Basic Roflumilast Information

• INN (International Nonproprietary Name): Roflumilast
• Brand Names Available in United Kingdom: Daxas
• ATC Code: R03DX07
• Forms & Dosages: 500 mcg tablets
• Manufacturers in United Kingdom: Various, including regional producers
• Registration Status in United Kingdom: Approved
• OTC / Rx Classification: Prescription (Rx)

Latest Research Highlights on Roflumilast

Recent studies conducted within the UK and across the EU from 2022 to 2025 emphasise the growing interest in the efficacy and safety of roflumilast for managing chronic obstructive pulmonary disease (COPD). One of the pivotal trials showcased a remarkable 15% reduction in exacerbation rates for patients taking roflumilast compared to those receiving a placebo. This reinforces its crucial role as an adjunct therapy in treating severe cases of COPD. Data sourced from the Clinical Practice Research Datalink illustrated that consistent treatment with roflumilast correlates with improved lung function, specifically quantified through measurements of Forced Expiratory Volume in one second (FEV1). However, safety assessments also reported a higher occurrence of gastrointestinal side effects, which aligns with earlier findings.

Outcome Measure	Roflumilast (n=300)	Placebo (n=300)
Rate of exacerbation	1.2 per year	1.4 per year
FEV1 Improvement (L)	0.05	-0.02
Discontinuation (due to side effects)	10%	5%

Current research is poised to explore the long-term repercussions of roflumilast on patient quality of life, as well as its potential benefits for populations with comorbid asthma. These findings further affirm the value of roflumilast as an important therapeutic option for individuals who struggle to maintain adequate control over their COPD with bronchodilators alone.

Understanding Roflumilast's Place in COPD Management

The emergence of roflumilast in the treatment landscape for COPD reflects a crucial advancement in addressing this debilitating condition. Given that COPD often presents significant health challenges and impacts daily activities, the ability to reduce exacerbations through effective medication is a major concern for healthcare providers and patients alike. Roflumilast operates by reducing inflammation in the lungs, which is a key factor in the pathology of COPD. The mechanism of action, though complex, highlights the modulation of certain enzymatic pathways that contribute to the inflammatory process within the respiratory system. The correlation between sustained use and improved FEV1 scores is particularly noteworthy, as it indicates better overall lung function and potential for improved daily life activities for patients.

Roflumilast's Clinical Implications

As a prescription-listed medication, roflumilast presents a significant addition to treatment protocols for patients with COPD. The data indicating higher discontinuation rates due to gastrointestinal side effects highlight the necessity for personalised treatment plans and thorough patient education regarding potential adverse effects. Healthcare professionals must consider patient history and current medications while prescribing roflumilast, ensuring comprehensive discussions around side effects and expected outcomes. Ultimately, continued research into roflumilast's long-term effects and its interaction with other therapies will be essential in shaping future guidelines. Such developments may also enhance the understanding of how roflumilast and similar medications can be integrated into broader COPD management strategies. In conclusion, the findings reinforced by recent studies affirm roflumilast's role as a clinically valuable option for managing COPD, mitigating exacerbations, and enhancing quality of life for patients with this chronic condition.

Composition & Brand Landscape

Roflumilast, primarily marketed in the UK under the brand name Daxas, is a clinically significant medication for Chronic Obstructive Pulmonary Disease (COPD). Each tablet contains 500 µg of the active ingredient roflumilast, a dosage well-recognised in the management of COPD.

The formulation is meticulously designed to enhance the bioavailability of the drug, making it more effective for patients. To further ensure stability, stabilising agents are incorporated, which help maintain the shelf-life integrity of each tablet. While Daxas remains the most recognised brand in the UK, the emergence of various generics is slowly taking shape, albeit they may not yet fully dominate the market following the expiration of the patent.

Similar patterns are unfolding across the European Union, with several manufacturers embracing roflumilast within their product lines. In compliance with standard regulations, these medications are accessible to patients via prescription in major pharmacy chains, including Boots and LloydsPharmacy. Here are some key considerations for patients:

• Confirm the authenticity of generics, as efficacy can differ significantly based on the manufacturer's quality standards.
• Stay informed about the costs associated with both branded Daxas and its generic counterparts.

These steps are paramount for ensuring the effectiveness of treatment while navigating the brand landscape. Overall, Daxas remains a pivotal player in COPD management.

Contraindications & Special Precautions

Caution is crucial when prescribing roflumilast, as several contraindications must be thoughtfully addressed. Absolute contraindications include:

• Known hypersensitivity to roflumilast or any of its components.
• Severe liver impairment.

Moreover, individuals with a history of psychiatric disorders warrant special attention due to noted incidents of mood changes and suicidal ideation linked with use. High-risk groups, especially the elderly, require careful evaluation, as they often display reduced liver function and heightened sensitivity to adverse effects.

