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Generic Roflumilast Information
Introduction
Roflumilast (active compound: roflumilast) is a phosphodiesterase‑4 (PDE‑4) inhibitor that is primarily prescribed to reduce the risk of chronic obstructive pulmonary disease (COPD) exacerbations in adults. The drug is marketed internationally under the brand name Daliresp and, in the United Kingdom, is available as a generic product supplied by a range of authorised manufacturers. Roflumilast belongs to the broader medication groups of skin‑care and general health due to its anti‑inflammatory properties, although its approved use in the UK is limited to respiratory disease.
The molecule was developed by Analiza Pharma (now part of Takeda) and received European Medicines Agency (EMA) approval in 2011. Its clinical relevance stems from the high prevalence of COPD in the UK—approximately 1.9 % of the adult population (≈1 million people) are diagnosed with the condition, of whom a significant proportion experience recurrent exacerbations that compromise quality of life and increase health‑care utilisation.
What is Roflumilast?
Roflumilast is a small‑molecule, once‑daily oral tablet that inhibits the enzyme PDE‑4, a key regulator of intracellular cyclic adenosine monophosphate (cAMP).
- Classification: anti‑inflammatory, PDE‑4 inhibitor.
- Development: discovered and initially commercialised by Analiza Pharma, later integrated into Takeda’s respiratory portfolio.
- Manufacturer (generic): multiple EU‑licensed manufacturers produce the generic tablet in compliance with the Medicines and Healthcare products Regulatory Agency (MHRA) standards.
Roflumilast is the generic version of Daliresp, containing the same active compound roflumilast. Our online pharmacy provides this generic alternative as a cost‑effective treatment option.
How Roflumilast Works
PDE‑4 catalyses the breakdown of cAMP, a signalling molecule that modulates inflammatory cell activity. By selectively inhibiting PDE‑4, roflumilast raises intracellular cAMP levels in neutrophils, macrophages, and T‑lymphocytes. Elevated cAMP suppresses the release of pro‑inflammatory cytokines (e.g., tumour necrosis factor‑α, interleukin‑8) and reduces the chemotactic response of neutrophils to irritants within the airway mucosa.
The anti‑inflammatory cascade results in:
- Decreased airway oedema – less swelling of bronchial walls.
- Reduced mucous‑gland hyperactivity – diminished sputum production.
- Lower frequency of acute exacerbations – fewer hospital‑presenting episodes.
Pharmacokinetic data (MHRA assessment report, 2011) show oral absorption of roflumilast is rapid, with a peak plasma concentration at 1–2 hours post‑dose. The active metabolite, roflumilast N‑oxide, has a terminal half‑life of ≈17 days, supporting once‑daily dosing. Steady‑state concentrations are achieved after ≈4 weeks of continuous therapy. Clearance is primarily hepatic via CYP3A4 and CYP1A2 pathways; renal excretion accounts for <10 % of elimination.
Conditions Treated with Roflumilast
Approved indication (UK) | Clinical relevance (UK) | Roflumilast’s therapeutic advantage |
---|---|---|
COPD with chronic bronchitis – adult patients with a history of ≥2 exacerbations per year, or those requiring regular oral corticosteroids. | Approximately 2.4 % of UK adults have COPD with chronic bronchitis; exacerbations lead to 40 % of COPD hospital admissions. | By attenuating airway inflammation, roflumilast reduces severe exacerbations, decreases need for systemic steroids, and improves health‑status scores (e.g., CAT score). |
No other indications are currently authorised in the United Kingdom. Off‑label use (e.g., for certain dermatological conditions) should be considered only under specialist supervision and is not supported by robust clinical evidence.
Suitable Candidates for Roflumilast Treatment
Roflumilast is appropriate for adult patients who meet the following criteria:
- Confirmed diagnosis of COPD with chronic bronchitis phenotype, documented by spirometry (post‑bronchodilator FEV1/FVC < .70).
- Frequent exacerbators: ≥2 documented exacerbations in the previous 12 months, or ≥1 exacerbation requiring oral corticosteroids.
