Medication info

Ceftriaxone Sodium Hydrate Injection 2g

Prescription medication근육 · 정맥
Ingredient · strength
Ceftriaxone Sodium Hydrate›2g / 1 vial
Manufacturer / importer
(주)한국피엠지제약
Appearance
A colorless, transparent vial filled with crystalline powder that is white to light yellow.
Packaging
1 vial, 10 vials
Approval status
Active

MFDS item code 201904461 · Notified 2019.06.28 · Insurance code 697100861

Summary

Main use
Treatment of infections in the respiratory system (pneumonia, bronchitis), and reproductive system (gonorrhea)
Who receives it
Adults · Children
Adult administration
For adults and children over 12 years, administer 1 to 2 g (potency) of ceftriaxone once daily via intravenous or intramuscular injection. For infections caused by severe or moderate-susceptibility pathogens, the dosage can be increased to 4 g (potency) once daily. For gonorrhea treatment, a single intramuscular injection of 250 mg (potency) is recommended. To prevent infection before and after surgery, a single dose of 1 to 2 g (potency) should be administered 30 to 90 minutes before surgery.
Child administration
For neonates (up to 14 days old), administer 20 to 50 mg/kg (potency) once daily, not exceeding 50 mg/kg (potency). Infants and children (15 days to 12 years) should receive a dosage based on weight.

Ingredients

Manufacturer
(주)한국피엠지제약

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
  • prevention of infections before and after surgery
  • bone infections
  • joint infections
  • skin infections
  • wound infections
View approved original text

This medication is effective against respiratory infections such as pneumonia and bronchitis, as well as ENT infections. It is also utilized for treating infections of the kidney and urinary tract, and reproductive infections such as gonorrhea. It can be used to prevent infections before and after surgery, and to treat bone and joint infections. It is also helpful in treating infections of the skin, wounds, soft tissues, peritonitis, cholecystitis, cholangitis, and gastrointestinal infections. It can be safely used for infections in immunocompromised patients and for meningitis. It is used to effectively treat a variety of infections.

How it is given

Adult administration

For adults and children over 12 years, administer 1 to 2 g (potency) of ceftriaxone once daily via intravenous or intramuscular injection. For infections caused by severe or moderate-susceptibility pathogens, the dosage can be increased to 4 g (potency) once daily. For gonorrhea treatment, a single intramuscular injection of 250 mg (potency) is recommended. To prevent infection before and after surgery, a single dose of 1 to 2 g (potency) should be administered 30 to 90 minutes before surgery.

Child administration

For neonates (up to 14 days old), administer 20 to 50 mg/kg (potency) once daily, not exceeding 50 mg/kg (potency). Infants 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 any calcium-containing solutions or medications. Particularly, it should not be used with calcium-containing solutions in neonates under 28 days of age due to the risk of dangerous precipitates. Cases of fatal side effects due to precipitates in the lungs and kidneys of newborns and premature infants who received this medication have been reported, so it must not be used in combination with calcium-containing solutions. This medication should not be given to patients with known allergies to it or its excipients, or to those with hypersensitivity to cephalosporins or penicillins. Additionally, if there is an allergy to the lidocaine component included in this medication, it should not be administered by intramuscular injection, nor should it be used intravenously. It should not be used in premature infants, particularly those with a combined gestational age and postnatal age of less than 41 weeks. This medication should also not be administered to neonates expected to have bilirubin binding disorders such as jaundice, hypoalbuminemia, or acidosis. Patients with a history of allergies to this medication or drug allergies should be administered with caution, and those with bronchial asthma or allergic conditions should also exercise caution. Patients with severely impaired renal function may have prolonged blood levels, requiring adjustment of dosage or administration interval. Patients who have difficulty in oral intake, elderly patients, and those in poor general condition may show vitamin K deficiency symptoms, and regular blood tests may be necessary. Various side effects including eosinophilia, leukopenia, thrombocytopenia, diarrhea, rash, elevated liver enzymes may occur when this medication is administered, so any abnormal symptoms should be reported to the medical staff immediately. Severe allergic reactions or shock symptoms may occur, so it is recommended to conduct thorough patient interviews and skin reaction tests before administration. Patients should be closely monitored after administration, and if side effects are suspected, use should be immediately discontinued and appropriate treatment sought. This medication can affect liver and kidney function, thus regular liver and kidney function tests are necessary. Pay careful attention in cases of patients with impaired renal function as there may be serious side effects such as acute renal failure. This medication can cause precipitation in the gallbladder; however, it usually resolves upon discontinuation and symptoms are minimal. In cases of overdose, removal through dialysis is not possible as there is no specific antidote, and symptomatic treatment is required. Patients should use caution when driving or operating machinery due to potential side effects such as dizziness. Women who are pregnant or may become pregnant should only use this medication if the benefits outweigh the risks as its safety has not been established. Lactating women should use caution as this medication may be excreted in breast milk. Safety has not been established in neonates and premature infants, and there is a risk of bilirubin encephalopathy, particularly in premature infants. Elderly patients have reduced physiological function which can lead to a higher incidence of side effects, and they may be prone to bleeding tendencies due to vitamin K deficiency, so dosages and intervals must be adjusted and administered with caution. This medication may affect blood test results, cautious attention is needed during examination. Intravenous administration of this medication may cause symptoms such as phlebitis, thrombotic saphenitis, nausea, and vomiting, so attention must be given to the method and speed of administration. Calcium-containing solutions should not be used for diluting this medication, nor should they be administered concurrently. Aminoglycoside antibiotics should not be mixed in the same syringe for administration.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • severe swelling (edema)
  • difficulty breathing
  • anaphylaxis and anaphylactoid reactions
  • serious allergic reactions
  • severe rash with high fever
  • blisters
  • skin peeling
  • oral/eye mucosal pain
  • serious skin reactions
Show 13 more
  • asthma attacks
  • respiratory difficulties
  • liver abnormalities (jaundice)
  • encephalopathy
  • altered consciousness
  • convulsions
  • seizures
  • vision disturbances
  • paralysis
  • severe neurological symptoms
  • drastically reduced urine output
  • generalized severe edema
  • blood

Mild side effects

  • Eosinophilia
  • leukopenia
  • thrombocytopenia
  • diarrhea
  • rash
  • elevated liver enzymes
  • headache
  • dizziness
  • bronchospasm
  • loose stools
Show 24 more
  • nausea
  • vomiting
  • itching
  • hematuria
  • diabetes
  • phlebitis
  • injection site pain
  • fever
  • chills
  • elevated serum creatinine
  • stomatitis
  • candidiasis
  • vitamin K deficiency symptoms
  • vitamin B group deficiency symptoms
  • edema
  • ventricular extrasystole
  • sweating
  • flushing
  • palpitations
  • epistaxis
  • hypotension
  • pancreatitis
  • stomatitis
  • diarrhea

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

Storage

This medication should be stored in a sealed container to prevent air and moisture ingress, maintaining a storage temperature between 1 and 30 degrees Celsius. Proper storage helps maintain the drug's efficacy and prevents deterioration.

Appearance and packaging

Appearance

A colorless, transparent vial filled with crystalline powder that is white to light yellow.

Package unit

1 vial, 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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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.