Даксас

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Даксас

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Treatment option: Bronchitis, Bronchospasm, COPD,Acute

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 Даксас

What is Даксас? (Roflumilast Overview)

Property Description
Active ingredient Roflumilast
Form Film-coated tablet
Pharmacological class Selective Phosphodiesterase 4 (PDE4) inhibitor
General purpose Long-acting, maintenance anti-inflammatory support
Origin Synthetic organic compound

What is the Active Ingredient and Type of Даксас?

The medicine Даксас is defined by its sole active ingredient, Roflumilast, which is a synthetic organic compound derived from the benzamide chemical class. This compound is consistently classified as a prescription-only, single-ingredient product, intended specifically for use in adults. The structural formula of Roflumilast has been chemically optimized to exhibit a high degree of selectivity for its molecular target, a characteristic documented in its compound records.

What is the Pharmacological Class of Даксас?

Даксас belongs to the distinct pharmacological class of selective Phosphodiesterase 4 (PDE4) inhibitors. This classification means the drug's core action is the targeted blockade of the PDE4 enzyme, which is a major regulator of inflammatory cell activity. Roflumilast is characterized by unique, potent anti-inflammatory properties. This mechanism positions the drug as an essential add-on therapy for severe, chronic conditions characterized by this specific inflammatory pathway.

What is the General Therapeutic Purpose and Form?

The general purpose of Даксас is to serve as long-acting, maintenance treatment, specifically to support adult patients requiring sustained anti-inflammatory control. The medication is provided as a film-coated tablet intended for oral administration, a differentiating feature when compared to many inhaled respiratory therapies. The oral route ensures consistent, systemic absorption, thereby providing persistent, foundational support to help reduce the frequency of inflammatory episodes associated with chronic respiratory conditions.

Regulatory References

  1. Daxas EPAR – Medicine overview

What side effects are possible with Даксас?

Possible Side Effects and Safety Information

The safety profile of Roflumilast (Даксас) details adverse reactions categorized by frequency and the body system affected, as documented in official regulatory sources like the EMA and FDA. This information is intended to communicate the officially documented risks, not to provide clinical advice or instructions for use.


Adverse Reaction Classifications

Adverse reactions are grouped by their incidence rate in clinical trials:

  • Common (occurring in ge 1/100 to < 1/10 patients): Diarrhea, weight decreased/loss, nausea, headache, abdominal pain, and insomnia. These effects, particularly gastrointestinal issues, often occur within the first few weeks of therapy and may mostly resolve upon continued treatment.
  • Uncommon (occurring in ge 1/1,000 to < 1/100 patients): Anxiety, depression, tremor, fatigue, and gastritis.
  • Rare (occurring in ge 1/10,000 to < 1/1,000 patients): Suicidal ideation and behavior, including completed suicide, which has also been observed usually within the first weeks of treatment.

Serious Safety Constraints

The official label highlights specific safety limitations and serious risks:

  • Contraindications: Use is strictly contraindicated in patients with moderate or severe hepatic impairment (Child-Pugh B or C).
  • Psychiatric Risk: The risk of suicidal ideation and behavior requires careful consideration, particularly in patients with a history of depression associated with such issues.
  • Acute Use: Даксас is not indicated as a rescue medication for the relief of acute bronchospasm; its role is limited to maintenance support.
  • Weight Loss: Clinically significant or severe weight loss is a documented risk requiring evaluation.

Overdose and Emergency Response

The official regulatory profile for Даксас (Roflumilast) overdose documents specific clinical manifestations observed during high single-dose exposure. These presentations include a cluster of central and gastrointestinal effects, such as headache, dizziness, lightheadedness, and general gastrointestinal disorders. The label also reports more serious physiological findings, including a drop in blood pressure (arterial hypotension) and rapid heartbeat (palpitations), which signify the event's potential severity.

Emergency regulatory guidance is explicit regarding when to seek help. It is required to call emergency services (911) immediately if the patient exhibits critical signs, including collapse, seizure, trouble breathing, or if they cannot be awakened. The guidance also instructs individuals to contact the poison control helpline for immediate advice.

Overdose management, as stated in the prescribing information, necessitates the administration of support medical care. The regulatory documentation confirms that no specific antidote is known for Roflumilast. A procedural constraint is also noted: hemodialysis is unlikely to be of benefit due to the drug’s significant and extensive protein binding. No special overdose considerations for specific populations are detailed in the official labeling.

Therapeutic Uses of Даксас

What Даксас Treats: Main Uses and Benefits

The primary therapeutic focus of Даксас (Roflumilast) is the long-term management of severe Chronic Obstructive Pulmonary Disease (COPD) in adult patients. It is applied in contexts involving inflammatory or irritative processes as a long-term supportive therapy. The medication is considered relevant in conditions characterized by periods of heightened symptoms, such as severe COPD associated with chronic bronchitis, and may be part of symptomatic management when patients experience recurrent episodic manifestations.

