For adults with severe chronic obstructive pulmonary disease (COPD) to decrease the number of flare-ups
DALIRESP is the only medicine of its kind for COPD and works differently from steroids. It belongs to a group of medications called PDE4 (phosphodiesterase-4) inhibitors. This medication helps to reduce the risk of COPD flare-ups for people with severe COPD. It comes in an oral tablet form.
You may not feel anything when you take DALIRESP, but that does not mean it is not working. Just as you may not feel blood pressure or cholesterol medications working, you may not feel DALIRESP working, but it is helping to lower your risk of a future flare-up.
DALIRESP comes in 2 different starting doses: 250 mcg and 500 mcg. Your doctor has determined which dose is appropriate for you to start on. DALIRESP is taken once daily, with or without food.
A STARTING DOSE OPTION 250 MCG
If your doctor started you on the 250-mcg dose, you should take it once daily for the first 4 weeks only. After the first 4 weeks, you will increase to the 500-mcg dose. The 250-mcg dose is a starting dose only. It is not the effective dose and should not be taken for more than the first 4 weeks.
A STARTING DOSE OPTION AND THE MAINTENANCE DOSE 500 MCG
If your doctor started you on the 500-mcg dose, you will stay on that dose as the maintenance dose.
Tablet images are representations and not actual size.
If your doctor prescribes DALIRESP, it is important that you continue to take the medication exactly as your doctor tells you to. If you take more than your prescribed dose of DALIRESP, call your doctor or go to the nearest hospital emergency room right away.
DOWNLOAD DOSING INFORMATION SHEET
Do not take DALIRESP if you have certain liver problems.Talk with your doctor before taking DALIRESP if you have liver problems.
You should store DALIRESP at room temperature (68˚F to 77˚F). However, storage as low as 59˚F and as high as 86˚F is permitted for short periods of time. Keep DALIRESP tablets and all medicines out of the reach of children.
Before you take DALIRESP, tell your doctor 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 since it is not known if DALIRESP will harm your unborn baby; are breastfeeding or plan to breastfeed since it is not known if DALIRESP passes into your breast milk.
DALIRESP can cause serious side effects. Tell your doctor right away if you have any of the symptoms listed below while taking DALIRESP.
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, or other unusual changes in behavior or mood.
DALIRESP can cause weight loss. You should check your weight on a regular basis. You will also need to see your doctor regularly to have your weight checked. If you notice that you are losing weight, call your doctor. Your doctor may ask you to stop taking DALIRESP if you lose too much weight.
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
The most common side effects of DALIRESP include
These are not all the possible side effects of DALIRESP. Always tell your doctor about any side effects that bother you or don't go away.
Diarrhea and nausea were the two side effects that most often caused people to discontinue treatment with DALIRESP in clinical trials. In these clinical trials, most of the people who had diarrhea and/or nausea experienced it in the beginning of their treatment, and it generally lasted less than four weeks. For some, it lasted longer and was severe.
If you experience these side effects, your doctor may be able to suggest ways to manage them. Remember, always talk to your doctor before stopping 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.
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 nonprescription medicines, vitamins, and herbal supplements.
Do not take DALIRESP if you have certain liver problems. Talk with your healthcare provider before taking DALIRESP if you have liver problems.
Before you take DALIRESP, tell your healthcare provider if you:
The most common side effects of DALIRESP include diarrhea, weight loss, nausea, headache, back pain, flu-like symptoms, problems sleeping (insomnia), dizziness, and decreased appetite. These are not all the possible side effects of DALIRESP. Always tell your healthcare provider about any side effects that bother you or don't go away.
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.
DALIRESP 250 mcg is a starting dose for the first 4 weeks only and is not the effective dose.
Please see full Prescribing Information, including Medication Guide.
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