Fluticasone/salmeterol: Difference between revisions

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__NOTOC__
{{DrugProjectFormSinglePage
{{Drugbox
|genericName=generic name
| type              = combo
|aOrAn=a
| image            = Fluticasone propionate.svg
|drugClass=Adrenergic receptor agonist
| image2            = Salmeterol.png
|indication=a list of indications, separated by commas.
| component1        = Fluticasone
|hasBlackBoxWarning=Yes
| class1            = [[Glucocorticoids|Glucocorticoid]]
|adverseReactions=a list of adverse reactions, separated by commas.
| component2        = Salmeterol
|blackBoxWarningTitle=Warning Title
| class2            = [[Beta2-adrenergic receptor agonist|Long-Acting Beta2 Agonist]]
|blackBoxWarningBody=<i><span style="color:#FF0000;">Condition Name:</span></i> (Content)
| CAS_number        =  
|fdaLIADAdult======Condition 1=====
| ATC_prefix        =  
 
| ATC_suffix        =  
* Dosing Information
| PubChem          =  
 
| DrugBank          =  
:* (Dosage)
| pregnancy_AU      = <!-- A / B1 / B2 / B3 / C / D / X -->
 
| pregnancy_US      = <!-- A / B           / C / D / X -->
=====Condition 2=====
| pregnancy_category=
 
| legal_AU          = <!-- Unscheduled / S2 / S3 / S4 / S5 / S6 / S7 / S8 / S9 -->
* Dosing Information
| legal_CA          = <!--            / Schedule I, II, III, IV, V, VI, VII, VIII -->
 
| legal_UK          = P
:* (Dosage)
| legal_US          = <!-- OTC                  / Rx-only  / Schedule I, II, III, IV, V -->
|offLabelAdultGuideSupport======Condition 1=====
| legal_status      =  
 
| routes_of_administration = Inhaled
* Developed by: (Organisation)
}}
 
{{CMG}}
* Class of Recommendation: (Class) (Link)
 
* Strength of Evidence: (Category A/B/C) (Link)
 
* Dosing Information/Recommendation
 
:* (Dosage)
 
=====Condition 2=====
 
* Developed by: (Organisation)
 
* Class of Recommendation: (Class) (Link)
 
* Strength of Evidence: (Category A/B/C) (Link)
 
* Dosing Information/Recommendation
 
:* (Dosage)
|offLabelAdultNoGuideSupport======Condition 1=====
 
* Dosing Information
 
:* (Dosage)
 
=====Condition 2=====
 
* Dosing Information
 
:* (Dosage)
 
=====Condition 3=====
 
* Dosing Information
 
:* (Dosage)
|fdaLIADPed======Condition 1=====
 
* Dosing Information
 
:* (Dosage)
 
=====Condition 2=====
 
* Dosing Information
 
:* (Dosage)
|offLabelPedGuideSupport======Condition 1=====
 
* Developed by: (Organisation)
 
* Class of Recommendation: (Class) (Link)
 
* Strength of Evidence: (Category A/B/C) (Link)
 
* Dosing Information/Recommendation
 
:* (Dosage)
 
=====Condition 2=====
 
* Developed by: (Organisation)
 
* Class of Recommendation: (Class) (Link)
 
* Strength of Evidence: (Category A/B/C) (Link)
 
* Dosing Information/Recommendation
 
:* (Dosage)
|offLabelPedNoGuideSupport======Condition 1=====
 
* Dosing Information
 
:* (Dosage)
 
=====Condition 2=====
 
* Dosing Information
 
:* (Dosage)
 
=====Condition 3=====
 
* Dosing Information
 
:* (Dosage)
|contraindications=* Condition 1
* Condition 2
* Condition 3
* Condition 4
* Condition 5
|warnings======Conidition 1=====
 
(Description)
 
|clinicalTrials=======Central Nervous System======
 
: (list/description of adverse reactions)
 
======Cardiovascular======
 
: (list/description of adverse reactions)
 
======Respiratory======
 
: (list/description of adverse reactions)
 
======Gastrointestinal======
 
: (list/description of adverse reactions)
 
======Hypersensitive Reactions======
 
: (list/description of adverse reactions)
 
======Miscellaneous======
 
: (list/description of adverse reactions)
 
=====Condition 2=====
 
======Central Nervous System======
 
: (list/description of adverse reactions)
 