Symptom and Stability Support

The main benefit is to help manage the risk of exacerbations, which are acute, disruptive episodes when COPD symptoms become more disruptive during flare-ups. The drug is considered relevant for easing symptoms related to systemic imbalance, such as excessive, chronic cough and persistent sputum production. By addressing heightened physiological activity, the treatment supports the patient during difficult episodes and helps maintain a sense of stability when symptoms are more noticeable.

“This maintenance support is key in helping to reduce the overall burden of symptoms associated with severe, chronic lung inflammation.”


Quick Fact: Therapeutic Focus

This medication is applied across domains where additional symptomatic support is needed to help manage the risk associated with recurrent episodes of acute disease worsening and assist with maintaining functional stability.

Regulatory References

  1. European Medicines Agency (EMA) Product Information for Daxas

Eligibility and Restrictions for Use

Who Can and Cannot Use Даксас?

The use of oral Даксас (Roflumilast) is strictly defined by regulatory eligibility criteria regarding age, organ function, and specific disease history.

Eligible Population The medicine is indicated solely for adult patients (18 years and older) who meet the criteria for severe Chronic Obstructive Pulmonary Disease (COPD). Use in the pediatric population is not recommended as safety and effectiveness have not been established.


Absolute Contraindications The medicine is formally contraindicated and must not be used in:

  • Patients with moderate or severe hepatic impairment (Child-Pugh B or C).
  • Patients with known hypersensitivity to Roflumilast or any components of the tablet.

Specific Restrictions and Limitations Use of Даксас is subject to several official limitations:

  • Not Recommended: The medicine is not recommended during pregnancy or in patients with a history of depression associated with suicidal ideation. It should not be used during breastfeeding.
  • Use with Caution: Caution is required in patients with mild hepatic impairment (Child-Pugh A) and those with severe immunological or acute infectious diseases.
  • Acute Symptoms: The medicine must not be used for the relief of acute bronchospasm.

What should I know about interactions with other medicines?

Interactions with other medicines and products

The interaction profile for Roflumilast (Даксас) is based on pharmacokinetic alterations involving the drug’s metabolism by Cytochrome P450 enzymes, primarily CYP3A4 and CYP1A2. Regulatory documents define specific constraints regarding co-administration with enzyme-modulating substances, which can alter the drug’s systemic exposure.

Documented Interaction Constraints

Substance Category Regulatory Restriction & Official Outcome
Strong CYP Enzyme Inducers (e.g., Rifampicin, Carbamazepine, Phenytoin) Not Recommended. These agents decrease the plasma concentration of Roflumilast, which may reduce its therapeutic effectiveness.
CYP3A4 or Dual CYP Inhibitors (e.g., Fluvoxamine, Ketoconazole, Erythromycin) Use with Caution. These agents increase Roflumilast systemic exposure, potentially resulting in an increased risk of adverse reactions.
Oral Contraceptives (e.g., Gestodene/Ethinyl Estradiol) Use with Caution. Co-administration may increase Roflumilast systemic exposure.

Population and Administration Context

The regulatory label establishes an absolute contraindication for use in patients with moderate to severe liver impairment (Child-Pugh B or C). This restriction is tied to the risk of significant drug accumulation due to impaired metabolic clearance. The prescribing information confirms that the medication may be taken with or without food, indicating no mandated timing separation is required for meals. No specific timing separation rules for other medicines are documented.

Mechanism of Action

How Даксас Works: Mechanism of Action


Selective Inhibition of the PDE4 Enzyme

Даксас acts by providing selective competitive inhibition against the enzyme Phosphodiesterase 4 ( PDE4), primarily via the parent drug, Roflumilast, and its primary active metabolite. PDE4 is the key enzyme responsible for breaking down the signaling molecule cyclic Adenosine Monophosphate ( cAMP) within various immune and structural cells.


Accumulation of Intracellular cAMP and Pathway Modulation

The blockade of PDE4 leads directly to the accumulation of cAMP inside the cell. This elevated second messenger activates the cAMP signaling cascade, which involves the enzyme Protein Kinase A ( PKA), and inhibits the downstream signaling required for pro-inflammatory responses.


Systemic Reduction of Inflammatory Mediator Release

This cAMP/ PKA cascade ultimately leads to the reduction of the synthesis and release of pro-inflammatory mediators (e.g., cytokines and chemokines) by targeted immune cells (neutrophils and eosinophils). This continuous, foundational modulation of cellular function maintains a modulated state of inflammatory cell activity and results in decreased inflammatory mediator load. This mechanism requires time to build up and is not associated with rapid smooth muscle effects.

