Medication info

Amobuprofen Injection (Ibuprofen)

Prescription medication
Ingredient · strength
Ibuprofen›100mg / 1mL
Manufacturer / importer
(주)휴온스
Appearance
A colorless or pale yellow transparent injection solution contained in a colorless and transparent glass vial.
Packaging
4mL/vial x 10, 8mL/vial x 10
Approval status
Active

MFDS item code 201706379 · Notified 2017.07.31

Summary

Main use
Moderate to severe pain control and antipyretic effect
Who uses it
Adults · Children
Adult dosage
For moderate to severe pain control as adjunct therapy to narcotic analgesics (morphine), 400 mg-800 mg may be administered intravenously at intervals of 6 hours as needed. The minimum administration time should be over 30 minutes, and the maximum daily dose can be 3,200 mg. For fever reduction, 400 mg may be administered intravenously at intervals of 4-6 hours, and based on the patient's condition, 100-200 mg may be given every 4 hours after the initial 400 mg dose.
Children's dosage
For children aged 6 months to under 12 years, 10 mg/kg per dose (maximum 400 mg) may be administered intravenously at intervals of 4-6 hours as needed, with a minimum administration time of over 10 minutes. The maximum daily dose is 40 mg/kg or 2,400 mg (whichever is lower).

Ingredients

Manufacturer
(주)휴온스

Efficacy & effects

Moderate to severe pain control and antipyretic effect

  • Moderate pain
  • severe pain
  • fever
View approved original text

This medication is used as an adjunct therapy to control moderate to severe pain. Additionally, it has antipyretic effects to reduce fever, helping to alleviate discomfort. Such drugs contribute to pain relief and temperature regulation, effectively improving the symptoms for patients.

Dosage and Administration

Adult dosage

For moderate to severe pain control as adjunct therapy to narcotic analgesics (morphine), 400 mg-800 mg may be administered intravenously at intervals of 6 hours as needed. The minimum administration time should be over 30 minutes, and the maximum daily dose can be 3,200 mg. For fever reduction, 400 mg may be administered intravenously at intervals of 4-6 hours, and based on the patient's condition, 100-200 mg may be given every 4 hours after the initial 400 mg dose.

Children's dosage

For children aged 6 months to under 12 years, 10 mg/kg per dose (maximum 400 mg) may be administered intravenously at intervals of 4-6 hours as needed, with a minimum administration time of over 10 minutes. The maximum daily dose is 40 mg/kg or 2,400 mg (whichever is lower).

Precautions

This medication may increase the risk of serious cardiovascular issues such as myocardial infarction and stroke in patients with cardiovascular diseases or risk factors. Caution is advised. Long-term use or high doses of this medication may lead to serious gastrointestinal issues such as bleeding, ulcers, or perforation, especially in elderly patients or those with a history of gastrointestinal conditions. Patients with gastrointestinal ulcers or bleeding, severe liver or kidney impairment, severe heart failure, hypertension, bronchial asthma, or aspirin hypersensitivity should not take this medication. Patients with blood disorders or tendency to bleed, liver cirrhosis, kidney impairment, heart disease, hypertension, systemic lupus erythematosus, ulcerative colitis, Crohn's disease, the elderly, pregnant women, nursing mothers, etc. should exercise extreme caution when using this medication and follow medical advice. Various side effects may occur, such as severe allergic reactions, skin rashes, liver dysfunction, blood disorders, respiratory distress, visual disturbances, and aseptic meningitis, so any abnormal symptoms should be reported to a healthcare professional immediately. It is safe to use this medication at the minimum effective dose for the shortest duration without exceeding the recommended dose, and patients with hypertension or heart failure should closely monitor blood pressure and fluid status during treatment. This medication may interact with other non-steroidal anti-inflammatory drugs, aspirin, anticoagulants, ACE inhibitors, diuretics, lithium, methotrexate, selective serotonin reuptake inhibitors, etc., so anyone taking other medications should inform their healthcare provider. It should not be used after 30 weeks of pregnancy due to the risk of ductus arteriosus closure, and caution is needed when nursing as the drug can transfer to breast milk and affect the baby. Safety and efficacy have not been established for children under 6 months, and elderly patients require careful dosage adjustment and close monitoring due to diminished bodily functions. In cases of overdose, severe symptoms such as dizziness, vomiting, liver dysfunction, kidney failure, respiratory distress, and hypotension may occur, so if suspected, use should be stopped immediately and medical treatment should be sought.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweats, pallor, anaphylaxis, severe rash with high fever, blisters, skin peeling, mucosal pain in the mouth/eyes, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), DRESS syndrome, acute generalized exanthematous pustulosis, asthma attacks, respiratory distress, wheezing, jaundice of the skin or eyes, hepatitis, liver dysfunction

Mild side effects

  • Nausea
  • vomiting
  • bloating
  • headache
  • dyspepsia
  • diarrhea
  • thirst
  • abdominal pain
  • abdominal distension
  • constipation
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  • stomatitis
  • oral ulcers
  • taste disturbances
  • dizziness
  • drowsiness
  • depression
  • lethargy
  • fever
  • nosebleeds
  • epistaxis
  • facial swelling
  • periorbital edema
  • hematuria
  • increased urinary protein
  • elevated serum creatinine
  • hyperkalemia
  • hypokalemia
  • hypoproteinemia
  • anemia
  • decreased hemoglobin
  • decreased hematocrit
  • thrombocytopenia
  • impaired platelet function
  • leukopenia

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

Storage

This medication should be stored in a sealed container to protect it from air, at room temperature between 1 degree and 30 degrees. Proper storage maintains the drug's effectiveness and ensures safe use.

Appearance and packaging

Appearance

A colorless or pale yellow transparent injection solution contained in a colorless and transparent glass vial.

Package unit

4mL/vial x 10, 8mL/vial x 10

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.