Have severe COPD? Learn how to manage your symptoms.

roflumilast

Generic Name: roflumilast (roe FLOO mi last)
Brand Name: Daliresp

What is roflumilast?

Roflumilast reduces inflammation in the lungs that leads to COPD (chronic obstructive pulmonary disease).

Roflumilast is used to prevent worsening of symptoms in people with severe chronic obstructive pulmonary disease (COPD).

Roflumilast is not a bronchodilator. It will not treat a bronchospasm attack that has already begun.

Roflumilast may also be used for purposes not listed in this medication guide.

What is the most important information I should know about roflumilast?

You should not use roflumilast if you have moderate or severe liver disease.

Slideshow: Flashback: FDA Drug Approvals 2013

What should I discuss with my healthcare provider before taking roflumilast?

You should not use roflumilast if you are allergic to it, or if you have moderate or severe liver disease.

To make sure you can safely take roflumilast, tell your doctor if you have any of these other conditions:

  • liver disease;

  • a history of depression, mental illness, or suicidal thoughts or actions.

You may have unusual thoughts or behavior, or thoughts about suicide, while taking this medicine. Tell your doctor if you have new or worsening depression, or suicidal thoughts. Your family or other caregivers should also be alert to changes in your mood or symptoms.

FDA pregnancy category C. It is not known whether roflumilast will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Roflumilast can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

Do not give this medication to anyone under 18 years old without medical advice. Do not share this medication with other people, even if they have the same symptoms you have.

How should I take roflumilast?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Roflumilast is usually taken once per day, with or without food. Follow your doctor's instructions.

Weight loss is a common side effect of roflumilast. While using roflumilast, weigh yourself regularly and tell your doctor if you have any unplanned or unexplained weight loss.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking roflumilast?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Roflumilast side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, depression, trouble sleeping, or if you feel impulsive, or you have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

  • rapid and unintended weight loss;

  • tremors;

  • pain or burning when you urinate;

Common side effects may include:

  • nausea, diarrhea;

  • loss of appetite, minor weight loss;

  • headache, dizziness;

  • occasional sleep problems;

  • back pain; or

  • flu symptoms.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Roflumilast dosing information

Usual Adult Dose for Chronic Obstructive Pulmonary Disease -- Maintenance:

To reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations: 500 mcg orally once a day, with or without food

What other drugs will affect roflumilast?

Many drugs can interact with roflumilast, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your pharmacist can provide more information about roflumilast.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 2.01. Revision Date: 2013-10-02, 8:59:24 AM.

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