Medication info

Aju Ceftriaxone Sodium Injection 1 Gram

Prescription medication근육 · 정맥Approval withdrawn
Ingredient · strength
Ceftriaxone Sodium Hydrate›1g / 1 vial
Manufacturer / importer
아주약품(주)
Appearance
<For Domestic Use> A brown vial containing white to pale yellow crystalline powder. <For Export> 1. A colorless vial containing white to pale yellow crystalline powder. 2. A colorless vial containing white to pale yellow crystalline powder.
Packaging
1, 10 vials [For Export: 1, 5, 10, 50 vials / Additive Solution: 10 mL × 1, 5, 10, 50 ampoules]
Approval status
Approval withdrawn

MFDS item code 199500575 · Notified 1995.04.06 · Insurance code 654001041

This product's status changed to Approval withdrawn on 2025.10.16. It may no longer be sold, so consult a doctor or pharmacist before taking it.

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 1–2 g (potency) of ceftriaxone intravenously or intramuscularly once a day. In the case of severe infections or infections caused by bacteria exhibiting moderate susceptibility, the dose may be increased to 4 g (potency) once a day. For gonorrhea treatment: A single intramuscular injection of 250 mg (potency) is recommended. For infection prevention before and after surgery: 1–2 g (potency) should be administered once 30–90 minutes before surgery. In conditions of renal and liver function.
Child administration
Neonates (within 14 days of birth): 20–50 mg/kg (potency) administered once daily, exceeding 50 mg (potency) is prohibited. Infants and children (15 days to 12 years): 20–80 mg/kg (potency) administered once daily.

Ingredients

Manufacturer
아주약품(주)

Efficacy & effects

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

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

This medication is effective against various bacteria and is used to treat respiratory infections such as pneumonia and bronchitis, as well as ENT infections like pharyngitis and otitis media. It is also effective for infections of the kidneys and urinary tract, including gonorrhea, and aids in the treatment of sepsis. It is used to prevent infections before and after surgery and for infections of the bones, joints, skin, and soft tissues, helping to prevent the spread of infections. It is suitable for patients with gastrointestinal infections such as peritonitis, cholecystitis, and cholangitis, and is also useful for treating infections in immunocompromised patients. Lastly, it is used for the treatment of meningitis, assisting in the management of various infections.

How it is given

Adult administration

Adults and children over 12 years: Administer 1–2 g (potency) of ceftriaxone intravenously or intramuscularly once a day. In the case of severe infections or infections caused by bacteria exhibiting moderate susceptibility, the dose may be increased to 4 g (potency) once a day. For gonorrhea treatment: A single intramuscular injection of 250 mg (potency) is recommended. For infection prevention before and after surgery: 1–2 g (potency) should be administered once 30–90 minutes before surgery. In conditions of renal and liver function.

Child administration

Neonates (within 14 days of birth): 20–50 mg/kg (potency) administered once daily, exceeding 50 mg (potency) is prohibited. Infants and children (15 days to 12 years): 20–80 mg/kg (potency) administered once daily.

Precautions

This medication should not be mixed with calcium-containing solutions or other drugs. In particular, it should never be administered to neonates when used in conjunction with calcium, as it can create precipitates leading to serious complications. Patients who are allergic to this medication or have shown hypersensitivity to cephalosporins or penicillin antibiotics should not use it. Moreover, it should not be administered to neonates or infants with bilirubin conjugation issues. Caution is advised for patients with a history of allergies, or those prone to allergic symptoms such as asthma or hives. Care should be taken when administering it to patients with severely impaired renal function, elderly patients, or those in poor general health, and regular liver and kidney function tests should occur during treatment. This medication can cause various side effects including eosinophilia, leukopenia, diarrhea, rash, liver enzyme elevation, and may rarely lead to severe allergic reactions, neurological abnormalities, or skin reactions. If symptoms such as fever, rash, difficulty breathing, or dizziness occur, administration should be stopped immediately and medical attention should be sought. It should only be administered for the necessary duration to prevent antibiotic resistance, and patient status should be closely monitored afterwards. Additionally, this medication may cause side effects such as dizziness that require caution when driving or operating machinery. Pregnant or nursing women should use this medication cautiously as it can impact the fetus or infant, and consultation with a doctor is advised. The risk of bilirubin encephalopathy prevents its use in neonates or preterm infants, and care should be taken with elderly patients due to the potential for bleeding tendencies. Regular blood tests and liver and kidney function tests should be conducted during administration, with caution advised for interactions with other medications. Specifically, co-administration with diuretics or aminoglycoside antibiotics may affect kidney function, requiring careful dosing. This medication should be used as soon as possible after preparation, and it's safest to use it within 6 hours at room temperature or within 24 hours when refrigerated.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), anaphylaxis and anaphylactoid reactions, severe skin reactions (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis), liver abnormalities (jaundice), encephalopathy, seizures, confusion, vision disturbances, paralysis, severe swelling, elevated blood pressure, markedly reduced urine output, acute renal failure, difficulty breathing, asthma attacks, respiratory problems, severe allergic reactions, shock

Mild side effects

Eosinophilia, leukopenia, thrombocytopenia, diarrhea, rash, liver enzyme elevation, headache, dizziness, bronchospasm, loose stools, nausea, vomiting, itching, hematuria, diabetes, thrombophlebitis, injection site pain, fever, edema, chills, increased serum creatinine, stomatitis, candidiasis, symptoms of vitamin K deficiency, symptoms of vitamin B group deficiency, ventricular ectopic beats, sweating, flushing, palpitations, nosebleeds, gastrointestinal symptoms (pancreatitis, stomatitis)

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

Storage

This medication should be stored in a light-protective sealed container at room temperature. The products used domestically should be stored in light-protective sealed containers, and those exported should be kept in sealed containers or light-protective sealed containers to maintain safety at room temperature.

Appearance and packaging

Appearance

<For Domestic Use> A brown vial containing white to pale yellow crystalline powder. <For Export> 1. A colorless vial containing white to pale yellow crystalline powder. 2. A colorless vial containing white to pale yellow crystalline powder.

Package unit

1, 10 vials [For Export: 1, 5, 10, 50 vials / Additive Solution: 10 mL × 1, 5, 10, 50 ampoules]

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.