Acetaminophen (rectal): Difference between revisions

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|drugClass=[[analgesic]] and [[antipyretic]]
|drugClass=[[analgesic]] and [[antipyretic]]
|indicationType=treatment
|indicationType=treatment
|indication=[[fever]] and relieves minor aches, [[pains]], and [[headache]]
|indication=[[fever]] and relieves minor [[aches]], [[pains]], and [[headache]]
|adverseReactions=[[pruritus]], [[constipation]], [[nausea]], [[vomiting]], [[headache]], [[agitation]], [[insomnia]] and [[atelectasis]]<!--Black Box Warning-->
|adverseReactions=[[pruritus]], [[constipation]], [[nausea]], [[vomiting]], [[headache]], [[agitation]], [[insomnia]], and [[atelectasis]]
|blackBoxWarningTitle=Title
|blackBoxWarningTitle=Title
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
|blackBoxWarningBody=<i><span style="color:#FF0000;">Condition Name:</span></i> (Content)
 
|fdaLIADAdult=There is limited information regarding <i>Adult Indications and Dosage</i> of {{PAGENAME}} in adult patients.
* Content
<!--Adult Indications and Dosage-->
 
<!--FDA-Labeled Indications and Dosage (Adult)-->
|fdaLIADAdult=
<!--Off-Label Use and Dosage (Adult)-->
 
<!--Guideline-Supported Use (Adult)-->
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


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<!--FDA-Labeled Indications and Dosage (Pediatric)-->
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|fdaLIADPed=
|fdaLIADPed=*Temporarily  
*Temporarily  
:*reduces [[fever]]  
:*reduces [[fever]]  
:*relieves minor aches, [[pains]], and [[headache]]
:*relieves minor aches, [[pains]], and [[headache]]
====Direction to use====
====Direction to use====
*This product does not contain directions or complete warnings for adult use.
*This product does not contain directions or complete warnings for adult use.
:*do not use more than directed
:*Do not use more than directed
:*remove foil wrapper
:*Remove foil wrapper
:*insert suppository well up into rectum
:*Insert suppository well up into rectum
*children 3-6 years
*Children 3-6 years
:* 1 suppository every 4 to 6 hours while symptoms persist
:* 1 suppository every 4 to 6 hours while symptoms persist
:*do not exceed 5 suppositories in any 24-hour period
:* Do not exceed 5 suppositories in any 24-hour period
*children under 3 years: ask a doctor
*Children under 3 years: ask a doctor
<!--Off-Label Use and Dosage (Pediatric)-->
<!--Off-Label Use and Dosage (Pediatric)-->


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<!--Contraindications-->
<!--Contraindications-->
|contraindications=<!--Warnings-->
|contraindications=There is limited information regarding ''Contraindications'' of {{PAGENAME}} in the drug label.
|warnings=*For rectal use only
|warnings=*For rectal use only
*Liver Warning: This product contains acetaminophen. Severe [[liver damage]] may occur if your child inserts
*Liver Warning: This product contains acetaminophen. Severe [[liver damage]] may occur if your child inserts
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<!--Clinical Trials Experience-->
<!--Clinical Trials Experience-->
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.






<!--Postmarketing Experience-->
<!--Postmarketing Experience-->
|clinicalTrials=There is limited information regarding <i>FDA-Labeled Indications and Dosage (Adult)</i> of {{PAGENAME}} in the drug label.
<!--Off-Label Use and Dosage (Adult)-->
<!--Guideline-Supported Use (Adult)-->
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.




<!--Drug Interactions-->
<!--Drug Interactions-->
|drugInteractions=<!--Use in Specific Populations-->
|drugInteractions=There is limited information regarding ''Drug Interactions'' of {{PAGENAME}} in the drug label.
|FDAPregCat=C
|FDAPregCat=C
|useInPregnancyFDA=* If pregnant or breast-feeding, ask a health professional before use.
|useInPregnancyFDA=* If pregnant or breast-feeding, ask a health professional before use.
Line 97: Line 92:


<!--Administration and Monitoring-->
<!--Administration and Monitoring-->
|administration=* [[Oral]]
|administration=* Suppository
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.


