Medication info

Medica Ceftriaxone 1g (Ceftriaxone Sodium Hydrate)

Prescription medicationApproval withdrawn
Ingredient · strength
Ceftriaxone Sodium Hydrate›Strength being verified
Manufacturer / importer
(주)메디카코리아
Appearance
A colorless, transparent vial containing white to pale yellow powder
Packaging
1g * 10 vials
Approval status
Approval withdrawn

MFDS item code 201801786 · Notified 2018.04.26

This product's status changed to Approval withdrawn on 2023.04.04. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of respiratory (pneumonia, bronchitis) and reproductive (gonorrhea) infections
Who uses it
Adults · Children
Adult dosage
For ceftriaxone, administer 1-2 g (activity) once daily by intravenous or intramuscular injection. In cases of severe disease or infections caused by moderately susceptible pathogens, the dose may be increased up to 4 g (activity) once daily. For gonorrhea treatment, a single intramuscular injection of 250 mg (activity) is recommended. For prevention of infections before and after surgery, a single dose of 1-2 g (activity) is preferable 30-90 minutes prior to surgery.
Children's dosage
Neonates (within 14 days of birth) are administered 20-50 mg (activity) per kg body weight once daily, not exceeding 50 mg (activity) per kg. Administered regardless of whether the infant is premature or full-term.

Ingredients

Manufacturer
(주)메디카코리아

Efficacy & effects

Treatment of respiratory (pneumonia, bronchitis) and reproductive (gonorrhea) 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 a variety of infections ranging from respiratory infections such as pneumonia and bronchitis to ENT infections, kidney and urinary tract infections, and reproductive infections such as gonorrhea. It is also effective for sepsis, prevention of infections before and after surgery, bone and joint infections, skin and wound infections, peritonitis and cholecystitis, and cholangitis, among gastrointestinal infections. It is widely used for treating infections in immunocompromised patients and is also helpful in the treatment of meningitis. This drug shows strong antibacterial activity against various types of bacteria, being effective in addressing diverse infection situations. Overall, this medication is used to effectively improve various bacterial infections.

Dosage and Administration

Adult dosage

For ceftriaxone, administer 1-2 g (activity) once daily by intravenous or intramuscular injection. In cases of severe disease or infections caused by moderately susceptible pathogens, the dose may be increased up to 4 g (activity) once daily. For gonorrhea treatment, a single intramuscular injection of 250 mg (activity) is recommended. For prevention of infections before and after surgery, a single dose of 1-2 g (activity) is preferable 30-90 minutes prior to surgery.

Children's dosage

Neonates (within 14 days of birth) are administered 20-50 mg (activity) per kg body weight once daily, not exceeding 50 mg (activity) per kg. Administered regardless of whether the infant is premature or full-term.

Precautions

This drug may cause precipitation when used in combination with calcium-containing solutions and should not be mixed or administered simultaneously with calcium-containing solutions. In particular, it should not be given to neonates under 28 days of age with calcium-containing solutions as it may lead to fatal side effects. Patients with allergies to this medication or those with hypersensitivity to cephalosporins or penicillins should not use it. Premature infants or neonates with jaundice or problems with bilirubin binding are also at risk if this drug is used and should not be administered. Patients with impaired kidney function or a history of allergies should use this drug cautiously, as dose adjustment and regular monitoring may be necessary. This medication may cause side effects like diarrhea, rash, liver function abnormalities, and decreased blood cell counts, so report any unusual symptoms to healthcare providers immediately. Regular checks of liver and kidney functions, and blood tests are important while using this drug. In case of overdose, since there is no specific antidote, symptomatic treatment should be provided, and patients should avoid driving or operating machinery if symptoms such as dizziness occur. Women who are pregnant or nursing should use this medication with caution and consult their physician regarding the potential effects on the fetus or infant. It is considered safer not to use this medication in children, especially neonates and premature infants, due to the risk of bilirubin encephalopathy. Older adults should be monitored closely for side effects due to declining physical function. This medication may interact with other drugs, so inform healthcare providers of any concomitant medications, particularly those that may increase renal toxicity. Injection sites may cause pain or inflammation, so care should be taken with the method and speed of injection, and prepared solutions should be used as soon as possible.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), difficulty breathing, chest tightness, cold sweat, pallor, severe allergic reaction, severe skin reaction, jaundice (yellowing of skin or eyes), extreme fatigue, liver abnormalities (jaundice), sudden and severe headache, lightning headache, seizure, confusion, visual disturbances, paralysis, severe neurological symptoms, markedly reduced urine output, generalized severe swelling and increased blood pressure

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 blood creatinine
  • pseudomembranous colitis
  • neutropenia
  • anemia
  • coagulopathy
  • granulocytopenia
  • lymphocytopenia
  • prolonged prothrombin time
  • serum sickness
  • coordination difficulties
  • sensory abnormalities
  • AST
  • ALT

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

Storage

This drug should be stored in a sealed container to prevent air or moisture ingress, and it is important to maintain storage temperatures between 1 to 30 degrees Celsius. Proper storage helps maintain the drug’s effectiveness and prevents degradation.

Appearance and packaging

Appearance

A colorless, transparent vial containing white to pale yellow powder

Package unit

1g * 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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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.