Rosuvastatin: Difference between revisions

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__NOTOC__
{{DrugProjectFormSinglePage
{{Rosuvastatin}}
|genericName=generic name
{{CMG}}; {{AE}}
|aOrAn=a
|drugClass=Adrenergic receptor agonist
|indication=a list of indications, separated by commas.
|hasBlackBoxWarning=Yes
|adverseReactions=a list of adverse reactions, separated by commas.
|blackBoxWarningTitle=Warning Title
|blackBoxWarningBody=<i><span style="color:#FF0000;">Condition Name:</span></i> (Content)
|fdaLIADAdult======Condition 1=====


'''''For patient information about Rosuvastatin, click [[Rosuvastatin (patient information)|here]].'''''
* Dosing Information


{{SB}} CRESTOR<sup>®</sup>
:* (Dosage)


==Overview==
=====Condition 2=====


'''Rosuvastatin''' is a member of the [[medication|drug]] class of [[statin]]s, used to treat [[hypercholesterolemia]] and related conditions, and to prevent [[cardiovascular disease]]. It is currently being marketed by the [[pharmaceutical company]] [[AstraZeneca]] as '''Crestor'''.
* Dosing Information
==Category==


Statins,Diols,Carboxylic acids,Sulfonamides,Pyrimidines,Organofluorides,Cardiovasular drugs.
:* (Dosage)
|offLabelAdultGuideSupport======Condition 1=====


==FDA Package Insert==
* Developed by: (Organisation)
'''  [[Rosuvastatin indications and usage|Indications and Usage]]'''
'''| [[Rosuvastatin dosage and administration|Dosage and Administration]]'''
'''| [[Rosuvastatin dosage forms and strengths|Dosage Forms and Strengths]]'''
'''| [[Rosuvastatin contraindications|Contraindications]]'''
'''| [[Rosuvastatin warnings and precautions|Warnings and Precautions]]'''
'''| [[Rosuvastatin adverse reactions|Adverse Reactions]]'''
'''| [[Rosuvastatin drug interactions|Drug Interactions]]'''
'''| [[Rosuvastatin use in specific populations|Use in Specific Populations]]'''
'''| [[Rosuvastatin overdosage|Overdosage]]'''
'''| [[Rosuvastatin description|Description]]'''
'''| [[Rosuvastatin clinical pharmacology|Clinical Pharmacology]]'''
'''| [[Rosuvastatin nonclinical toxicology|Nonclinical Toxicology]]'''
'''| [[Rosuvastatin clinical studies|Clinical Studies]]'''
'''| [[Rosuvastatin how supplied storage and handling|How Supplied/Storage and Handling]]'''
'''| [[Rosuvastatin patient counseling information|Patient Counseling Information]]'''
'''| [[Rosuvastatin labels and packages|Labels and Packages]]'''


==Mechanism of Action==
* Class of Recommendation: (Class) (Link)


CRESTOR is a selective and competitive inhibitor of [[HMG-CoA]] reductase, the rate-limiting enzyme that converts 3‑hydroxy‑3‑methylglutaryl coenzyme A to mevalonate, a precursor of [[cholesterol]]. In vivo studies in animals, and in vitro studies in cultured animal and human cells have shown rosuvastatin to have a high uptake into, and selectivity for, action in the liver, the target organ for [[cholesterol]] lowering. In in vivo and in vitro studies, rosuvastatin produces its lipid-modifying effects in two ways. First, it increases the number of hepatic LDL receptors on the cell-surface to enhance uptake and catabolism of LDL. Second, rosuvastatin inhibits hepatic synthesis of VLDL, which reduces the total number of VLDL and LDL particles.
* Strength of Evidence: (Category A/B/C) (Link)
==Interaction with Alcohol==


CRESTOR should be used with caution in patients who consume substantial quantities of alcohol and/or have a history of chronic liver disease.Chronic alcohol liver disease is known to increase rosuvastatin exposure.
* Dosing Information/Recommendation
==References==
{{Reflist|2}}


{{Statins}}
:* (Dosage)


[[Category:Statins]]
=====Condition 2=====
[[Category:AstraZeneca]]
 
[[Category:Carboxylic acids]]
* Developed by: (Organisation)
[[Category:Sulfonamides]]
 
[[Category:Pyrimidines]]
* Class of Recommendation: (Class) (Link)
[[Category:Organofluorides]]
 
[[Category:Cardiovasular drugs]]
* Strength of Evidence: (Category A/B/C) (Link)
[[Category:Drugs]]
 
* 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====
 
(Description)
 
====Management====
 
(Description)
|drugBox={{Drugbox2
| verifiedrevid =
| IUPAC_name =
| image =
| drug_name =
 
<!--Clinical data-->
| tradename =
| MedlinePlus =
| licence_US =
| pregnancy_AU =
| pregnancy_US =
| legal_status =
| routes_of_administration =
 
<!--Pharmacokinetic data-->
| bioavailability =
| metabolism =
| elimination_half-life =
| excretion =
 
<!--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 =
 
<!--Chemical data-->
| C= | H= | N= | O=
| 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=====
 
(Description)
 
=====Condition 2=====
 
(Description)
 
=====Condition 3=====
 
(Description)
|howSupplied=(Description)
|fdaPatientInfo=(Patient Counseling Information)
|nlmPatientInfo=(Link to patient information page)
|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
}}

Revision as of 14:03, 30 June 2014

Rosuvastatin
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

Rosuvastatin 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

Chemical structure of Rosuvastatin
Rosuvastatin
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 Rosuvastatin Storage in the drug label.

Images

Drug Images

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

Patient Counseling Information

(Patient Counseling Information)

Precautions with Alcohol

Alcohol-Rosuvastatin 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 Rosuvastatin 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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