Quetiapine: Difference between revisions

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{{Drugbox|
{{DrugProjectFormSinglePage
| IUPAC_name = 2-(2-(4-dibenzo[''b,f''][1,4]thiazepine- 11-yl-1-piperazinyl)ethoxy)ethanol
|genericName=generic name
| width = 199
|aOrAn=a
| CAS_number = 111974-69-7
|drugClass=Adrenergic receptor agonist
| ATC_prefix = N05
|indication=a list of indications, separated by commas.
| ATC_suffix = AH04
|hasBlackBoxWarning=Yes
| PubChem = 5002
|adverseReactions=a list of adverse reactions, separated by commas.
| DrugBank = APRD00675
|blackBoxWarningTitle=Warning Title
| C=21|H=25|N=3|O=2|S=1
|blackBoxWarningBody=<i><span style="color:#FF0000;">Condition Name:</span></i> (Content)
| molecular_weight = 383.5099 g/mol
|fdaLIADAdult======Condition 1=====
| bioavailability = 9%
 
| metabolism = [[Liver|Hepatic]]
* Dosing Information
| elimination_half-life = 6 hours
 
| excretion = [[Kidney|Renal]]
:* (Dosage)
| pregnancy_US = C
 
| legal_US = Rx-only
=====Condition 2=====
| routes_of_administration = Oral
 
}}
* Dosing Information
 
:* (Dosage)
|offLabelAdultGuideSupport======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)
|offLabelAdultNoGuideSupport======Condition 1=====
 
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* Developed by: (Organisation)
 
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* 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)
 
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* Dosing Information
 
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* 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
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* Drug 5
 
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|othersTitle=Others
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|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===
 
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{{SI}}
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{{CMG}}
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==Overview==
====Variable====
'''Quetiapine''' ({{IPA2|kwəˈtɑɪəˌpiːn}}, kwe-TYE-a-peen), marketed by [[AstraZeneca]] with the brand name '''Seroquel''', belongs to a series of [[neuroleptic]]s known as [[atypical antipsychotic|"atypical antipsychotics"]], which have, over the last two decades, become increasingly popular alternatives to [[typical antipsychotic|"typical antipsychotics"]], such as [[haloperidol]].


== Uses ==
* Solution 1
Seroquel is indicated for the treatment of schizophrenia as well as for the treatment of acute manic episodes associated with bipolar I disorder, as either monotherapy or adjunct therapy to [[lithium]] or divalproex. Seroquel received its initial indication from the FDA for treatment of schizophrenia in 1997.  In 2004, it received its second indication for the treatment of mania-associated bipolar disorder.<ref>[http://www.seroquel.com/prof_asp/faq/ FAQ About Seroquel]</ref>  Seroquel is controversially marketed to parents of moody and irritable teenagers in magazines such as ''Parade'' and ''TV Guide''.<ref>http://www.nytimes.com/2007/02/15/us/15bipolar.html "Debate Over Children and Psychiatric Drugs", ''New York Times'', February 15, 2007.</ref><ref>[http://www.dailykos.com/story/2007/7/9/95332/43540 Seroquel is an Antipsychotic.]</ref> It is sometimes used [[off-label]], often as an augmentation agent, to treat such conditions as [[obsessive-compulsive disorder]], [[post-traumatic stress disorder]], [[restless legs syndrome]], [[autism]], [[alcoholism]], [[Tourette syndrome]],<ref>[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=14642017 Quetiapine treatment of children and adolescents with Tourette's disorder].  Fall 2003etrieved January 27, 2007.</ref> and has been used by physicians as a [[sedative]] for those with [[sleep disorder]]s or [[anxiety disorder]]s.
* Solution 2
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In 2005, Seroquel and other "atypical antipsychotics" were shown by the ''[[New England Journal of Medicine]]'' to be no more effective than [[perphenazine]] (Trilifon®), a [[typical antipsychotic]], for the treatment of schizophrenia. However, the subsequent CATIE trial, funded by AstraZeneca and other major pharmaceutical manufacturers,<ref>[http://www.ahrp.org/cms/content/view/400/94/ New Schizophrenia Drugs No Better Than Cheaper Generics]</ref> contradicted the 2005 study in certain instances.
====Incompatible====


