Acetaminophen (rectal)

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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.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-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.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-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

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

## Structure

## 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

## Package and Label Display Panel

# 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