Roflumilast is the active ingredient in the medication.It belongs to a class of drugs called phosphodiesterase 4 (PDE4) inhibitors.
Roflumilast is used to treat moderate to severe chronic obstructive pulmonary disease (COPD) in adults who continue to have symptoms despite using inhaled bronchodilators.
It helps to reduce the frequency of exacerbations (flareups) of COPD.
Rofluren Tablet (Roflumilast) works by blocking the enzyme phosphodiesterase 4 (PDE4). This enzyme breaks down a chemical messenger called cyclic adenosine monophosphate (cAMP), which plays a role in inflammation and airway narrowing in COPD. By inhibiting PDE4, roflumilast increases the levels of cAMP, which helps to reduce inflammation and relax the airway muscles, making it easier to breathe.
Store roflumilast tablets at room temperature between 20°C and 25°C (68°F and 77°F).
Protect it from light and moisture.
Keep it out of reach of children and pets.
Do not use roflumilast after the expiration date printed on the bottle.
The usual starting dose of roflumilast is one 500 mcg tablet taken once daily by mouth.
Your doctor may adjust your dose depending on your individual needs and response to treatment.
Take roflumilast with a meal to reduce the risk of side effects.
Do not crush, break, or chew the tablets. Swallow them whole with a glass of water.
Common side effects of roflumilast include nausea, diarrhea, headache, and weight loss.
Serious side effects can occur, including:
Liver problems (hepatic injury)
Mental health problems (depression, suicidal thoughts)
Severe allergic reactions (anaphylaxis)
It is best to avoid alcohol while taking roflumilast, as it can increase the risk of side effects.
Roflumilast can cause dizziness, drowsiness, or other side effects that could impair your ability to drive or operate machinery. Do not drive or operate machinery until you know how this medication affects you.
Roflumilast should not be used during pregnancy unless the potential benefits outweigh the risks. It is not known if roflumilast passes into breast milk. Talk to your doctor about the risks and benefits of breastfeeding while taking this medication.
Roflumilast is not approved for use in children.
Roflumilast is not recommended for people with severe kidney problems.
Roflumilast should be used with caution in people with liver problems. Your doctor may monitor your liver function while you are taking this medication.
DailyMed: https://dailymed.nlm.nih.gov/
FDA: https://www.fda.gov/
National Institutes of Health (NIH): https://www.nih.gov/