A 2005 [[British Medical Journal]] report showed that Seroquel was ineffective in reducing agitation among Alzheimer’s patients, whose consumption of the drug then constituted 29% of sales; in fact, Seroquel was found to make cognitive functioning worse in elderly patients with dementia.<ref>[http://zmagsite.zmag.org/Nov2006/rosenberg1106.html Misogyny marketing.]</ref>
* Solution 1
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The [[National Institutes of Health]] recommends against the use of Seroquel and almost all other psychotropic medications (including all atypicals, most anti-depressants, and all benzodiazepines) by children or those under 18,<ref>[http://www.seroquel.com/cons_bip/seroquel/understand_seroquel/stories.asp Seroquel stories: understanding Seroquel, important safety information]</ref> observing that teenagers taking Seroquel "may be more likely to think about harming or killing themselves or to plan or try to do so."<ref>[http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a698019.html National Institutes of Health, Medline guidelines for Quetiapine]</ref>
===TPN/TNA===


AstraZeneca's patent for Seroquel expires September 2011, which will allow other companies to manufacture Seroquel as its generic equivalent quetiapine.
====Compatible====


== Pharmacology ==
* Solution 1
<!-- Deleted image removed: [[Image:Seroquel logo.png|left|frame|Seroquel logo]] -->
* Solution 2
The antipsychotic effect of quetiapine is thought by some to be mediated through [[Receptor antagonist|antagonist]] activity at [[dopamine]] and [[serotonin]] receptors. Specifically the D<sub>1</sub> and D<sub>2</sub> dopamine, the alpha 1 adrenoreceptor and alpha 2 adrenoreceptor, and 5-HT<sub>1A</sub> and 5-HT<sub>2</sub> serotonin receptor subtypes are antagonized. Serial PET scans evaluating the D<sub>2</sub> receptor occupancy of quetiapine have demonstrated that quetiapine very rapidly disassociates from the D<sub>2</sub> receptor.  Theoretically, this allows for normal physiological surges of dopamine to elicit their normal effects in areas such as the nigrostriatal and tuberoinfundibular pathways, thus minimizing the risk of side effects such as pseudo-parkinsonism as well as elevations in [[prolactin]].   
* Solution 3


Quetiapine also has an antagonistic effect on the histamine H<sub>1</sub> receptor.  This is thought to be responsible for the sedative effect of the drug.<ref>{{cite web| title =Schizophrenia: From Circuits to Symptoms | publisher =Medscape Today | url =http://www.medscape.com/viewarticle/484929_8| accessdate =June 5, 2007}}</ref>
====Not Tested====


== Forms ==
* Solution 1
Quetiapine is available under the brand name Seroquel.  It was originally available in 25 mg, 100 mg, 200 mg, and 300 mg tablets.  Since then, 50 mg and 400 mg tablets were added to increase dosing flexibility.
* Solution 2
* Solution 3


=== Quetiapine Sustained Release (SEROQUEL XR) ===
====Variable====
AstraZeneca has submitted a [[New Drug Application]] for a sustained release version of quetiapine in the United States, Canada, and the European Union in the second half of 2006 for treatment of schizophrenia.<ref>http://www.astrazeneca.com/pressrelease/5256.aspx AstraZeneca Submits an NDA For Sustained Release Formulation SEROQUEL SR™. For the treatment of [[schizophrenia]]. July 18, 2006, retrieved January 1, 2007</ref><ref>[http://www.astrazeneca.com/pressrelease/5275.aspx AstraZeneca Submits EU and Canadian Regulatory Filings for Sustained Release Formulation SEROQUEL XR™ for the Treatment of Schizophrenia].  October 19, 2006, retrieved January 1, 2007</ref>  AstraZeneca will retain the exclusive right to market sustained release quetiapine until year 2017.


