Pill Identifier App

Roflumilast

Generic Name: roflumilast (roe-FLUE-mi-last)
Brand Name: Daliresp

Roflumilast is used for:

Reducing the risk of flare-ups and worsened breathing problems in certain patients with severe chronic obstructive pulmonary disease (COPD).

Roflumilast is a phosphodiesterase type 4 (PDE4) inhibitor. Exactly how it works is not known.

Do NOT use roflumilast if:

  • you are allergic to any ingredient in roflumilast
  • you have moderate to severe liver problems
  • you are taking carbamazepine, hydantoins (eg, phenytoin), phenobarbital, primidone, rifamycins (eg, rifampin), or St. John's wort

Contact your doctor or health care provider right away if any of these apply to you.

Slideshow: Flashback: FDA Drug Approvals 2013

Before using roflumilast:

Some medical conditions may interact with roflumilast. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have a history of liver problems, mental or mood problems (eg, depression), or suicidal thoughts or behaviors

Some MEDICINES MAY INTERACT with roflumilast. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Certain birth control pills (eg, containing gestodene or ethinyl estradiol), cimetidine, enoxacin, erythromycin, fluvoxamine, itraconazole, or ketoconazole because they may increase the risk of roflumilast's side effects
  • Carbamazepine, hydantoins (eg, phenytoin), phenobarbital, primidone, rifamycins (eg, rifampin), or St. John's wort because they may decrease roflumilast's effectiveness

This may not be a complete list of all interactions that may occur. Ask your health care provider if roflumilast may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use roflumilast:

Use roflumilast as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Roflumilast comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get roflumilast refilled.
  • Take roflumilast by mouth with or without food.
  • If you miss a dose of roflumilast, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use roflumilast.

Important safety information:

  • Roflumilast may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use roflumilast with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Roflumilast will not stop sudden, severe breathing problems. Be sure to carry a short-acting bronchodilator inhaler with you at all times to treat any breathing problems that may occur between doses of roflumilast (eg, severe or sudden onset of wheezing or shortness of breath). If you have any questions about which medicines stop sudden, severe breathing problems, check with your doctor or pharmacist.
  • Patients who take roflumilast may be at increased risk of mental or mood changes, including suicidal thoughts or actions. The risk may be greater in patients who have had these problems in the past. Watch patients who take roflumilast closely. Contact the doctor at once if new, worsened, or sudden symptoms, such as depressed mood, anxious behavior, trouble sleeping, or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
  • Roflumilast may cause weight loss in some patients. You may need regular weight checks while taking roflumilast. Discuss any questions or concerns with your doctor.
  • Roflumilast should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking roflumilast while you are pregnant. It is not known if roflumilast is found in breast milk. Do not breast-feed while taking roflumilast.

Possible side effects of roflumilast:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back pain; decreased appetite; diarrhea; dizziness; flu-like symptoms; headache; mild weight loss; nausea.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); decreased, difficult, or painful urination; irregular heartbeat; new or worsening mental or mood problems (eg, anxiety, depression); severe or persistent stomach or back pain; severe or unexplained weight loss; suicidal thoughts or behaviors; tremor; trouble sleeping.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include cool, moist, and unusually pale skin; dizziness, light-headedness, or fainting; headache; irregular heartbeat.

Proper storage of roflumilast:

Store roflumilast at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep roflumilast out of the reach of children and away from pets.

General information:

  • If you have any questions about roflumilast, please talk with your doctor, pharmacist, or other health care provider.
  • Roflumilast is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take roflumilast or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about roflumilast. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to roflumilast. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using roflumilast.

Issue Date: July 2, 2014
Database Edition 14.3.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

Hide
(web4)
Close