Medication info

Ibuprofen Premix Injection (Ibuprofen)

Prescription medicationInjections
Ingredient · strength
Ibuprofen›400mg / 100mL
Manufacturer / importer
(주)보령바이오파마
Appearance
An injection filled in a clear plastic container with a colorless or pale yellow liquid.
Packaging
100 milliliters/vial
Approval status
Active

MFDS item code 202202366 · Notified 2022.06.07

Summary

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

Ingredients

Manufacturer
(주)보령바이오파마

Efficacy & effects

Moderate to severe pain control and antipyretic effect

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

This medication is used to control pain ranging from moderate to severe, particularly as an adjunct to narcotic analgesics. It is also effective for reducing fever. It helps alleviate pain and fever, thereby reducing the discomfort of patients and managing symptoms. Through these effects, it improves both pain and fever.

Dosage and Administration

Adult dosage

For adjunct therapy with narcotic analgesics (morphine) to control moderate to severe pain, administer intravenously 400 mg to 800 mg as needed at intervals of 6 hours. A maximum of 3,200 mg can be administered per day, with a minimum administration time of 30 minutes. For antipyretic, administer 400 mg intravenously as needed at intervals of 4-6 hours. Depending on the patient's condition, after the initial 400 mg administration, 100-200 mg may be administered every 4 hours.

Children's dosage

For antipyretic in children aged 6 months to under 12 years, administer intravenously starting at 10 mg/kg (maximum 400 mg) as needed at intervals of 4 to 6 hours, with a minimum administration time of 10 minutes. Maximum daily dosage is 40 mg/kg or 2,400 mg (the lower of the two doses).

Precautions

This medication may increase the risk of thrombosis, myocardial infarction, and stroke in patients with cardiovascular diseases or risk factors, therefore caution is needed. Particularly, patients with hypertension, congestive heart failure, ischemic heart disease, peripheral arterial disease, and cerebrovascular disease should use this medication carefully and avoid high doses. This medication can cause serious gastrointestinal adverse reactions such as gastrointestinal bleeding, ulcers, and perforation, thus elderly patients or those on prolonged therapy should take special caution. Patients with a history of gastrointestinal ulcers or bleeding, severe blood disorders, liver impairment, kidney impairment, cardiac failure, or hypertension should avoid using this medication for safety. Patients with bronchial asthma or hypersensitivity to aspirin and other non-steroidal anti-inflammatory drugs should also avoid use. It should not be used in the late stages of pregnancy due to the risk of premature closure of the ductus arteriosus in the fetus. Patients with blood disorders or bleeding tendencies, impaired liver or kidney function, elderly patients, pregnant women, and breastfeeding individuals should use this medication with caution. This drug may reduce the antiplatelet effect of aspirin, thus patients taking low-dose aspirin should exercise caution. Various serious adverse reactions can occur, including allergic reactions, skin rashes, liver dysfunction, kidney dysfunction, gastrointestinal bleeding, and blood disorders. If uncomfortable symptoms occur during use, immediate consultation with a healthcare professional is necessary. Do not exceed the recommended dose, and it is advisable not to use it concurrently with other non-steroidal anti-inflammatory drugs. Patients with hypertension should regularly monitor blood pressure while taking this medication, and those with impaired kidney function should avoid dehydration and closely monitor kidney function. If symptoms of liver dysfunction arise, discontinue use immediately and consult a healthcare professional. Severe allergic reactions such as anaphylaxis may occur, so emergency treatment should be sought if symptoms appear. During pregnancy, especially after 20 weeks, there is a risk of fetal kidney dysfunction and reduced amniotic fluid, so if necessary, use the minimum effective dose for a short duration. In cases of breastfeeding, consider that the medication may pass into breast milk and cause adverse reactions in infants, and consider either discontinuing breastfeeding or the medication. Safety for children under 6 months has not been established, so it is advisable not to use it. Elderly individuals may have decreased bodily function, hence dosing should be adjusted and closely monitored. In the event of an overdose, symptoms such as dizziness, nausea, vomiting, liver dysfunction, renal failure, dyspnea, hypotension, and other symptoms may appear, necessitating immediate cessation of use and medical treatment.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (angioedema, periorbital edema, facial swelling), chest tightness (angina), difficulty breathing, asthma attacks, dyspnea, cold sweat, pallor, severe rash with fever, blisters, skin peeling (exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, DRESS syndrome, AGEP), pain in oral/ocular mucosa, severe allergic reactions (anaphylaxis)

Mild side effects

  • Nausea
  • vomiting
  • abdominal distention
  • headache
  • loss of appetite
  • abdominal pain
  • dyspepsia
  • diarrhea
  • thirst
  • stomatitis
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  • constipation
  • black stools
  • rash
  • itching
  • drowsiness
  • dizziness
  • depression
  • palpitations
  • hypotension
  • hypertension
  • malaise
  • fever
  • epistaxis
  • edema
  • peripheral edema
  • periorbital edema
  • facial swelling
  • blurred vision
  • decreased vision
  • scotomas
  • color vision changes
  • hearing loss
  • tinnitus
  • altered taste
  • urticaria (less than 1%)
  • anemia
  • hemoglobin decrease

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 or humidity from entering. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius. This helps to preserve its effectiveness and safety for a longer time.

Appearance and packaging

Appearance

An injection filled in a clear plastic container with a colorless or pale yellow liquid.

Package unit

100 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.

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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.