Medication info

Samsung Ibuprofen Premix Injection

Prescription medicationInjections
Ingredient · strength
Ibuprofen›400mg
Manufacturer / importer
삼성제약(주)
Appearance
A colorless or light yellow liquid filled in a colorless transparent plastic container for injection.
Packaging
100 milliliters/vial, 200 milliliters/vial
Approval status
Active

MFDS item code 202202348 · Approved 2022.06.07

Summary

Main use
Moderate to severe pain control and antipyretic effect
Who uses it
Adults · Children
Adult dosage
Used as an adjunct therapy for moderate to severe pain control with narcotic analgesics (morphine) at a dosage of 400 mg to 800 mg intravenously as needed at intervals of 6 hours. The maximum daily dose can be up to 3200 mg, and infusion time must be at least 30 minutes. For antipyretic purposes, 400 mg can be administered intravenously at intervals of 4-6 hours as needed. Depending on the patient's condition, after an initial 400 mg dose, additional doses may be administered at 4-hour intervals.
Children's dosage
From 6 months to under 12 years: Administer intravenously starting at 10 mg/kg (maximum 400 mg) as needed at intervals of 4-6 hours, with a minimum infusion time of 10 minutes. Maximum daily dose of 40 mg/kg or

Ingredients

Manufacturer
삼성제약(주)

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 for controlling moderate to severe pain in combination with narcotic analgesics, thereby enhancing pain relief effects. It is also effective as an antipyretic for use in cases of fever. In other words, this drug helps manage both pain and fever together.

Dosage and Administration

Adult dosage

Used as an adjunct therapy for moderate to severe pain control with narcotic analgesics (morphine) at a dosage of 400 mg to 800 mg intravenously as needed at intervals of 6 hours. The maximum daily dose can be up to 3200 mg, and infusion time must be at least 30 minutes. For antipyretic purposes, 400 mg can be administered intravenously at intervals of 4-6 hours as needed. Depending on the patient's condition, after an initial 400 mg dose, additional doses may be administered at 4-hour intervals.

Children's dosage

From 6 months to under 12 years: Administer intravenously starting at 10 mg/kg (maximum 400 mg) as needed at intervals of 4-6 hours, with a minimum infusion time of 10 minutes. Maximum daily dose of 40 mg/kg or

Precautions

This drug should be used with caution in patients with cardiovascular diseases or risk factors, as there is a higher risk of serious cardiovascular issues such as myocardial infarction and stroke. In addition, serious gastrointestinal side effects such as gastrointestinal bleeding or ulcers may occur, so the elderly or long-term users should be particularly careful. This medication should not be taken by individuals with a history of gastrointestinal ulcers or bleeding, severe liver or kidney impairment, severe hypertension, or allergies to any component of this drug. Those with bronchial asthma or who have experienced hypersensitivity reactions to aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) should not use this medication. During late pregnancy, it may pose risks to the fetus, so it should be avoided. Patients undergoing cancer treatment with high-dose methotrexate should also refrain from using this drug. Patients with blood disorders or tendencies to bleed, those with impaired liver or kidney function, the elderly, pregnant women, and nursing mothers should use this drug with caution. If serious allergic reactions or unusual symptoms such as nausea, vomiting, headache, skin rash, or respiratory difficulty occur during treatment, medical consultation should be sought immediately. In particular, patients with hypertension, heart failure, or impaired kidney function should closely monitor their blood pressure and fluid status when taking this drug. This drug should not be used in conjunction with other nonsteroidal anti-inflammatory drugs, and it is recommended to take the lowest effective dose for the shortest duration. Adverse interactions may occur when taken with aspirin, anticoagulants, ACE inhibitors, diuretics, lithium, and methotrexate, so it is paramount to inform healthcare professionals and take necessary precautions. During pregnancy, especially after 20 weeks, it may affect fetal kidney function, so amniotic fluid status should be monitored. In breastfeeding women, this medication may pass into breast milk, so considering discontinuation of breastfeeding or the medication itself is advised. Safety and effectiveness have not been established for children under 6 months, and the elderly may have decreased bodily functions, necessitating dose adjustment and close monitoring. In cases of overdose, serious symptoms such as dizziness, nausea, vomiting, kidney failure, respiratory difficulties, and hypotension may occur, and immediate medical attention should be sought if symptoms are suspected.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, peeling skin, pain in mouth/eyes mucous membranes, shortness of breath or difficulty breathing, asthma attacks, cough with fever and respiratory abnormalities, jaundice (yellowing of skin or eyes), profound malaise, sudden and intense headache, thunderclap headache, seizures, altered consciousness, vision abnormalities, paralysis, and urinary issues

Mild side effects

  • Nausea
  • vomiting
  • bloating
  • headache
  • hemolysis
  • drowsiness
  • indigestion
  • diarrhea
  • wound hemolysis
  • abdominal discomfort
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  • blurred vision
  • decreased vision
  • scotoma
  • color vision changes
  • dizziness
  • sleepiness
  • fever
  • malaise
  • epistaxis (nosebleed)
  • swelling (edema)
  • peripheral edema
  • urination disorders
  • anemia
  • decreased hemoglobin
  • hematuria
  • proteinuria
  • hypokalemia
  • hypoalbuminemia
  • thrombocytosis
  • increased blood LDH
  • thrombocytopenia
  • decreased hematocrit
  • and platelet dysfunction

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 and moisture. It is important to maintain a room temperature between 1 degree and 30 degrees.

Appearance and packaging

Appearance

A colorless or light yellow liquid filled in a colorless transparent plastic container for injection.

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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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.