- Stable on optimal inhaled therapy: use of long‑acting bronchodilators, inhaled corticosteroids, or combination regimens as prescribed by a respiratory specialist.
Clinical scenarios where roflumilast is particularly recommended
- Patients with a marked neutrophilic inflammatory profile, reflected by sputum neutrophilia or elevated blood eosinophils (< 300 cells/µL).
- Individuals who experience steroid‑related adverse events and would benefit from an oral anti‑inflammatory that reduces systemic steroid reliance.
Contra‑indications / cautionary cases
- Severe hepatic impairment (Child‑Pugh C) – the drug is not recommended.
- Concomitant strong CYP3A4 inhibitors (e.g., ketoconazole, HIV protease inhibitors) – may increase roflumilast levels and raise toxicity risk.
- Pregnancy, lactation, or children under 18 years – insufficient safety data; use is not advised.
Risks, Side Effects, and Interactions
Common adverse events
- Diarrhoea – reported in up to 10 % of patients; usually mild and self‑limiting.
- Nausea / dyspepsia – 8–12 % of users; may be mitigated by taking the tablet with food.
- Weight loss – modest (average 2 kg over 12 weeks); monitor in frail or under‑weight patients.
Rare adverse events
- Depression and suicidal ideation – observed in < 1 % of treated subjects; requires prompt psychiatric assessment if symptoms emerge.
- Elevated liver enzymes – isolated transaminase elevations (< 2 × ULN) without clinical hepatitis.
Serious adverse events
- Severe cardiac arrhythmias – rare (<.1 %); caution in patients with QT‑prolonging drugs.
- Severe hypersensitivity reactions – including angioedema; immediate discontinuation and emergency care are mandatory.
Drug–drug interactions
- Strong CYP3A4 inducers (e.g., rifampicin, carbamazepine) → decrease roflumilast exposure, potentially diminishing efficacy.
- Strong CYP3A4 inhibitors (e.g., itraconazole, clarithromycin) → increase roflumilast exposure, raising risk of toxicity; dose reduction may be required.
- Concurrent oral corticosteroids – additive infection risk; monitor for opportunistic infections.
Patients should disclose all current medications, including over‑the‑counter products and herbal supplements, to avoid unexpected interactions.
Practical Use: Dosing, Missed Dose, Overdose
- Standard adult dose: 1 tablet (500 µg) taken orally once daily, preferably at the same time each day.
- Administration: Swallow with a full glass of water; food can be taken concurrently to reduce gastrointestinal upset.
- Missed dose: If a dose is forgotten by less than 12 hours, take it immediately. If ≥12 hours have passed, skip the missed dose and resume the regular schedule the following day; do not double a dose.
- Overdose: Single‑dose overdose of up to 2 g has been reported without serious toxicity; however, any suspected overdose should be treated as a medical emergency. Contact the nearest urgent care centre or the UK National Poisons Information Service (NPIS) at 111.
Precautions
- Avoid excessive alcohol consumption; ethanol may potentiate central nervous system side effects.
- Patients with moderate hepatic impairment (Child‑Pugh B) should use the drug with caution; dose adjustment is not formally approved.
- Renal dysfunction does not markedly affect clearance, but regular monitoring of renal function is suggested in end‑stage disease.
Buying Roflumilast from Our Online Pharmacy
Roflumilast can be purchased from our online pharmacy in the United Kingdom. We specialise in delivering authentic, cost‑effective generic medicines that meet the same quality standards as brand‑name products.
- Affordable pricing: Generic tablets are offered at near‑manufacturer cost, providing a transparent and budget‑friendly alternative to brand‑name pricing.
- Verified quality: All batches are sourced from EU‑licensed manufacturers, with certificates of analysis and MHRA conformity checks performed before dispatch.
- Guaranteed delivery: Discreet, secure packaging is used for all orders; express shipping (7 working days) is available for urgent needs, while standard airmail (≈3 weeks) is the default option.
