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Roflumilast

Generic Name: roflumilast (roe-FLOOmi-last)

Brand Name: Dairesp
Oral tablet: 250 mcg or 500 mcg
Drug class: selective phosphodiesterase-4 inhibitors

What is Roflumilast?

Roflumilast is a drug that reduces inflammation of the lungs, which can lead to COPD. Roflumilast can be used to treat severe COPD and prevent symptoms from worsening. Roflumilast does not act as a bronchodilator, and it will not work to treat a bronchospasm that has already started. This medication guide does not list all possible uses of Roflumilast.

Side effects of Roflumilast

If you experience any of the following signs and symptoms of an allergic reaction: difficulty breathing, hives or facial or throat swelling - seek medical assistance immediately! As soon as any symptoms worsen or change, such as mood or behavior changes, anxiety, or depression. If you are having difficulty sleeping or have thoughts of suicide or harming yourself it is imperative that these signs are reported immediately to a healthcare provider.

If you experience rapid and unexpected weight loss, call your doctor immediately.

  • Rapid and unintended weight gain;
  • Tremors;
  • Pain or burning after urinating;

Some of the common side effects associated with roflumilast include:

  • Nausea, diarrhea;
  • Loss of appetite and minor weight loss
  • Headache, dizziness;
  • Sleep problems can occur at any time.
  • Backache
  • Flu symptoms

There may be other side effects. Call your doctor immediately if experiencing side effects; for the FDA reporting service call: 1-800-FDA-1088.

Similar/related drugs

Prednisone, Symbicort, Ventolin, Breo Ellipta, Spiriva, Ventolin HFA, and Anoro Ellipta

Warnings

If you have a moderate or severe liver condition, then you should not take roflumilast. Roflumilast can cause suicidal thoughts in some people. Be alert if you notice any changes in your mood or symptoms. Inform your doctor if you experience any new symptoms or if they worsen. Inform your physician of all medications taken currently as well as any new ones prescribed to you.Some drugs are not to be taken together, and others can cause drug interactions. If you notice rapid weight loss that is not intended, call your doctor immediately.

Before you take this drug

If you have liver disease or are allergic to roflumilast, you should avoid using it.

Inform your physician of any of the following issues:

  • Liver disease

Depression, mental illness or suicidal thoughts and actions all pose potential threats of imminent danger to ones wellbeing and life. Some individuals taking Roflumilast may experience unwanted thoughts. Your physician should monitor your progress at regular doctor's visits. Furthermore, any changes in mood or symptoms should be brought to their attention immediately by you or family members. Uncertain is whether roflumilast can harm an unborn baby. Please notify your healthcare provider if you are expecting or planning on becoming pregnant during this treatment course. Breast-feeding is not recommended while using roflumilast. Do not administer this medicine to an infant without consulting a doctor.

How to take Roflumilast?

Read all instructions or guides included with your medication and follow all label directions exactly. Follow the directions on the label. Take roflumilast either with or without food. Roflumilast can cause weight loss. Weigh yourself regularly while using roflumilast, and let your doctor know if there is any sudden or unplanned weight loss. This medicine should not be shared with anyone else, even if the other person has similar symptoms. Store away from heat and moisture at room temperature.

Details on dosage

Adult dose for chronic obstructive pulmonary disease—Maintenance:

Initial dose: 250 mg once daily for four weeks.
Maintenance dose: 500 mg once daily orally
Comments:
Starting the dose at 250 mcg daily may reduce the rate of treatment discontinuation, but it is not an effective or therapeutic dose.
This drug is not a bronchodilator, and it is not recommended for the treatment of acute exacerbations.
Use(s): To reduce the exacerbation risk in patients with severe COPD and chronic lung bronchitis, as well as a history of exacerbations.

What happens if I miss the dose?

If you are almost due for your next dose, skip the missed one. Never take two doses of the same medicine at once.

What happens if I overdose?

Contact 1-800-222-1222 immediately in case of poisoning and seek immediate medical advice.

What should be avoided?

If your doctor prescribes any restrictions regarding food, beverage, or activity, follow their instructions.

Interaction with other drug

Roflumilast can be affected by many drugs. These include prescription and over-the-counter medicines, vitamins, and herbal products. This list does not include all possible interactions. Inform your doctor of all medications you are currently taking and those that you will stop or start using.

DRUG STATUS

Availability

Prescription only

Pregnancy & Lactation

CSA Schedule*
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