Daliresp: Advanced COPD Management with PDE4 Inhibition
Daliresp
| Product dosage: 500 mg | |||
|---|---|---|---|
| Package (num) | Per tab | Price | Buy |
| 30 | $2.27 | $68.00 (0%) | 🛒 Add to cart |
| 60 | $1.83 | $136.00 $110.00 (19%) | 🛒 Add to cart |
| 90 | $1.58 | $204.00 $142.00 (30%) | 🛒 Add to cart |
| 120 | $1.38 | $272.00 $165.00 (39%) | 🛒 Add to cart |
| 180 | $1.22
Best per tab | $408.00 $220.00 (46%) | 🛒 Add to cart |
Daliresp (roflumilast) is a selective phosphodiesterase-4 (PDE4) inhibitor indicated for the severe chronic obstructive pulmonary disease (COPD) patient population. It represents a significant advancement in the maintenance treatment of airflow obstruction and reduction of exacerbations in adults with a history of exacerbations and chronic bronchitis. Unlike traditional bronchodilators, Daliresp operates through a distinct anti-inflammatory mechanism, targeting the underlying pathophysiology of COPD. This oral tablet offers a complementary approach to existing bronchodilator therapy, providing clinicians with an additional tool for high-risk patients. Its targeted action makes it particularly valuable in cases where standard therapies yield suboptimal control.
Features
- Contains roflumilast as the active pharmaceutical ingredient
- Available in 500 mcg tablet strength
- Selective phosphodiesterase-4 (PDE4) inhibitor class
- Oral administration once daily
- White to off-white, round tablets with “D” on one side and “500” on the other
- Manufactured under current Good Manufacturing Practices (cGMP)
- Requires prescription and professional medical supervision
Benefits
- Reduces risk of COPD exacerbations in severe chronic bronchitis patients
- Decreases airway inflammation through targeted PDE4 inhibition
- Provides complementary mechanism to bronchodilator therapy
- Once-daily dosing supports medication adherence
- Improves lung function measurements over time
- Offers non-steroidal anti-inflammatory approach for COPD management
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 not indicated for the relief of acute bronchospasm. Clinical use typically involves patients who continue to experience exacerbations despite optimized bronchodilator therapy. The medication is generally prescribed as part of a comprehensive COPD management program that includes smoking cessation, pulmonary rehabilitation, and other maintenance therapies. Healthcare providers typically reserve Daliresp for patients with severe disease (GOLD stage 3 or 4) who demonstrate particular characteristics that suggest responsiveness to PDE4 inhibition.
Dosage and direction
The recommended dosage is one 500 mcg tablet taken orally once daily, with or without food. Administration should occur at approximately the same time each day to maintain consistent plasma concentrations. Tablets should be swallowed whole and not crushed, chewed, or broken. Dose titration is not required, as the 500 mcg dose represents the therapeutic dosage. No adjustment is necessary for elderly patients, but careful monitoring is advised. For patients with hepatic impairment, use is contraindicated. Treatment should be initiated and supervised by physicians experienced in the treatment of COPD. Patients should be advised that clinical benefit may not be apparent for several weeks or months of continuous therapy.
Precautions
Patients should be monitored for weight loss during treatment, as Daliresp is associated with dose-dependent weight decrease. Regular weight monitoring is recommended, with consideration of discontinuation if unexplained or clinically significant weight loss occurs. Mental health parameters should be observed, including monitoring for insomnia, anxiety, and depression. Use with caution in patients with a history of depression or suicidal ideation. Patients should be advised that Daliresp is not a bronchodilator and should not be used for immediate relief of breathing problems. Caution is advised when co-administering with strong cytochrome P450 enzyme inducers or inhibitors. The medication’s effects may be diminished in current smokers compared to ex-smokers.
Contraindications
Daliresp is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C). Use is contraindicated 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 the potential benefit justifies the potential risk to the fetus. Breastfeeding is not recommended during treatment. Concomitant use with theophylline is contraindicated due to increased roflumilast exposure. The medication should not be used as rescue medication for acute bronchospasm.
Possible side effects
The most 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 (1.9%). Psychiatric disorders including anxiety (1.4%) and depression (1.2%) have been reported. Less common but serious side effects may include suicidal ideation, severe weight loss, and hypersensitivity reactions. Patients should be instructed to report any persistent or severe side effects to their healthcare provider promptly. Most adverse reactions are dose-dependent and may decrease in frequency and severity over time.
Drug interaction
Strong cytochrome P450 enzyme inducers such as rifampicin, phenobarbital, carbamazepine, and phenytoin may significantly decrease roflumilast exposure and reduce efficacy. Concurrent administration with fluvoxamine or enoxacin may increase roflumilast exposure. Co-administration with oral contraceptives containing gestodene and ethinyl estradiol may increase roflumilast exposure by approximately 38%. Theophylline co-administration is contraindicated. While no clinically significant interactions have been observed with salmeterol or budesonide, careful monitoring is advised when combining with other COPD medications.
Missed dose
If a dose is missed, patients should take it as soon as remembered on the same day. If remembered the next day, the missed dose should be skipped and the regular dosing schedule resumed. Patients should not take a double dose to make up for a missed dose. The relatively long half-life of roflumilast (approximately 17 hours) provides some forgiveness for occasional missed doses, but consistent daily administration is important for optimal therapeutic effect. Patients should be educated about the importance of adherence and provided with strategies to support regular dosing.
Overdose
In case of suspected overdose, supportive measures should be instituted based on clinical presentation. There is no specific antidote for roflumilast overdose. Symptoms may include gastrointestinal disturbances (severe diarrhea, nausea), headache, dizziness, palpitations, and lightheadedness. Gastric lavage may be considered if performed soon after ingestion. Medical supervision should be maintained until symptoms resolve. Hemodialysis is not expected to enhance elimination significantly due to high protein binding. Patients should be advised to seek immediate medical attention if overdose is suspected.
Storage
Store at room temperature between 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C to 30°C (59°F to 86°F). Keep in the original container with the lid tightly closed to protect from moisture. Do not store in bathroom medicine cabinets where humidity may affect stability. Keep out of reach of children and pets. Do not use beyond the expiration date printed on the packaging. Protect from light and excessive heat. Do not transfer tablets to other containers as this may affect stability.
Disclaimer
This information is provided for educational purposes only and does not constitute medical advice. Treatment decisions should be made by qualified healthcare professionals based on individual patient circumstances. The prescribing physician should be consulted for complete information regarding indications, contraindications, warnings, precautions, and adverse reactions. Patients should not alter or discontinue medication without professional medical guidance. While every effort has been made to ensure accuracy, medical knowledge evolves and the most current prescribing information should always be consulted.
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 particular value in patients with frequent exacerbations despite optimal bronchodilator therapy. Many clinicians note the medication’s unique mechanism of action provides an important additional option for difficult-to-control patients. Some practitioners emphasize the need for careful patient selection and monitoring due to the side effect profile. Patient-reported outcomes suggest improved quality of life measures in responders, though individual responses vary. The medication has been incorporated into international treatment guidelines for appropriate patient populations.