Medication info

Ceftriaxone Sodium Injection 1 Gram

Prescription medication근육 · 정맥Expired
Ingredient · strength
Ceftriaxone Sodium Hydrate›1g / 1 vial
Manufacturer / importer
한국신텍스제약(주)
Appearance
A vial containing a white to pale yellow powder.
Packaging
1 gram X 1 vial, 1 gram X 10 vials
Approval status
Expired

MFDS item code 202002043 · Notified 2020.03.24

This product's status changed to Expired on 2025.03.24. 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 of age 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 up to 4 g (potency) once daily. For treatment of gonorrhea, a single intramuscular injection of 250 mg (potency) is recommended. To prevent infections before and after surgery, an administration of 1-2 g (potency) is recommended as a single dose 30-90 minutes prior to the procedure.
Child administration
For newborns (within 14 days of birth), administer 20-50 mg (potency) per kg of body weight once daily, not exceeding 50 mg (potency). For infants and children (from 15 days to 12 years), administer 20-

Ingredients

Manufacturer
한국신텍스제약(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
  • bone infections
  • joint infections
  • skin infections
  • wound infections
  • soft tissue infections
View approved original text

This medication is used to treat various infections caused by a wide range of bacteria. It is particularly effective against respiratory infections such as pneumonia and bronchitis, as well as ENT infections. It is also applicable for kidney and urinary tract infections, gonorrhea, and is used in the treatment of sepsis and meningitis. It helps prevent infections before and after surgery and aids in the treatment of bone, joint, skin, and soft tissue infections. It is widely used for gastrointestinal infections such as peritonitis, cholecystitis, cholangitis, and in immunocompromised patients.

How it is given

Adult administration

Adults and children over 12 years of age 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 up to 4 g (potency) once daily. For treatment of gonorrhea, a single intramuscular injection of 250 mg (potency) is recommended. To prevent infections before and after surgery, an administration of 1-2 g (potency) is recommended as a single dose 30-90 minutes prior to the procedure.

Child administration

For newborns (within 14 days of birth), administer 20-50 mg (potency) per kg of body weight once daily, not exceeding 50 mg (potency). For infants and children (from 15 days to 12 years), administer 20-

Precautions

This medication should not be mixed or administered simultaneously with calcium-containing solutions. In particular, it must not be used with calcium in newborns, as precipitates can form, risking serious side effects. Patients with hypersensitivity to this medication or allergies to cephalosporins and penicillins should not use it. Furthermore, it should not be given to premature infants or newborns with issues related to bilirubin binding, as it may cause bilirubin encephalopathy. Patients with a history of drug allergies, bronchial asthma, or urticaria should use this medicine with caution, and those with impaired kidney function may need dose adjustments. Additionally, patients at risk for vitamin K deficiency should have their coagulation status monitored regularly and supplement with vitamin K as necessary. During administration of this drug, various side effects such as rash, diarrhea, headache, dizziness, blood abnormalities, and liver function abnormalities may occur, so any unusual symptoms should be reported to a healthcare professional immediately. Although rare, severe allergic reactions or shock can occur, requiring careful observation. If diarrhea occurs during antibiotic treatment, consider Clostridium difficile infection and appropriate treatment is required. Additionally, patients with severe renal impairment or the elderly may experience neurological adverse reactions and should be administered with caution. This medication may interact with other antibiotics or diuretics, so it is important to inform the healthcare provider of all medications being taken. Pregnant or breastfeeding women should consult their physician before administration. Injection may cause pain or inflammation at the injection site, so care must be taken regarding the injection method and speed, and prepared solutions should be used as soon as possible. Be cautious of potential dizziness while driving or operating machinery.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), shock, anaphylaxis and anaphylactoid reactions, severe allergic reactions, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, kernicterus due to elevated bilirubin, serious neurological symptoms (encephalopathy, seizures, generalized muscle tremors, non-convulsive status epilepticus), acute renal failure, severe skin adverse reactions, severe hypersensitivity reactions, severe hemolytic anemia, agranulocytosis.

Mild side effects

  • Eosinophilia
  • leukopenia
  • thrombocytopenia
  • diarrhea
  • rash
  • elevated liver enzymes
  • headache
  • dizziness
  • bronchial spasm
  • loose stools
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  • nausea
  • vomiting
  • itching
  • hematuria
  • diabetes
  • phlebitis
  • injection site pain
  • fever
  • edema
  • chills
  • increased blood creatinine
  • stomatitis
  • candidiasis
  • symptoms of vitamin K deficiency
  • symptoms of vitamin B deficiency
  • ventricular ectopy
  • sweating
  • flushing
  • palpitations
  • nosebleeds
  • hypotension
  • pancreatitis
  • glossitis
  • coordination issues.

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

Storage

This medicine should be stored in a sealed container to prevent exposure to air, and it is best kept at a temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

A vial containing a white to pale yellow powder.

Package unit

1 gram X 1 vial, 1 gram X 10 vials

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.