8% Off
Roflast500 mcg
Beacon Pharmaceuticals PLC
৳138.46
Add to cart
Generic medicine
Roflumilast: Brands, Price & Uses in Bangladesh
Roflumilast is indicated as a treatment to reduce the risk of exacerbations (flare-ups) in adults with severe chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis who have…
About Roflumilast
Indications of Roflumilast
Roflumilast is indicated as a treatment to reduce the risk of exacerbations (flare-ups) in adults with severe chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis who have a history of frequent exacerbations.
- Established/FDA-approved use: Maintenance treatment to reduce the frequency of COPD exacerbations in patients with severe COPD and chronic bronchitis with a history of exacerbations, used as an add-on (adjunct) to bronchodilator therapy (e.g., long-acting bronchodilators).
- Important distinction: Roflumilast is not a bronchodilator and does not provide immediate relief of acute bronchospasm or acute worsening of COPD symptoms.
Use of Roflumilast for any other condition should only be considered under specific physician guidance, as this is not an approved indication for this oral formulation.
Dosage & Administration of Roflumilast
Dosing of Roflumilast by indication and population:
| Population / Indication | Recommended Dose |
|---|---|
| Adults – severe COPD with chronic bronchitis and a history of exacerbations | Roflumilast 500 microgram (mcg) orally, once daily, long-term, as an add-on to bronchodilator therapy |
| Mild hepatic impairment (Child-Pugh A) | No dose adjustment required; use with caution |
| Moderate-to-severe hepatic impairment (Child-Pugh B or C) | Contraindicated — see Contraindications |
| Renal impairment | No dose adjustment required |
| Elderly patients | No dose adjustment required; monitor as for general adult population |
| Pediatric patients (under 18 years) | Safety and efficacy not established; not recommended |
Tablets should be swallowed whole with water, with or without food, at approximately the same time each day. Full clinical benefit in reducing exacerbations may take several weeks to months of continuous therapy to become apparent; do not stop treatment abruptly without consulting a physician.
Side Effects of Roflumilast
The most commonly reported side effects of Roflumilast include:
- Diarrhea
- Weight loss / decreased appetite
- Nausea
- Headache
- Insomnia
- Back pain and other musculoskeletal pain
- Dizziness
Psychiatric effects such as anxiety, depression, and — rarely — suicidal thoughts or behavior have been reported (see Precautions and Warnings). Gastrointestinal side effects tend to occur early in treatment and often diminish over time; however, any persistent or severe symptoms, mood changes, or significant unintentional weight loss should be reported to a physician promptly.
Contraindications of Roflumilast
Roflumilast is contraindicated in:
- Patients with known hypersensitivity to Roflumilast or any component of the formulation.
- Patients with moderate-to-severe hepatic impairment (Child-Pugh B or C), due to significantly increased drug exposure in this population.
Frequently Asked Questions about Roflumilast
What is Roflumilast used for?
Roflumilast is used to reduce the risk of exacerbations (flare-ups) in adults with severe COPD associated with chronic bronchitis who have a history of frequent exacerbations. It is used together with, not instead of, bronchodilator therapy.
Will Roflumilast relieve my COPD symptoms immediately?
No. Roflumilast is not a bronchodilator and does not provide immediate relief of breathlessness or acute worsening of symptoms. It works over time to reduce inflammation and lower the frequency of exacerbations; continue using your prescribed rescue and maintenance inhalers as directed by your physician.
What are the most serious risks I should know about with Roflumilast?
Roflumilast has been associated with psychiatric side effects such as insomnia, anxiety, depression, and — rarely — suicidal thoughts or behavior. Tell your physician immediately if you or a family member notice mood changes, unusual behavior, or thoughts of self-harm. Roflumilast can also cause weight loss, so your weight should be monitored during treatment.
Can I take Roflumilast if I have liver problems?
Roflumilast is contraindicated in people with moderate-to-severe liver impairment, because drug levels can build up to unsafe amounts. Tell your physician about any history of liver disease before starting Roflumilast.
Is Roflumilast safe during pregnancy or breastfeeding?
Data are limited. Roflumilast should be used in pregnancy only if clearly needed, when the potential benefit justifies the potential risk to the fetus, and only under a physician's guidance. Discuss breastfeeding plans with your physician, as it is not known whether Roflumilast passes into human breast milk.
What should I do if I miss a dose or take too much Roflumilast?
If you miss a dose, take it as soon as you remember unless it is close to the next dose — do not double up. If you suspect you have taken too much Roflumilast, seek immediate medical attention or contact a poison control center, as overdose can increase side effects like headache, nausea, diarrhea, and dizziness.
Disclaimer
The information provided is accurate to the best of our knowledge, but it does not replace professional medical advice. We cannot guarantee its completeness or accuracy, and the absence of specific information about a drug should not be taken as an endorsement. We are not responsible for any consequences arising from this information, so please consult a healthcare professional for any concerns or questions.