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<!--Overdosage-->
<!--Overdosage-->
|overdose=
|overdose=<!--Pharmacology-->
<!--Pharmacology-->


<!--Drug box 2-->
<!--Drug box 2-->
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<!--Clinical data-->
<!--Clinical data-->
| tradename = Tylenol (U.S. and Japan), Panadol (United Kingdom and Australia), and many others; see this thorough [[list of paracetamol brand names]]
| tradename = Tylenol (U.S. and Japan), Panadol (United Kingdom and Australia), and many others; see this thorough [[list of paracetamol brand names]]
| Drugs.com = {{drugs.com|monograph|acetaminophen}}
| MedlinePlus = a681004
| MedlinePlus = a681004
| licence_US = Acetaminophen
| licence_US = Acetaminophen
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<!--Pharmacokinetic data-->
<!--Pharmacokinetic data-->
| bioavailability = 63-89%<ref>{{cite isbn|978-0-9775174-5-9}}</ref>{{rp|73}}
| bioavailability = 63-89%
| protein_bound = 10-25%<ref>{{cite web|title=Tylenol, Tylenol [[infants]]' Drops (acetaminophen) dosing, indications, interactions, adverse effects, and more|work=Medscape Reference|publisher=WebMD|accessdate=10 May 2014|url=http://reference.medscape.com/drug/tylenol-acetaminophen-343346#showall}}</ref>
| protein_bound = 10-25%<ref>{{cite web|title=Tylenol, Tylenol [[infants]]' Drops (acetaminophen) dosing, indications, interactions, adverse effects, and more|work=Medscape Reference|publisher=WebMD|accessdate=10 May 2014|url=http://reference.medscape.com/drug/tylenol-acetaminophen-343346#showall}}</ref>
| metabolism = Predominantly in the liver<ref name = TGA>{{cite web|title=Codapane Forte Paracetamol and codeine phosphate PRODUCT INFORMATION|work=TGA eBusiness Services|publisher=Alphapharm Pty Limited|date=29 April 2013|accessdate=10 May 2014|url=https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2010-PI-05623-3|format=PDF}}</ref>
| metabolism = Predominantly in the liver<ref name = TGA>{{cite web|title=Codapane Forte Paracetamol and codeine phosphate PRODUCT INFORMATION|work=TGA eBusiness Services|publisher=Alphapharm Pty Limited|date=29 April 2013|accessdate=10 May 2014|url=https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2010-PI-05623-3|format=PDF}}</ref>
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<!--Identifiers-->
<!--Identifiers-->
| CASNo_Ref = {{cascite|correct|CAS}}
| CASNo_Ref =
| CAS_number_Ref = {{cascite|correct|??}}
| CAS_number_Ref =
| CAS_number = 103-90-2
| CAS_number = 103-90-2
| ATC_prefix = N02
| ATC_prefix = N02
| ATC_suffix = BE01
| ATC_suffix = BE01
| PubChem = 1983
| PubChem = 1983
| DrugBank_Ref = {{drugbankcite|correct|drugbank}}
| DrugBank_Ref =
| DrugBank = DB00316
| DrugBank = DB00316
| ChemSpiderID_Ref = {{chemspidercite|correct|chemspider}}
| ChemSpiderID_Ref =
| ChemSpiderID = 1906
| ChemSpiderID = 1906
| UNII_Ref = {{fdacite|correct|FDA}}
| UNII_Ref =
| UNII = 362O9ITL9D
| UNII = 362O9ITL9D
| KEGG_Ref = {{keggcite|correct|kegg}}
| KEGG_Ref =
| KEGG = D00217
| KEGG = D00217
| ChEBI_Ref = {{ebicite|correct|EBI}}
| ChEBI_Ref =
| ChEBI = 46195
| ChEBI = 46195
| ChEMBL_Ref = {{ebicite|correct|EBI}}
| ChEMBL_Ref =
| ChEMBL = 112
| ChEMBL = 112
| PDB_ligand = TYL
| PDB_ligand = TYL
Line 164: Line 157:
| smiles = CC(NC1=CC=C(O)C=C1)=O
| smiles = CC(NC1=CC=C(O)C=C1)=O
| InChI = 1/C8H9NO2/c1-6(10)9-7-2-4-8(11)5-3-7/h2-5,11H,1H3,(H,9,10)
| InChI = 1/C8H9NO2/c1-6(10)9-7-2-4-8(11)5-3-7/h2-5,11H,1H3,(H,9,10)
| StdInChI_Ref = {{stdinchicite|correct|chemspider}}
| StdInChI_Ref =
| StdInChI = 1S/C8H9NO2/c1-6(10)9-7-2-4-8(11)5-3-7/h2-5,11H,1H3,(H,9,10)
| StdInChI = 1S/C8H9NO2/c1-6(10)9-7-2-4-8(11)5-3-7/h2-5,11H,1H3,(H,9,10)
| StdInChIKey_Ref = {{stdinchicite|correct|chemspider}}
| StdInChIKey_Ref =
| StdInChIKey = RZVAJINKPMORJF-UHFFFAOYSA-N
| StdInChIKey = RZVAJINKPMORJF-UHFFFAOYSA-N
| density = 1.263
| density = 1.263
| melting_point = 169
| melting_point = 169
| melting_notes =<ref>{{cite doi|10.1021/ci0500132}}</ref><ref>{{cite web | url = http://lxsrv7.oru.edu/~alang/meltingpoints/meltingpointof.php?csid=1906 | title = melting point data for paracetamol |publisher=Lxsrv7.oru.edu | accessdate = 2011-03-19}}</ref>
| melting_notes =
| solubility = 12.78<ref>{{cite journal | doi = 10.1021/je990124v | title = Solubility of paracetamol in pure solvents | author = Granberg RA, Rasmuson AC | journal = [[Journal of Chemical & Engineering Data]] | volume = 44 | issue = 6 | pages = 1391–95 | year = 1999}}</ref>
}}
}}


