Medication info

International Ceftriaxone Sodium Hydrate Injection 1 Gram

Prescription medication근육 · 정맥
Ingredient · strength
Ceftriaxone Sodium Hydrate›1g / 1 vial
Manufacturer / importer
국제약품(주)
Appearance
(For domestic use) A vial filled with white to light yellow crystalline powder. (For export) A colorless, transparent vial containing white to light yellow powder.
Packaging
10 vials/box [(1 vial × 10)]
Approval status
Active

MFDS item code 199400355 · Notified 1994.05.23 · Insurance code 643700481

Summary

Main use
Treatment of respiratory and reproductive infections, prevention of postoperative infections
Who receives it
Adults · Children
Adult administration
For adults and children over 12 years old, administer 1-2 g (potency) of ceftriaxone once daily via intravenous or intramuscular injection. For infections by pathogens with moderate susceptibility or in severe disease, the dose can be increased to 4 g (potency) once daily. For treatment of meningitis, adults, including elderly patients, should follow the adult dosage without modification. For the treatment of gonorrhea, a single intramuscular injection of 250 mg (potency) is advised.
Child administration
For newborns (up to 14 days old), 20-50 mg (potency) per kg of body weight is administered once daily, not exceeding 50 mg (potency). For infants and children (15 days to 12 years old), 20-

Ingredients

Manufacturer
국제약품(주)

Efficacy & effects

Treatment of respiratory and reproductive infections, prevention of postoperative infections

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

This drug is used to treat various infections including respiratory infections such as pneumonia and bronchitis, ENT infections, kidney and urinary tract infections, and reproductive infections such as gonorrhea and septicemia. It is also effective for the prevention of postoperative infections and the treatment of bone and joint infections, as well as skin, wound, and soft tissue infections. It is applicable for gastrointestinal infections such as peritonitis, cholecystitis, and cholangitis, and for infections in patients with reduced immune function, as well as meningitis. It provides broad-spectrum antimicrobial action against various bacteria, aiding in the treatment of infections. This drug is used to safely and effectively improve infections in complex infection situations.

How it is given

Adult administration

For adults and children over 12 years old, administer 1-2 g (potency) of ceftriaxone once daily via intravenous or intramuscular injection. For infections by pathogens with moderate susceptibility or in severe disease, the dose can be increased to 4 g (potency) once daily. For treatment of meningitis, adults, including elderly patients, should follow the adult dosage without modification. For the treatment of gonorrhea, a single intramuscular injection of 250 mg (potency) is advised.

Child administration

For newborns (up to 14 days old), 20-50 mg (potency) per kg of body weight is administered once daily, not exceeding 50 mg (potency). For infants and children (15 days to 12 years old), 20-

Precautions

This drug should not be mixed or administered simultaneously with solutions containing calcium or other drugs. Particularly, it should not be administered to newborns younger than 28 days in conjunction with calcium-containing solutions, as it may be dangerous. Serious side effects have been reported in newborns or premature infants who received this drug with calcium solutions, leading to the formation of deposits in the lungs or kidneys. Patients with allergic reactions to this drug or hypersensitivity to cephalosporins or penicillin antibiotics should not use this product. This drug, which contains lidocaine, should not be given via intravenous injection. Newborns with jaundice or issues with bilirubin binding should not use this drug due to the risk of bilirubin encephalopathy. Patients with a history of drug allergies or allergic constitution and those with severe renal impairment should be administered this drug with caution. During administration, it is important to monitor liver function, kidney function, and blood tests regularly. Various side effects such as diarrhea, rash, increased liver enzymes, and reduced blood cell counts may occur; if any adverse symptoms are noted, immediate medical attention should be sought. If severe allergic reactions or symptoms of shock occur, administration must be stopped immediately and emergency treatment should be received. This drug should be used cautiously during pregnancy or breastfeeding based on the physician's judgment. Elderly patients or those with reduced kidney function need dosage adjustments and status monitoring. This drug may interact with other medications, so disclosure of current medications is essential. During administration, avoid mixing with calcium-containing solutions and do not mix with aminoglycoside antibiotics in the same syringe. Prepared solutions should be used as soon as possible, and it is recommended to use within 6 hours at room temperature or within 24 hours if refrigerated.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), cold sweats, pallor, severe allergic reactions, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory problems with cough and fever, jaundice (yellowing of skin or eyes), profound lethargy, liver dysfunction (jaundice), sudden and severe headache, thunderclap headache

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
  • swelling
  • chills
  • increased blood creatinine
  • stomatitis
  • candidiasis
  • symptoms of vitamin K deficiency
  • symptoms of vitamin B group deficiency
  • ventricular extrasystole
  • sweating
  • flushing
  • palpitations
  • epistaxis
  • hypotension
  • Conn's syndrome
  • pancreas

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

Storage

Store this drug in a sealed container to prevent exposure to air, and it is advisable to keep it at room temperature away from direct sunlight. This will help maintain the efficacy of the drug for a longer period.

Appearance and packaging

Appearance

(For domestic use) A vial filled with white to light yellow crystalline powder. (For export) A colorless, transparent vial containing white to light yellow powder.

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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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.