Acetaminophen

Description

Acetaminophen Suppositories USP contain 120 mg of acetaminophen per suppository, serving as a pain reliever and fever reducer. Each package includes 10 rectal suppositories, with each suppository individually wrapped to ensure tamper-evidence. The product is manufactured in the USA. Users are advised not to use the suppositories if the printed wrapper is open or damaged.

Uses and Indications

This drug is indicated for the temporary reduction of fever. It also provides temporary relief from minor aches, pains, and headaches.

Limitations of Use: There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

This product is not indicated for use in adults. For pediatric patients under 3 years of age, the product should not be used unless directed by a physician.

For children aged 3 to 6 years, the recommended dosage is one suppository administered every 4 to 6 hours, with a maximum of five doses within a 24-hour period.

Prior to administration, the wrapper should be removed. The suppository should be carefully inserted well up into the rectum to ensure proper delivery of the medication. It is imperative to adhere strictly to the recommended dosing guidelines and not exceed the directed amount.

Contraindications

Use of this product is contraindicated in patients who are concurrently taking any other medication that contains acetaminophen, whether prescription or nonprescription. This is due to the potential risk of acetaminophen overdose, which can lead to serious liver damage. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

Warnings and Precautions

Severe liver damage may occur in patients taking this product, which contains acetaminophen. It is critical to adhere to the recommended dosage guidelines, as exceeding five doses within a 24-hour period, which represents the maximum daily amount, or concomitant use with other medications containing acetaminophen can significantly increase the risk of liver injury.

Healthcare professionals should be vigilant regarding the potential for severe skin reactions associated with acetaminophen. Symptoms indicative of such reactions may include skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

In cases of ingestion or suspected overdose, immediate medical intervention is essential. Patients or caregivers should contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help without delay, as prompt attention is crucial for both adults and children, even in the absence of overt symptoms.

Patients should be advised to discontinue use and consult a healthcare provider if any of the following occur: fever persists for more than three days (72 hours) or recurs; pain lasts beyond five days or worsens; new symptoms develop; or if there is redness or swelling in the area of pain. These signs may indicate a serious underlying condition that requires further evaluation.

Side Effects

Patients using this product should be aware of potential adverse reactions associated with its use.

Severe liver damage is a significant concern, particularly in patients who exceed the recommended dosage of more than 5 doses in 24 hours or who concurrently use other medications containing acetaminophen. It is crucial for patients to monitor their intake closely to avoid this serious risk.

Additionally, there is an allergy alert associated with acetaminophen, as it may lead to severe skin reactions. Symptoms of such reactions can include skin reddening, blisters, and rash. In the event of a skin reaction, patients are advised to discontinue use immediately and seek medical assistance.

Patients should also be instructed to stop use and consult a healthcare professional if fever persists for more than 3 days (72 hours) or recurs, if pain lasts longer than 5 days or worsens, if new symptoms arise, or if there is redness or swelling in the painful area, as these may indicate a serious underlying condition.

Before using this product, it is recommended that patients consult a doctor if they have a history of liver disease or if they are taking the blood-thinning medication warfarin, as these factors may increase the risk of adverse effects.

Drug Interactions

Co-administration of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose, which can lead to severe liver damage.

In pediatric patients, it is advisable to consult a healthcare professional prior to use if the child is concurrently taking warfarin, a blood-thinning agent. This is essential to ensure appropriate monitoring and to mitigate the risk of potential interactions that could affect coagulation parameters.

Packaging & NDC

Below are the non-prescription pack sizes of Acetaminophen. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 3 to 6 years may be administered 1 suppository every 4 to 6 hours, with a maximum of 5 doses in a 24-hour period. For children under 3 years of age, use is not recommended unless directed by a physician.

Healthcare professionals should be aware of the potential for severe liver damage in pediatric patients if more than 5 doses are taken within 24 hours or if the child is concurrently using other medications containing acetaminophen. It is advised to consult a doctor prior to use if the child has liver disease or is taking the anticoagulant warfarin.

Parents and caregivers should be instructed to discontinue use and seek medical advice if a child's fever persists for more than 3 days (72 hours), if pain lasts longer than 5 days or worsens, if new symptoms arise, or if there is redness or swelling in the affected area, as these may indicate a serious condition.