<!--Mechanism of Action-->
<!--Mechanism of Action-->
|mechAction=<!--Structure-->
|mechAction=There is limited information regarding ''Mechanism of Action'' of Acetaminophen (rectal) in the drug label.
|structure=[[File:Acetaminophen structural formula.png|thumb|none|400px|This image is provided by the National Library of Medicine.]]
|structure=[[File:Acetaminophen structural formula.png|thumb|none|400px|This image is provided by the National Library of Medicine.]]
<!--Pharmacodynamics-->
<!--Pharmacodynamics-->
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<!--How Supplied-->
<!--How Supplied-->
|howSupplied=
|howSupplied=* For your safety, suppositories are packaged in tamper-evident sealed foil. Do not use if foil is torn or open.
*for your safety, suppositories are packaged in tamper-evident sealed foil. Do not use if foil is torn or open.
*store at 8˚-25˚C (46˚-77˚F)
<!--Patient Counseling Information-->
<!--Patient Counseling Information-->
|storage=* Store at 8˚-25˚C (46˚-77˚F)
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
<!--Precautions with Alcohol-->
<!--Precautions with Alcohol-->
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<!--Brand Names-->
<!--Brand Names-->
|brandNames=
|brandNames=* ACEPHEN<ref>{{Cite web | title = ACEPHEN - acetaminophen suppository  | url = http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=32bbe845-7f0e-c33d-adb2-659f18fedfa9 }}</ref>
 
|lookAlike=There is limited information regarding Look-Alike Drug Names.
<!--Look-Alike Drug Names-->
|lookAlike=
<!--Drug Shortage Status-->
|drugShortage=
|drugShortage=
}}
}}

Latest revision as of 17:07, 18 August 2015

Acetaminophen (rectal)
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: Aparna Vuppala, M.B.B.S. [2]

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.

Overview

Acetaminophen (rectal) is an analgesic and antipyretic that is FDA approved for the treatment of fever and relieves minor aches, pains, and headache. Common adverse reactions include pruritus, constipation, nausea, vomiting, headache, agitation, insomnia, and atelectasis.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

There is limited information regarding Adult Indications and Dosage of Acetaminophen (rectal) in adult patients.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Acetaminophen (rectal) in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Acetaminophen (rectal) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

  • Temporarily

Direction to use

  • This product does not contain directions or complete warnings for adult use.
  • Do not use more than directed
  • Remove foil wrapper
  • Insert suppository well up into rectum
  • Children 3-6 years
  • 1 suppository every 4 to 6 hours while symptoms persist
  • Do not exceed 5 suppositories in any 24-hour period
  • Children under 3 years: ask a doctor

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Acetaminophen (rectal) in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Acetaminophen (rectal) in pediatric patients.

