Daliresp

Generic name: roflumilast
Drug class: Selective phosphodiesterase-4 inhibitors

Medically reviewed by A Ras MD.

What is Daliresp?

Daliresp 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).

Daliresp is not a bronchodilator and should not be used for treating sudden breathing problems. Your healthcare provider may give you other medicine to use for sudden breathing problems.

It is not known if Daliresp is safe and effective in children.

Description

The active ingredient in DALIRESP tablets is roflumilast. Roflumilast and its active metabolite (roflumilast N-oxide) are selective phosphodiesterase 4 (PDE4) inhibitors. The chemical name of roflumilast is N-(3,5-dichloropyridin-4-yl)-3-cyclopropylmethoxy-4-difluoromethoxy-benzamide. Its empirical formula is C17H14Cl2F2N2O3 and the molecular weight is 403.22.

The chemical structure is:

The drug substance is a white to off-white non-hygroscopic powder with a melting point of 160°C. It is practically insoluble in water and hexane, sparingly soluble in ethanol, and freely soluble in acetone.

DALIRESP is supplied as white to off-white, round tablets, embossed with “D” on one side and “250” or “500” on the other side. Each tablet contains 250 mcg or 500 mcg of roflumilast.

Each tablet of DALIRESP for oral administration contains the following inactive ingredients: lactose monohydrate, corn starch, povidone, and magnesium stearate.

Mechanism of Action

Roflumilast and its active metabolite (roflumilast N-oxide) are selective inhibitors of phosphodiesterase 4 (PDE4). Roflumilast and roflumilast N-oxide inhibition of PDE4 (a major cyclic-3′,5′-adenosine monophosphate (cyclic AMP)-metabolizing enzyme in lung tissue) activity leads to accumulation of intracellular cyclic AMP. While the specific mechanism(s) by which DALIRESP exerts its therapeutic action in COPD patients is not well defined, it is thought to be related to the effects of increased intracellular cyclic AMP in lung cells.

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

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

1. Daliresp may cause mental health problems including suicidal thoughts and behavior. Some people taking Daliresp 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. Daliresp 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 Daliresp if you lose too much weight.

Daliresp may affect the way other medicines work, and other medicines may affect how Daliresp works. Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Who should not take Daliresp?

Do not take Daliresp if you:

have certain liver problems. Talk with your healthcare provider before you take Daliresp if you have liver problems.

What should I tell my healthcare provider before taking Daliresp?

Before you take Daliresp, 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. It is not known if Daliresp will harm your unborn baby. Talk to your healthcare provider if you are pregnant or plan to become pregnant.
are breastfeeding or plan to breastfeed. It is not known if Daliresp passes into your breast milk. You and your healthcare provider should decide if you will take Daliresp or breastfeed. You should not do both.

How should I take Daliresp?

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

What are the possible side effects of Daliresp?

Daliresp can cause serious side effects, including:

See “What is the most important information I should know about Daliresp?”

The most common side effects of Daliresp 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 Daliresp.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of Daliresp

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Daliresp for a condition for which it was not prescribed. Do not give Daliresp to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about Daliresp. For more information about Daliresp, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Daliresp that is written for health professionals.

For more information about Daliresp call 1-800-236-9933.