On May 18, 2007, AstraZeneca announced that U.S. [[Food and Drug Administration]] has approved SEROQUEL XR for treatment of schizophrenia.<ref>[http://www.astrazeneca.com/pressrelease/5330.aspx FDA Approves AstraZeneca’s Once-Daily SEROQUEL XR™ Extended-Release Tablets For The Treatment Of Schizophrenia]. May 18, 2007, retrieved August 2, 2007</ref> During its 2007 Q2 earnings conference, AstraZeneca announced that it plans to launch SEROQUEL XR in the U.S. during August 2007.<ref>[http://www.astrazeneca.com/pressrelease/5341.aspx Second Quarter and Half Year Results 2007]. July 26, 2007, retrieved August 2, 2007</ref> However, SEROQUEL XR is not yet available for purchase in pharmacies across the U.S., nor has AstraZeneca begun advertising for the drug as of October, 2007. The company has not provided a reason for the delay of SEROQUEL XR's launch.
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[[Clinical trial|Phase III]] trials are being conducted to prove quetiapine's efficacy in treating [[generalized anxiety disorder]] and [[major depressive disorder]] as of January 2007.  The company expects to file New Drug Application for treating generalized anxiety disorder in the second half of 2007 and for major depressive disorder in 2008.<ref>[http://www.astrazeneca.com/article/511390.aspx AstraZeneca&mdash;Pipeline Summary&mdash;New chemical entities and line extensions]. Retrieved January 5, 2007</ref>
====Incompatible====


==Side effects==
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|overdose====Acute Overdose===


Seroquel has many side effects, some of them common, a few of them serious and life-threatening.
====Signs and Symptoms====


The most common [[side effect]] of Seroquel is [[sedation]]. It is prescribed specifically (off-label) for this effect in patients with sleep disorders. Beginning users may feel extremely tired and 'out of it' for the first few days, sometimes longer. Seroquel's newest indication, for bipolar depression, usually specifically calls for the entire dose to be taken before bedtime due to its sedative effects. Although quetiapine is approved by the FDA for the treatment of [[schizophrenia]] and bipolar disorder, it is frequently prescribed for off-label purposes, including insomnia and the treatment of anxiety disorders.
(Description)


Common side effects include: [[constipation]], [[headache]], mild weight gain (or loss).  Less common side effects (less than 1% of patients) include: abnormal [[liver]] tests, [[dizziness]], upset [[stomach]], substantial [[weight gain]] or [[weight loss]], a stuffy nose, and increased paranoia.
====Management====


There is a risk of development of [[tardive dyskinesia]], an incurable [[neurological disorder]], with any prolonged use of quetiapine and some other neuroleptic drugs. However, quetiapine is believed to cause tardive dyskinesia somewhat less often than [[typical antipsychotic|typical]] [[antipsychotic]]s based on the data sources which point to placebo-level incidence of extrapyramidal side effects.<ref>{{cite web| url=http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11579018&dopt=Abstract |title=Quetiapine-related tardive dyskinesia.}}</ref><ref>{{cite web| url=http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10327920&dopt=Abstract |title=
(Description)
Tardive dyskinesia with quetiapine.}}</ref>


The rare, but life-threatening [[neuroleptic malignant syndrome]] may also result from quetiapine use.
===Chronic Overdose===


Weight gain can be a problem for some patients using quetiapine, by causing the patient's appetite to persist even after meals. However, this effect may occur to a lesser degree compared to some other atypical antipsychotics such as olanzapine or clozapine. As with other atypical antipsychotics, there is evidence suggesting a link to the development of [[diabetes]] and [[blood sugar]] disorders, however this remains controversial due to disparities between the results of studies.
====Signs and Symptoms====


In the United States, two separate lawsuits over claims that Seroquel use has led to diabetes have been filed in federal court.<ref>{{Cite web | url=http://www.madisonrecord.com/news/198781-seroquel-suit-claims-so-much-is-poured-into-marketing-and-away-from-research%3C/ref | title=Seroquel suit claims 'so much' is poured into marketing and away from research| work = The Madison St. Clair Record}}</ref>
(Description)


Studies conducted on beagles have resulted in the formation of [[cataract]]s&mdash;while there are reports of cataracts occurring in humans, controlled studies including thousands of patients have not demonstrated a clear causal association between quetiapine therapy and this side effect.  (Reference needed to April 2006 results of CATIE study.) However, the Seroquel® website<ref>http://www.seroquel.com/</ref> still recommends users have eye examinations every six months.
====Management====


