Medication info

Amoburofen Primix Injection (Ibuprofen)

Prescription medicationInjections
Ingredient · strength
Ibuprofen›400mg / 104mL
Manufacturer / importer
(주)휴온스
Appearance
An injection filled with a clear colorless to pale yellow liquid in polypropylene and multilayer film plastic containers.
Packaging
104 mL/vial, 208 mL/vial
Approval status
Active

MFDS item code 202201732 · Approved 2022.04.28

Summary

Main use
Control of moderate to severe pain and antipyretic effect
Who uses it
Adults · Children
Adult dosage
As an adjunct therapy for control of moderate to severe pain with narcotic analgesics (morphine), administer 400 mg to 800 mg intravenously as needed every 6 hours, with a maximum daily dose of 3200 mg. Administration time must be more than 30 minutes. For antipyretic purposes, administer 400 mg intravenously as needed every 4-6 hours. Depending on the patient's condition, after the initial dose of 400 mg, it may be administered every 4 hours.
Children's dosage
For fever in children aged 6 months to under 12 years, administer 10 mg/kg initially (maximum 400 mg) intravenously as needed every 4-6 hours, with a minimum administration time of more than 10 minutes. Maximum per day.

Ingredients

Manufacturer
(주)휴온스

Efficacy & effects

Control of moderate to severe pain and antipyretic effect

  • Moderate pain
  • severe pain
View approved original text

This medication acts as an adjunct to narcotic analgesics in controlling moderate to severe pain, and is also used to reduce fever.

Dosage and Administration

Adult dosage

As an adjunct therapy for control of moderate to severe pain with narcotic analgesics (morphine), administer 400 mg to 800 mg intravenously as needed every 6 hours, with a maximum daily dose of 3200 mg. Administration time must be more than 30 minutes. For antipyretic purposes, administer 400 mg intravenously as needed every 4-6 hours. Depending on the patient's condition, after the initial dose of 400 mg, it may be administered every 4 hours.

Children's dosage

For fever in children aged 6 months to under 12 years, administer 10 mg/kg initially (maximum 400 mg) intravenously as needed every 4-6 hours, with a minimum administration time of more than 10 minutes. Maximum per day.

Precautions

This medication may affect the cardiovascular system; therefore, patients with heart disease or at risk of stroke should consult a doctor before use. Care is particularly needed for those with hypertension or heart failure, or those using it for a long time, as cardiovascular adverse reactions may occur. Serious gastrointestinal side effects such as gastrointestinal bleeding, ulcers, and perforations may occur, so patients with a history of gastrointestinal diseases should avoid its use. Elderly patients or those taking it for a long time are at higher risk of gastrointestinal adverse reactions and should be closely monitored. This medication is contraindicated for certain patients. For example, those with severe liver disorders, renal disorders, severe hypertension, severe heart failure, and those with hypersensitivity to any ingredients in this medication should not take it. Pregnant women in late pregnancy or those with hypersensitivity reactions to aspirin should also avoid its use. Patients with blood disorders or a tendency to bleed, those with impaired liver or kidney function, hypertension, or heart disease should use this medication with caution, and special care is required for pregnant or nursing women and the elderly. While taking this medication, unusual symptoms such as allergic reactions, difficulty breathing, skin rash, severe headache, visual disturbances, and reduced urination may occur, so if any of these symptoms arise, consult a doctor immediately. Do not exceed the recommended dosage, and avoid taking it together with other nonsteroidal anti-inflammatory drugs. Patients with hypertension should frequently monitor their blood pressure at the beginning and during treatment, as fluid retention or edema may occur. Patients with reduced kidney function should be cautious when taking this medication in a dehydrated state, as it may cause kidney damage, and if liver dysfunction is suspected, liver function tests should be conducted. Anemia may occur as observed in blood tests, so blood status should be monitored when taken long-term, and those at risk of bleeding should be cautious as it may affect platelet function. Severe allergic reactions such as anaphylaxis may occur; if symptoms such as difficulty breathing or rash develop after taking, immediate emergency treatment is necessary. This medication should not be taken during pregnancy after 30 weeks, as it may harm the fetus, nor should it be taken by nursing mothers due to the potential transfer of the drug into breast milk. Safety and efficacy have not been established for children under 6 months of age, so it is advisable not to use it for them. Elderly patients may require dosage adjustments and careful monitoring due to decreased bodily function. In cases of overdose, severe symptoms such as dizziness, vomiting, liver dysfunction, kidney failure, or difficulty breathing may occur, and immediate discontinuation and medical treatment are necessary. Finally, there may be interactions with other medications, so patients taking aspirin, anticoagulants, ACE inhibitors, diuretics, lithium, methotrexate, serotonin reuptake inhibitors, etc., should definitely consult with a doctor or pharmacist.

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 oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headaches, thunderclap headaches, seizures, confusion, visual abnormalities, paralysis, urinary changes.

Mild side effects

  • Nausea
  • vomiting
  • bloating
  • headache
  • diarrhea
  • indigestion
  • abdominal discomfort
  • drowsiness
  • dizziness
  • depression
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  • blurred vision
  • visual disturbances
  • scotoma
  • color vision changes
  • fatigue
  • fever
  • epistaxis
  • edema
  • peripheral edema
  • periorbital edema
  • facial edema
  • hematuria
  • proteinuria
  • elevated BUN
  • elevated serum creatinine
  • hyperkalemia
  • hypokalemia
  • hypoalbuminemia
  • thrombocytosis
  • elevated LDH
  • anemia
  • decreased hemoglobin
  • decreased hematocrit
  • anemia
  • urge to urinate.

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

Storage

This medication should be stored at room temperature between 1 to 30 degrees Celsius, in a sealed container to prevent air exposure. This helps maintain the drug's effectiveness for a longer period.

Appearance and packaging

Appearance

An injection filled with a clear colorless to pale yellow liquid in polypropylene and multilayer film plastic containers.

Package unit

104 mL/vial, 208 mL/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.