======Cardiovascular======
 
: (list/description of adverse reactions)
 
======Respiratory======
 
: (list/description of adverse reactions)
 
======Gastrointestinal======
 
: (list/description of adverse reactions)
 
======Hypersensitive Reactions======
 
: (list/description of adverse reactions)
 
======Miscellaneous======
 
: (list/description of adverse reactions)
|postmarketing=(Description)
|drugInteractions=* Drug 1
* Drug 2
* Drug 3
* Drug 4
* Drug 5
 
=====Drug 1=====
 
(Description)
 
=====Drug 2=====
 
(Description)
 
=====Drug 3=====
 
(Description)
 
=====Drug 4=====
 
(Description)
 
=====Drug 5=====
 
(Description)
|useInPregnancyFDA=(Description)
|useInPregnancyAUS=(Description)
|useInLaborDelivery=(Description)
|useInNursing=(Description)
|useInPed=(Description)
|useInGeri=(Description)
|useInGender=(Description)
|useInRace=(Description)
|useInRenalImpair=(Description)
|useInHepaticImpair=(Description)
|useInReproPotential=(Description)
|useInImmunocomp=(Description)
|othersTitle=Others
|useInOthers=(Description)
 
|administration=(Oral/Intravenous/etc)
|monitoring======Condition 1=====
 
(Description regarding monitoring, from ''Warnings'' section)
 
=====Condition 2=====
 
(Description regarding monitoring, from ''Warnings'' section)
 
=====Condition 3=====
 
(Description regarding monitoring, from ''Warnings'' section)
|IVCompat====Solution===
 
====Compatible====
 
* Solution 1
* Solution 2
* Solution 3
 
====Not Tested====
 
* Solution 1
* Solution 2
* Solution 3
 
====Variable====
 
* Solution 1
* Solution 2
* Solution 3
 
====Incompatible====
 
* Solution 1
* Solution 2
* Solution 3
 
===Y-Site===
 
====Compatible====
 
* Solution 1
* Solution 2
* Solution 3
 
====Not Tested====
 
* Solution 1
* Solution 2
* Solution 3
 
====Variable====
 
* Solution 1
* Solution 2
* Solution 3
 
====Incompatible====
 
* Solution 1
* Solution 2
* Solution 3
 
===Admixture===
 
====Compatible====
 
* Solution 1
* Solution 2
* Solution 3
 
====Not Tested====
 
* Solution 1
* Solution 2
* Solution 3
 
====Variable====
 
* Solution 1
* Solution 2
* Solution 3
 
====Incompatible====
 
* Solution 1
* Solution 2
* Solution 3
 
===Syringe===
 
====Compatible====
 
* Solution 1
* Solution 2
* Solution 3
 
====Not Tested====
 
* Solution 1
* Solution 2
* Solution 3
 
====Variable====
 
* Solution 1
* Solution 2
* Solution 3
 
====Incompatible====
 
* Solution 1
* Solution 2
* Solution 3
 
===TPN/TNA===
 
====Compatible====
 
* Solution 1
* Solution 2
* Solution 3
 
====Not Tested====
 
* Solution 1
* Solution 2
* Solution 3
 
====Variable====
 
* Solution 1
* Solution 2
* Solution 3
 
====Incompatible====
 
* Solution 1
* Solution 2
* Solution 3
|overdose====Acute Overdose===
 
====Signs and Symptoms====
 
(Description)
 
====Management====


(Description)


===Chronic Overdose===


====Signs and Symptoms====


The combination preparation '''fluticasone/salmeterol''' is a formulation containing [[fluticasone|fluticasone propionate]] and [[salmeterol|salmeterol xinafoate]] used in the management of [[asthma]] and [[chronic obstructive pulmonary disease]] (COPD). It is marketed by [[GlaxoSmithKline]] under various trade names including '''Advair'''(USA), '''Seretide'''(EU), '''Viani'''(Germany), '''Adoair'''(Japan), and '''ForAir'''(India).
(Description)


Fluticasone, a corticosteroid, is the anti-inflammatory component of the combination, while salmeterol treats constriction of the airways. Together, they relieve the symptoms of coughing, wheezing and shortness of breath better than either fluticasone or salmeterol taken on its own.
====Management====


