Medication info

International Ceftriaxone Sodium Injection 500 milligrams

Prescription medication근육 · 정맥
Ingredient · strength
Ceftriaxone Sodium Hydrate›500mg / 1 vial
Manufacturer / importer
국제약품(주)
Appearance
A white to light yellow crystalline powder contained in vials.
Packaging
10 vials/box [(1 vial × 10)]
Approval status
Active

MFDS item code 199400351 · Notified 1994.05.23 · Insurance code 643700501

Summary

Main use
Treatment of infections in the respiratory system (pneumonia, bronchitis) and reproductive system (gonorrhea).
Who receives it
Adults · Children
Adult administration
Adults and children over 12 years: Administer 1–2g (potency) of ceftriaxone once daily via intravenous or intramuscular injection. In cases of severe illness or infection caused by moderately susceptible pathogens, the dosage can be increased up to 4g (potency) once daily. For the treatment of gonorrhea, a single intramuscular injection of 250mg (potency) is recommended. For prevention of infections before and after surgery, a single dose of 1–2g (potency) should be administered 30–90 minutes before surgery.
Child administration
Newborns (within 14 days of birth): Administer 20–50mg (potency) per kg of body weight once daily, not exceeding 50mg (potency) per kg of body weight. No need to differentiate between premature and full-term infants.

Ingredients

Manufacturer
국제약품(주)

Efficacy & effects

Treatment of infections in the respiratory system (pneumonia, bronchitis) and reproductive system (gonorrhea).

  • Pneumonia
  • bronchitis
  • otolaryngological infections
  • kidney infections
  • urinary tract infections
  • gonorrhea
  • sepsis
  • bone infections
  • joint infections
  • skin infections
  • wound infections
  • soft tissue infections
View approved original text

This medication is effective against various bacteria and is used for respiratory infections such as pneumonia and bronchitis, as well as for otolaryngological infections, kidney and urinary tract infections, and reproductive infections like gonorrhea. It is also helpful in preventing sepsis and infections before and after surgery. It is useful in treating gastrointestinal infections such as osteomyelitis, joint infections, skin and soft tissue infections, peritonitis, and cholecystitis. It can also be applied for managing infections in immunocompromised patients and is effective in treating meningitis. It is broadly used for various infections to improve patient symptoms and treat infections.

How it is given

Adult administration

Adults and children over 12 years: Administer 1–2g (potency) of ceftriaxone once daily via intravenous or intramuscular injection. In cases of severe illness or infection caused by moderately susceptible pathogens, the dosage can be increased up to 4g (potency) once daily. For the treatment of gonorrhea, a single intramuscular injection of 250mg (potency) is recommended. For prevention of infections before and after surgery, a single dose of 1–2g (potency) should be administered 30–90 minutes before surgery.

Child administration

Newborns (within 14 days of birth): Administer 20–50mg (potency) per kg of body weight once daily, not exceeding 50mg (potency) per kg of body weight. No need to differentiate between premature and full-term infants.

Precautions

This medication should not be mixed or administered simultaneously with solutions or medications containing calcium. Especially in newborns, this medication can form precipitate when combined with calcium, hence it should not be administered. Patients with an allergy to this medication or hypersensitivity to cephalosporins or penicillin antibiotics, as well as those allergic to certain local anesthetics, should not use it. Premature infants and newborns with problems related to bilirubin conjugation should also not receive this medication. Patients with a history of drug allergies or those with an allergic constitution, severely impaired kidney function, and elderly individuals should use this medication with caution, and dosage adjustments may be necessary. Side effects such as diarrhea, rash, blood abnormalities, liver dysfunction, headache, dizziness, bronchospasm, loose stools, nausea, vomiting, itching, hematuria, diabetes, phlebitis, injection site pain, fever, chills, increased serum creatinine, pseudomembranous colitis, granulocytopenia, anemia, coagulation disorders, thrombocytosis, agranulocytosis, hemolytic anemia, lymphocytopenia, prothrombin time prolongation, serum sickness, coordination dysfunction, and sensory effects may occur. If abnormal symptoms appear, consult a doctor immediately. To prevent the emergence of resistant bacteria, this medication should only be administered for the necessary duration after confirming susceptibility, and regular monitoring of liver and kidney function along with blood tests is recommended during treatment. In case of overdose, there is no specific antidote, so appropriate treatment should be provided according to symptoms, and caution is required during driving or operating machinery while on this medication. Pregnant or breastfeeding women should consult a doctor about the use of this medication, and it should not be used in newborns or premature infants due to the risk of bilirubin encephalopathy. This medication may interact with other drugs, so it is essential to inform healthcare providers of any other medications being taken, particularly those containing calcium or specific diuretics and aminoglycoside antibiotics. Prepared solutions should be used promptly and stored according to specified temperatures and periods.

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 high fever, blisters, peeling skin, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, breathing abnormalities with cough and fever, jaundice (yellowing of skin or eyes), generalized lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urinary issues.

Mild side effects

  • Eosinophilia
  • leukopenia
  • thrombocytopenia
  • diarrhea
  • rash
  • increased liver enzymes
  • headache
  • dizziness
  • bronchospasm
  • loose stools
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  • nausea
  • vomiting
  • itching
  • hematuria
  • diabetes
  • phlebitis
  • injection site pain
  • fever
  • chills
  • increased serum creatinine
  • pseudomembranous colitis
  • granulocytopenia
  • anemia
  • coagulation disorders
  • thrombocytosis
  • agranulocytosis
  • hemolytic anemia
  • lymphocytopenia
  • prothrombin time prolongation
  • serum sickness
  • coordination dysfunction
  • sensory effects.

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

Storage

This medication should be stored in a sealed container to prevent contact with air and should be kept away from direct sunlight at room temperature. Room temperature refers to an average temperature between 15 degrees and 25 degrees, and extremes of hot or cold should be avoided.

Appearance and packaging

Appearance

A white to light yellow crystalline powder contained in vials.

Package unit

10 vials/box [(1 vial × 10)]

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.