Medication info

New Aminofen Primix Injection (Acetaminophen)

Prescription medication
Ingredient · strength
Acetaminophen›1g / 100mL
Manufacturer / importer
신라젠주식회사
Appearance
Clear, light yellow, transparent liquid filled in a colorless and transparent plastic container for injection
Packaging
50 milliliters/bag, 65 milliliters/bag, 75 milliliters/bag, 100 milliliters/bag
Approval status
Active

MFDS item code 202102323 · Approved 2021.03.15

Summary

Main use
Short-term treatment of moderate pain (post-operative) and fever
Who uses it
Adults · Children
Adult dosage
Adults weighing over 50 kg should be administered 1000 mg of acetaminophen 4 times a day. The dosing interval is at least 4 hours, and the maximum daily dose should not exceed 4 grams. Children weighing 33 kg or more and adults weighing less than 50 kg should be administered 15 mg/kg (1.5 mL/kg) per dose. The dosing interval is at least 4 hours, and the maximum daily dose should not exceed 60 mg/kg or 4 grams.
Children's dosage
Children weighing 10 kg to less than 33 kg (aged 2 years to under 11 years) should be administered 15 mg/kg (1.5 mL/kg) per dose. The dosing interval is at least 4 hours, and the maximum daily dose is 60 mg.

Ingredients

Manufacturer
신라젠주식회사

Efficacy & effects

Short-term treatment of moderate pain (post-operative) and fever

  • Pain
  • high fever
  • fever
View approved original text

This medication is used to rapidly alleviate moderate pain and fever after surgery in adults and children aged 11 years and older. It can also be administered to children aged 2 to under 11 years when there is a need for swift care of moderate pain. It is particularly effective in situations requiring intravenous administration or where other routes of administration are not available. Therefore, this medication is very useful for the short-term treatment of pain and fever following surgery.

Dosage and Administration

Adult dosage

Adults weighing over 50 kg should be administered 1000 mg of acetaminophen 4 times a day. The dosing interval is at least 4 hours, and the maximum daily dose should not exceed 4 grams. Children weighing 33 kg or more and adults weighing less than 50 kg should be administered 15 mg/kg (1.5 mL/kg) per dose. The dosing interval is at least 4 hours, and the maximum daily dose should not exceed 60 mg/kg or 4 grams.

Children's dosage

Children weighing 10 kg to less than 33 kg (aged 2 years to under 11 years) should be administered 15 mg/kg (1.5 mL/kg) per dose. The dosing interval is at least 4 hours, and the maximum daily dose is 60 mg.

Precautions

This medication carries a risk of overdose due to confusion between milligrams and milliliters during administration; therefore, the exact dosage must be verified. It is advisable to transition to an appropriate oral analgesic as soon as it is possible. Ensure to check if acetaminophen is included in other medications to avoid excessive intake. Exceeding the recommended dose can lead to serious liver damage, necessitating caution. Symptoms of liver damage usually appear between 4 to 6 days after administration, and rapid detoxification treatment is required. Patients with liver dysfunction must consult a physician before use and should undergo regular liver function tests if using high doses for an extended period. Individuals who consume multiple alcoholic beverages daily should consult a specialist before taking this medication; otherwise, liver damage may occur. Very rarely, serious skin reactions may occur, and if a rash or allergic symptoms appear, the medication should be stopped immediately. Patients with allergies to acetaminophen or this medication, as well as those with peptic ulcers, severe liver or kidney dysfunction, and severe blood disorders should not take this medication. Caution should be exercised for patients with liver or kidney dysfunction, elderly patients, pregnant women, nursing mothers, and patients on certain medications. This medication should not be mixed with other drugs, and children and elderly patients should use the minimum dose and be monitored for adverse reactions. Symptoms such as vomiting, abdominal pain, loss of appetite, etc., may occur in case of overdose, which can progress to severe liver failure or coma, requiring immediate medical attention. During pregnancy, the benefits and risks of this medication should be carefully evaluated before use, and it can be safely used while breastfeeding. This medication is primarily metabolized in the liver and excreted through urine; therefore, dosage adjustments may be necessary for patients with liver or kidney dysfunction. There may be interactions with other medications while taking this medication, so it is essential to inform healthcare professionals of any other medications being taken. When storing, keep in a sealed container at a cool place below 30 degrees Celsius, avoiding refrigeration or freezing. Before administration, check for impurities or discoloration; as this is a single-use medication, any remaining solution should be discarded.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), anaphylactic shock, anaphylaxis, acute generalized exanthematous pustulosis, toxic epidermal necrolysis, Stevens-Johnson syndrome, angioedema, fulminant hepatitis, liver necrosis, liver failure, acute kidney failure, agranulocytosis, neutropenia, leukopenia, thrombocytopenia, shock, coma, acute liver failure

Mild side effects

  • Abdominal pain
  • fatigue
  • low blood pressure
  • increased liver transaminase levels
  • neurological disorders
  • maculopapular rash
  • injection site reactions
  • erythema
  • flushing
  • itching
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  • rash
  • urticaria
  • high anion gap metabolic acidosis
  • nausea
  • vomiting
  • headache
  • constipation
  • phlegm
  • sensory abnormalities
  • dizziness
  • hemoglobin decrease
  • urinary disorders
  • nausea
  • tachycardia

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

Storage

This medication should be stored at room temperature between 1 and 30 degrees Celsius, and it is essential to keep it in a sealed container to prevent air or moisture from entering. Proper storage will help maintain the effectiveness of the medication for a longer period.

Appearance and packaging

Appearance

Clear, light yellow, transparent liquid filled in a colorless and transparent plastic container for injection

Package unit

50 milliliters/bag, 65 milliliters/bag, 75 milliliters/bag, 100 milliliters/bag

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.