As with some other antipsychotics, quetiapine may lower the seizure threshold, and should be taken with care in combination with drugs such as [[bupropion]] and the benzodiazepines (e.g., [[lorazepam]]), as they also lower the seizure threshold.
(Description)
|drugBox={{Drugbox2
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==Addiction and abuse==
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Seroquel is not currently classified as a controlled substance. Reports of quetiapine abuse have emerged in the medical literature, however, and while the drug is usually abused through the crushing and snorting of tablets ([[insufflation]]), there have also been reports of intravenous abuse and intravenous co-administration with cocaine.<ref>[http://ajp.psychiatryonline.org/cgi/content/full/164/1/173-a Intravenous Quetiapine-Cocaine Use ("Q-Ball")]</ref> A 2004 report recorded a 30% rate of inmate use in the Los Angeles County Jail, where the drug was obtained by inmates faking schizophrenic symptoms and resold under the street name "quell."<ref>[http://ajp.psychiatryonline.org/cgi/content/full/161/9/1718 Intranasal Quetiapine Abuse]</ref> Also known as "Susie-Q," the drug may be more commonly abused in prisons due to its capacity to be regularly prescribed as a sedative and the unavailability in prison of more commonly-abused substances. It is unique among common "atypical antipsychotics"{{fact|date=August 2007}} in showing a capacity for dependence, with inmates threatening legal action and suicide if not given prescriptions.<ref>[http://ajp.psychiatryonline.org/cgi/content/full/164/1/174 Quetiapine addiction?]</ref>
<!--Pharmacokinetic data-->
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Seroquel abuse was mentioned in the 2003 rap song "Oxy Cotton" by Lil Wyte:<ref>[http://www.seeklyrics.com/lyrics/Lil-Wyte/Oxy-Cotton.html "Oxy Cotton" lyrics &mdash; Lil' Wyte, 2003]</ref>
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:Take a chill pill to slow me down and git back in this game
<!--Chemical data-->
:Gatta be up on ya P's and Q's to even feel it main...
| C= | H= | N= | O=
:Some people melt 'em down in a needle and shoot 'em up
| molecular_weight =
:But I pop 'em with Seroquel like glue, I am stuck.
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|mechAction=(Description)
|structure=(Description with picture)
|PD=(Description)
|PK=(Description)
|nonClinToxic=(Description)
|clinicalStudies======Condition 1=====


Along with [[benzodiazepines]], atypical antipsychotics have sometimes been used to "come down" off [[amphetamine]]s. When used in this manner the slang term "downer" is often applied.
(Description)


==References==
=====Condition 2=====
{{reflist|2}}


{{Antipsychotics}}
(Description)
[[Category:Atypical antipsychotics]]
[[Category:Hypnotics]]
[[Category:Sedatives]]
[[Category:Psychiatry]]
[[Category:Drugs]]


[[ja:クエチアピン]]
=====Condition 3=====
[[ru:Кветиапин]]


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|fdaPatientInfo=(Patient Counseling Information)
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* (Paired Confused Name 2a) — (Paired Confused Name 2b)
* (Paired Confused Name 3a) — (Paired Confused Name 3b)
|drugShortage=Drug Shortage
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Revision as of 15:11, 27 June 2014

Quetiapine
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];

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Black Box Warning

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

Overview

Quetiapine 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
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Condition 2
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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
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Condition 2
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Condition 3
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Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition 1
  • Dosing Information
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Condition 2
  • Dosing Information
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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
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Condition 2
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Condition 3
  • Dosing Information
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Contraindications

  • Condition 1
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  • 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
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  • 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

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Gender

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Race

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Renal Impairment

(Description)

Hepatic Impairment

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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

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Not Tested

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Variable

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Incompatible

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Y-Site

Compatible

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Not Tested

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Variable

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Incompatible

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Admixture

Compatible

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Not Tested

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Variable

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Incompatible

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Syringe

Compatible

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Not Tested

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Variable

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Incompatible

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TPN/TNA

Compatible

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Not Tested

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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 Quetiapine
Quetiapine
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 Quetiapine Storage in the drug label.

Images

Drug Images

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

Patient Counseling Information

(Patient Counseling Information)

Precautions with Alcohol

Alcohol-Quetiapine 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 Quetiapine 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.