Medication info

Samsun Ceftriaxone Sodium Hydrate Injection 2g

Prescription medication근육 · 정맥
Ingredient · strength
Ceftriaxone Sodium Hydrate›2g / 1 vial
Manufacturer / importer
삼성제약(주)
Appearance
Vial containing a white to pale yellow powder
Packaging
10 vials/box (1 vial X 10)
Approval status
Active

MFDS item code 201905264 · Notified 2019.07.24 · Insurance code 642307991

Summary

Main use
Treatment of infections in the respiratory system (pneumonia, bronchitis) and genitourinary system (gonorrhea)
Who receives it
Adults · Children
Adult administration
Adults and children aged 12 years and older should be injected intravenously or intramuscularly with 1 - 2 g (potency) of ceftriaxone once daily. For severe or moderately susceptible infections, the dose can be increased to 4 g (potency) once daily. Elderly patients should follow the adult dosage regimen without modification. For treatment of gonorrhea, a single intramuscular injection of 250 mg (potency) is recommended. For pre- and post-surgical infections,
Child administration
For neonates (within 14 days of birth), administer 20 - 50 mg/kg (potency) once daily, not exceeding 50 mg (potency). For infants and children (from 15 days to 12 years), administer 20 -

Ingredients

Manufacturer
삼성제약(주)

Efficacy & effects

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

  • Pneumonia
  • bronchitis
  • ENT infections
  • kidney infections
  • urinary tract infections
  • gonorrhea
  • sepsis
  • infection prevention before and after surgery
  • osteomyelitis
  • joint infections
  • skin infections
  • wound infections
View approved original text

This drug is an effective antibiotic against various types of bacteria, used not only for respiratory infections such as pneumonia and bronchitis but also for ENT infections. Furthermore, it helps in the treatment of kidney and urinary tract infections, gonorrhea, and is widely utilized for the prevention of infection before and after surgery. It is also effective against osteomyelitis, joint infections, skin and soft tissue infections, peritonitis, and cholecystitis. It is applicable for treating infections in immunocompromised patients and is used in the treatment of severe meningitis. Notably, this drug is effective against a variety of resistant strains, including penicillinase-producing organisms, providing reassurance for its use. In summary, this drug is utilized for treating infections from the respiratory system to the skin, urinary tract, genitourinary system, and nervous system.

How it is given

Adult administration

Adults and children aged 12 years and older should be injected intravenously or intramuscularly with 1 - 2 g (potency) of ceftriaxone once daily. For severe or moderately susceptible infections, the dose can be increased to 4 g (potency) once daily. Elderly patients should follow the adult dosage regimen without modification. For treatment of gonorrhea, a single intramuscular injection of 250 mg (potency) is recommended. For pre- and post-surgical infections,

Child administration

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

Precautions

This drug should not be mixed with solutions or drugs containing calcium. Especially in neonates, administering this drug simultaneously with calcium-containing solutions can lead to precipitation in the body, causing severe adverse effects, and should never be done. Patients who have had allergic reactions to this drug, or who have hypersensitivity to cephalosporin or penicillin antibiotics, should not be administered this drug. Furthermore, it should not be used in patients with allergies to certain local anesthetics or in neonates, premature infants, or in neonates with jaundice or hypoalbuminemia. Patients with a history of hypersensitivity or allergies, severely impaired kidney function, elderly patients, and those in poor general condition should be given this drug cautiously, and it may be necessary to adjust the dosage or dosing interval as needed. This drug may cause side effects such as eosinophilia, leukopenia, diarrhea, rash, liver function anomalies, and others, so if any abnormal symptoms appear, notify the healthcare provider immediately. During administration, it is important to regularly check liver function, kidney function, and conduct blood tests to confirm any abnormalities. The safety of this drug during pregnancy has not been fully established, so women who are pregnant or may become pregnant should use it cautiously after consulting a doctor, and caution is also needed during breastfeeding. Be cautious as side effects such as dizziness may occur while driving or operating machinery. When using this drug, follow the duration and dosage prescribed by the doctor to prevent the emergence of resistant bacteria, and avoid unnecessary prolonged use. Additionally, this drug can interact with other medications, so if you are taking other drugs, be sure to inform your healthcare provider.

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, skin peeling, pain in oral/eye mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory difficulties accompanied by cough and fever, jaundice (yellowing of the skin or eyes), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination

Mild side effects

  • Eosinophilia
  • leukopenia
  • thrombocytopenia
  • diarrhea
  • rash
  • increased liver enzymes
  • headache
  • dizziness
  • bronchospasm
  • itching
Show 22 more
  • hematuria
  • diabetes
  • phlebitis
  • injection site pain
  • fever
  • chills
  • increased serum creatinine
  • stomatitis
  • candidiasis
  • symptoms of vitamin K deficiency
  • symptoms of vitamin B-group deficiency
  • edema
  • ventricular extrasystole
  • sweating
  • flushing
  • palpitations
  • nosebleed
  • hypotension
  • pancreatitis
  • glossitis
  • Cornelia de Lange syndrome
  • dysbiosis

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

Storage

This drug should be stored in a sealed container to avoid contact with air, and the storage temperature should be kept between 1 and 30 degrees Celsius (room temperature). By storing it this way, the effectiveness of the drug can be maintained for a longer period.

Appearance and packaging

Appearance

Vial containing a white to pale yellow powder

Package unit

10 vials/box (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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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.