Acetaminophen

Description

Acetaminophen Suppositories USP contain 120 mg of acetaminophen per suppository and are indicated as a pain reliever and fever reducer for children aged 3 to 6 years. Each package contains 12 rectal suppositories, each delivering the specified dosage of 120 mg.

Uses and Indications

This drug is indicated for the reduction of fever and the relief of minor aches, pains, and headaches.

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 1 suppository administered every 4 to 6 hours, with a maximum of 5 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 dosing guidelines and not exceed the recommended dosage.

Contraindications

Use is contraindicated in patients with a known allergy to acetaminophen. Additionally, concurrent use with any other medication containing acetaminophen, whether prescription or nonprescription, is prohibited. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

Warnings and Precautions

Severe liver damage may occur in children taking this product, which contains acetaminophen, if they exceed five doses within a 24-hour period, the maximum daily amount, or if they are concurrently using other medications that contain acetaminophen.

Acetaminophen has been associated with severe skin reactions, which may manifest as skin reddening, blisters, or rash. In the event of any skin reaction, it is imperative to discontinue use immediately and seek medical assistance.

Healthcare professionals should advise caregivers to consult a physician prior to administering this product if the child has a history of liver disease or is currently taking the anticoagulant warfarin.

In cases of ingestion or suspected overdose, immediate medical attention is essential. Caregivers should contact a Poison Control Center at 1-800-222-1222 without delay, as prompt intervention is critical, particularly for children, even in the absence of noticeable symptoms.

Patients should be instructed to discontinue use and consult a healthcare provider if fever persists for more than three days (72 hours), pain lasts beyond five days or worsens, new symptoms arise, or if there is any redness or swelling in the area of pain, as these may indicate a serious underlying condition.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of five doses within a 24-hour period or who concurrently use other medications containing acetaminophen. Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Patients should not use this medication if they have a known allergy to acetaminophen or if they are taking any other drug that contains acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

Prior to use, patients should consult a healthcare provider if they have liver disease or are currently taking the anticoagulant warfarin.

Patients are advised to discontinue use and seek medical advice if fever persists for more than three days (72 hours) or recurs, if pain lasts longer than five days or worsens, if new symptoms develop, or if there is redness or swelling in the area of pain, as these may indicate a serious condition.

Drug Interactions

Acetaminophen has the potential to interact with warfarin, a commonly used anticoagulant. This interaction may enhance the anticoagulant effect of warfarin, leading to an increased risk of bleeding.

It is advisable for healthcare professionals to monitor patients closely for signs of bleeding when acetaminophen is administered concurrently with warfarin. Dosage adjustments of warfarin may be necessary based on the patient's clinical response and INR (International Normalized Ratio) levels. Regular monitoring of INR is recommended to ensure therapeutic efficacy while minimizing the risk of adverse effects.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 3 years of age should not use this medication unless directed by a doctor. For children aged 3 to 6 years, the recommended dosage is 1 suppository every 4 to 6 hours, with a maximum of 5 doses in a 24-hour period.

Healthcare professionals should be aware of the potential for severe liver damage if a child exceeds the maximum daily dosage of 5 doses. Caution is advised for pediatric patients with liver disease or those taking the anticoagulant warfarin; consultation with a doctor is recommended prior to use in these cases.

Parents and caregivers should seek medical attention if a child's fever persists for more than 3 days (72 hours), if pain lasts longer than 5 days or worsens, or if new symptoms, redness, or swelling occur in the painful area, as these may indicate a serious condition.

It is essential to keep this medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or a Poison Control Center should be contacted, as prompt medical attention is critical for children, even if no signs or symptoms are present.

Geriatric Use

Elderly patients may not have specific directions or warnings for adult use associated with this product. Therefore, healthcare providers should exercise caution when prescribing this product to geriatric patients. It is essential to consider the individual health status and potential comorbidities of elderly patients, as they may respond differently to treatment compared to younger populations. Monitoring for efficacy and safety is advised, and any necessary dose adjustments should be made based on the clinical judgment of the healthcare provider.

Pregnancy

Pregnant patients and those who are breastfeeding should not use this medication unless directed by a healthcare professional. The potential risks associated with the use of this medication during pregnancy have not been fully established, and its safety profile in this population remains unclear. Therefore, it is essential for healthcare providers to evaluate the benefits and risks before prescribing this medication to pregnant or breastfeeding women.

Lactation

There are no specific warnings or recommendations regarding the use of acetaminophen suppositories in lactating mothers. Additionally, the insert does not provide information on the potential for excretion of acetaminophen in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this product, particularly if they have a history of liver disease. The formulation contains acetaminophen, which poses a risk of severe liver damage if the maximum daily dosage of 5 doses within a 24-hour period is exceeded. Additionally, caution is advised when administering this product alongside other medications that also contain acetaminophen, as this may further increase the risk of liver injury. Monitoring of liver function may be warranted in patients with compromised liver health to prevent potential adverse effects.

Overdosage

In the event of an overdose, immediate medical assistance is essential. Healthcare professionals are advised to instruct patients or caregivers to seek medical help or contact a Poison Control Center without delay. The national Poison Control Center can be reached at 1-800-222-1222.

It is important to note that prompt medical attention is crucial for both adults and children, even if no signs or symptoms of overdose are apparent. Vigilance in monitoring for potential symptoms is necessary, as the absence of immediate symptoms does not preclude the possibility of serious effects. Therefore, healthcare providers should emphasize the importance of seeking help in all overdose situations.

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 potential effects 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. Quick medical attention is essential, particularly for adults and children, even if no signs or symptoms are apparent.

Patients should be informed not to use the medication if they have a known allergy to acetaminophen. Additionally, they should be cautioned against using this medication in conjunction with any other products containing acetaminophen, whether prescription or nonprescription. If patients are uncertain about the contents of another medication, they should be encouraged to consult a doctor or pharmacist.

Patients should be instructed to discontinue use and consult a doctor if a fever persists for more than 3 days (72 hours) or if it recurs. Similarly, they should stop using the medication and seek medical advice if pain lasts longer than 5 days or worsens. Patients should also be advised to stop use and contact a healthcare professional if new symptoms arise or if there is any redness or swelling in the area of pain, as these may indicate a serious condition.

For pediatric patients, healthcare providers should recommend consulting a doctor before use if the child has liver disease or is taking the anticoagulant medication warfarin.

Storage and Handling

The product is supplied in a tamper-evident configuration, with suppositories individually wrapped to ensure integrity. It is imperative that the product is not used if the printed wrapper is opened or damaged.

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

Additional Clinical Information

For patients aged 3 to 6 years, the recommended administration is one suppository every 4 to 6 hours, with a maximum of five doses within a 24-hour period. Clinicians should advise patients and caregivers to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) if the medication is swallowed or in the event of an overdose. Prompt medical attention is crucial, particularly for children, even if no signs or symptoms are apparent.

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)