Acetaminophen

Description

Acetaminophen Suppositories USP contain 650 mg of acetaminophen per suppository and are indicated as a pain reliever and fever reducer for individuals aged 12 and over. Each package contains 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 opened 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.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Healthcare professionals should instruct patients to adhere strictly to the recommended dosage and administration guidelines.

For adults and children aged 12 years and older, the recommended dosage is one suppository administered every 4 to 6 hours as needed for symptom relief. It is imperative that patients do not exceed a total of six suppositories within a 24-hour period.

Prior to administration, patients should remove the suppository from its wrapper. The suppository should then be carefully inserted well up into the rectum to ensure proper placement and effectiveness.

Patients must be advised not to use more than the directed amount to avoid potential adverse effects.

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 with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that the risk of liver injury increases significantly if an adult or child aged 12 years and older exceeds 6 doses within a 24-hour period, which is the maximum recommended daily amount. Additionally, caution is warranted when this product is taken concurrently with other medications containing acetaminophen. Patients who consume 3 or more alcoholic beverages daily while using this product are also at an elevated risk for liver damage.

Acetaminophen may induce severe skin reactions, necessitating an allergy alert. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any of these symptoms manifest, patients must be instructed to discontinue use immediately and seek medical assistance.

In the event of accidental ingestion or overdose, it is imperative to obtain emergency medical help or contact a Poison Control Center (1-800-222-1222) without delay. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Patients should be advised to discontinue use and consult a healthcare provider 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 arise; 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, particularly those related to liver health and allergic responses.

Severe liver damage may occur if an adult or child aged 12 years and older exceeds 6 doses within a 24-hour period, which is the maximum recommended daily amount. Additionally, the risk of liver damage increases if this product is taken concurrently with other medications containing acetaminophen or if an adult consumes 3 or more alcoholic drinks daily while using this product.

Patients should also be alert for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Participants are advised to stop use and consult a healthcare provider 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 affected area, as these may indicate a serious condition.

Before using this product, patients should consult a doctor if they have liver disease or are taking the blood-thinning medication warfarin.

Drug Interactions

Concurrent use 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.

Additionally, caution is advised when this medication is used in conjunction with warfarin, a blood-thinning agent. Patients should consult a healthcare professional prior to using this medication if they are currently taking warfarin, as the combination may increase the risk of bleeding. Monitoring of coagulation parameters may be warranted to ensure patient safety.

Packaging & NDC

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

Pediatric Use

Pediatric patients should be closely monitored to ensure that the medication is kept out of reach of children. In the event of accidental ingestion or overdose, immediate medical assistance should be sought, and contacting a Poison Control Center (1-800-222-1222) is advised. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

For pediatric patients aged 12 years and older, the recommended dosage is one suppository every 4 to 6 hours as needed for symptom relief, with a maximum limit of six suppositories within a 24-hour period. Exceeding this dosage may lead to severe liver damage. Caution is advised to prevent administration beyond the specified limits.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

Acetaminophen suppositories have not been associated with specific warnings or precautions for use during pregnancy. The available information does not indicate whether the product is contraindicated in pregnant patients or if there are any known risks to fetal outcomes. Additionally, there are no recommended dosage modifications or special precautions for women of childbearing potential. As with any medication, healthcare professionals should consider the overall clinical context when advising pregnant patients.

Lactation

There are no specific warnings or recommendations regarding the use of acetaminophen suppositories in lactating mothers. Additionally, there are no specific considerations or precautions related to lactation or breastfeeding mentioned in the provided text.

Renal Impairment

There is no specific information regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider individual patient factors when prescribing to patients with renal impairment, as the absence of detailed guidance necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. Severe liver damage may occur if the maximum daily dosage is exceeded. Specifically, adults and children aged 12 years and older should not take more than 6 doses within a 24-hour period.

Additionally, patients should be advised against the concurrent use of other medications containing acetaminophen, as this can further increase the risk of liver damage. It is also important to note that adults consuming 3 or more alcoholic drinks daily while using this product may be at an elevated risk for severe liver damage.

Due to these risks, healthcare providers should exercise caution and consider alternative therapies for patients with compromised liver function. Regular monitoring of liver function tests may be warranted in these patients to ensure safety and efficacy.

Overdosage

In cases of overdosage, severe liver damage may occur under specific circumstances. It is critical for healthcare professionals to be aware of the following conditions that can lead to significant hepatic injury.

Risk Factors for Severe Liver Damage

1. Exceeding Maximum Daily Dose: An adult or child aged 12 years and older who consumes more than 6 doses within a 24-hour period is at risk of severe liver damage. This dosage exceeds the maximum recommended daily amount and should be strictly monitored.

2. Concurrent Use with Acetaminophen: The risk of liver damage is heightened when this product is taken in conjunction with other medications that contain acetaminophen. Healthcare providers should ensure that patients are not inadvertently exceeding the safe dosage of acetaminophen through multiple sources.

3. Alcohol Consumption: Adults who consume 3 or more alcoholic drinks daily while using this product are also at increased risk for liver damage. It is advisable to counsel patients on the dangers of combining alcohol with this medication.

Recommended Actions and Management Procedures

In the event of suspected overdosage, immediate medical evaluation is warranted. Healthcare professionals should assess the patient's symptoms and consider the following management strategies:

• Monitoring Liver Function: Regular monitoring of liver function tests is essential to detect any early signs of hepatic injury.

• Supportive Care: Provide supportive care as needed, which may include intravenous fluids and monitoring of vital signs.

• Consideration of Antidotes: In cases of significant overdose, the administration of N-acetylcysteine may be indicated as an antidote to mitigate liver damage.

Prompt recognition and intervention are crucial in managing overdosage effectively and preventing serious complications.

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 in these areas limits the understanding of the compound's safety profile in nonclinical settings.

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 prescription or nonprescription. 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, patients should be advised to consult a doctor before using this medication if they have liver disease or are currently taking the blood-thinning medication warfarin. This precaution is important to ensure safe and effective use of the medication.

Storage and Handling

The product is supplied as tamper-evident suppositories, which are individually wrapped to ensure integrity and safety. Each suppository must not be used if the printed wrapper is open or damaged, as this may compromise the product's effectiveness.

For optimal storage, the suppositories should be maintained at a temperature range of 20°-25°C (68°-77°F) or in a cool place. Proper handling and storage conditions are essential to preserve the quality and efficacy of the product.

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)