Medication info

Amitapen Injection (Acetaminophen)

Prescription medicationInjections정맥
Ingredient · strength
Acetaminophen›1000mg / 100mL
Manufacturer / importer
(주)대웅제약
Appearance
A clear colorless to pale yellow solution in a plastic container for injection.
Packaging
100mL/pack
Approval status
Active

MFDS item code 202402794 · Approved 2024.11.26

Summary

Main use
Rapid relief treatment for moderate pain (post-surgery) and fever.
Who receives it
Adults · Children
Adult administration
For adults weighing over 50kg: Administer 1000mg as acetaminophen, 4 times a day. The dosage interval is at least 4 hours. The maximum daily dosage should not exceed 4 grams. For patients with severe renal impairment (creatinine clearance ≤30ml/min): The dosage interval should be at least 6 hours.
Child administration
For children over 33kg (approximately 11 years old) and adults under 50kg: Administer approximately 15mg/kg (this drug is 1.5ml/kg) as a single dose. The dosage interval is at least 4 hours.

Ingredients

Manufacturer
(주)대웅제약

Efficacy & effects

Rapid relief treatment for moderate pain (post-surgery) and fever.

  • Pain
  • high fever
  • moderate pain
  • fever
View approved original text

This medication is used when rapid administration via intravenous injection is necessary to relieve moderate pain, especially pain occurring after surgery, and to effectively reduce fever for a short period when other routes of administration are difficult.

How it is given

Adult administration

For adults weighing over 50kg: Administer 1000mg as acetaminophen, 4 times a day. The dosage interval is at least 4 hours. The maximum daily dosage should not exceed 4 grams. For patients with severe renal impairment (creatinine clearance ≤30ml/min): The dosage interval should be at least 6 hours.

Child administration

For children over 33kg (approximately 11 years old) and adults under 50kg: Administer approximately 15mg/kg (this drug is 1.5ml/kg) as a single dose. The dosage interval is at least 4 hours.

Precautions

This medication must be used as prescribed with precise dosing; an incorrect dose due to confusion between milligrams and milliliters can lead to serious poisoning or death. It is advisable to use appropriate analgesics as soon as oral medication can be administered. Be sure to check if acetaminophen is present in other medications to avoid overdose. Exceeding the recommended dose can lead to severe liver damage, so patients with liver dysfunction should consult a physician before use. Individuals who consume excessive alcohol should consult a specialist before taking this medication, as failure to do so increases the risk of liver damage. If sudden rashes, blisters, or severe allergic reactions occur, discontinue use immediately and inform healthcare personnel. This medication should not be taken by those who are allergic to it, have peptic ulcers, or have severe liver, kidney, or heart disease. Patients with certain asthma conditions or blood disorders, and those taking specific medications, should carefully consult their physicians before using this drug. Children, the elderly, pregnant women, and nursing mothers should use the minimum dose and monitor for adverse reactions, particularly observing their condition closely. Periodic examinations such as liver function tests or blood tests may be required. This drug should not be mixed with other medications and does not affect driving or machinery operation. Overdose may result in symptoms such as nausea, vomiting, appetite loss, and severe cases may lead to liver failure or coma, requiring immediate medical attention. Certain medications may interact with this drug, so it is essential to inform healthcare professionals if any medications are being taken.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), anaphylactic shock, hypersensitivity, acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, toxic epidermal necrolysis, generalized pustular dermatosis, angioedema, anaphylaxis, hypersensitivity requiring discontinuation of treatment, fulminant hepatitis, liver necrosis, liver failure, increased liver enzymes, agranulocytosis, neutropenia, leukopenia, thrombocytopenia, coma, acute renal failure, Lyell syndrome.

Mild side effects

  • Fatigue
  • low blood pressure
  • increased liver transaminase levels
  • nervous disorders
  • rash
  • injection site reactions
  • maculopapular rash
  • pemphigoid-like reactions
  • pustular rash
  • thrombocytopenia
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  • tachycardia
  • nausea
  • vomiting
  • erythema
  • flushing
  • itching
  • rash
  • urticaria
  • high anion gap metabolic acidosis
  • nausea
  • constipation
  • expectoration
  • sensory disturbances
  • dizziness
  • hemoglobin reduction
  • urinary disorders.

Not everyone experiences these, and they can vary from person to person.

Storage

Store this medication in a sealed container to prevent exposure to air, preferably at room temperature between 1°C to 30°C. This helps maintain the medication's effectiveness and safety.

Appearance and packaging

Appearance

A clear colorless to pale yellow solution in a plastic container for injection.

Package unit

100mL/pack

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.