Acetaminophen 120mg Suppositories
WARNING: Liver problems have happened with the use of acetaminophen. Sometimes, this has led to a liver transplant or death. Most of the time, liver problems happened in people taking more than 4,000 mg (milligrams) of acetaminophen in a day. People were also often taking more than 1 drug that had acetaminophen in it. If you have questions, talk with your doctor. @ COMMON USES: It is used to ease pain and fever.
Drug Class
Analgesic, Antipyretic
Pharmacologic Class
Para-aminophenol derivative
Pregnancy Category
Not available
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Acetaminophen is a medicine used to reduce fever and relieve mild to moderate pain. This 120mg suppository form is given rectally (into the bottom) and is often used for infants and young children, especially when they cannot take medicine by mouth (e.g., due to vomiting or refusal).
How to Use This Medicine
Taking Your Medication Correctly
To use this medication safely and effectively, follow your doctor's instructions and read all the information provided. Use the suppository rectally, as directed. Before and after handling the suppository, wash your hands thoroughly. If the suppository is soft, you can chill it in the refrigerator or run it under cold water to firm it up. To insert the suppository, remove the foil wrapper, wet the suppository, and gently push it into your rectum with the pointed end first. Avoid handling the suppository excessively.
Storing and Disposing of Your Medication
Store this medication at room temperature, protected from light and moisture. Keep it in a dry place, away from the bathroom. Do not freeze the medication. Some brands may require refrigeration, so be sure to ask your pharmacist or check the package label for specific storage instructions. Keep all medications in a safe and secure location, out of the reach of children and pets.
What to Do If You Miss a Dose
If you take this medication on a regular schedule, take the missed dose as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses. If you take this medication as needed, do not take it more frequently than directed by your doctor.
To use this medication safely and effectively, follow your doctor's instructions and read all the information provided. Use the suppository rectally, as directed. Before and after handling the suppository, wash your hands thoroughly. If the suppository is soft, you can chill it in the refrigerator or run it under cold water to firm it up. To insert the suppository, remove the foil wrapper, wet the suppository, and gently push it into your rectum with the pointed end first. Avoid handling the suppository excessively.
Storing and Disposing of Your Medication
Store this medication at room temperature, protected from light and moisture. Keep it in a dry place, away from the bathroom. Do not freeze the medication. Some brands may require refrigeration, so be sure to ask your pharmacist or check the package label for specific storage instructions. Keep all medications in a safe and secure location, out of the reach of children and pets.
What to Do If You Miss a Dose
If you take this medication on a regular schedule, take the missed dose as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses. If you take this medication as needed, do not take it more frequently than directed by your doctor.
Lifestyle & Tips
- Do not exceed the recommended dose or frequency. Overdosing can cause severe liver damage.
- Do not use with other acetaminophen-containing products (prescription or OTC) to avoid accidental overdose.
- Store suppositories in a cool, dry place, or refrigerate if directed, to prevent melting.
- Wash hands before and after administering the suppository.
- Ensure the child's bowel is empty before administration for best absorption.
Available Forms & Alternatives
Available Strengths:
- Acetaminophen 120mg Suppositories
- Acetaminophen 650mg Suppositories
- Acetaminophen 500mg Tablets
- Acetaminophen Child 160mg/5ml Susp
- Acetaminophen 500mg X/s Tablets
- Acetaminophen 500mg E/s Caplets
- Acetaminophen 160mg/5ml Solution
- Acetaminophen 325mg Tablets
- Acetaminophen 10mg/ml Inj, 100ml
- Acetaminophen 160mg/5ml Liquid
- Acetaminophen 500mg E/s Tablets
- Acetaminophen Child 160mg/5ml Susp
- Acetaminophen Infant 160mg/5ml Susp
- Acetaminophen 650mg ER Tablets
Dosing & Administration
Adult Dosing
Standard Dose:
Not typically used for adults; 120mg is a pediatric strength. Adult rectal doses are usually 650mg or higher.
Pediatric Dosing
Neonatal:
Not established for routine use; consult physician. Dosing is highly individualized based on weight and gestational age.
Infant:
10-15 mg/kg/dose every 4-6 hours as needed, not to exceed 5 doses in 24 hours. For 120mg suppository, typically for infants 10-15 kg (22-33 lbs).
Child:
10-15 mg/kg/dose every 4-6 hours as needed, not to exceed 5 doses in 24 hours. For 120mg suppository, typically for children 10-15 kg (22-33 lbs).
Adolescent:
Not typically used for adolescents; higher strengths (e.g., 650mg) are more appropriate if rectal route is necessary.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed.
Moderate:
No adjustment needed.
Severe:
Consider increasing dosing interval to every 8 hours for CrCl < 30 mL/min.
Dialysis:
Acetaminophen is dialyzable. Administer dose after dialysis. Consider increasing dosing interval to every 8 hours.
