Medication info

Crystal Ibuprofen Injection

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

MFDS item code 202202473 · Approved 2022.06.13

Summary

Main use
Moderate to severe pain relief and antipyretic effect
Who uses it
Adults · Children
Adult dosage
Adults can be administered up to a maximum of 3200 mg per day. (1) Adjunctive therapy for moderate to severe pain management with opioids (morphine) Adults (17 years and older): Administer 400 mg-800 mg intravenously every 6 hours as needed. The maximum daily dose can be up to 3200 mg. The administration time should be more than 30 minutes. (2) Antipyretic Adults (17 years and older): 400 mg as needed
Children's dosage
Fever reduction for children (ages 6 months to under 17 years): - For ages 6 months to under 12 years: Administer 10 mg/kg (maximum 400 mg) intravenously every 4–6 hours as needed. The administration time is

Ingredients

Manufacturer
(주)휴온스생명과학

Efficacy & effects

Moderate to severe pain relief and antipyretic effect

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

This medication is used as an adjunctive treatment with opioid analgesics to help control pain from moderate to severe. It also has an antipyretic effect to reduce fever, effectively alleviating both pain and fever simultaneously. Therefore, it is primarily used for pain relief and temperature regulation.

Dosage and Administration

Adult dosage

Adults can be administered up to a maximum of 3200 mg per day. (1) Adjunctive therapy for moderate to severe pain management with opioids (morphine) Adults (17 years and older): Administer 400 mg-800 mg intravenously every 6 hours as needed. The maximum daily dose can be up to 3200 mg. The administration time should be more than 30 minutes. (2) Antipyretic Adults (17 years and older): 400 mg as needed

Children's dosage

Fever reduction for children (ages 6 months to under 17 years): - For ages 6 months to under 12 years: Administer 10 mg/kg (maximum 400 mg) intravenously every 4–6 hours as needed. The administration time is

Precautions

This medication should be used with caution in patients with cardiovascular diseases or risk factors, as serious cardiovascular issues such as myocardial infarction or stroke may occur. It may cause serious gastrointestinal adverse reactions such as bleeding, ulcers, and perforations, so elderly patients or those on long-term treatment should be particularly careful. Patients with a history of gastrointestinal ulcers or bleeding, severe liver or kidney impairment, severe hypertension, heart failure, or asthma should not take this medication. Patients with blood disorders, cirrhosis, kidney impairment, cardiac dysfunction, hypertension, systemic lupus erythematosus, ulcerative colitis, Crohn's disease, etc., should use this medication with caution. Pregnant women should not take this medication during late pregnancy due to the risk of ductus arteriosus closure in the fetus, and administration is recommended at the lowest dose and for the shortest duration after mid-pregnancy due to the risk of fetal renal dysfunction and oligohydramnios. Care should be taken as this medication may reduce the cardioprotective effects of aspirin and increase the risk of gastrointestinal bleeding when taken together with aspirin. Adverse effects may include allergic reactions, skin rashes, liver dysfunction, kidney impairment, blood disorders, gastrointestinal issues, difficulty in breathing, headaches, and dizziness, and if symptoms occur, immediate consultation with a doctor is advised. Patients with hypertension should frequently monitor their blood pressure while taking this medication, and patients with heart failure or edema should be cautious due to the potential worsening of fluid retention. It is recommended not to take this medication in conjunction with other non-steroidal anti-inflammatory drugs and not to exceed the recommended dose. In cases of overdose, severe symptoms such as dizziness, vomiting, abdominal pain, renal failure, difficulty in breathing, and hypotension may occur, so the patient should visit a medical institution immediately. Women who are breastfeeding should consider discontinuing breastfeeding or stopping the medication, as it can be transmitted through breast milk and may cause adverse reactions in infants. The safety and efficacy of this medication have not been established in infants under 6 months, and elderly patients require dose adjustments and close monitoring due to decreased body function.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in the mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities with cough + fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headaches, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

  • Nausea
  • vomiting
  • bloating
  • headaches
  • hemolysis
  • drowsiness
  • peripheral edema
  • urination disorders
  • anemia
  • decreased hemoglobin
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  • dyspepsia
  • wound hemolysis
  • abdominal discomfort
  • cough
  • hypokalemia
  • hypoalbuminemia
  • neutropenia
  • increased hematuria
  • hypernatremia
  • hypertension
  • hypoalbuminemia
  • hypotension
  • diarrhea
  • bacterial pneumonia
  • increased blood LDH
  • thrombocytosis
  • bacteremia
  • injection site pain
  • nausea
  • anemia
  • headache
  • fatigue
  • fever
  • nosebleeds
  • edema
  • peripheral blood

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 safe to store at room temperature between 1 and 30 degrees Celsius. Storing it this way helps maintain the medication's effectiveness and prevents degradation.

Appearance and packaging

Appearance

A colorless or pale yellow liquid filled in a colorless transparent plastic vial.

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.