reduces the tension in bronchial smooth muscle fibers. This process culminates in the physiological effect of bronchodilation and a resultant wider bronchial lumen.

Furthermore, Doxofylline exhibits a selective molecular profile defined by its negligible functional affinity for adenosine receptors (A1 and A2A) at therapeutic concentrations. This distinction ensures the drug's activity is not primarily mediated by widespread systemic signaling associated with adenosine receptor antagonism. The drug also engages pathways that contribute to the modulation of localized inflammatory mediators and cellular activity in the airways, a separate mechanistic component co-occurring with muscle relaxation.

Dosage and Administration Information

How to Use Dilatair (Doxofylline)

Dilatair (Doxofylline) is administered via two primary routes based on the clinical context: the oral route for long-term chronic management and the intravenous (IV) route for acute situations. The distinction between these two routes defines the administration protocol.

The standard adult regimen for oral maintenance is typically 400 mg administered two or three times daily (b.i.d. or t.i.d.), with a maximum recommended daily dose of 1200 mg. This frequency pattern is required to establish a sustained therapeutic level in the bloodstream over time. The oral form can generally be taken with or without food.

For acute management, the drug is administered via slow intravenous injection at a dose of 200 mg. This procedure requires specific conditions: the patient must be in a supine position (lying down), the injection must be delivered slowly over 15 to 20 minutes, and the solution should preferably be diluted before use. Repeated IV doses can be given at 12-hour intervals in the acute phase.

Dose adjustments are specified for certain populations. Older adults typically require a reduced oral dosage of 200 mg two or three times daily. The dose may be reduced for patients with confirmed hepatic or renal impairment.


Use Context Route and Form Standard Adult Dose
Chronic Maintenance Oral Tablet/Capsule/Syrup 400 mg two to three times daily
Acute Management Intravenous Injection 200 mg per dose, repeated at 12-hour intervals

This structural protocol defines the approach to using the medicine based on the patient's immediate need (acute vs. chronic) and requires adherence to specific administration techniques and dosing adjustments.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Dilatair

Research Evidence for Dilatair (Doxofylline) Studies

Dilatair (Doxofylline) was studied in research exploring airflow restriction in the context of chronic respiratory conditions. The evidence base consists of official clinical research, including Randomized Controlled Trials (RCTs) and subsequent systematic reviews that bring together data from multiple individual studies.

Evidence for Use in Managing Bronchial Asthma

Research explored this medicine primarily in adult patients with stable, chronic asthma. The main outcomes research examined were spirometric parameters (such as FEV1) and the pattern of rescue bronchodilator medication usage.

Findings describe patterns related to the measurement of lung function observed during the studies. Some pooled analyses, however, was observed in some studies to show variability (heterogeneity) in FEV1 changes across results. The evidence for these outcomes is broadly classified by analysts as Moderate to High.

Evidence for Use in Managing Chronic Obstructive Pulmonary Disease (COPD)

Research for Dilatair in COPD was evaluated in adult patients with stable disease, often during short-term crossover trials and as an add-on treatment. Studies explored changes in pulmonary function testing alongside patient-reported outcomes describing perceived discomfort and measures of functional outcomes (like the 6-Minute Walk Distance). This research provides insight into short-term changes in these outcomes. The evidence for the examined outcomes in COPD is broadly classified by analysts as Moderate.

Long-Term Studies and Durability of Research

Most highly controlled comparison studies had follow-up durations that were limited (typically up to three months). Long-term open-label Phase III clinical trials evaluated patients for periods extending up to 1 year, examining patterns observed over the course of the year and monitoring patient-reported outcomes.

Evidence in Specific Patient Groups

Research explored patterns in different adult subgroups, including older adult patient populations. Evidence was also studied for the use of Dilatair in children with asthma, but data for certain groups remain insufficient compared to the adult population. Subgroup findings are uncertain for many other specific groups.

Research Gaps and What Remains Uncertain

Follow-up durations were limited in many controlled comparison studies. Information for long-term outcomes is limited, and research has yet to fully explore patterns related to the rate of severe COPD exacerbations. Furthermore, some research exploring functional capacity showed patterns related to certain outcomes without providing definitive insight.

Key Studies & References

  1. WHO Collaborating Centre for Drug Statistics Methodology: ATC Classification Index (R03DA11)
  2. Philippines FDA Verification Portal: Doxofylline Product Information Sheet (PI)

Frequently Asked Questions (FAQ)

Common questions about Dilatair (FAQ)

Q: What is the main difference between Dilatair and other similar medicines?

The active ingredient in Dilatair, Doxofylline, is considered a unique methylxanthine derivative. Official information indicates that Doxofylline has a lower affinity for adenosine receptors compared to a related drug, Theophylline. This difference in how the drug interacts with the body's systems is associated with its distinct pharmacological and safety profile.

Q: What does 'Dilatair works by targeting the [Target Name/Pathway]' mean in simple terms?

The medicine works to ease breathing by causing the smooth muscles surrounding the airways to relax. It achieves this by affecting natural body enzymes called phosphodiesterase within the bronchial tissues. This process helps to widen the air passages in the lungs, which is the primary therapeutic effect.

Q: What are the most common side effects listed for Dilatair?

Official regulatory documents group the documented adverse reactions by the body systems they affect. These commonly include gastrointestinal disturbances (such as nausea and vomiting), nervous system effects (like headache and insomnia), and certain cardiac disorders (such as palpitation). These classifications are based on official reports and clinical trial data.

Q: Is a mild headache normal when starting Dilatair?

