acetaminophen rectal

Acetaminophen rectal is an analgesic and antipyretic suppository that is rectally administered to relieve pain and fever.

Acetaminophen rectal is available over the counter (OTC) and is typically used in children and adults who are unable to take it orally. Acetaminophen temporarily reduces fever and relieves minor pains, aches and headaches, but it does not reduce swelling or inflammation.

Acetaminophen rectal blocks pain impulse generation by inhibiting the cyclooxygenase (COX-1 and COX-2) enzymes involved in the synthesis of prostaglandin in the central nervous system (CNS). Prostaglandin is a natural substance in the body that initiates inflammation and release of inflammatory substances. Acetaminophen rectal reduces fever by acting on the hypothalamus region of the brain which regulates temperature.

• Do not use acetaminophen rectal if you are hypersensitive to any of the components in the formulation.
• Check with your physician before using OTC acetaminophen rectal if you have liver disease.
• Check with your physician before using acetaminophen rectal if you are taking warfarin or any other blood-thinning medication.
• The risk for liver damage is higher with chronic high doses or alcoholism.
• Use acetaminophen with caution in patients with G6PD enzyme deficiency, a genetic disorder.
• There have been rare reports of life-threatening skin reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP) with symptoms such as blisters, rash and redness. Discontinue treatment if such symptoms develop.

Common side effects of acetaminophen rectal include:

• Rectal discomfort
• Hypersensitivity reactions, including:
  • Itchy rash with red bumps (pruritic maculopapular rash)
  • Hives (urticaria)
  • Swelling in the tissue under the skin or mucous membranes (angioedema)
  • Severe hypersensitivity reaction (anaphylaxis)
  • Swelling of the voice box (laryngeal edema)
• Increase in bilirubin, alkaline phosphatase levels
• Kidney disease from long-term analgesic use (analgesic nephropathy)
• Kidney toxicity with chronic overdose (nephrotoxicity)
• Decrease in chloride, glucose, and uric acid
• Decrease in bicarbonate, sodium, calcium
• Blood disorders including:
  • Severely low level of granulocyte immune cells (agranulocytosis)
  • Low count of leukocyte immune cells (leukopenia)
  • Low count of neutrophil immune cells (neutropenia)
  • Low count of all types of blood cells (pancytopenia)
  • Low platelet count (thrombocytopenia)
  • Easy bruising and bleeding due to thrombocytopenia (thrombocytopenic purpura)

Call your doctor immediately if you experience any of the following symptoms or serious side effects while using this drug:

• Serious heart symptoms include fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness;
• Severe headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady;
• Severe nervous system reaction with very stiff muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, and feeling like you might pass out; or
• Serious eye symptoms include blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights.

This is not a complete list of all side effects or adverse reactions that may occur from the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.

Suppository

• 80 mg
• 120 mg
• 325 mg
• 650 mg

Adult:

Antipyretic/Analgesic

• 325-650 mg rectally every 4-6 hours as needed
• Not to exceed 4 g/day

Pediatric:

Antipyretic/Analgesic

• Children 3 months to 1 year: 80 mg rectally every 6 hours as needed
• Children 1-3 years: 80 mg rectally every 4 hours as needed
• Children 3-6 years: 120 mg rectally every 4-6 hours as needed
• Children 6-12 years: 325 mg rectally every 4-6 hours as needed
• Children over 12 years: As adults; 325-650 mg rectally every 4-6 hours as needed.

Maximum daily dose

• Children under 12 years: Not to exceed 5 doses/24 hours
• Children over 12 years: Not to exceed 4 g/day

Administration

• Patient should lie on the left side with knees bent
• Remove protective wrap before inserting
• Gently insert the tip into rectum with slight side-to-side movement (tip of suppository pointing toward navel)

Overdose

• Acetaminophen overdose can damage the liver and cause severe adverse effects with symptoms that include nausea, vomiting, loss of appetite, sweating, abdominal pain, extreme tiredness, yellowing eyes and skin, dark urine, agitation, confusion, hallucinations, and seizures. Acetaminophen can also be toxic to the kidneys.
• Overdose treatment may include administration of N-acetylcysteine (NAC), an antidote to acetaminophen, and other symptomatic and supportive measures as needed.

Inform your doctor of all medications you are currently taking, who can advise you on any possible drug interactions. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor’s recommendation.

• Acetaminophen rectal has no listed severe interactions with other drugs.
• Serious interactions of acetaminophen rectal include:
  • lonafarnib
• Moderate interactions of acetaminophen rectal include:
  • avapritinib
  • axitinib
  • eltrombopag
  • finerenone
  • flibanserin
  • imatinib
  • isavuconazonium sulfate
  • isoniazid
  • ivacaftor
  • lemborexant
  • levonorgestrel oral/ethinylestradiol/ferrous bisglycinate
  • lomitapide
  • midazolam intranasal
  • mipomersen
  • tazemetostat
  • tetracaine
  • tinidazole
  • warfarin
• Acetaminophen rectal has mild interactions with at least 52 different drugs.

The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.

It is important to always tell your doctor, pharmacist, or health care provider about all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of the information. Check with your doctor or healthcare provider if you have any questions about the medication.

• Acetaminophen crosses the placenta. It is acceptable for short-term use during pregnancy.
• Acetaminophen is present in breast milk. It is compatible with breastfeeding, use with caution.
• Do not use any OTC drugs, including acetaminophen rectal, without first checking with your healthcare provider, if you are pregnant or breastfeeding.

• Acetaminophen rectal is for rectal use only, do not swallow.
• Use acetaminophen rectal exactly as prescribed, or as per label instructions if using OTC acetaminophen suppository.
• Avoid higher doses and more frequent use than recommended. Do not exceed daily recommended dosage and do not use for prolonged periods.
• Avoid overdose by checking product labels carefully. Acetaminophen is found in many dosage forms and many combination products. Check with the pharmacist or a physician if you are not sure whether a medication contains acetaminophen.
• Discontinue acetaminophen rectal immediately if you develop hypersensitivity reactions.
• Discontinue use and consult with your healthcare provider if your fever lasts for longer than 3 days or recurs, or if pain lasts for longer than 5 days continuously or recurs.
• Discontinue use and check with your physician if you develop severe skin reactions.
• Avoid or limit intake of alcohol while on treatment with acetaminophen rectal.
• Store safely out of reach of children.
• In case of overdose, seek immediate medical help or contact Poison Control.