Daliresp: Advanced COPD Management for Improved Respiratory Function

Product dosage: 500 mg
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Daliresp (roflumilast) is a selective phosphodiesterase 4 (PDE4) inhibitor indicated to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. As an oral maintenance treatment, it targets underlying inflammation in the airways, offering a novel mechanism distinct from bronchodilators. It is not a rescue medication and does not replace bronchodilator therapy.

Features

  • Active ingredient: Roflumilast 500 mcg
  • Pharmaceutical form: Film-coated tablet
  • Prescription-only medication
  • Once-daily dosing regimen
  • Selective PDE4 inhibition mechanism
  • Temperature-stable formulation

Benefits

  • Reduces frequency of moderate or severe COPD exacerbations
  • Decreases airway inflammation through targeted PDE4 inhibition
  • Improves lung function parameters when used with bronchodilators
  • Offers convenient once-daily oral administration
  • Provides complementary mechanism to existing bronchodilator therapy
  • May reduce healthcare utilization associated with exacerbations

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 combination with bronchodilator therapy. The medication is typically prescribed for patients who continue to experience exacerbations despite optimal bronchodilator treatment. Clinical studies have demonstrated efficacy particularly in patients with chronic cough and sputum production.

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 adjustment is not required for elderly patients or those with mild to moderate hepatic impairment. The medication is not recommended for patients with severe hepatic impairment.

Precautions

Patients should be monitored for weight loss during treatment, with regular weight checks recommended. Neuropsychiatric events including insomnia, anxiety, and depression may occur and should be closely monitored. Use with caution in patients with a history of depression or suicidal thoughts. Patients should be advised that Daliresp is not a bronchodilator and should not be used for immediate relief of breathing problems. Regular assessment of COPD status and treatment response is essential throughout therapy.

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 necessary, and breastfeeding should be avoided during treatment. Concomitant use with strong cytochrome P450 enzyme inducers such as rifampicin, phenobarbital, carbamazepine, or phenytoin is contraindicated.

Possible side effects

Common adverse reactions include diarrhea (9.5%), weight decrease (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 such as depression, suicidal ideation, and anxiety. Gastrointestinal disorders typically occur early in treatment and may decrease with continued therapy. Weight loss should be monitored regularly throughout treatment.

Drug interaction

Roflumilast is primarily metabolized by CYP3A4 and CYP1A2 enzymes. Concomitant use with strong CYP enzyme inducers (rifampicin, phenobarbital, carbamazepine, phenytoin) may significantly decrease roflumilast exposure and is contraindicated. Fluconazole (CYP2C9 and CYP3A4 inhibitor) may increase roflumilast exposure. Cimetidine and oral contraceptives containing gestodene and ethinylestradiol may moderately increase roflumilast plasma concentrations. Theophylline coadministration is not recommended due to limited safety data.

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 be educated about the importance of adherence to the prescribed regimen for optimal treatment outcomes.

Overdose

In case of overdose, supportive measures should be implemented based on clinical presentation. Symptoms may include gastrointestinal disturbances, headache, dizziness, palpitations, and lightheadedness. There is no specific antidote for roflumilast overdose. Gastric lavage may be considered if performed soon after ingestion. Medical supervision is recommended, particularly for large overdoses. Hemodialysis is not expected to enhance elimination due to high protein binding.

Storage

Store at room temperature between 15°C and 30°C (59°F to 86°F). Keep in the original container with the lid tightly closed to protect from moisture. Do not remove the desiccant from the bottle. Keep out of reach of children and pets. Do not use after the expiration date printed on the packaging. Protect from light and excessive humidity. Do not store in bathroom cabinets where moisture levels may fluctuate.

Disclaimer

This information is provided for educational purposes only and does not replace professional medical advice. Always consult with a qualified healthcare provider before starting or changing any medication regimen. Individual patient responses may vary, and treatment decisions should be based on comprehensive medical evaluation. The prescribing physician should be aware of the complete medical history and concurrent medications before initiating therapy with Daliresp.

Reviews

Clinical trials have demonstrated that Daliresp reduces the rate of moderate or severe exacerbations by approximately 17% compared to placebo when added to standard bronchodilator therapy. Many pulmonologists report positive experiences with appropriate patient selection, particularly noting benefits in patients with frequent exacerbations despite optimal inhaled therapy. Some clinicians emphasize the importance of careful patient monitoring, especially during the initial treatment period. Real-world evidence suggests that patients who tolerate the medication well often experience meaningful reductions in exacerbation frequency and associated healthcare utilization.