- Pharmacy‑broker service: As a broker, we work with overseas licensed pharmacies that hold the required licences for exporting to the UK. This model enables a discreet service that respects patient privacy, especially for individuals who have limited access to local pharmacy stock or insurance coverage.
Our service is intended for patients who have already consulted a qualified healthcare professional and hold a valid prescription for roflumilast.
FAQ
-
Is Roflumilast available in both brand‑name and generic forms in the UK?
Yes. The original brand‑name product is marketed as Daliresp, while generic manufacturers produce roflumilast tablets that contain the identical active molecule. Generic versions are typically priced lower than the branded product. -
What are the visual characteristics of a roflumilast tablet?
The standard 500 µg tablet is round, bicolour (usually white and yellow) with “ROF” imprint on one side. Inactive ingredients may include lactose, magnesium stearate, and microcrystalline cellulose. -
Does roflumilast require refrigeration?
No refrigeration is needed. The tablets should be stored at controlled room temperature (15 °C–30 °C), protected from direct light and moisture. -
Can I travel internationally with roflumilast in my carry‑on luggage?
Yes. Carrying the medication in your hand luggage is permissible, provided you retain the original packaging and a copy of the prescription. Check the destination country’s customs regulations for personal import of prescription medicines. -
Is there a difference in formulation between EU and US roflumilast tablets?
The core active ingredient, roflumilast, is identical across regions. However, excipient composition may vary slightly (e.g., different binder or coating agents) to meet local regulatory specifications. -
What are the storage conditions recommended for roflumilast in humid climates?
In high‑humidity environments, keep tablets in a sealed, moisture‑resistant container and avoid bathroom or kitchen cabinets where steam may accumulate. -
Are there special warnings for roflumilast in patients of Asian descent?
Pharmacogenomic data suggest a higher incidence of gastrointestinal side effects among East Asian populations, possibly due to genetic variations in CYP3A4 activity. Clinicians may consider initiating therapy at a reduced dose and monitor tolerance closely. -
How does roflumilast compare to oral corticosteroids for COPD exacerbation prevention?
Roflumilast provides a chronic anti‑inflammatory effect without the systemic immunosuppression and metabolic disturbances associated with long‑term oral steroids. Clinical trials (e.g., IMPACT, 2014) demonstrated comparable reductions in severe exacerbation rates with fewer steroid‑related adverse events. -
What is the legal status of personal import of roflumilast into the UK?
Personal import of a prescription‑only medicine is permitted if the medication is for personal use, the quantity does not exceed a three‑month supply, and it is declared appropriately at customs. A valid UK prescription must be presented on request. -
Does roflumilast have any impact on laboratory lung function tests?
Roflumilast does not directly alter spirometric measurements; however, by reducing airway inflammation, it may lead to modest improvements in FEV₁ over extended treatment periods, which can be observed in follow‑up lung function assessments.
Glossary
- Phosphodiesterase‑4 (PDE‑4)
- An enzyme that breaks down cyclic adenosine monophosphate (cAMP), a messenger involved in regulating inflammation and immune cell activity.
- cAMP (Cyclic Adenosine Monophosphate)
- A intracellular signalling molecule that, when increased, suppresses the release of inflammatory cytokines from immune cells.
- Exacerbation
- A worsening of COPD symptoms that often requires additional treatment, such as antibiotics, systemic steroids, or hospital admission.
- Half‑life
- The time required for the plasma concentration of a drug to decrease by 50 %; roflumilast’s active metabolite has a half‑life of about 17 days.
⚠️ Disclaimer
The information provided about Roflumilast is for general knowledge only. It does not replace professional medical consultation. All treatment decisions should be made under the supervision of a qualified healthcare provider. We assume all readers are responsible adults capable of making informed decisions about their health. Our online pharmacy offers access to Roflumilast for individuals who may have limited availability through traditional pharmacies, prescription‑based insurance schemes, or who are seeking affordable generic alternatives. Always consult your doctor before starting, changing, or discontinuing any medication.