Daliresp

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

What is Daliresp?

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

Daliresp is used to prevent worsening of chronic obstructive pulmonary disease (COPD) in people with severe COPD and chronic bronchitis.

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

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

Important information about roflumilas?

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

There are many other drugs that can make Daliresp less effective and should not be used at the same time. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

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Before you take Daliresp, tell your doctor if you have liver disease or a history of depression, mental illness, or suicidal thoughts or actions.

You may have unusual thoughts or behavior, or thoughts about suicide, while taking Daliresp. 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.

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.

Before taking Daliresp

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

There are many other drugs that can make Daliresp less effective and should not be used at the same time. This includes:

• bosentan (Tracleer);

• dexamethasone (Cortastat, Dexasone, Solurex, DexPak);

• St. John's wort;

• rifabutin (Mycobutin), rifampin (Rifadin, Rifater, Rifamate), or rifapentine (Priftin);

• a barbiturate such as butabarbital (Butisol), secobarbital (Seconal), pentobarbital (Nembutal), or phenobarbital (Solfoton);

• HIV medication such as efavirenz (Sustiva, Atripla), etravirine (Intelence), nevirapine (Viramune), or ritonavir (Norvir, Kaletra);

• medicines to treat narcolepsy, such as armodafinil (Nuvigil) or modafinil (Progivil); or

• seizure medication such as carbamazepine (Carbatrol, Equetro, Tegretol), felbamate (Felbatol), oxcarbazepine (Trileptal), phenytoin (Dilantin), or primidone (Mysoline).

To make sure you can safely take Daliresp, 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 Daliresp. 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 Daliresp will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using Daliresp. Roflumilast can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using Daliresp. Do not give this medication to anyone under 18 years old without medical advice. Do not share Daliresp with other people, even if they have the same symptoms you have.

See also: Daliresp pregnancy and breastfeeding warnings (in more detail)

How should I take Daliresp?

Take Daliresp exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

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

See also: Daliresp dosage (in more detail)

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.

Overdose symptoms may include fast or pounding heartbeats, cold or clammy skin, or feeling like you might pass out.

What should I avoid while taking Daliresp?

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

Daliresp side effects

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

You may have unusual thoughts or behavior, or thoughts about suicide, while taking Daliresp. 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 a serious side effect such as:

• rapid and unintended weight loss;

• tremors;

• pain or burning when you urinate;

Less serious Daliresp side effects may include:

• nausea, diarrhea, stomach pain;

• loss of appetite, minor weight loss;

• dizziness;

• runny or stuffy nose;

• 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: Daliresp side effects (in more detail)

What other drugs will affect Daliresp?

Tell your doctor about all other medicines you use, especially:

• birth control pills;

• cimetidine (Tagamet);

• conivaptan (Vaprisol);

• imatinib (Gleevec);

• isoniazid (for treating tuberculosis);

• lidocaine (Xylocaine);

• methoxsalen (Oxsoralen, Uvadex, 8-Mop);

• primaquine (anti-malaria medication);

• an antidepressant such as fluvoxamine (Luvox) or nefazodone;

• an antibiotic such as ciprofloxacin (Cipro), clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), norfloxacin (Noroxin), ofloxacin (Floxin), or telithromycin (Ketex);

• antifungal medication such as itraconazole (Sporanox), ketoconazole (Nizoral), miconazole (Oravig), o thiabendazole (Mintezol);

• heart or blood pressure medication such as amiodarone (Cordarone, Pacerone), mexiletine (Mexitil), nicardipine (Cardene) or quinidine (Quin-G);

• HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase), or ritonavir (Norvir, Kaletra);

This list is not complete and other drugs may interact with Daliresp. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about Daliresp.