Hepatic Impairment:
Mild:
Use with caution; consider reduced dose or extended interval.
Moderate:
Use with extreme caution; consider reduced dose or extended interval. Avoid if possible.
Severe:
Contraindicated due to risk of hepatotoxicity.
Pharmacology
Mechanism of Action
Acetaminophen's exact mechanism is not fully elucidated but is believed to involve inhibition of prostaglandin synthesis, primarily in the central nervous system (CNS), leading to analgesic and antipyretic effects. It has minimal anti-inflammatory effects.
Pharmacokinetics
Absorption:
Bioavailability:
Variable (20-90%) via rectal route, generally lower and slower than oral.
Tmax:
2-4 hours (rectal), highly variable.
FoodEffect:
Not applicable for rectal administration.
Distribution:
Vd:
0.95 L/kg
ProteinBinding:
10-25% at therapeutic concentrations; increases with overdose.
CnssPenetration:
Yes
Elimination:
HalfLife:
2-3 hours (adults), 2-5 hours (neonates/infants), 1.5-3 hours (children). May be prolonged in hepatic dysfunction or overdose.
Clearance:
Not readily available for rectal route, but overall clearance is primarily hepatic.
ExcretionRoute:
Renal (as glucuronide and sulfate conjugates, and cysteine and mercapturic acid conjugates of NAPQI).
Unchanged:
< 5%
Pharmacodynamics
OnsetOfAction:
30-60 minutes (rectal)
PeakEffect:
1-2 hours (analgesia), 2-4 hours (antipyresis) via rectal route.
DurationOfAction:
4-6 hours
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Difficulty urinating or changes in urine output
Severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis), characterized by:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, or eyes
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you encounter any of the following side effects or any other symptoms that concern you or do not go away, contact your doctor:
Upset stomach or vomiting
Trouble sleeping
Headache
Constipation
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Difficulty urinating or changes in urine output
Severe skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis), characterized by:
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Red or irritated eyes
+ Sores in the mouth, throat, nose, or eyes
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you encounter any of the following side effects or any other symptoms that concern you or do not go away, contact your doctor:
Upset stomach or vomiting
Trouble sleeping
Headache
Constipation
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Signs of liver damage: yellowing of skin or eyes (jaundice), dark urine, persistent nausea or vomiting, stomach pain, unusual tiredness.
- Signs of allergic reaction: rash, itching, swelling (especially of face/tongue/throat), severe dizziness, trouble breathing.
- Pain or fever worsening or lasting more than 3 days.
- New symptoms appearing.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
If you have liver disease, as this may affect your ability to take this medication.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine whether it is safe to take this medication in conjunction with your other medications and health issues.
Remember, do not start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
If you have liver disease, as this may affect your ability to take this medication.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine whether it is safe to take this medication in conjunction with your other medications and health issues.
Remember, do not start, stop, or adjust the dosage of any medication without first consulting your doctor to ensure your safety.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
To avoid potential liver problems, be cautious not to take other products that contain acetaminophen. Carefully check the labels of all medications and supplements to ensure you are not exceeding the recommended daily dose of acetaminophen.
Follow the dosage instructions precisely, and do not exceed the maximum daily dose of acetaminophen as directed. The recommended daily dose can vary, but it should not exceed 4,000 mg (milligrams) per day unless specifically advised by your doctor. However, certain individuals, such as those with liver problems or children, may require lower doses. If you are unsure about the appropriate dose for your specific situation, consult your doctor or pharmacist. If you suspect you have taken too much acetaminophen in a day, contact your doctor immediately, even if you are not experiencing any symptoms.
Before consuming alcohol, discuss the potential risks with your doctor.
Additionally, this medication may interfere with certain laboratory tests. Therefore, it is crucial to inform all your healthcare providers and laboratory personnel that you are taking this drug.
When administering this medication to children, note that different brands may have varying dosage recommendations. Consult your doctor before giving this medication to a child to ensure the correct dose is used.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. It is necessary to discuss the potential benefits and risks of taking this medication during these situations to make an informed decision about your health and the health of your baby.
To avoid potential liver problems, be cautious not to take other products that contain acetaminophen. Carefully check the labels of all medications and supplements to ensure you are not exceeding the recommended daily dose of acetaminophen.
Follow the dosage instructions precisely, and do not exceed the maximum daily dose of acetaminophen as directed. The recommended daily dose can vary, but it should not exceed 4,000 mg (milligrams) per day unless specifically advised by your doctor. However, certain individuals, such as those with liver problems or children, may require lower doses. If you are unsure about the appropriate dose for your specific situation, consult your doctor or pharmacist. If you suspect you have taken too much acetaminophen in a day, contact your doctor immediately, even if you are not experiencing any symptoms.
Before consuming alcohol, discuss the potential risks with your doctor.
Additionally, this medication may interfere with certain laboratory tests. Therefore, it is crucial to inform all your healthcare providers and laboratory personnel that you are taking this drug.