==Formulations==
(Description)
[[Image:Seretide250.jpg|left|thumb|The Diskus device]]
|drugBox={{Drugbox2
[[Image:Disassembled-Diskus.jpg|right|thumb|Inner Workings of Diskus]]
| verifiedrevid =  
Advair is available in 3 or 4 dosage strengths, depending on the patient's country, as a '''DPI''' ([[dry powder inhaler]]). The smallest dosage is 100mcg/50mcg, the intermediate dosage is 250mcg/50mcg and the highest dosage is 500/50.  (mcg refers to micrograms)
| IUPAC_name =  
| image =
| drug_name =


Advair HFA inhalation aerosol as a '''MDI''' ([[metered dose inhaler]]) is now available in the US and Canada as Advair HFA 45mcg/21mcg, Advair HFA 115mcg/21mcg, and Advair HFA 230mcg/21mcg. These contain 120 inhalations and are generally prescribed as a 30 day supply. (2 inhalations twice a day)
<!--Clinical data-->
| tradename =
| MedlinePlus =
| licence_US =
| pregnancy_AU =
| pregnancy_US =
| legal_status =
| routes_of_administration =


Internationally the fluticasone/salmeterol combination is delivered by a number of devices, including standard aerosol metered dose inhalers (brand name "Evohaler" in the UK) or dry-powder devices termed "Accuhaler" in the UK and Australia, and "Diskus" in the U.S.  These purple disk-shaped containers are about 3.5&nbsp;inches (8.9&nbsp;cm) across and about 1&nbsp;inch thick (2.5&nbsp;cm). The cleverly designed discus container utilizes a machined 2 piece long foil ribbon with each unit dose held in a small caplet shaped depressions along the entire dose-count-length. Once the lever is actuated the dose is advanced by pealing away the flat outer most layer exposing the medication that is ready to be breathed in.
<!--Pharmacokinetic data-->
| bioavailability =
| metabolism =
| elimination_half-life =
| excretion =


On August 8, 2007 the FDA issued a "not approved" letter to GlaxoSmithKline (GSK) on the 500/50 strength for the treatment of patients with chronic obstructive pulmonary disease ([[COPD]]). [http://us.gsk.com/ControllerServlet?appId=4&pageId=402&newsid=1133 The GSK internal notice]
<!--Identifiers-->
| CAS_number_Ref =  
| CAS_number =  
| ATC_prefix =
| ATC_suffix =
| PubChem =
| IUPHAR_ligand =
| DrugBank_Ref =
| DrugBank =
| ChemSpiderID_Ref =
| ChemSpiderID =
| UNII_Ref =
| UNII =
| KEGG_Ref =
| KEGG =
| ChEBI_Ref =
| ChEBI =
| ChEMBL_Ref =
| ChEMBL =  


==Side effects==
<!--Chemical data-->
{{main|Salmeterol}}
| C= | H= | N= | O=  
The common and minor side effects of this combination are those of its individual drugs. For instance, the use of inhaled corticosteroids is associated with oral [[candidiasis]].
| molecular_weight =
| smiles =
| InChI =
| InChIKey =
| StdInChI_Ref =
| StdInChI =
| StdInChIKey_Ref =
| StdInChIKey =  
| melting_point =
}}
|mechAction=(Description)
|structure=(Description with picture)
|PD=(Description)
|PK=(Description)
|nonClinToxic=(Description)
|clinicalStudies======Condition 1=====


Whilst the use of inhaled steroids and [[long acting beta-adrenoceptor agonist]] (LABA) are recommended in asthma guidelines for the resulting improved symptom control,<!--
(Description)
  --><ref name=SIGN>British Thoracic Society & Scottish Intercollegiate Guidelines Network (SIGN). ''British Guideline on the Management of Asthma''. Guideline No. 63. Edinburgh:SIGN; 2004. ([http://www.sign.ac.uk/guidelines/fulltext/63/index.html HTML], [http://www.sign.ac.uk/pdf/sign63.pdf Full PDF], [http://www.sign.ac.uk/pdf/qrg63.pdf Summary PDF])</ref>
concerns have been raised that salmeterol may increase the small risks of asthma deaths and this additional risk is not reduced with the additional use of inhaled steroids.<!--
  --><ref>{{cite journal | author = Salpeter S, Buckley N, Ormiston T, Salpeter E | title = Meta-analysis: effect of long-acting beta-agonists on severe asthma exacerbations and asthma-related deaths. | journal = Ann Intern Med | volume = 144 | issue = 12 | pages = 904-12 | year = 2006 | id = PMID 16754916}}</ref>
This seems to occur because although LABAs relieve asthma symptoms, they also promote bronchial inflammation and sensitivity without warning.<!--
  --><ref>{{cite news | author=Krishna Ramanujan | title=Common asthma inhalers cause up to 80 percent of asthma-related deaths, Cornell and Stanford researchers assert | month=June 9 | year=2006 | publisher=ChronicalOnline - Cornell University}}</ref>