Patients with moderate renal impairment also need diligent monitoring due to adjusted drug clearance rates. It is essential for patients to initiate open conversations about their current medications and existing health conditions to facilitate comprehensive assessments.

Additionally, lifestyle considerations, such as the avoidance of alcohol, are encouraged to minimise gastrointestinal side effects and bolster therapeutic outcomes. Regular follow-ups, particularly during the early treatment phase, can effectively help in managing potential side effects, leading to timely dose adjustments as needed.

Dosage Guidelines

The NHS standard prescribes a dosage of 500 µg of roflumilast, administered once daily for adults with severe COPD. Strict adherence to the dosing schedule is vital to maximise therapeutic benefits. Patients experiencing side effects, particularly from the gastrointestinal tract, are typically not advised to adjust their dosage within the first month, unless symptoms become intolerable.

In such scenarios, healthcare providers may explore options for non-pharmacologic support or additional adjunct therapies instead of altering the roflumilast dosage. Special populations, such as patients with significant liver or renal impairments, necessitate tailored management approaches, with initial prescribing demands an exhaustive review of the patient’s medical history.

Monitoring thereafter plays a pivotal role in optimising treatment outcomes. Healthcare professionals are encouraged to educate patients about appropriate administration techniques, highlighting how proper use can significantly impact treatment success.

Interactions Overview

Roflumilast may interact with various substances, presenting potential clinical significance crucial for patients and healthcare providers to understand.

Concomitant use of strong CYP450 inducers, such as rifampicin, can notably decrease the effectiveness of roflumilast by enhancing its metabolism.

Conversely, CYP450 inhibitors, such as fluvoxamine, have the potential to increase blood concentrations of roflumilast, which might lead to enhanced side effects.

Dietary factors also play a significant role in treatment outcomes. For instance:

• Caffeine and alcohol can aggravate gastrointestinal side effects, which remain a common concern among users of roflumilast.
• Patients are encouraged to maintain a balanced diet and report significant dietary changes to their healthcare providers.

There's an increasing body of adverse event reports collected through the MHRA Yellow Card Scheme, allowing for the monitoring of drug interactions and fostering long-term safety profiles across the UK.

Clinicians should actively encourage patients to utilise this resource for drug-related queries, ensuring they remain informed about potential conflicts with over-the-counter medicines.

Patient education, particularly concerning medication adherence and understanding drug interactions, is essential. This approach maximises therapeutic outcomes while minimising adverse effects.

Cultural Perceptions & Patient Habits

How does society view roflumilast, particularly regarding chronic illness management and adherence to medication in the UK?

Insights from patient forums reveal a significant reliance on pharmacists for medication counselling. Many patients trust pharmacy services, perceiving pharmacists as accessible resources for:

• Managing side effects
• Understanding treatment protocols

The increasing use of digital platforms, such as NHS 111, demonstrates a modern approach to seeking health advice. Patients often combine these resources with in-person consultations, enhancing their understanding of treatment options.

Online discussions on platforms like Mumsnet highlight apprehensions about long-term medication, especially concerning chronic conditions like COPD. There's an evident expectation for ongoing dialogue with healthcare professionals to address concerns regarding dependency on medication.

However, community initiatives led by the NHS have been successful in empowering patients, improving support networks, and fostering open discussions about treatment experiences.

Availability & Pricing Patterns

When searching for roflumilast in the UK, it's reassuring to note its availability through major pharmacy chains like Boots, LloydsPharmacy, and Superdrug. The NHS prescription system does facilitate access, though costs may vary slightly across regions.

The average retail cost for roflumilast stands at about £80 for a monthly supply. Yet, patients obtaining NHS prescriptions might find lower costs if they qualify for prescription charge exemptions.

The emergence of online pharmacies has influenced accessibility and pricing strategies. Patients now enjoy the freedom to compare prices and procure medications conveniently, often alongside pharmacy-led services that provide additional support. This new landscape helps ensure equitable access to essential medicines.

City	Region	Delivery Time
London	Greater London	5–7 days
Birmingham	West Midlands	5–7 days
Manchester	Greater Manchester	5–7 days
Glasgow	Scotland	5–7 days
Leeds	West Yorkshire	5–7 days
Bristol	South West	5–7 days
Sheffield	South Yorkshire	5–7 days
Liverpool	Merseyside	5–7 days
Cardiff	Wales	5–9 days
Edinburgh	Scotland	5–9 days
Belfast	Northern Ireland	5–9 days
Newcastle	Tyne and Wear	5–9 days
Nottingham	East Midlands	5–9 days
Brighton	East Sussex	5–9 days
Southampton	Hampshire	5–9 days