Medication info

Cefaxone Injection 500 mg (Sodium Ceftriaxone Hydrate)

Prescription medicationInjections근육 · 정맥
Ingredient · strength
Ceftriaxone Sodium Hydrate›500mg / 1 vial
Manufacturer / importer
신풍제약(주)
Appearance
White or pale yellow powder or colorless transparent vial injection.
Packaging
1 vial X 10
Approval status
Active

MFDS item code 199600054 · Notified 1996.12.30 · Insurance code 648501651

Summary

Main use
Treatment of respiratory (pneumonia, bronchitis) and genitourinary (gonorrhea) infections.
Who receives it
Adults · Children
Adult administration
Adults and children over 12 years should receive 1-2 g (potency) of ceftriaxone once daily via intravenous or intramuscular injection. In cases of severe illness or infections caused by moderately susceptible pathogens, the dose may be increased to 4 g (potency) once daily. Elderly patients may follow the adult dosage without change.
Child administration
Neonates (up to 14 days old) should receive 20-50 mg/kg (potency) once daily, not exceeding 50 mg/kg (potency). Infants, toddlers, and children (15 days to 12 years) should receive a dosage based on weight.

Ingredients

Manufacturer
신풍제약(주)

Efficacy & effects

Treatment of respiratory (pneumonia, bronchitis) and genitourinary (gonorrhea) infections.

  • Pneumonia
  • bronchitis
  • ear
  • nose
  • and throat infections
  • kidney infections
  • urinary tract infections
  • gonorrhea
  • sepsis
  • pre- and post-surgical infections
  • bone infections
  • joint infections
View approved original text

This medication is effective against various harmful bacteria and is used to treat respiratory infections such as pneumonia and bronchitis, as well as ear, nose, and throat infections. Additionally, it is effective for genitourinary infections, including kidney and urinary tract infections, gonorrhea, and for the prevention of surgical infections. It also aids in the treatment of bone and joint infections, as well as skin, wound, and soft tissue infections, and is applicable for gastrointestinal infections such as peritonitis, cholecystitis, and cholangitis. It is also used to treat infections and meningitis in patients with decreased immune function, improving patient health.

How it is given

Adult administration

Adults and children over 12 years should receive 1-2 g (potency) of ceftriaxone once daily via intravenous or intramuscular injection. In cases of severe illness or infections caused by moderately susceptible pathogens, the dose may be increased to 4 g (potency) once daily. Elderly patients may follow the adult dosage without change.

Child administration

Neonates (up to 14 days old) should receive 20-50 mg/kg (potency) once daily, not exceeding 50 mg/kg (potency). Infants, toddlers, and children (15 days to 12 years) should receive a dosage based on weight.

Precautions

This drug should not be mixed or administered simultaneously with calcium-containing solutions or drugs. In particular, when used in neonates, mixing this drug with calcium can cause precipitation and serious side effects. Those with a history of allergic reactions to this drug or hypersensitivity to cephalosporins or penicillin antibiotics should avoid its use. Furthermore, it should be avoided in premature infants or neonates with jaundice, hypoalbuminemia, or acidosis. Caution is advised when administering this drug to patients with a history of drug allergies or those prone to allergic reactions such as bronchial asthma, rashes, or urticaria. Patients with severely impaired kidney function may require dosage adjustments due to higher drug concentrations. This drug may cause decreased blood cell counts or impaired liver function, and skin reactions such as diarrhea or rashes may occur. In severe cases, acute allergic reactions such as shock or anaphylaxis may occur, and if symptoms appear, administration should be stopped immediately and treatment sought. This drug should only be used for the necessary duration to prevent the emergence of resistant bacteria, and regular monitoring of liver and kidney function and blood status during treatment is important. Particularly, when administering more than 1 gram per day, symptoms of precipitation in the gallbladder should be observed closely. In case of overdose, as there is no specific antidote, treatment should be symptomatic, and caution should be taken due to potential side effects like dizziness when driving or operating machinery. This drug may interact with other medications, especially diuretics, aminoglycoside antibiotics, and vitamin K antagonists, necessitating careful monitoring of kidney function and bleeding risks during co-administration. Pregnant or breastfeeding women should use this drug only when absolutely necessary, under doctor supervision, as its safety has not been fully established, and it should not be used in neonates or premature infants due to the risk of bilirubin encephalopathy. Elderly patients should be observed closely and dosage intervals adjusted due to increased susceptibility to adverse reactions. This drug may result in false positives for glucose in urine tests, necessitating careful testing methods, and may affect blood glucose measurements, so accurate testing methods should be used. During administration, care should be taken with the preparation of the injection, injection sites, and injection speed to reduce the risk of phlebitis or injection site pain, and it must be administered separately from calcium-containing solutions. Furthermore, it should not be mixed with other antibiotics in the same syringe. The prepared solution should be used within 6 hours at room temperature or within 24 hours if refrigerated, and color changes do not affect its efficacy.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), cold sweat, pallor, high fever with severe rash, blisters, painful mucous membranes in mouth/eyes, difficulty breathing or shortness of breath, asthma attack, respiratory distress with cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, lightning headache, seizures, confusion of consciousness, visual disturbances, paralysis, markedly reduced urine output, systemic effects.

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
  • edema
  • chills
  • increased serum creatinine
  • stomatitis
  • candidiasis
  • symptoms of vitamin K deficiency
  • symptoms of vitamin B group deficiency
  • ventricular extrasystole
  • sweating
  • flushing
  • palpitations
  • nosebleeds
  • hypotension
  • stomatitis
  • glossitis
  • seizures.

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

Storage

This drug should be stored in a tightly sealed container to prevent exposure to air or moisture and is best kept in a cool place at temperatures below 25 degrees. Proper storage maintains the drug's effectiveness over time.

Appearance and packaging

Appearance

White or pale yellow powder or colorless transparent vial injection.

Package unit

1 vial X 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.