Indications
Roflumilast is used as an add-on long-term treatment for adults with severe chronic obstructive pulmonary disease (COPD) linked to chronic bronchitis (daily cough with phlegm) who have frequent flare-ups. It is taken together with inhaler treatment (bronchodilators). It is not a reliever and does not treat sudden breathlessness.
How It Works
Roflumilast blocks an enzyme called phosphodiesterase-4 (PDE4) in inflammatory cells of the lungs. This reduces inflammation in the airways, which helps lower the number of COPD flare-ups.
Dosage and Administration
Adults: 500 micrograms (0.5 mg) once a day. Some doctors start with 250 micrograms once a day for the first 4 weeks to reduce side effects, then increase to 500 micrograms. Swallow the tablet whole with water at the same time each day, with or without food. It may take several weeks to show benefit. Keep using your inhalers as prescribed.
Interactions
- Rifampicin, Phenobarbital, Carbamazepine and Phenytoin reduce its effect and are not recommended together.
- Erythromycin, Ketoconazole, Fluvoxamine, Cimetidine and Enoxacin can raise its levels and side effects.
- Theophylline is not recommended together with it.
- Medicines that weaken the immune system (such as Methotrexate or Azathioprine) are not recommended long term with it.
Contraindications
Moderate or severe liver disease; allergy to roflumilast or any ingredient.
Side Effects
Common: diarrhoea, nausea, weight loss, reduced appetite, stomach pain, headache, trouble sleeping and back pain. These often settle after the first few weeks. It can also cause anxiety, nervousness, low mood or depression. Get urgent medical help if you have thoughts of harming yourself, sudden severe low mood or behaviour changes, severe or ongoing diarrhoea, or signs of an allergic reaction (swelling of the face or throat, difficulty breathing, widespread rash). Tell your doctor if you keep losing weight.
Pregnancy and Lactation
Not recommended in pregnancy. Women who can become pregnant should use effective contraception during treatment. Do not breastfeed while taking it.
Precautions and Warnings
Tell your doctor if you have a history of depression or mental health problems, liver problems, heart failure, a weak immune system, or serious infections such as tuberculosis, hepatitis or HIV. Your weight may be checked regularly. It is not for asthma, and it is not used in people under 18 years.
Overdose
Overdose may cause headache, dizziness, nausea, stomach upset, a fast heartbeat and low blood pressure. Seek medical help.
Therapeutic Class
Respiratory anti-inflammatory medicine (phosphodiesterase-4 inhibitor).
Storage
Store below 30°C in a dry place, away from light and out of the reach of children.
Prepared by the Oshud Alo team from standard drug references. For information only; always follow your doctor's advice.