Acetaminophen (rectal): Difference between revisions

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(Created page with "{{DrugProjectFormSinglePage |authorTag={{AV}} |genericName=acetaminophen(rectal) |aOrAn=an |drugClass=analgesic and antipyretic |indicationType=treatment |indication=m...")
 
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|drugClass=[[analgesic]] and [[antipyretic]]
|drugClass=[[analgesic]] and [[antipyretic]]
|indicationType=treatment
|indicationType=treatment
|indication=minor aches and pains due to [[headache]], [[muscular aches]], [[backache]]
|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]]<!--Black Box Warning-->
|blackBoxWarningTitle=Title
|blackBoxWarningTitle=Title
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<!--FDA-Labeled Indications and Dosage (Adult)-->
<!--FDA-Labeled Indications and Dosage (Adult)-->
|fdaLIADAdult=*Temporarily relieves minor aches and pains due to:
|fdaLIADAdult=
:*[[headache]]
:*[[muscular aches]]
:*[[backache]]
:*minor pain of [[arthritis]]
:*the [[common cold]]
:*[[toothache]]
:*premenstrual and menstrual cramps
:*temporarily reduces [[fever]]
 
=====Dosing Information=====
 
*Do not take more than directed
 
[[File:Acetaminophen02.png|thumb|none|400px|This image is provided by the National Library of Medicine.]]
<!--Off-Label Use and Dosage (Adult)-->
<!--Off-Label Use and Dosage (Adult)-->


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<!--FDA-Labeled Indications and Dosage (Pediatric)-->
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|fdaLIADPed=There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
|fdaLIADPed=
*Temporarily
:*reduces fever
:*relieves minor aches, [[pains]], and [[headache]]


====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)-->
<!--Off-Label Use and Dosage (Pediatric)-->


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<!--Contraindications-->
<!--Contraindications-->
|contraindications=<!--Warnings-->
|contraindications=<!--Warnings-->
|warnings=* Liver warning
|warnings=*For rectal use only
*This product contains acetaminophen. Severe liver damage may occur if:
*Liver Warning: This product contains acetaminophen. Severe liver damage may occur if your child inserts
:*adult takes more than 6 doses in 24 hours, which is the maximum daily amount
:*more than 5 suppositories in 24 hours, which is the maximum daily amount
:*child takes more than 5 doses in 24 hours
:*with other drugs containing acetaminophen
:*adult has 3 or more alcoholic drinks everyday while using this product
*Allergy alert: Acetaminophen may cause severe skin reactions.
 
*Symptoms may include:
*Sore throat warning
:*skin reddening
:*If sore throat is severe, persists for more than 2 days, is accompanied or followed by [[fever]], [[headache]], [[rash]], [[nausea]], or [[vomiting]], consult a doctor promptly.
:*blisters
 
:* rash
*If a skin reaction occurs, stop use and seek medical help right away.
*Do not use
*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.
:*with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
:*if you are allergic to acetaminophen or any of the inactive ingredients of this product
*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
*Ask a doctor before use if the user has liver disease.
 
*Ask a doctor or pharmacist before use if the user is taking the blood thinning drug [[warfarin]].
 
*Stop use and ask a doctor if
*Stop use and ask a doctor if
:*pain gets worse or lasts more than 10 days in adults and children
:*fever lasts more than 3 days (72 hours), or recurs
:*pain gets worse or lasts more than 5 days in children under 12 years
:*you need to use this product for pain for more than 5 days continuously
:*fever gets worse or lasts more than 3 days
*Severe or recurrent pain, or high or continued fever may indicate a serious illness.
:*new symptoms occur
:*redness or swelling is present
*These could be signs of a serious condition.


<!--Adverse Reactions-->
<!--Adverse Reactions-->
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|useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInNursing=There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
|useInNursing=There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
|useInPed=*Keep out of reach of children.
|useInPed=*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.
|useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
|useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
|useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
|useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
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<!--How Supplied-->
<!--How Supplied-->
|howSupplied=*sodium content: 2 mg/5 mLstore at 20° to 25°C (68° to 77°F). [See USP controlled room temperature]
|howSupplied=
*keep tightly closed
*for your safety, suppositories are packaged in tamper-evident sealed foil. Do not use if foil is torn or open.
*protect from light
*store at 8˚-25˚C (46˚-77˚F)
*a red, cherry flavored solution supplied in the following oral dosage forms:
*NDC 0121-0657-05 (unit dose cups of 5 mL, 10 × 10's), NDC 0121-0657-11 (unit dose cups of 10.15 mL, 10 × 10's), and NDC 0121-0657-21 (unit dose cups of 20.3 mL, 10 × 10's).
 
<!--Patient Counseling Information-->
<!--Patient Counseling Information-->
|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-->
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
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{{LabelImage
{{LabelImage
|fileName={{PAGENAME}}03.png|This image is provided by the National Library of Medicine.
|fileName={{PAGENAME}}01.png|This image is provided by the National Library of Medicine.
}}
}}


{{LabelImage
{{LabelImage
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Revision as of 15:11, 5 May 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 Acetaminophen (rectal) FDA-Labeled Indications and Dosage (Adult) in the drug label.

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 Acetaminophen (rectal) Contraindications 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:
  • skin reddening
  • blisters
  • rash
  • 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 Clinical Trial Experience 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 Acetaminophen (rectal) Drug Interactions 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

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

  • Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222). Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

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) [1][2]
Solubility in water 12.78[3] mg/mL (20 °C)
Pharmacokinetic data
Bioavailability 63-89%[4]:73
Protein binding 10-25%[5]
Metabolism Predominantly in the liver[6]
Half life 1–4 hours[6]
Excretion Urine (85-90%)[6]
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 Acetaminophen (rectal) Mechanism of Action 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.
  • store at 8˚-25˚C (46˚-77˚F)

Storage

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

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

There is limited information regarding Acetaminophen (rectal) Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Acetaminophen (rectal) Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

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

  1. ↑ Template:Cite doi
  2. ↑ "melting point data for paracetamol". Lxsrv7.oru.edu. Retrieved 2011-03-19.
  3. ↑ Granberg RA, Rasmuson AC (1999). "Solubility of paracetamol in pure solvents". Journal of Chemical & Engineering Data. 44 (6): 1391–95. doi:10.1021/je990124v.
  4. ↑ Template:Cite isbn
  5. ↑ "Tylenol, Tylenol [[infants]]' Drops (acetaminophen) dosing, indications, interactions, adverse effects, and more". Medscape Reference. WebMD. Retrieved 10 May 2014. URL–wikilink conflict (help)
  6. ↑ 6.0 6.1 6.2 "Codapane Forte Paracetamol and codeine phosphate PRODUCT INFORMATION" (PDF). TGA eBusiness Services. Alphapharm Pty Limited. 29 April 2013. Retrieved 10 May 2014.



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