Dosage and Administration Information

How to Use Даксас

Даксас (Roflumilast) is an oral medication with a structured administration protocol for its intended purpose as a long-term maintenance treatment.


Official Administration Guidelines

Instruction Entity Detail
Route of administration Oral (swallowing the film-coated tablet).
Dosing schedule Begins with 250 mcg once daily for the first 4 weeks, followed by a transition to the 500 mcg maintenance dose once daily.
Maximum Dose The maximum daily recommended dose is 500 mcg.
Timing in relation to meals May be taken with or without food.
Preparation requirements The tablet should be swallowed whole with water.
Missed-dose rules If a dose is missed, the next dose should be taken at the next regularly scheduled time; do not take two doses to make up for the missed one.

Procedural and Population-Specific Use

Administration of Даксас is standardized, requiring the patient to take the tablet at the same time every day to maintain consistent systemic support. It is crucial to understand that the medicine is not a bronchodilator and is not indicated for the relief of acute bronchospasm or sudden, severe respiratory episodes.

Regarding specific populations, no dose adjustment is required for older adults (ge 65 years) or patients with renal impairment. The therapeutic benefits of this long-term agent may require several weeks of continuous use at the 500 mcg dose to become fully relevant, confirming its role in a sustained treatment protocol.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Даксас

Evidence for Severe COPD with Chronic Bronchitis and Exacerbations

The clinical evaluation of oral Roflumilast (Даксас) was primarily studied for its use as an add-on treatment for specific adult patients with severe Chronic Obstructive Pulmonary Disease (COPD). The research focused on individuals whose condition was associated with acute or disruptive episodes (flare-ups) and the chronic bronchitis phenotype (a persistent cough and sputum production). The core research base consists of multiple pivotal Randomized Controlled Trials (RCTs) that typically observed patients over a period of 6 to 12 months.

In these trials, researchers primarily examined outcomes describing episodic or acute changes, specifically focusing on the frequency of moderate or severe COPD exacerbations. Lung function, measured by forced expiratory volume in 1 second (FEV1), was evaluated in parallel. Findings describe patterns observed in the studies where the measured frequency of exacerbations was reported across the Roflumilast group and the control group, allowing researchers to examine whether the event rate varied between groups. Early research that included broader COPD populations was described by regulatory bodies as having mixed findings for the primary endpoint.

Outcomes Studied, Duration, and Limitations

The core focus of the research was placed on outcomes capturing phases of heightened symptom activity, which are the disruptive exacerbation events. Beyond flare-ups, research also examined patient-reported outcomes describing perceived discomfort associated with chronic COPD symptoms like cough. These findings contribute to the broader evidence landscape by showing patterns related to both objective functional measures and subjective patient experience.

The initial, most rigorous evidence relies on intermediate-term trials that followed patients for up to one year. Long-term effects are not fully established based on these initial designs, although post-marketing observational studies track patient patterns over longer periods. Data for certain groups remain insufficient; for instance, the safety and effectiveness was not studied for pediatric populations. Furthermore, because the drug was studied for use as an add-on, comparative evidence is lacking regarding the observed patterns when used alone (monotherapy).

Frequently Asked Questions (FAQ)

Common questions about Даксас (FAQ)


Q: What is the main difference between Даксас and an inhaled corticosteroid?

Даксас (Roflumilast) is an oral selective Phosphodiesterase 4 (PDE4) inhibitor, which acts systemically as a long-term maintenance treatment to help reduce the risk of flare-ups. In contrast, inhaled corticosteroids are a different class of medicine used to reduce inflammation directly in the airways. Official information specifies that Даксас is not a bronchodilator and is not used for quick relief of acute breathing problems.


Q: What happens if you suddenly stop taking Даксас?

Даксас is prescribed as a long-term maintenance treatment. While official information does not list specific 'withdrawal symptoms' upon cessation, regulatory documents state that if a patient experiences unexplained or clinically concerning weight decrease (a known side effect), the medicine should be stopped and weight monitored. Discussions about stopping treatment should be held with a qualified healthcare professional.


Q: Is it normal to feel slightly nauseous when first starting Даксас?

Official reports indicate that nausea is a common adverse reaction noted during clinical trials. Gastrointestinal issues, including nausea, often occur within the first few weeks of therapy. Regulatory documents state that these effects may often lessen or resolve upon continued treatment.


Q: Does Даксас interact with birth control pills?

The regulatory label advises that the co-administration of Даксас with certain oral contraceptives may increase the amount of Даксас in the body. This increase in systemic exposure may result in an increased risk of experiencing adverse reactions. The potential interaction is an important factor for healthcare providers to consider.


