Medication info

Shinpoong Acetaminophen Injection

Prescription medicationInjections정맥
Ingredient · strength
Acetaminophen›1000mg / 100mL
Manufacturer / importer
신풍제약(주)
Appearance
A clear colorless to yellowish liquid contained in a plastic container for infusion.
Packaging
100 milliliters/pack
Approval status
Active

MFDS item code 202400384 · Approved 2024.02.22

Summary

Main use
Rapid short-term treatment of moderate pain (post-surgery) and fever.
Who receives it
Adults · Children
Adult administration
For adults weighing over 50 kg, administer 1,000 mg of acetaminophen intravenously over 15 minutes, 4 times a day, with a minimum dosing interval of 4 hours. The maximum daily dose should not exceed 4 grams. For children weighing 33 kg or more and adults weighing less than 50 kg, administer approximately 15 mg/kg (this product 1.5 ml/kg) of acetaminophen intravenously over 15 minutes.
Child administration
For children weighing 33 kg (about 11 years or older), administer 15 mg/kg (this product 1.5 ml/kg) of acetaminophen intravenously over 15 minutes, with a minimum dosing interval of 4 hours.

Ingredients

Manufacturer
신풍제약(주)

Efficacy & effects

Rapid short-term treatment of moderate pain (post-surgery) and fever.

  • Moderate pain
  • fever
View approved original text

This medication can be quickly administered intravenously to alleviate symptoms of pain or high fever. It is particularly used for the treatment of moderate pain occurring after surgery and short-term fever. It can be effectively used when administration by other routes is difficult, making it convenient. This medication can quickly improve the patient's pain and fever.

How it is given

Adult administration

For adults weighing over 50 kg, administer 1,000 mg of acetaminophen intravenously over 15 minutes, 4 times a day, with a minimum dosing interval of 4 hours. The maximum daily dose should not exceed 4 grams. For children weighing 33 kg or more and adults weighing less than 50 kg, administer approximately 15 mg/kg (this product 1.5 ml/kg) of acetaminophen intravenously over 15 minutes.

Child administration

For children weighing 33 kg (about 11 years or older), administer 15 mg/kg (this product 1.5 ml/kg) of acetaminophen intravenously over 15 minutes, with a minimum dosing interval of 4 hours.

Precautions

Care should be taken not to confuse the dosage units of milligrams and milliliters when administering this drug, as incorrect dosing can lead to severe toxicity or death. Once oral administration becomes possible, it is advisable to use appropriate analgesics immediately. To avoid overdosing this medication, it is essential to check if other medications being taken contain acetaminophen. Taking this medication in excess of the recommended dose may cause severe liver damage. Liver damage symptoms typically appear 2 to 6 days after administration, and if symptoms occur, immediate detoxification treatment should be received. Patients with poor liver function or liver disease should consult a doctor before taking this medication, and those who take high doses exceeding 1,500 milligrams daily for an extended period should have regular liver function tests. People who drink alcohol frequently should consult a doctor or pharmacist before taking this medication, as there is a risk of liver damage if they do not. After taking this medication, serious skin reactions such as acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, and toxic epidermal necrolysis may rarely occur, so if skin rashes or signs of hypersensitivity occur, administration should be stopped immediately. Patients with hypersensitivity to acetaminophen or this medication, those with peptic ulcers, severe blood disorders, liver dysfunction, severe renal impairment, severe cardiac function decline, aspirin-sensitive asthma, and those currently taking specific medications should not use this medication. Patients with liver or kidney disorders, peptic ulcers, blood disorders, bleeding tendencies, heart function anomalies, a history of hypersensitivity, bronchial asthma, the elderly, children, pregnant and breastfeeding women, long-term users of warfarin, those taking specific medications, chronic alcoholics, malnourished patients, and dehydrated individuals should use this medication with caution. Adverse reactions reported in clinical trials and post-marketing include malaise, hypersensitivity reactions, hypotension, shock, increased liver enzyme levels, decreased blood cells, neurological disorders, acute renal failure, skin rashes, and injection site reactions. This medication may interact with specific drugs, so caution should be exercised when used with probenecid, salicylamide, isoniazid, carbamazepine, phenobarbital, primidone, rifampicin, phenytoin, oral anticoagulants, and flucloxacillin, as there may be risks of hepatotoxicity or changes in drug effectiveness. It does not affect driving or machine operation, and should not be mixed with other medications. Children and the elderly should take the minimum dose and be monitored for adverse reactions. During pregnancy, administration should be done after carefully assessing the benefits and risks, and in breastfeeding, although a small amount may be excreted in breast milk, no adverse reaction reports exist. In patients with severely impaired kidney function, the excretion of this medication will be delayed, so it is advisable to space out administration by at least 6 hours. Signs of overdose may include nausea, vomiting, loss of appetite, pallor, abdominal pain, and in severe cases can result in liver cell destruction and brain disease, coma, or death, necessitating immediate visit to the hospital for detoxification treatment. This medication should not be stored at temperatures exceeding 30 degrees Celsius, and should be kept away from refrigeration or freezing. The outer packaging should be maintained, and prior to administration, the solution should be checked for foreign substances or discoloration. Unused solution should be discarded and is for single use only.

Side effects and when to seek care immediately

Serious side effects

Hypersensitivity reactions, shock, agranulocytosis, neutropenia, leukopenia, thrombocytopenia, coma, acute renal failure, Lyell's syndrome, acute generalized exanthematous pustulosis, toxic epidermal necrolysis, Stevens-Johnson syndrome, fulminant hepatitis, hepatic necrosis, hepatic failure, angioedema, anaphylactic shock, anaphylaxis, and hypersensitivity reactions requiring treatment discontinuation.

Mild side effects

  • Malaise
  • hypotension
  • increased liver transaminase levels
  • neurological disorders
  • maculopapular rash
  • injection site reactions
  • papular rash
  • similar to pemphigus reactions
  • pustular rash
  • nausea
Show 17 more
  • vomiting
  • headache
  • constipation
  • phlegm
  • sensory abnormalities
  • dizziness
  • reduced hemoglobin
  • urination abnormalities
  • thrombocytopenia
  • tachycardia
  • nausea
  • erythema
  • flushing
  • itching
  • rash
  • hives
  • and high anion gap metabolic acidosis.

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

Storage

Keep this medication sealed in a container that prevents air and moisture from entering, preferably stored at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the drug's effectiveness over time.

Appearance and packaging

Appearance

A clear colorless to yellowish liquid contained in a plastic container for infusion.

Package unit

100 milliliters/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.