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 years and older. Each package contains 12 rectal suppositories, each delivering the specified dosage of 650 mg. The product is manufactured by Padagis®.

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

Patients should adhere strictly to the recommended dosage and administration guidelines. The suppository should be removed from its wrapper prior to use. It is essential to carefully insert the suppository well up into the rectum for effective administration.

For adults and children aged 12 years and older, the recommended dosage is one suppository every 4 to 6 hours as needed while symptoms persist. It is important not to exceed a total of six suppositories within a 24-hour period.

For children under 12 years of age, it is advised to consult a physician for appropriate dosing recommendations.

Contraindications

Use is contraindicated in the following situations:

• Children under 12 years of age.

• Patients with a known allergy to acetaminophen.

• Concurrent use with any other medication containing acetaminophen, whether prescription or nonprescription. If there is uncertainty regarding the presence of acetaminophen in a medication, consultation with a healthcare professional is advised.

Warnings and Precautions

This product contains acetaminophen, which carries significant risks that healthcare professionals must communicate to patients.

Liver Warning 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 daily amount. The risk of liver damage is heightened when acetaminophen is taken in conjunction with other medications containing acetaminophen or if an adult consumes 3 or more alcoholic drinks daily while using this product.

Allergy Alert Acetaminophen may lead to severe skin reactions. Symptoms indicative of such reactions include skin reddening, blisters, and rash. Should any of these symptoms manifest, it is imperative to discontinue use immediately and seek medical assistance.

General Precautions Healthcare professionals should advise patients to consult a physician prior to using this product if they have liver disease or are concurrently taking the anticoagulant warfarin.

Emergency Medical Help In the event of ingestion or suspected overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222. Prompt intervention is essential, particularly in cases of overdose, regardless of the presence of symptoms.

Discontinuation of Use Patients should be advised to stop taking this product and consult a healthcare provider if any of the following occur: fever persists for more than 3 days (72 hours) or recurs; pain worsens or lasts longer than 10 days; new symptoms arise; or if redness or swelling is observed in the affected area, as these may indicate a serious condition.

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of six doses within a 24-hour period, particularly in adults and children aged 12 years and older. The risk of liver damage is further heightened when acetaminophen is taken in conjunction with other medications containing acetaminophen or when an adult consumes three or more alcoholic beverages daily while using this product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen use. Symptoms may include skin reddening, blisters, and rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

This product is contraindicated in children under 12 years of age, in individuals with a known allergy to acetaminophen, and in those taking any other medications that contain acetaminophen, whether prescription or nonprescription. Patients uncertain about the presence of acetaminophen in their medications should consult a healthcare professional.

Prior to use, patients should consult a doctor 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), if pain worsens or lasts longer than ten days, if new symptoms arise, or if there is redness or swelling in the area of pain, as these may indicate a serious underlying 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 and to consider adjusting the dosage of warfarin as necessary when acetaminophen is used concurrently. Regular monitoring of INR (International Normalized Ratio) levels may be warranted to ensure therapeutic efficacy and 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 under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is one suppository every 4 to 6 hours as needed for symptom relief, with a maximum of six suppositories in a 24-hour period.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

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. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to using this medication. It is essential for individuals with liver disease to receive appropriate guidance regarding the use of this product, as compromised liver function may affect the metabolism and clearance of the medication. Monitoring of liver function may be necessary to ensure safety and efficacy in this population.

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 effects does not preclude the possibility of 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 limits the assessment of potential risks associated with the compound in these areas.

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 that this medication is not recommended for use in children under 12 years of age. It is crucial to avoid using this medication if the patient has a known allergy to acetaminophen. Additionally, patients should not use 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 with 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. They should also stop using the medication and seek medical advice if pain worsens or lasts longer than 10 days, if new symptoms arise, or if there is any redness or swelling in the area of pain, as these may indicate a serious condition.

Furthermore, patients should be advised to consult a doctor before using this medication if they have liver disease or if they are currently taking the blood-thinning 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 product remains effective and safe for use.

Additional Clinical Information

The route of administration for the medication is rectal. For adults and children aged 12 years and older, the recommended dosage is one suppository every 4 to 6 hours as needed, with a maximum of six suppositories in a 24-hour period. For children under 12 years, it is advised to consult a doctor before use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. It is important to keep the medication out of reach of children. In the event of accidental ingestion or overdose, immediate medical assistance should be sought, or contact a Poison Control Center, as prompt attention is crucial, particularly for children, even if no 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)