In a clinical trial, thirteen people died out of a group of 13,176 people taking salmeterol.
=====Condition 2=====


Other side effects include increased blood pressure, increase of aggression, change in heart rate, or an irregular heartbeat.
(Description)


==Footnotes==
=====Condition 3=====
{{reflist|2}}


==External links==
(Description)
*[http://www.advair.com/ Advair.com]
|howSupplied=(Description)
*[https://online.epocrates.com/u/10a2444?src=PK/ Advair on Epocrates Drug Lookup]
|fdaPatientInfo=(Patient Counseling Information)
*[http://www.docguide.com/news/content.nsf/news/852571020057CCF6852571880049276F meta-analysis article]
|nlmPatientInfo=(Link to patient information page)
*[http://www.medicalnewstoday.com/youropinions.php?opinionid=10361 Leora A. Traynor, M.D. op-ed]
|lookAlike=* (Paired Confused Name 1a) — (Paired Confused Name 1b)
* (Paired Confused Name 2a) — (Paired Confused Name 2b)
* (Paired Confused Name 3a) — (Paired Confused Name 3b)
|drugShortage=Drug Shortage
}}


{{Asthma_and_copd_rx}}
{{Asthma_and_copd_rx}}

Revision as of 13:29, 4 August 2014

Fluticasone/salmeterol
Black Box Warning
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];

Disclaimer

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Black Box Warning

Warning Title
See full prescribing information for complete Boxed Warning.
Condition Name: (Content)

Overview

Fluticasone/salmeterol is a Adrenergic receptor agonist that is FDA approved for the {{{indicationType}}} of a list of indications, separated by commas.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include a list of adverse reactions, separated by commas..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Condition 1
  • Dosing Information
  • (Dosage)
Condition 2
  • Dosing Information
  • (Dosage)

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition 1
  • Developed by: (Organisation)
  • Class of Recommendation: (Class) (Link)
  • Strength of Evidence: (Category A/B/C) (Link)
  • Dosing Information/Recommendation
  • (Dosage)
Condition 2
  • Developed by: (Organisation)
  • Class of Recommendation: (Class) (Link)
  • Strength of Evidence: (Category A/B/C) (Link)
  • Dosing Information/Recommendation
  • (Dosage)

Non–Guideline-Supported Use

Condition 1
  • Dosing Information
  • (Dosage)
Condition 2
  • Dosing Information
  • (Dosage)
Condition 3
  • Dosing Information
  • (Dosage)

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition 1
  • Dosing Information
  • (Dosage)
Condition 2
  • Dosing Information
  • (Dosage)

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition 1
  • Developed by: (Organisation)
  • Class of Recommendation: (Class) (Link)
  • Strength of Evidence: (Category A/B/C) (Link)
  • Dosing Information/Recommendation
  • (Dosage)
Condition 2
  • Developed by: (Organisation)
  • Class of Recommendation: (Class) (Link)
  • Strength of Evidence: (Category A/B/C) (Link)
  • Dosing Information/Recommendation
  • (Dosage)

Non–Guideline-Supported Use

Condition 1
  • Dosing Information
  • (Dosage)
Condition 2
  • Dosing Information
  • (Dosage)
Condition 3
  • Dosing Information
  • (Dosage)

Contraindications

  • Condition 1
  • Condition 2
  • Condition 3
  • Condition 4
  • Condition 5

Warnings

Warning Title
See full prescribing information for complete Boxed Warning.
Condition Name: (Content)
Conidition 1

(Description)

Adverse Reactions

Clinical Trials Experience

Central Nervous System
(list/description of adverse reactions)
Cardiovascular
(list/description of adverse reactions)
Respiratory
(list/description of adverse reactions)
Gastrointestinal
(list/description of adverse reactions)
Hypersensitive Reactions
(list/description of adverse reactions)
Miscellaneous
(list/description of adverse reactions)
Condition 2
Central Nervous System
(list/description of adverse reactions)
Cardiovascular
(list/description of adverse reactions)
Respiratory
(list/description of adverse reactions)
Gastrointestinal
(list/description of adverse reactions)
Hypersensitive Reactions
(list/description of adverse reactions)
Miscellaneous
(list/description of adverse reactions)