Geriatric Use

There is no specific information regarding the use of Acetaminophen Suppositories for Children in geriatric patients. The prescribing information does not provide any recommended age considerations, dosage adjustments, safety concerns, or special precautions for elderly patients. Therefore, healthcare providers should exercise caution when considering the use of this medication in geriatric populations, as the absence of data necessitates careful clinical judgment and monitoring.

Pregnancy

The available data does not indicate any specific warnings or contraindications regarding the use of acetaminophen suppositories during pregnancy. There are no documented safety concerns, dosage modifications, or special precautions associated with the use of this product in pregnant patients. As such, healthcare professionals may consider the use of acetaminophen suppositories in this population, although it is always advisable to weigh the benefits against any potential risks on a case-by-case basis. Further studies may be warranted to fully understand the implications of acetaminophen use during pregnancy.

Lactation

Nursing mothers should consult a doctor before using this product. There is a potential for excretion in breast milk, and caution is advised when administering to nursing mothers due to the risk of infant exposure.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring of these patients.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, as it contains acetaminophen, which is associated with the risk of severe liver damage. It is critical to adhere to the recommended dosage guidelines to minimize the risk of hepatotoxicity.

Specifically, patients must not exceed 5 doses within a 24-hour period, as this represents the maximum daily amount. Additionally, caution should be exercised to avoid concomitant use with other medications that contain acetaminophen, as this can further increase the risk of liver injury.

Healthcare providers should evaluate liver function prior to initiating treatment and consider regular monitoring throughout the course of therapy, particularly in patients with known liver impairment. Adjustments to the dosing regimen may be necessary based on the severity of hepatic impairment and the patient's overall clinical status.

Overdosage

In cases of overdosage, it is critical to recognize the potential for severe liver damage, particularly in pediatric patients.

Risk of Liver Damage Administration of more than five doses within a 24-hour period exceeds the maximum recommended daily amount and significantly increases the risk of severe liver damage. Healthcare professionals should be vigilant in assessing the total dosage of acetaminophen administered to the child, including any additional medications that may contain acetaminophen.

Co-Administration with Other Acetaminophen-Containing Products The risk of severe liver damage is further heightened if the product is taken concurrently with other medications that also contain acetaminophen. It is essential for healthcare providers to evaluate the complete medication history of the patient to prevent unintentional overdose.

Recommended Actions In the event of suspected overdosage, immediate medical attention is warranted. Healthcare professionals should initiate appropriate management procedures, which may include monitoring liver function tests and considering the administration of N-acetylcysteine as an antidote, depending on the severity of the situation and the time elapsed since ingestion.

Prompt recognition and intervention are crucial in mitigating the risks associated with acetaminophen overdosage.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the use of the compound in question.

Postmarketing Experience

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions. Reports indicate that symptoms can include skin reddening, blisters, and rash. In the event of a skin reaction, it is advised to discontinue use immediately and seek medical assistance.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 if the medication is swallowed or in the event of an overdose. It is crucial to emphasize that prompt medical attention is necessary for both adults and children, even if no signs or symptoms are initially apparent.

Patients should be informed not to use this medication in conjunction with any other drug that contains acetaminophen, whether it is a prescription or nonprescription product. If patients are uncertain about the presence of acetaminophen in their other medications, they should be encouraged to consult with a doctor or pharmacist for clarification.

Healthcare providers should instruct patients to discontinue use and consult a doctor if any of the following occur: fever persists for more than 3 days (72 hours) or recurs; pain lasts longer than 5 days or worsens; new symptoms develop; or if there is redness or swelling in the area of pain, as these may indicate a serious condition.

Additionally, it is important for healthcare providers to recommend that patients consult a doctor before using this medication if their child has liver disease or is currently taking the blood-thinning medication warfarin.

Storage and Handling

The product is supplied as tamper-evident suppositories, each individually wrapped to ensure integrity and safety. It is essential to store the suppositories at a temperature range of 20°-25°C (68°-77°F).

Healthcare professionals should ensure that the packaging remains intact; the product should not be used if the printed wrapper is open or damaged, as this may compromise the product's safety and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Acetaminophen, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)