Daliresp (roflumilast) is a selective phosphodiesterase-4 (PDE4) inhibitor indicated as a treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. It represents a distinct class of maintenance therapy, working through novel anti-inflammatory mechanisms rather than bronchodilation. This oral medication is designed for long-term use as part of a comprehensive COPD management plan, complementing bronchodilator therapy. Clinical evidence supports its role in decreasing the frequency of flare-ups and improving lung function over time.

Features

• Contains roflumilast as the active pharmaceutical ingredient
• Available in 500 mcg tablet formulation
• Selective phosphodiesterase-4 (PDE4) inhibitor mechanism
• Once-daily oral administration
• White to off-white, round film-coated tablets
• Manufactured under strict pharmaceutical quality standards
• Packaged in blister packs for stability protection

Benefits

• Reduces risk of COPD exacerbations requiring corticosteroids
• Decreases frequency of moderate to severe flare-ups
• Improves lung function measurements (pre-bronchodilator FEV₁)
• Provides anti-inflammatory action targeting underlying COPD pathology
• Offers convenient once-daily dosing regimen
• Complements existing bronchodilator therapy without duplication

Common use

Daliresp is specifically indicated to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. It is used as maintenance treatment in adults and is not indicated for relief of acute bronchospasm. The medication is typically prescribed for patients who continue to experience exacerbations despite optimized bronchodilator therapy. Clinical studies have demonstrated particular benefit in patients with more severe disease (GOLD stages 3 and 4) and those with a history of frequent exacerbations.

Dosage and direction

The recommended dosage is one 500 mcg tablet taken orally once daily, with or without food. Tablets should be swallowed whole and not crushed, chewed, or broken. Treatment should be initiated under medical supervision, and patients should be monitored for potential adverse effects, particularly weight loss and neuropsychiatric events. Dose adjustments are not recommended for elderly patients or those with mild to moderate hepatic impairment. The full therapeutic effect may take several weeks to manifest, and treatment should be continued as long as clinically beneficial.

Precautions

Patients should be monitored for weight loss during treatment; unexplained or clinically significant weight loss should prompt evaluation and possible discontinuation. Neuropsychiatric events including insomnia, anxiety, depression, and suicidal ideation have been reported—prompt medical attention is required for mood changes or behavioral symptoms. Use with caution in patients with a history of depression or suicidal thoughts. Regular monitoring of lung function and exacerbation frequency is recommended to assess treatment response. Patients should not use Daliresp for relief of acute bronchospasm and should maintain their rescue medication.

Contraindications

Daliresp is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C). It should not be used in patients with a history of hypersensitivity to roflumilast or any component of the formulation. The medication is not recommended for use during pregnancy unless clearly needed, and breastfeeding should be discontinued during treatment. Concomitant administration with strong cytochrome P450 enzyme inducers (such as rifampicin, phenobarbital, carbamazepine, phenytoin) is contraindicated due to significantly reduced roflumilast exposure.

Possible side effects

The most common adverse reactions include diarrhea (9.5%), weight loss (7.5%), nausea (4.7%), headache (4.4%), back pain (3.2%), influenza (2.8%), insomnia (2.4%), dizziness (2.1%), and decreased appetite (2.0%). Less frequent but serious side effects may include psychiatric symptoms (depression, suicidal ideation), significant weight loss, and hypersensitivity reactions. Gastrointestinal symptoms often improve with continued treatment. Patients should report persistent or severe side effects to their healthcare provider.

Drug interaction

Strong CYP450 inducers (rifampicin, phenobarbital, carbamazepine, phenytoin) significantly decrease roflumilast exposure and are contraindicated. Fluvoxamine and other CYP450 inhibitors may increase roflumilast exposure—concomitant use requires caution. Oral contraceptives containing gestodene and ethinyl estradiol may interact with roflumilast metabolism. The medication may be used with common COPD medications including short-acting and long-acting beta-agonists, anticholinergics, and inhaled corticosteroids without expected clinically relevant interactions.

Missed dose

If a dose is missed, it should be taken as soon as remembered on the same day. If missed entirely for that day, the patient should resume the regular dosing schedule the following day and not double the dose. Maintaining regular daily administration is important for consistent therapeutic effect. Patients should establish a routine (such as taking with breakfast or at bedtime) to improve adherence. If multiple doses are missed, consultation with a healthcare provider is recommended before resuming treatment.

Overdose

In case of suspected overdose, symptomatic and supportive care is recommended. There is no specific antidote for roflumilast overdose. Reported overdose symptoms may include gastrointestinal disturbances (nausea, vomiting, diarrhea), headache, dizziness, and palpitations. Medical attention should be sought immediately, and treatment should focus on managing symptoms. Hemodialysis is not expected to enhance elimination due to high protein binding. Patients should be monitored for potential extended effects given the medication’s long half-life.

Storage

Store at room temperature (20-25°C or 68-77°F) with excursions permitted between 15-30°C (59-86°F). Keep in the original blister packaging to protect from moisture and light. Keep out of reach of children and pets. Do not use after the expiration date printed on the packaging. Tablets should not be removed from blister packs until immediately before use. Do not store in bathrooms or other areas with high humidity.

Disclaimer

This information is provided for educational purposes only and does not replace professional medical advice. Treatment decisions should be made in consultation with a qualified healthcare provider familiar with the patient’s complete medical history. Dosage and administration should follow the prescribing information provided with the medication. Individual responses to treatment may vary, and not all side effects are listed here. Patients should report any concerns or adverse effects to their healthcare provider promptly.

Reviews

Clinical trials demonstrate that Daliresp reduces the rate of moderate or severe exacerbations by approximately 17% compared to placebo in severe COPD patients with chronic bronchitis. Pulmonary specialists report value in specific patient populations, particularly those with frequent exacerbations despite optimized bronchodilator therapy. Many clinicians note the importance of careful patient selection and monitoring for adverse effects. Real-world evidence supports the clinical trial findings regarding exacerbation reduction, though individual responses vary. The novel mechanism of action provides an additional option for patients not adequately controlled with conventional therapies.