Medication info

Spotrin 1 gram (Ceftriaxone Sodium Hydrate)

Prescription medicationInjections근육 · 정맥
Ingredient · strength
Ceftriaxone Sodium Hydrate›1g / 1 vial
Manufacturer / importer
(주)제뉴파마
Appearance
A colorless transparent vial injection containing white or pale yellow powder.
Packaging
10g (1g/vial X 10)
Approval status
Active

MFDS item code 201310936 · Notified 2013.12.30 · Insurance code 698002201

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 1-2g (strength) of ceftriaxone once daily by intravenous or intramuscular injection. In cases of infection from pathogens showing moderate to severe sensitivity, it may be increased to 4g (strength) once daily. For gonorrhea, a single intramuscular injection of 250mg (strength) is recommended. To prevent infections before and after surgery, based on the risk of infection, administer 1-2g (strength) once 30-90 minutes before surgery.
Child administration
For neonates (within 14 days of birth), administer 20-50mg (strength) per kg of body weight once a day, not exceeding 50mg (strength). For infants and children (15 days to 12 years), administer 20-

Ingredients

Manufacturer
(주)제뉴파마

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
  • bone infections
  • joint infections
  • skin infections
  • wound infections
  • soft tissue infections
View approved original text

This medication is effective against various types of bacteria and is used for respiratory infections such as pneumonia and bronchitis, ENT infections, kidney and urinary tract infections, reproductive infections such as gonorrhea, sepsis, and prevention of infections before and after surgery. It is also effective for bone and joint infections, skin and wound infections, peritonitis, cholecystitis, and cholangitis, which are gastrointestinal infections. It helps treat infections in immunocompromised patients. It is also used for the treatment of meningitis, thus can broadly respond to various bacterial infections. This medicine is very useful for preventing and treating infections.

How it is given

Adult administration

For adults and children over 12 years, administer 1-2g (strength) of ceftriaxone once daily by intravenous or intramuscular injection. In cases of infection from pathogens showing moderate to severe sensitivity, it may be increased to 4g (strength) once daily. For gonorrhea, a single intramuscular injection of 250mg (strength) is recommended. To prevent infections before and after surgery, based on the risk of infection, administer 1-2g (strength) once 30-90 minutes before surgery.

Child administration

For neonates (within 14 days of birth), administer 20-50mg (strength) per kg of body weight once a day, not exceeding 50mg (strength). For infants and children (15 days to 12 years), administer 20-

Precautions

This medication should not be mixed or injected concurrently with calcium-containing solutions. This is particularly dangerous for newborns as the combination can cause precipitation and pose risks. It is contraindicated for patients with allergies to this medication, or who have had hypersensitivity reactions to cephalosporin or penicillin antibiotics, or those with allergies to specific local anesthetics. It should not be administered to premature infants or newborns with bilirubin metabolism issues. Patients with a history of allergic reactions to this medication or similar antibiotics, patients with allergic constitutions, and patients with severely impaired kidney function should use this medication cautiously and may require dosage adjustments or spacing of doses. This medication may cause changes in blood cell counts, diarrhea, rash, liver function abnormalities, headaches, dizziness, etc., so if symptoms occur, the healthcare professional should be informed immediately. Especially, if severe allergic reactions or shock symptoms occur, administration should be stopped immediately, and emergency treatment should be sought. This medication can interact with other drugs; caution is required, especially when used with diuretics, aminoglycoside antibiotics, and vitamin K antagonists. Women who are pregnant or breastfeeding should consult their doctor before administering this medication, as it may affect the fetus or newborn. This medication should not be used in newborns and premature infants due to the risk of bilirubin encephalopathy, and special caution is needed for the elderly due to increased risk of side effects from declined bodily functions. Regular monitoring of liver, kidney function, and blood tests is required during the administration of this medication, and the patient's condition should be carefully observed after administration. At the time of administration, symptoms such as pain or fever at the injection site, phlebitis, etc., may occur; thus, care should be taken with the injection method and speed, and the prepared solution should be used as soon as possible.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), difficulty breathing, cold sweat, pallor, severe allergic reactions, severe skin adverse reactions, severe neurological symptoms, neurologic abnormalities (encephalopathy, seizures, consciousness confusion), severe edema or urinary abnormalities (oliguria), jaundice, anaphylaxis and anaphylaxis-like reactions, severe skin adverse reactions (erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis), severe respiratory issues (dyspnea, asthma).

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
  • chills
  • increased serum creatinine
  • stomatitis
  • candidiasis
  • symptoms of vitamin K deficiency
  • symptoms of vitamin B deficiency
  • edema
  • ventricular extrasystole
  • sweating
  • flushing
  • palpitations
  • nosebleeds
  • hypotension
  • pancreatitis
  • microbial shift.

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 from entering. Additionally, it is advisable to store it in a cool place below 25 degrees Celsius.

Appearance and packaging

Appearance

A colorless transparent vial injection containing white or pale yellow powder.

Package unit

10g (1g/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.

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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.