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{{Label template
{{Sandboxrx1}}
|drugClass=P2Y12 platelet inhibitor
<div style="width: 80%">
__NOTOC__
{{CMG}} {{AE}} {{JH}}
 
'''''For information about (Ticagrelor), click [[(Ticagrelor)|here]].'''''
 
==Disclaimer==
 
'''''WikiDoc Drug Project is a constellation of drug information for healthcare providers and patients vigorously vetted on the basis of FDA package insert, MedlinePlus, Practice Guidelines, Scientific Statements, and scholarly medical literature.  The information provided is not a medical advice or treatment.  WikiDoc does not promote any medication or off-label use of drugs. Please read our full disclaimer [[wikidoc:General_disclaimer|{{fontcolor|#FF0000|here}}]].'''''
==<span style="color:#FF0000; background:#000000;">Black Box Warning</span>==
 
{| style="border: 3px solid #696969;"
| style="background: #000000; border: 0px; padding: 20px 20px; width: 800px;" |
<center>
<font color="#F8F8FF" style="font-weight: bold;">WARNING: (A) BLEEDING RISK, and (B) ASPIRIN DOSE AND Brilinta EFFECTIVENESS</font>
</center>
 
<center>
<font color="#F8F8FF" size="1" style="font-style: italic;">See full prescribing information for complete boxed warning.</font>
</center>
 
<font color="#F8F8FF" style="font-weight: bold;">
''{{fontcolor|#FF0000|BLEEDING RISK:}}''
* Brilinta, like other antiplatelet agents, can cause significant, sometimes fatal bleeding.
* Do not use Brilinta in patients with active pathological bleeding or a history of intracranial hemorrhage.
* Do not start Brilinta in patients planned to undergo urgent coronary artery bypass graft surgery (CABG). When possible, discontinue Brilinta at least 5 days prior to any surgery.
* Suspect bleeding in any patient who is hypotensive and has recently undergone coronary angiography, percutaneous coronary intervention (PCI), CABG, or other surgery.
* If possible, manage bleeding without discontinuing Brilinta. Stopping Brilinta increases the risk of subsequent cardiovascular events.
''{{fontcolor|#FF0000|ASPIRIN DOSE AND Brilinta EFFECTIVENESS:}}''
* Maintenance doses of aspirin above 100 mg reduce the effectiveness of Brilinta and should be avoided.
</font>
|}
 
==Overview==
 
{{PAGENAME}} is a [[P2Y12]] [[platelet]] inhibitor and [[platelet aggregation]] inhibitor drug that is FDA approved for the treatment of [[acute coronary syndromes|acute coronary syndromes (ACS)]] ([[unstable angina]], [[NSTEMI|non-ST elevation myocardial infarction]], or [[STEMI|ST elevation myocardial infarction]]). There is a Black Box Warning for this drug as shown <span style="background:#000000; font-weight: bold;">[[{{PAGENAME}}#Black Box Warning|{{fontcolor|#FF0000|here}}]]</span>. Common adverse reactions include _______.
 
==Adult Indications and Dosage==
 
===FDA-Labeled Indications and Dosage (Adult)===
 
====Acute Coronary Syndromes====
 
* Dosing Information
 
:: [[Brilinta tablet]] 180 mg tablet PO (two 90 mg tablets) loading dose and then continue treatment with 90 mg twice daily.
:: After the initial loading dose of aspirin (usually 325 mg), use BRILINTA with a daily maintenance dose of aspirin of 75-100 mg.
:: ACS patients who have received a loading dose of clopidogrel may be started on BRILINTA.
:: BRILINTA can be administered with or without food.
:: A patient who misses a dose of BRILINTA should take one 90 mg tablet (their next dose) at its scheduled time.
 
 
===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
 
:: (Dosage)
 
=====Condition 2=====
 
* Developed by: (Organisation)
 
* Class of Recommendation: (Class) (Link)
 
* Strength of Evidence: (Category A/B/C) (Link)
 
* Dosing Information
 
:: (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
 
:: (Dosage)
 
=====Condition 2=====
 
* Developed by: (Organisation)
 
* Class of Recommendation: (Class) (Link)
 
* Strength of Evidence: (Category A/B/C) (Link)
 
* Dosing Information
 
:: (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==
 
=====Conidition 1=====
 
(Description)
 
=====Conidition 2=====
 
(Description)
 
=====Conidition 3=====
 
(Description)
 
==Adverse Reactions==
 
===Clinical Trials Experience===
 
=====Condition 1=====
 
======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 1=====
 
======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#United States|Pregnancy Category (FDA)]]: X'''
 
: '''[[Pregnancy category#Australia|Pregnancy Category (AUS)]]: X'''
 
(Description)
 
====Labor and Delivery====
 
(Description)
 
====Nursing Mothers====
 
(Description)
 
====Pediatric Use====
 
(Description)
 
====Geriatric Use====
 
(Description)
 
====Gender====
 
(Description)
 
====Race====
 
(Description)
 
====Renal Impairment====
 
(Description)
 
====Hepatic Impairment====
 
(Description)
 
====Females of Reproductive Potential and Males====
 
(Description)
 
====Immunocompromised Patients====
 
(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==
 
{{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 =
}}
}}
{{DrugProjectForm
|hasBlackBoxWarning=Yes
|blackBoxWarningTitle=WARNING: (A) BLEEDING RISK, (B) ASPIRIN DOSE AND BRILINTA EFFECTIVENESS
|blackBoxWarningBody= A. BLEEDING RISK


* BRILINTA, like other antiplatelet agents, can cause significant, sometimes fatal bleeding.
===Mechanism of Action===
* Do not use BRILINTA in patients with active pathological bleeding or a history of intracranial hemorrhage.
 
