Medication info

Setrisone 2000 milligrams (Ceftriaxone Sodium Hydrate)

Prescription medicationInjections근육 · 정맥
Ingredient · strength
Ceftriaxone Sodium Hydrate›2g
Manufacturer / importer
한올바이오파마(주)
Appearance
Type I (Vial): A vial filled with a white to pale yellow powder Type II (Kit): A vial containing white to pale yellow powder and a transparent polypropylene container with a diluent are assembled
Packaging
Type I (Vial): 10 vials Type II (Kit): 1 kit X 1, 10
Approval status
Active

MFDS item code 201605693 · Notified 2016.09.28

Summary

Main use
Improvement of infections in the respiratory system (pneumonia, bronchitis) and urogenital infections
Who receives it
Adults · Children
Adult administration
Adults and children over 12 years: Administer 1-2 g (potency) of ceftriaxone intravenously or intramuscularly once daily. For infections caused by severe pathogens or moderately susceptible organisms, the dose can be increased to 4 g (potency) once daily. Elderly patients: No changes are needed in the adult dosage regimen. Gonorrhea: For treatment of gonorrhea caused by penicillin-susceptible and resistant strains, a single intramuscular dose of 250 mg (potency) is recommended.
Child administration
Newborns (up to 14 days old): Administer 20-50 mg (potency) per kg of body weight once daily, not exceeding 50 mg (potency) per kg. Infants and children (from 15 days to 12 years): Dosage

Ingredients

Manufacturer
한올바이오파마(주)

Efficacy & effects

Improvement of infections in the respiratory system (pneumonia, bronchitis) and urogenital infections

  • 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 bacterial infections. It is effective against respiratory infections such as pneumonia and bronchitis, ENT infections, kidney and urinary tract infections, and urogenital infections like gonorrhea. It is also used to treat sepsis, prevent infections before and after surgery, and treat bone and joint infections. It helps with infections of the skin, wounds, and soft tissues, as well as gastrointestinal infections such as peritonitis or cholecystitis. It can also be used to treat various infections in immunocompromised patients and meningitis. This medication is effective against multiple types of bacteria and is used to treat a wide range of infections.

How it is given

Adult administration

Adults and children over 12 years: Administer 1-2 g (potency) of ceftriaxone intravenously or intramuscularly once daily. For infections caused by severe pathogens or moderately susceptible organisms, the dose can be increased to 4 g (potency) once daily. Elderly patients: No changes are needed in the adult dosage regimen. Gonorrhea: For treatment of gonorrhea caused by penicillin-susceptible and resistant strains, a single intramuscular dose of 250 mg (potency) is recommended.

Child administration

Newborns (up to 14 days old): Administer 20-50 mg (potency) per kg of body weight once daily, not exceeding 50 mg (potency) per kg. Infants and children (from 15 days to 12 years): Dosage

Precautions

This medication must not be administered mixed with calcium-containing solutions or other drugs. It is also important to avoid using the same infusion port or administering it simultaneously. Particularly, it should not be administered to newborns under 28 days of age, as a reaction between calcium and this drug could lead to precipitation. In newborns who have received both this drug and calcium, serious issues may arise due to precipitation in the lungs or kidneys. It should not be administered to patients who are allergic to this drug or who have had hypersensitivity reactions to cephalosporins or penicillin antibiotics. Additionally, it should not be used in premature infants or newborns with issues in bilirubin binding or who are receiving calcium-containing solutions. Caution should be exercised when administering it to patients who have a history of allergies or who easily display allergic symptoms such as asthma, rash, or hives. Patients with severely impaired kidney function may have increased drug concentration, necessitating dosage adjustments. Regular monitoring of liver function, kidney function, and blood status during administration is needed to detect adverse reactions early. The most common side effects include decreased blood cell counts, diarrhea, rash, and increased liver enzyme levels. Rarely, severe allergic reactions, gastroenteritis, pneumonia, kidney dysfunction, and central nervous system abnormalities have been reported. Dizziness or lightheadedness may occur after this medication is administered, so caution is advised when driving or operating machinery. Women who are pregnant or breastfeeding should use it cautiously after consulting with a physician. It is contraindicated in newborns or premature infants due to the risk of bilirubin encephalopathy. The elderly should be cautious due to the increased risk of side effects from decreased physiological function, paying close attention to dosage and intervals. This medication may affect certain clinical test results, so this should be taken into account when performing tests. When this drug is administered, care should be taken in the preparation of the infusion solution, ensuring that it is not given simultaneously with calcium-containing solutions. In case of overdose, there is no specific antidote, and symptomatic treatment according to symptoms is required.

Side effects and when to seek care immediately

Serious side effects

Urticaria, swelling, anaphylaxis, anaphylactic reaction, shock, severe skin adverse reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis), polymorphic erythema, encephalopathy, seizures, altered consciousness, liver abnormalities (symptoms related to jaundice), acute renal failure, serum sickness, severe thrombocytopenia, kidney failure, difficulty breathing, asthma attacks, respiratory distress, edema associated with hypertension, severe allergic reactions, Churg-Strauss syndrome

Mild side effects

  • Eosinophilia
  • leukopenia
  • thrombocytopenia
  • diarrhea
  • rash
  • increased liver enzymes
  • headache
  • dizziness
  • bronchoconstriction
  • loose stools
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  • nausea
  • vomiting
  • itching
  • hematuria
  • diabetes
  • phlebitis
  • pain at the injection site
  • fever
  • chills
  • increased serum creatinine
  • erythema
  • flushing
  • polymorphic erythema
  • swelling
  • stomatitis
  • candidiasis
  • symptoms of vitamin K deficiency
  • symptoms of vitamin B group deficiency
  • ventricular extrasystole
  • sweating
  • flushing
  • palpitations
  • nosebleeds
  • low blood pressure

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air and at a temperature between 1 and 30 degrees Celsius. This will help maintain the drug's effectiveness for a longer period.

Appearance and packaging

Appearance

Type I (Vial): A vial filled with a white to pale yellow powder Type II (Kit): A vial containing white to pale yellow powder and a transparent polypropylene container with a diluent are assembled

Package unit

Type I (Vial): 10 vials Type II (Kit): 1 kit X 1, 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.