Headache is listed in the official information as a documented adverse reaction related to the nervous system. The official documents do not specify whether the headache is expected to be 'mild' or if it is commonly experienced only 'when starting' the medicine. For clarification or concern, consultation with a qualified health professional is appropriate.

Q: How long does the effect of a single dose of Dilatair usually last?

Following oral administration, the amount of the drug in the bloodstream typically reaches its highest level approximately one hour after the dose. The elimination half-life is usually greater than six hours. This sustained presence in the body indicates that consistent, regular use is required to maintain therapeutic levels.

Q: What are the contraindications for Dilatair in simple language?

Contraindications are conditions where the medicine should absolutely not be used. This includes individuals with a known sensitivity to Dilatair or related methylxanthines, those who have recently experienced an acute myocardial infarction (a type of heart attack), or those with hypotension (abnormally low blood pressure). It is also officially contraindicated in lactating women.

Q: What does the term 'mechanism of action' refer to for Dilatair?

The mechanism of action is the term used to describe the underlying physiological and biochemical process by which the medicine produces its effect in the body. For Dilatair, the mechanism involves bronchodilation, which is the widening of the airways, achieved primarily by inhibiting specific enzymes within the lung tissues.

Q: Is Dilatair used to prevent a condition or just to treat it?

According to the official product information, the medicine is indicated for the treatment and management of restricted airflow symptoms. These symptoms are those commonly associated with chronic respiratory conditions, such as bronchial asthma and COPD. The stated purpose is managing existing symptoms and maintaining airflow, not prevention.

Q: What evidence exists about Dilatair's effect on quality of life?

Clinical studies have examined various patient-reported outcomes alongside standard pulmonary function tests. These outcomes describe the patient's perceived discomfort and their functional capacity. The collected data provides insight into the medicine's effect on these aspects of a patient's daily life.

Q: Is it true that the efficacy of Dilatair can vary by individual?

Studies and official information indicate that the response to the medicine may vary. Clinical research findings have documented variability (heterogeneity) in the measured changes in lung function (FEV1) across different study results. This suggests that individual patient response is an expected observation.

Q: How quickly does Dilatair typically start to work after the first dose?

Official data on the drug's absorption shows that the concentration in the blood, known as peak plasma levels (Cmax), is typically reached approximately one hour after the first oral dose. This pharmacokinetic data relates to how quickly the body absorbs the medicine after it is taken.

Q: Is it safe to drink alcohol while using Dilatair?

Official regulatory information states that the interaction with alcohol is unknown or not specifically documented in the product labeling. For safety reasons and due to the known effects of the drug's class on the nervous system, the general standard of care is to discuss all concurrent substance use with a healthcare provider.

Q: Are there any reported long-term side effects associated with Dilatair use?

While most highly controlled studies have limited follow-up durations, official documents mention that monitoring of liver function and electrolyte levels is a precaution considered for patients with pre-existing conditions or those on extended use.

Q: What kind of monitoring is typically required when starting Dilatair?

The need for monitoring is often related to the patient's overall health status. For individuals with certain pre-existing conditions, such as liver or heart disease, or during long-term therapy, monitoring of parameters like liver function and electrolyte levels is noted in the official precautions for these patient groups.

Q: Are there specific warnings about driving or operating machinery while on Dilatair?

The medicine is documented to cause nervous system effects, which can include dizziness, insomnia, and irritability. Official warnings advise that patients who experience these kinds of effects should exercise caution when operating machinery or driving vehicles.

Q: Does Dilatair have a 'black box' warning from the FDA?

According to the official regulatory documents, the product labeling for the active ingredient, Doxofylline, does not contain an FDA 'Black Box' Warning. A 'Black Box' Warning is the strictest safety-related warning required by the FDA.

Q: What should I do if I experience a side effect that is not listed in the patient information?

Official guidance provides channels for reporting all suspected adverse drug reactions to the national regulatory body, such as the FDA or EMA. In the event of a serious or unexpected reaction, immediate consultation with a health professional is a priority.

Q: Does Dilatair affect blood pressure?

Official information lists cardiac disorders as a possible adverse reaction. Furthermore, the medicine is formally contraindicated in patients with hypotension (abnormally low blood pressure), suggesting that the drug has a potential impact on the circulatory system.

Q: What are the initial symptoms of an allergic reaction to Dilatair?

The medicine is officially contraindicated in cases of known hypersensitivity to the active ingredient or other methylxanthines. Any sudden and severe signs of an allergic reaction, such as swelling of the face or difficulty breathing, are noted in the regulatory guidance, which states that any severe symptoms should prompt immediate contact with a health professional.

Q: Does the formulation (tablet, capsule, liquid) of Dilatair make a difference?

Official information shows that standard oral formulations are designed for release within approximately one hour. Different formulations, such as those designed for modified or extended release, impact the required frequency of use to maintain therapeutic blood levels.

How should Dilatair be stored and disposed of?

How to Store and Dispose of Dilatair (Doxofylline)

Official regulatory documents define strict conditions for the storage and disposal of Dilatair (doxofylline) tablets to ensure product stability and safety.

Storage Requirements

Dilatair must be stored at a temperature not exceeding 30 C.

The product should be protected from light and moisture, and must be kept in its original packaging.

Storage Condition Requirement
Temperature Maximum 30 C
Protection Protect from light and moisture
Child Safety Keep out of the sight and reach of children

Disposal Instructions

There are no unique, specific requirements for the disposal of this medicinal product. Any unused or expired Dilatair, along with related waste, must be discarded in accordance with local pharmaceutical disposal requirements.

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

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