Postmarketing Experience

(Description)

Drug Interactions

  • Drug 1
  • Drug 2
  • Drug 3
  • Drug 4
  • Drug 5
Drug 1

(Description)

Drug 2

(Description)

Drug 3

(Description)

Drug 4

(Description)

Drug 5

(Description)

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): (Description)
Pregnancy Category (AUS): (Description)

Labor and Delivery

(Description)

Nursing Mothers

(Description)

Pediatric Use

(Description)

Geriatic Use

(Description)

Gender

(Description)

Race

(Description)

Renal Impairment

(Description)

Hepatic Impairment

(Description)

Females of Reproductive Potential and Males

(Description)

Immunocompromised Patients

(Description)

Others

(Description)

Administration and Monitoring

Administration

(Oral/Intravenous/etc)

Monitoring

Condition 1

(Description regarding monitoring, from Warnings section)

Condition 2

(Description regarding monitoring, from Warnings section)

Condition 3

(Description regarding monitoring, from Warnings section)

IV Compatibility

Solution

Compatible

  • Solution 1
  • Solution 2
  • Solution 3

Not Tested

  • Solution 1
  • Solution 2
  • Solution 3

Variable

  • Solution 1
  • Solution 2
  • Solution 3

Incompatible

  • Solution 1
  • Solution 2
  • Solution 3

Y-Site

Compatible

  • Solution 1
  • Solution 2
  • Solution 3

Not Tested

  • Solution 1
  • Solution 2
  • Solution 3

Variable

  • Solution 1
  • Solution 2
  • Solution 3

Incompatible

  • Solution 1
  • Solution 2
  • Solution 3

Admixture

Compatible

  • Solution 1
  • Solution 2
  • Solution 3

Not Tested

  • Solution 1
  • Solution 2
  • Solution 3

Variable

  • Solution 1
  • Solution 2
  • Solution 3

Incompatible

  • Solution 1
  • Solution 2
  • Solution 3

Syringe

Compatible

  • Solution 1
  • Solution 2
  • Solution 3

Not Tested

  • Solution 1
  • Solution 2
  • Solution 3

Variable

  • Solution 1
  • Solution 2
  • Solution 3

Incompatible

  • Solution 1
  • Solution 2
  • Solution 3

TPN/TNA

Compatible

  • Solution 1
  • Solution 2
  • Solution 3

Not Tested

  • Solution 1
  • Solution 2
  • Solution 3

Variable

  • Solution 1
  • Solution 2
  • Solution 3

Incompatible

  • Solution 1
  • Solution 2
  • Solution 3

Overdosage

Acute Overdose

Signs and Symptoms

(Description)

Management

(Description)

Chronic Overdose

Signs and Symptoms

(Description)

Management

(Description)

Pharmacology

Fluticasone/salmeterol
Systematic (IUPAC) name
?
Identifiers
CAS number ?
ATC code ?
PubChem ?
Chemical data
Formula ?
Mol. mass ?
Pharmacokinetic data
Bioavailability ?
Metabolism ?
Half life ?
Excretion ?
Therapeutic considerations
Pregnancy cat.

?

Legal status
Routes ?

Mechanism of Action

(Description)

Structure

(Description with picture)

Pharmacodynamics

(Description)

Pharmacokinetics

(Description)

Nonclinical Toxicology

(Description)

Clinical Studies

Condition 1

(Description)

Condition 2

(Description)

Condition 3

(Description)

How Supplied

(Description)

Storage

There is limited information regarding Fluticasone/salmeterol Storage in the drug label.

Images

Drug Images

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

Patient Counseling Information

(Patient Counseling Information)

Precautions with Alcohol

Alcohol-Fluticasone/salmeterol interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Fluticasone/salmeterol Brand Names in the drug label.

Look-Alike Drug Names

  • (Paired Confused Name 1a) — (Paired Confused Name 1b)
  • (Paired Confused Name 2a) — (Paired Confused Name 2b)
  • (Paired Confused Name 3a) — (Paired Confused Name 3b)

Drug Shortage Status

Drug Shortage

Price

References

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


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