Medication info

Ibefo Primix Injection (Ibuprofen)

Prescription medicationInjections
Ingredient · strength
Ibuprofen›400mg / 100mL
Manufacturer / importer
주식회사제뉴원사이언스
Appearance
A colorless or light yellow liquid filled in a colorless, transparent plastic container as an injectable solution.
Packaging
100 milliliters/vial, 200 milliliters/vial
Approval status
Active

MFDS item code 202201485 · Approved 2022.04.07

Summary

Main use
Effective for moderating and controlling moderate to severe pain and reducing fever.
Who uses it
Adults · Children
Adult dosage
For adjuvant therapy with opioid analgesics (morphine) for moderate to severe pain control, administer 400 mg to 800 mg intravenously every 6 hours as needed. The administration time should exceed 30 minutes, and the maximum daily dose can be 3200 mg. For antipyretic purposes, administer 400 mg intravenously every 4 to 6 hours as needed, and depending on the patient's condition, 400 mg can be administered initially, followed by every 4 hours.
Children's dosage
For children aged 6 months to under 12 years, administer intravenously starting at 10 mg/kg (maximum 400 mg), as needed, every 4 to 6 hours, for a duration of at least 10 minutes. The maximum daily dose is 40 mg.

Ingredients

Manufacturer
주식회사제뉴원사이언스

Efficacy & effects

Effective for moderating and controlling moderate to severe pain and reducing fever.

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

This medication is used as an adjuvant treatment for opioid analgesics to manage moderate to severe pain. It also has antipyretic effects that help to lower fever. It is effective in pain relief and temperature regulation, playing a crucial role in improving the patient's symptoms.

Dosage and Administration

Adult dosage

For adjuvant therapy with opioid analgesics (morphine) for moderate to severe pain control, administer 400 mg to 800 mg intravenously every 6 hours as needed. The administration time should exceed 30 minutes, and the maximum daily dose can be 3200 mg. For antipyretic purposes, administer 400 mg intravenously every 4 to 6 hours as needed, and depending on the patient's condition, 400 mg can be administered initially, followed by every 4 hours.

Children's dosage

For children aged 6 months to under 12 years, administer intravenously starting at 10 mg/kg (maximum 400 mg), as needed, every 4 to 6 hours, for a duration of at least 10 minutes. The maximum daily dose is 40 mg.

Precautions

This medication may increase the risk of serious thrombotic events such as myocardial infarction and stroke in patients with cardiovascular disease or risk factors. Caution is particularly needed for patients with cardiovascular issues such as hypertension, congestive heart failure, and ischemic heart disease, as careful use is required, and high doses should be avoided. This medication can cause serious gastrointestinal adverse reactions including gastrointestinal bleeding, ulcers, and perforation, so elderly patients or those on long-term therapy should be more cautious. It should not be administered to patients with a history of gastrointestinal ulceration or bleeding, severe liver, kidney, or heart dysfunction, or those who are hypersensitive to the components of this medication. Patients with bronchial asthma or allergic reactions to aspirin or other non-steroidal anti-inflammatory drugs should not use this medication. It should not be used in late pregnancy due to the risk of early closure of the ductus arteriosus in the fetus and should be avoided in patients undergoing high-dose methotrexate during cancer therapy. Patients with hematological abnormalities or tendencies to bleed, liver or kidney disease, cardiac dysfunction, hypertension, the elderly, etc., should use this drug cautiously. This medication may reduce the cardioprotective effect of aspirin and increase the risk of gastrointestinal adverse effects when combined, so caution is needed. While taking this medication, nausea, vomiting, headaches, skin rashes, respiratory difficulty, blood pressure changes, renal function abnormalities, and other adverse reactions may occur; therefore, symptoms should be closely monitored. Do not exceed the recommended dosage and avoid taking it with other non-steroidal anti-inflammatory drugs. Hypertensive patients should regularly check their blood pressure at the beginning and throughout the treatment period, and patients with fluid retention or edema should use it cautiously. Patients with decreased renal function should be attentive to symptoms of dehydration and consult healthcare professionals if renal function deterioration is suspected. If liver dysfunction is suspected, liver function tests should be conducted, and treatment should be discontinued if unusual symptoms arise. Patients on long-term therapy need regular blood tests for potential anemia or platelet function abnormalities. Allergic reactions or anaphylaxis may occur, so hypersensitive patients need to be especially cautious and receive immediate treatment if symptoms arise. If severe rashes or unusual symptoms occur, discontinue the medication immediately and consult a doctor. This medication may mask infection symptoms, so care should be taken in diagnosing suspected infections. Patients with asthma or aspirin hypersensitivity should avoid or use this medication cautiously. If ocular symptoms like blurred vision or decreased vision appear, discontinue use and seek examination. If symptoms of aseptic meningitis appear, their association with this medication should be investigated. There may be interactions with other medications taken concurrently, especially with aspirin, anticoagulants, ACE inhibitors, diuretics, lithium, methotrexate, and selective serotonin reuptake inhibitors. Pregnant women should avoid this medication in the late stages of pregnancy, especially after 30 weeks, and during the second trimester, the minimum dose and short-term use are recommended, monitoring the fetal condition. Nursing mothers should either discontinue breastfeeding or stop using this medication, as it may be transmitted through breast milk. This medication is not recommended for children under 6 months as its safety and efficacy have not been established. The elderly should have their doses adjusted and adverse reactions closely monitored due to decreased bodily function. In cases of overdose, serious symptoms such as dizziness, vomiting, liver dysfunction, renal failure, respiratory difficulty, and low blood pressure may occur, requiring immediate medical attention.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (including angioedema, periorbital swelling, facial swelling), chest tightness, difficulty breathing, respiratory distress, asthma attacks, hypertension, hypotension, anaphylaxis, anaphylactoid reactions, myocardial infarction, stroke, thrombotic events, heart failure, Conn's syndrome, shock, blood disorders (including aplastic anemia, hemolytic anemia, agranulocytosis, neutropenia), peptic ulcers, gastrointestinal bleeding, perforation.

Mild side effects

Headache, nausea, vomiting, abdominal pain, dyspepsia, diarrhea, drowsiness, dizziness, bloating, thirst, stomatitis, abdominal fullness, constipation, dark stool, wound hemolysis, dysgeusia, hearing loss, tinnitus, blurred vision, reduced vision, color vision changes, fatigue, fever, nasal bleeding, edema (including periorbital, facial swelling, and peripheral edema), hematuria, urinary protein, elevated serum creatinine, hypokalemia, hypoalbuminemia, increased platelets, decreased platelet function, anemia.

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

Storage

This medication should be stored in a sealed container to prevent air and moisture from entering, and it is best to keep it at room temperature between 1 to 30 degrees Celsius. Proper storage maintains the medication's effectiveness and prevents degradation.

Appearance and packaging

Appearance

A colorless or light yellow liquid filled in a colorless, transparent plastic container as an injectable solution.

Package unit

100 milliliters/vial, 200 milliliters/vial

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.