Roflumilast: Difference between revisions

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{{DrugProjectFormSinglePage
{{DrugProjectFormSinglePage
|authorTag=<!--Overview-->
|authorTag={{KS}}
|genericName=roflumilast
|aOrAn=a
|aOrAn=a
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|indicationType=treatment
|adverseReactions=<!--Black Box Warning-->
|indication= COPD exacerbations
|adverseReactions=[[diarrhea]], weight decrease, [[nausea]], [[headache]], [[back pain]], [[influenza]], insomnia, [[dizziness]] and decreased appetite
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<!--FDA-Labeled Indications and Dosage (Adult)-->
<!--FDA-Labeled Indications and Dosage (Adult)-->
|fdaLIADAdult======Condition1=====
* Dosing Information
:* Dosage
=====Condition2=====
* Dosing Information
:* Dosage
=====Condition3=====
* Dosing Information
:* Dosage
=====Condition4=====
* Dosing Information
:* Dosage
<!--Off-Label Use and Dosage (Adult)-->
<!--Guideline-Supported Use (Adult)-->
|offLabelAdultGuideSupport======Condition1=====
|offLabelAdultGuideSupport======Condition1=====


Revision as of 15:50, 26 January 2015

Roflumilast
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

Disclaimer

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Overview

Roflumilast is a {{{drugClass}}} that is FDA approved for the treatment of COPD exacerbations. Common adverse reactions include diarrhea, weight decrease, nausea, headache, back pain, influenza, insomnia, dizziness and decreased appetite.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

There is limited information regarding Roflumilast FDA-Labeled Indications and Dosage (Adult) in the drug label.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Roflumilast in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Roflumilast in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding FDA-Labeled Use of Roflumilast in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Roflumilast in pediatric patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Roflumilast in pediatric patients.

Contraindications

  • Condition1

Warnings

  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Roflumilast in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Roflumilast in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Drug Interactions

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Roflumilast in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Roflumilast during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Roflumilast with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Roflumilast with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Roflumilast with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Roflumilast with respect to specific gender populations.

Race

There is no FDA guidance on the use of Roflumilast with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Roflumilast in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Roflumilast in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Roflumilast in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Roflumilast in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Roflumilast in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Roflumilast in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Roflumilast in the drug label.

Pharmacology

There is limited information regarding Roflumilast Pharmacology in the drug label.

Mechanism of Action

Structure

File:Roflumilast01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Roflumilast in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Roflumilast in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Roflumilast in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Roflumilast in the drug label.

How Supplied

Storage

There is limited information regarding Roflumilast Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Roflumilast |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Roflumilast |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Roflumilast in the drug label.

Precautions with Alcohol

  • Alcohol-Roflumilast interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ Empty citation (help)
  2. ↑ "http://www.ismp.org". External link in |title= (help)

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