* Do not start BRILINTA in patients planned to undergo urgent coronary artery bypass graft surgery (CABG). When possible, discontinue BRILINTA at least 5 days prior to any surgery.
(Description)
* Suspect bleeding in any patient who is hypotensive and has recently undergone coronary angiography, percutaneous coronary intervention (PCI), CABG, or other surgical procedures in the setting of BRILINTA.
 
* If possible, manage bleeding without discontinuing BRILINTA. Stopping BRILINTA increases the risk of subsequent cardiovascular events.
===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)
 
* National Drug Code (NDC):
* Storage:
* Manufactured by: 
* Distributed by:
 
==Images==
 
===Drug Images===
 
(PillBox Images)
 
===Package and Label Display Panel===
 
(Package Images)
 
(Display Panel Images)
 
==Patient Information==
 
===Patient Information from FDA===
 
(Patient Counseling Information)
 
===Patient Information from NLM===
 
(Link to patient information page)
 
==Precautions with Alcohol==
 
Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
 
==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)
 
==[http://www.fda.gov/drugs/drugsafety/drugshortages/ucm050792.htm Drug Shortage Status]==
 
==[http://www.goodrx.com/{{urlencode:{{#if:{{{1|}}}|{{{1}}}|{{PAGENAME}}}}}}/price Price]==
 
==References==


B. ASPIRIN DOSE AND BRILINTA EFFECTIVENESS
{{reflist}}


Maintenance doses of aspirin above 100 mg reduce the effectiveness of BRILINTA and should be avoided. After any initial dose, use with aspirin 75-100 mg per day.
</div>
|hasUsageInfo=In Progress
}}

Latest revision as of 19:42, 28 March 2014

Brilinta tablet®
Black Box Warning
Adult Indications and Dosage
Pediatric Indications and Dosage
Contraindications
Warnings
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration and Monitoring
IV Compatibility
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient information
Precautions with Alcohol
Brand Names
Look-Alike Drug Names
Drug Shortage Status
Price

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1] Associate Editor(s)-in-Chief: Jesus Rosario Hernandez, M.D. [2]

For information about (Ticagrelor), click here.

Disclaimer

WikiDoc Drug Project is a constellation of drug information for healthcare providers and patients vigorously vetted on the basis of FDA package insert, MedlinePlus, Practice Guidelines, Scientific Statements, and scholarly medical literature. The information provided is not a medical advice or treatment. WikiDoc does not promote any medication or off-label use of drugs. Please read our full disclaimer here.

Black Box Warning

WARNING: (A) BLEEDING RISK, and (B) ASPIRIN DOSE AND Brilinta EFFECTIVENESS

See full prescribing information for complete boxed warning.

BLEEDING RISK:

  • Brilinta, like other antiplatelet agents, can cause significant, sometimes fatal bleeding.
  • Do not use Brilinta in patients with active pathological bleeding or a history of intracranial hemorrhage.
  • Do not start Brilinta in patients planned to undergo urgent coronary artery bypass graft surgery (CABG). When possible, discontinue Brilinta at least 5 days prior to any surgery.
  • Suspect bleeding in any patient who is hypotensive and has recently undergone coronary angiography, percutaneous coronary intervention (PCI), CABG, or other surgery.
  • If possible, manage bleeding without discontinuing Brilinta. Stopping Brilinta increases the risk of subsequent cardiovascular events.

ASPIRIN DOSE AND Brilinta EFFECTIVENESS:

  • Maintenance doses of aspirin above 100 mg reduce the effectiveness of Brilinta and should be avoided.

Overview

Brilinta tablet is a P2Y12 platelet inhibitor and platelet aggregation inhibitor drug that is FDA approved for the treatment of acute coronary syndromes (ACS) (unstable angina, non-ST elevation myocardial infarction, or ST elevation myocardial infarction). There is a Black Box Warning for this drug as shown here. Common adverse reactions include _______.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Acute Coronary Syndromes

  • Dosing Information
Brilinta tablet 180 mg tablet PO (two 90 mg tablets) loading dose and then continue treatment with 90 mg twice daily.
After the initial loading dose of aspirin (usually 325 mg), use BRILINTA with a daily maintenance dose of aspirin of 75-100 mg.
ACS patients who have received a loading dose of clopidogrel may be started on BRILINTA.
BRILINTA can be administered with or without food.
A patient who misses a dose of BRILINTA should take one 90 mg tablet (their next dose) at its scheduled time.


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

Conidition 1

(Description)

Conidition 2

(Description)

Conidition 3

(Description)

Adverse Reactions

Clinical Trials Experience

Condition 1
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 1
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): X
Pregnancy Category (AUS): X

(Description)

Labor and Delivery

(Description)

Nursing Mothers

(Description)

Pediatric Use

(Description)

Geriatric Use

(Description)

Gender

(Description)

Race

(Description)

Renal Impairment

(Description)

Hepatic Impairment

(Description)

Females of Reproductive Potential and Males

(Description)

Immunocompromised Patients

(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

Brilinta tablet
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)

  • National Drug Code (NDC):
  • Storage:
  • Manufactured by:
  • Distributed by:

Images

Drug Images

(PillBox Images)

Package and Label Display Panel

(Package Images)

(Display Panel Images)

Patient Information

Patient Information from FDA

(Patient Counseling Information)

Patient Information from NLM

(Link to patient information page)

Precautions with Alcohol

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

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

Price

References

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