Q: What patient experience themes are commonly discussed in relation to Даксас?

The research evidence base primarily focuses on the objective measure of reducing acute events like COPD exacerbations. Additionally, studies have examined patient-reported outcomes, which describe perceived discomfort related to chronic symptoms like cough. Common experiences reported as adverse reactions include changes in the gastrointestinal system and weight decrease.


Q: Is there a link between taking Даксас and sleep disturbances?

Yes, regulatory documents list insomnia (difficulty sleeping) as a common adverse reaction observed in clinical trials. It is classified as a psychiatric event that has been reported, particularly within the first few weeks of treatment.


Q: Does Даксас belong to the steroid class of medicines?

No. Даксас (Roflumilast) is classified as a selective Phosphodiesterase 4 (PDE4) inhibitor. Although it has anti-inflammatory properties, its chemical structure is a benzamide derivative, which is not categorized as a steroid medicine.


Q: Can Даксас cause changes in a person's mood or weight?

Official information indicates that treatment with Даксас is associated with potential psychiatric adverse reactions, including the emergence or worsening of insomnia, anxiety, and depression (changes in mood). Additionally, weight decrease or loss is listed as a common adverse reaction, and monitoring weight regularly is required during therapy.


Q: Are there any specific foods or drinks to avoid when taking Даксас?

Regulatory instructions state that the tablet may be taken with or without food. This indicates that there are no mandated rules regarding the timing of meals. Official documents do not specify any particular foods or drinks that must be avoided while using the medicine.


Q: Is there any information about using Даксас in older adults?

Regulatory documents confirm that no dose adjustment is required for older adults (aged 65 years and over). This is consistent with the standard dosing recommendation provided for adults of any age.


Q: What kind of studies support the use of Даксас for its approved condition?

The core evidence supporting its use comes from multiple pivotal Randomized Controlled Trials (RCTs). These studies typically followed patients for 6 to 12 months and primarily focused on adults with severe COPD, chronic bronchitis, and a history of exacerbations.


Q: What evidence exists regarding the effectiveness of Даксас in different patient groups?

Clinical trials focused on adults with severe COPD. The regulatory label notes that dose adjustment is not required based on age (for adults), gender, or race. Official information also states that data on safety and effectiveness is not established for use in children.


Q: Is there a maximum time someone can stay on Даксас treatment?

Даксас is officially defined as a long-acting, maintenance treatment. While the initial rigorous evidence was based on intermediate-term trials of up to one year, the regulatory label does not define a specific maximum time limit for the total duration of treatment.


Q: Do any official sources mention hair loss as a potential side effect of Даксас?

In official regulatory summaries, hair loss is not listed as a Common, Uncommon, or Rare adverse reaction for the oral tablet formulation of Roflumilast.


Q: Can Даксас be purchased over the counter?

No. Official documents confirm that Даксас is classified as a prescription-only, single-ingredient product and is not available for purchase without a prescription.


Q: Are there any warnings about taking Даксас with herbal supplements?

The medicine is known to interact with certain other medicines that affect liver enzymes. While herbal supplements are not specifically listed as constraints, patient information often advises providing the healthcare provider with a list of all medicines, herbs, non-prescription drugs, or dietary supplements that are currently being used.


Q: How often are follow-up visits recommended when using Даксас?

While there is no universally fixed schedule, regulatory warnings indicate the need to monitor a patient's weight regularly while taking the medicine. The clinical trials that informed the official dosage schedule included patient visits at intervals such as 2, 4, 8, and 12 weeks.


Q: Is it a common practice to start with a lower dose of Даксас?

The official administration protocol defined by regulatory authorities begins with a lower dose for the first four weeks of therapy. This is followed by a transition to the higher maintenance dose. This dosing is outlined as part of the established administration protocol.

How should Даксас be stored and disposed of?

How to Store and Dispose of Даксас?

Official regulatory guidelines define specific conditions for storing and discarding Даксас (Roflumilast) tablets, focusing on stability and safety. The product should be stored at Controlled Room Temperature, typically 20 C to 25 C (68 F to 77 F), with permitted excursions. However, European authorities note that the product requires no special storage conditions beyond maintaining the packaging integrity.

Mandatory Storage and Disposal Rules

  • Child Safety: It is a mandatory requirement that the medicine must be stored out of the sight and reach of children.
  • Packaging: Keep the tablets in their original container, whether blister packaging or a closed bottle, to support the official shelf life.
  • Disposal: Unused or expired Даксас must be discarded in accordance with local requirements. Official documents state there are no special requirements for disposal, meaning the method is delegated to national and local pharmaceutical waste ordinances.

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

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