When administering this medication to children, note that different brands may have varying dosage recommendations. Consult your doctor before giving this medication to a child to ensure the correct dose is used.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. It is necessary to discuss the potential benefits and risks of taking this medication during these situations to make an informed decision about your health and the health of your baby.
Overdose Information
Overdose Symptoms:
- Early symptoms (within 24 hours): Nausea, vomiting, sweating, general discomfort, abdominal pain.
- Later symptoms (24-72 hours): Right upper quadrant abdominal pain, liver tenderness, jaundice, dark urine, signs of liver failure (e.g., confusion, bleeding tendencies).
What to Do:
Seek immediate medical attention. Call 911 or Poison Control (1-800-222-1222) right away, even if there are no symptoms. Treatment may involve activated charcoal (if within 1-2 hours of ingestion) and N-acetylcysteine (NAC) as an antidote.
Drug Interactions
Major Interactions
- Alcohol (chronic heavy use): Increases risk of hepatotoxicity.
- Warfarin: May enhance anticoagulant effect, increasing bleeding risk (especially with chronic high doses of acetaminophen).
Moderate Interactions
- Isoniazid: May increase risk of hepatotoxicity.
- Phenytoin, Carbamazepine, Phenobarbital, Rifampin (CYP inducers): May increase formation of toxic acetaminophen metabolite, increasing hepatotoxicity risk.
- Lamotrigine: Acetaminophen may reduce lamotrigine levels.
- Cholestyramine: May reduce acetaminophen absorption if given concurrently (not relevant for rectal route).
Monitoring
Routine Monitoring
Pain level/Fever
Frequency: As needed, before each dose and 1-2 hours after.
Target: Reduction in symptoms.
Action Threshold: If symptoms persist or worsen, re-evaluate treatment.
Signs of liver injury (e.g., jaundice, dark urine, abdominal pain)
Frequency: Daily, especially with prolonged use or high doses.
Target: Absence of symptoms.
Action Threshold: Discontinue drug and seek medical attention immediately.
Symptom Monitoring
- Pain relief
- Fever reduction
- Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
- Signs of liver damage (yellowing of skin/eyes, dark urine, persistent nausea/vomiting, stomach pain, unusual tiredness)
Special Patient Groups
Pregnancy
Acetaminophen is generally considered the analgesic and antipyretic of choice during pregnancy when medically indicated. It crosses the placenta. While large observational studies have not shown a consistent pattern of increased risk for major birth defects, some studies have suggested a possible association with neurodevelopmental disorders in children with prolonged or high-dose exposure during pregnancy; however, these findings are not conclusive and require further research. Use the lowest effective dose for the shortest duration.
Trimester-Specific Risks:
First Trimester:
Generally considered low risk.
Second Trimester:
Generally considered low risk.
Third Trimester:
Generally considered low risk.
Lactation
Acetaminophen is considered compatible with breastfeeding. It is excreted into breast milk in small amounts, but adverse effects on breastfed infants are not expected at therapeutic doses. It is the preferred analgesic/antipyretic for breastfeeding mothers.
Infant Risk:
Low risk (L1)
Pediatric Use
Acetaminophen 120mg suppositories are primarily indicated for pediatric use, especially in infants and young children who cannot take oral medication. Dosing must be carefully calculated based on weight (10-15 mg/kg/dose) and age, and the maximum daily dose should not be exceeded to prevent hepatotoxicity. Rectal absorption can be variable.
Geriatric Use
No specific dose adjustment is typically required for elderly patients with normal renal and hepatic function. However, elderly patients may be more susceptible to adverse effects, and caution should be exercised, especially in those with pre-existing liver or kidney impairment. Start with the lowest effective dose.
Clinical Information
Clinical Pearls
- Rectal acetaminophen is useful when oral administration is not possible (e.g., vomiting, refusal, post-operative).
- Rectal absorption of acetaminophen can be slower and more variable than oral absorption, leading to delayed onset and potentially lower peak concentrations.
- Always confirm the child's weight for accurate dosing, as age-based dosing can be less precise.
- Educate caregivers on the importance of not exceeding the maximum daily dose and avoiding concomitant use of other acetaminophen-containing products.
- Monitor for signs of liver toxicity, especially with prolonged use or in patients with underlying liver conditions.
- Ensure proper insertion technique for suppositories (pointed end first, hold buttocks together for a few minutes).
Alternative Therapies
- Oral acetaminophen (liquid, chewable tablets)
- Oral ibuprofen (for pain and fever, generally not recommended for infants under 6 months without medical supervision)
- Topical cooling measures (for fever)
- Non-pharmacological pain relief (e.g., comfort measures, distraction)
Cost & Coverage
Average Cost:
$5 - $20 per 12 suppositories
Generic Available:
Yes
Insurance Coverage:
OTC (Over-the-Counter), generally not covered by insurance unless prescribed or part of a specific plan.
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.