Roflumilast

Roflumilast is a prescription medication that is currently approved in two formulations. It comes as a tablet which is used to decrease the number of flare-ups or the worsening of COPD (Chronic Obstructive Pulmonary Disease). Roflumilast is also available as a topical cream. This formulation is approved for the treatment of plaque psoriasis.

Roflumilast belongs to a group of medications called phosphodiesterase inhibitors. It is thought to work by decreasing inflammation in the lungs (tablet formulation), and on the skin when used topically to treat plaque psoriasis.

Roflumilast tablets are taken once daily, with or without food. The cream is applied to affected areas once daily.

Common side effects of Roflumilast tablets include diarrhea, weight loss, nausea, and headache.

Common side effects of Roflumilast topical cream include diarrhea, headache, insomnia and nausea.

Roflumilast is a prescription medicine used in adults with severe Chronic Obstructive Pulmonary Disease (COPD) to decrease the number of flare-ups or the worsening of COPD symptoms (exacerbations).

In topical form, Roflumilast is approved to treat plaque psoriasis, in patients 12 years of age and older.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Roflumilast may be found in some form under the following brand names:

• Daliresp

• Zoryve

Roflumilast can cause serious side effects. See "Roflumilast Precautions" section.

The most common side effects of roflumilast include:

• diarrhea
• weight loss
• nausea
• headache
• back pain
• flu like symptoms
• problems sleeping (insomnia)
• dizziness
• decreased appetite

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of roflumilast. Ask your doctor or pharmacist for more information.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• rifampicin;
• phenobarbital; 
• carbamazepine;
• phenytoin;
• erythromycin;
• ketoconazole;
• fluvoxamine; 
• enoxacin; 
• cimetidine;
• certain birth control pills.

This is not a complete list of roflumilast drug interactions. Ask your doctor or pharmacist for more information.

Roflumilast can cause serious side effects. Tell your healthcare provider right away if you have any of the symptoms listed below while taking roflumilast.

1. Roflumilast may cause mental health problems including suicidal thoughts and behavior. Some people taking roflumilast may develop mood or behavior problems including:
   • thoughts of suicide or dying
   • attempt to commit suicide
   • trouble sleeping (insomnia)
   • new or worse anxiety
   • new or worse depression
   • acting on dangerous impulses
   • other unusual changes in your behavior or mood
2. Weight loss. Roflumilast can cause weight loss. You should check your weight on a regular basis. You will also need to see your healthcare provider regularly to have your weight checked. If you notice that you are losing weight, call your healthcare provider. Your healthcare provider may ask you to stop taking roflumilast if you lose too much weight.

Do not take roflumilast if you have certain liver problems. Talk with your healthcare provider before you take roflumilast if you have liver problems.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of roflumilast there are no specific foods that you must exclude from your diet when receiving roflumilast.

Before you take roflumilast, tell your healthcare provider if you:

• have or have had a history of mental health problems including depression and suicidal behavior
• have liver problems
• have any other medical conditions
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if roflumilast will harm your unborn baby. 

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if roflumilast passes into your breast milk. You and your healthcare provider should decide if you will take roflumilast or breastfeed. You should not do both.

• Take roflumilast exactly as your healthcare provider tells you to take it.
• Roflumilast can be taken with or without food.
• If you take more than your prescribed dose of roflumilast, call your healthcare provider or go to the nearest hospital emergency room right away.

Take roflumilast exactly as prescribed. Follow the directions on your prescription label carefully.

The recommended dose of roflumilast is one 500 microgram (mcg) tablet per day with or without food.

Roflumilast topical cream is applied once daily to all affected areas of the body.

If you take too much roflumilast, call your local Poison Control Center or seek emergency medical attention right away.

• Store roflumilast at 68°F to 77°F (20°C to 25°C); excursions permitted to 15° - 30°C (59° - 86°F). 
• Keep roflumilast and all medicines out of the reach of children.