Roflumilast

Description

Roflumilast is used for the maintenance treatment of severe chronic obstructive pulmonary disease (COPD- a lung disease) associated with chronic bronchitis in adult patients. It is used as an add on to bronchodilator treatment to reduce the risk of COPD exacerbations. This medicine also prevents the worsening of COPD symptoms.

Side effects

Major & minor side effects for Roflumilast

  • Unexplained weight loss
  • Cough
  • Joint pain
  • Loss of appetite
  • Diarrhea
  • Headache
  • Nausea and vomiting
  • Unusual tiredness and weakness
  • Dizziness
  • Stomach pain

Uses of Roflumilast

What is it prescribed for?

  • Chronic obstructive pulmonary disease-Maintenance
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Concerns

Commonly asked questions

  • Onset of action
    The amount of time required for this medicine to show its action is not clinically established.
  • Duration of effect
    The amount of time for which this medicine remains active in the body is not clinically established.
  • Safe with alcohol?
    Interaction with alcohol is unknown. It is advisable to consult your doctor before consumption.
  • Is it habit forming?
    No habit-forming tendencies were reported
  • Usage in pregnancy?
    This medicine is not recommended for use in pregnant women unless absolutely necessary. All the risks and benefits should be discussed with the doctor before taking this medicine.
  • Usage while breast-feeding?
    This medicine is not recommended for use in breastfeeding women unless absolutely necessary. All the risks and benefits should be discussed with the doctor before taking this medicine. If the medicine is used, the infant should be monitored closely for any undesirable side effects.

Allergy

This medicine is not recommended for use if you have a known allergy to roflumilast or any other inactive ingredients present along with it.

Moderate to Severe Hepatic Impairment

This medicine is not recommended for use in patients with moderate to severe liver impairment due to the risk of worsening of the patient's condition.
Warnings for special population

Pregnancy

This medicine is not recommended for use in pregnant women unless absolutely necessary. All the risks and benefits should be discussed with the doctor before taking this medicine.

Breast-feeding

This medicine is not recommended for use in breastfeeding women unless absolutely necessary. All the risks and benefits should be discussed with the doctor before taking this medicine. If the medicine is used, the infant should be monitored closely for any undesirable side effects.
General warnings

Acute bronchospasm

This medicine is not used for the relief of acute bronchospasm since it is not a bronchodilator.

Suicidal tendency

This medicine may increase the risk of suicidal thoughts in some patients. Patients should be monitored closely for any changes in behavior or mood. Appropriate dose adjustments or replacement with a suitable alternative may be necessary based on the clinical condition of the patient.

Kidney impairment

This medicine should be used with extreme caution in patients with kidney impairment due to the risk of worsening of the patient's condition. Close monitoring of kidney function is recommended while receiving this medicine. Appropriate dose adjustments or replacement with a suitable alternative might be required in some cases.

Use in children

This medicine is not recommended for use in patients less than 18 years of age since the safety and efficacy of use are not clinically established.

Weight loss

This medicine should be used with caution due to the increased risk of weight loss. This risk is especially higher in patients with a history of anorexia and/or malnourishment. Close monitoring of weight changes is recommended during treatment with this medicine. Appropriate corrective measures, dose adjustments, or replacement with a suitable alternative may be necessary based on the clinical condition of the patient.

Depression

This medicine should be used with caution due to the increased risk of depressive symptoms, mood changes, changes in behavior, etc. Appropriate patient and caregiver counseling, dose adjustments, or replacement with a suitable alternative may be necessary based on the clinical condition of the patient.

Missed Dose

Take the missed dose as soon as you remember. If it is almost time for the next scheduled dose, then the missed dose can be skipped. Do not use extra medicine to make up for the missed dose.

Overdose

Seek emergency medical treatment or contact the doctor in case of an overdose.
All drugs interact differently for person to person. You should check all the possible interactions with your doctor before starting any medicine.
Interaction with Alcohol

Description

Interaction with alcohol is unknown. It is advisable to consult your doctor before consumption.

Instructions

Interaction with alcohol is unknown. It is advisable to consult your doctor before consumption.
Interaction with Medicine

Erythromycin

Ethinyl Estradiol

Ketoconazole

Rifampicin

Fluvoxamine

Disease interactions

Disease

Information not available.
Food interactions
Information not available.
Lab interactions
Information not available.
Take this medicine exactly as instructed by the doctor. Do not take larger amounts than prescribed. Seek emergency medical treatment in case of any severe side effects. Ensure that the course of treatment is completed. Do not stop the use of this medicine without consulting your doctor.
Miscelleneous

Can be taken with or without food, as advised by your doctor

To be taken as instructed by doctor

Does not cause sleepiness

How it works
This medicine inhibits the release of an isoenzyme that is responsible for swelling and inflammation of the lungs.
Legal Status

Approved

Approved

Unknown

Approved

Classification

Category

Selective phosphodiesterase-4 inhibitors

Schedule

Schedule H

[Internet]. Medicines.org.uk. 2018 [cited 12 September 2018]. Available from:

https://www.medicines.org.uk/emc/product/5650

[Internet]. Accessdata.fda.gov. 2018 [cited 12 September 2018]. Available from:

https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022522s003lbl.pdf

[Internet]. Drugbank.ca. 2018 [cited 12 September 2018]. Available from:

https://www.drugbank.ca/drugs/DB01656

[Internet]. Medlineplus.gov. 2018 [cited 12 September 2018]. Available from:

https://medlineplus.gov/druginfo/meds/a611034.html

Roflair Tablets [Internet]. CiplaMed. 2019 [cited 6 March 2019]. Available from:

https://ciplamed.com/content/roflair-tablets

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Information on this page was last updated on 6 Mar 2019

Disclaimer

We’ve made all possible efforts to ensure that the information provided here is accurate, up-to-date and complete, however, it should not be treated as a substitute for professional medical advice, diagnosis or treatment. Practo only provides reference source for common information on medicines and does not guarantee its accuracy or exhaustiveness. The absence of a warning for any drug or combination thereof, should not be assumed to indicate that the drug or combination is safe, effective, or appropriate for any given patient. Practo does not assume any responsibility for any aspect of healthcare administered with the aid of information provided above. If you have any doubts about your medication then we strongly recommend that you consult with your doctor, nurse or healthcare provider. See detailed T&C here.