Medication info

Samsun Ceftriaxone Sodium Hydrate Injection 1 Gram

Prescription medication근육 · 정맥
Ingredient · strength
Ceftriaxone Sodium Hydrate›1g / 1 vial
Manufacturer / importer
삼성제약(주)
Appearance
A colorless transparent vial containing a white to pale yellow powder
Packaging
10 vials/box [(1 vial x 10)]
Approval status
Active

MFDS item code 199700418 · Notified 1997.04.04 · Insurance code 642301581

Summary

Main use
Treatment of respiratory tract (pneumonia, bronchitis) and genital (gonorrhea) infections
Who receives it
Adults · Children
Adult administration
For adults and children over 12 years old, administer 1 to 2 g (potency) of ceftriaxone intravenously or intramuscularly once daily. In infections caused by pathogens showing severe illness or moderate sensitivity, the dosage can be increased to 4 g (potency) once daily. For the treatment of gonorrhea, a single intramuscular injection of 250 mg (potency) is recommended. For the prevention of infections 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 newborns (up to 14 days old), administer 20 to 50 mg per kg (potency) once daily, not exceeding 50 mg (potency). For infants and children (from 15 days to 12 years old), administer 20 mg per kg

Ingredients

Manufacturer
삼성제약(주)

Efficacy & effects

Treatment of respiratory tract (pneumonia, bronchitis) and genital (gonorrhea) infections

  • Pneumonia
  • bronchitis
  • otolaryngological 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 tract infections such as pneumonia and bronchitis, as well as otolaryngological infections, kidney and urinary tract infections, and genital infections including gonorrhea. It is also used for the treatment of sepsis and the prevention of infections before and after surgery, as well as bone and joint infections. It can be utilized for various gastrointestinal infections, including skin and wound infections, soft tissue infections, peritonitis, cholecystitis, and cholangitis. This medication is particularly helpful in treating infections in patients with reduced immune function and is also used for the treatment of meningitis. Due to this antibacterial spectrum, it is effective in improving various types of bacterial infections.

How it is given

Adult administration

For adults and children over 12 years old, administer 1 to 2 g (potency) of ceftriaxone intravenously or intramuscularly once daily. In infections caused by pathogens showing severe illness or moderate sensitivity, the dosage can be increased to 4 g (potency) once daily. For the treatment of gonorrhea, a single intramuscular injection of 250 mg (potency) is recommended. For the prevention of infections 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 newborns (up to 14 days old), administer 20 to 50 mg per kg (potency) once daily, not exceeding 50 mg (potency). For infants and children (from 15 days to 12 years old), administer 20 mg per kg

Precautions

This medication should not be mixed or administered simultaneously with solutions or medications containing calcium. In particular, it should not be used in conjunction with calcium-containing solutions in newborns up to 28 days old, as this can cause precipitation and lead to serious side effects. Patients with hypersensitivity to this medication or those allergic to cephalosporin or penicillin antibiotics should not receive it. Additionally, this medication containing lidocaine should not be administered intravenously, and it should not be used in premature infants or newborns with bilirubin binding disorders. Close monitoring of the patient's condition is necessary during administration for allergic reactions or impaired kidney and liver functions. During administration, side effects such as rashes, diarrhea, headache, dizziness, blood abnormalities, and elevated liver enzymes may occur; if any abnormal symptoms arise, immediate notification to medical personnel is necessary. If severe allergic reactions or shock symptoms occur, administration must be stopped immediately, and emergency treatment should be sought. The risk of renal toxicity may increase when this medication is combined with other antibiotics, so caution is advised, and it should always be administered separately from calcium. Pregnant or nursing women should make prudent judgments if the use of this medication is deemed necessary. It is advisable not to use this medication in newborns, particularly premature infants, due to the risk of bilirubin encephalopathy. Elderly patients are at a higher risk of side effects due to decreased bodily functions, requiring dose adjustment and monitoring. Regular liver and kidney function tests and blood tests are recommended during the administration of this medication. Furthermore, this medication may cause dizziness, affecting driving or operation of machinery; therefore, caution is needed. During storage, the prepared solution should be used as soon as possible, as it may change color depending on storage temperature and time, but this does not affect its efficacy.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), cold sweat, difficulty breathing, chest tightness, anaphylaxis and anaphylactic-like reactions, severe allergic reaction, severe skin adverse reactions (such as erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis), encephalopathy, acute renal failure, neurological disorders (including headache, confusion, seizures), jaundice, generalized severe lethargy, severe edema with elevated blood pressure or urination abnormalities, urine

Mild side effects

  • Eosinophilia
  • leukopenia
  • thrombocytopenia
  • diarrhea
  • rash
  • elevated liver enzymes
  • headache
  • dizziness
  • bronchospasm
  • loose stools
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  • nausea
  • vomiting
  • itching
  • hematuria
  • diabetes
  • phlebitis
  • injection site pain
  • fever
  • chills
  • increased serum creatinine
  • stomatitis
  • candidiasis
  • symptoms of vitamin K deficiency
  • symptoms of vitamin B group deficiency
  • swelling
  • ventricular extrasystoles
  • sweating
  • flushing
  • palpitations
  • nosebleeds
  • 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 exposure to air, and it is recommended to keep it at room temperature between 1 to 30 degrees Celsius. This will help maintain the medication's efficacy and prevent deterioration.

Appearance and packaging

Appearance

A colorless transparent 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.