Contraindications

There is limited information regarding Contraindications of Acetaminophen (rectal) in the drug label.

Warnings

  • For rectal use only
  • Liver Warning: This product contains acetaminophen. Severe liver damage may occur if your child inserts
  • more than 5 suppositories in 24 hours, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • Allergy alert: Acetaminophen may cause severe skin reactions.
  • Symptoms may include:
  • If a skin reaction occurs, stop use and seek medical help right away.
  • Do not use
  • if your child is allergic to acetaminophen
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • Ask a doctor before use if your child has liver disease
  • Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin
  • Stop use and ask a doctor if
  • fever lasts more than 3 days (72 hours), or recurs
  • you need to use this product for pain for more than 5 days continuously
  • Severe or recurrent pain, or high or continued fever may indicate a serious illness.

Adverse Reactions

Clinical Trials Experience

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

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Acetaminophen (rectal) in the drug label.

Drug Interactions

There is limited information regarding Drug Interactions of Acetaminophen (rectal) in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): C

  • If pregnant or breast-feeding, ask a health professional before use.


Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Acetaminophen (rectal) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Acetaminophen (rectal) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Acetaminophen (rectal) with respect to nursing mothers.

Pediatric Use

  • If swallowed or in case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical in case of overdose for children even if you do not notice any signs or symptoms.

Geriatic Use

There is no FDA guidance on the use of Acetaminophen (rectal) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Acetaminophen (rectal) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Acetaminophen (rectal) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Acetaminophen (rectal) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Acetaminophen (rectal) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Acetaminophen (rectal) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Acetaminophen (rectal) in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Suppository

Monitoring

There is limited information regarding Monitoring of Acetaminophen (rectal) in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Acetaminophen (rectal) in the drug label.

Overdosage

There is limited information regarding Acetaminophen (rectal) overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

Template:Px
Paracetamol (acetaminophen)
Systematic (IUPAC) name
N-(4-hydroxyphenyl)ethanamide
N-(4-hydroxyphenyl)acetamide
Identifiers
CAS number 103-90-2
ATC code N02BE01
PubChem 1983
DrugBank DB00316
Chemical data
Formula Template:OrganicBox atomTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox 
Mol. mass 151.163 g/mol
SMILES eMolecules & PubChem
Physical data
Density 1.263 g/cm³
Melt. point 169 °C (336 °F)
Pharmacokinetic data
Bioavailability 63-89%
Protein binding 10-25%[1]
Metabolism Predominantly in the liver[2]
Half life 1–4 hours[2]
Excretion Urine (85-90%)[2]
Therapeutic considerations
Licence data

US

Pregnancy cat.

A(AU) C(US) Not tested but seems to be safe

Legal status

Unscheduled(AU) GSL(UK) OTC(US)

Routes Oral, rectal, intravenous

Mechanism of Action

There is limited information regarding Mechanism of Action of Acetaminophen (rectal) in the drug label.

Structure

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Acetaminophen (rectal) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Acetaminophen (rectal) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Acetaminophen (rectal) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Acetaminophen (rectal) in the drug label.

How Supplied

  • For your safety, suppositories are packaged in tamper-evident sealed foil. Do not use if foil is torn or open.

Storage

  • Store at 8˚-25˚C (46˚-77˚F)

Images

Drug Images

{{#ask: Page Name::Acetaminophen (rectal) |?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::Acetaminophen (rectal) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Acetaminophen (rectal) in the drug label.

Precautions with Alcohol

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

Brand Names

Look-Alike Drug Names

There is limited information regarding Look-Alike Drug Names.

Drug Shortage Status

Price

References

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

  1. ↑ "Tylenol, Tylenol [[infants]]' Drops (acetaminophen) dosing, indications, interactions, adverse effects, and more". Medscape Reference. WebMD. Retrieved 10 May 2014. URL–wikilink conflict (help)
  2. ↑ 2.0 2.1 2.2 "Codapane Forte Paracetamol and codeine phosphate PRODUCT INFORMATION" (PDF). TGA eBusiness Services. Alphapharm Pty Limited. 29 April 2013. Retrieved 10 May 2014.
  3. ↑ "ACEPHEN - acetaminophen suppository".



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}}


{{#subobject: 

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