Acetaminophen (rectal)

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

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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

• 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)

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:

• 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 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

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%
Metabolism	Predominantly in the liver
Half life	1–4 hours
Excretion	Urine (85-90%)
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

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Package and Label Display Panel

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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

• ACEPHEN

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.

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