Medication info

Optus Ceftriaxone Sodium Hydrate Injection 2 grams

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

MFDS item code 201702648 · Notified 2017.05.29 · Insurance code 674102131

Summary

Main use
Treatment of respiratory infections (pneumonia, bronchitis) and genital infections (gonorrhea)
Who receives it
Adults · Children
Adult administration
Adults and children over 12 years: 1 to 2 g (activity) of ceftriaxone administered once daily intravenously or intramuscularly. For infections caused by severe pathogens or pathogens exhibiting moderate sensitivity, the dosage may be increased to 4 g (activity) once daily. Elderly patients: No changes are needed to the standard dosage for adults. Gonorrhea: For treatment of gonorrhea caused by penicillin-sensitive and resistant bacteria, a single intramuscular injection of 250 mg (activity) is recommended.
Child administration
Newborns (within 14 days of birth): 20 to 50 mg (activity) per kg of body weight administered once daily, not exceeding 50 mg (activity) per kg of body weight. Infants and children (from 15 days to 12 years): The dosage.

Ingredients

Manufacturer
(주)옵투스제약

Efficacy & effects

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

  • Pneumonia
  • bronchitis
  • otolaryngological infections
  • kidney infections
  • urinary tract infections
  • gonorrhea
  • sepsis
  • infections
  • bone infections
  • joint infections
  • skin infections
  • wound infections
View approved original text

This medication is used to treat infections caused by various bacteria. It is effective for respiratory infections such as pneumonia and bronchitis, as well as otolaryngological infections. It can also treat infections of the kidneys and urinary tract, including gonorrhea, and helps prevent sepsis and infections before and after surgery. It is also used for infections of the bones and joints, as well as gastrointestinal infections such as peritonitis, cholecystitis, and cholangitis. It is widely used for the treatment of infections in immunocompromised patients and for meningitis.

How it is given

Adult administration

Adults and children over 12 years: 1 to 2 g (activity) of ceftriaxone administered once daily intravenously or intramuscularly. For infections caused by severe pathogens or pathogens exhibiting moderate sensitivity, the dosage may be increased to 4 g (activity) once daily. Elderly patients: No changes are needed to the standard dosage for adults. Gonorrhea: For treatment of gonorrhea caused by penicillin-sensitive and resistant bacteria, a single intramuscular injection of 250 mg (activity) is recommended.

Child administration

Newborns (within 14 days of birth): 20 to 50 mg (activity) per kg of body weight administered once daily, not exceeding 50 mg (activity) per kg of body weight. Infants and children (from 15 days to 12 years): The dosage.

Precautions

This medication should not be mixed with calcium-containing solutions or other medications. Even if administered separately, simultaneous administration can be dangerous. In particular, it should not be administered to newborns within 28 days of birth due to the risk of precipitation when combined with calcium. There have been reports of fatal outcomes due to precipitation in the lungs and kidneys of newborns or premature infants who received this medication with calcium-containing solutions, so caution is needed. Patients with hypersensitivity to this medication or allergic to cephalosporin or penicillin antibiotics should not be administered this medication. If allergic to local anesthetics like lidocaine, the intramuscular injection of this medication should be avoided, and this medication should not be injected intravenously if it contains lidocaine. It is not safe to use this medication in premature infants, especially those with a sum of gestational age and postnatal age less than 41 weeks. Additionally, it is not administered to newborns with jaundice, hypoalbuminemia, or acidosis due to the risk of encephalopathy from impaired bilirubin conjugation. Newborns receiving calcium-containing solutions should also not use this medication. Patients with a history of allergic reactions to this medication or similar antibiotics should be administered with caution, and those with allergic conditions or a history of drug allergies should also be careful. Patients with severe renal dysfunction may have increased blood drug levels, requiring dosage adjustment or extended dosing intervals. Patients who cannot take the medication orally, the elderly, or those in poor general condition may have an increased risk of bleeding due to vitamin K deficiency, so blood coagulation status should be monitored frequently, and vitamin K should be administered if necessary. Common side effects when using this medication include eosinophilia, leukopenia, thrombocytopenia, diarrhea, rash, increased liver enzymes, headache, dizziness, bronchospasm, loose stools, 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, ventricular premature contractions, sweating, flushing, palpitations, epistaxis, hypotension, Connes syndrome, pancreatitis, diarrhea. Serious allergic reactions, pseudomembranous colitis, interstitial pneumonia, severe skin reactions, and acute renal failure may occur rarely, so immediate consultation with healthcare providers is necessary if abnormal symptoms appear. It is important to administer this medication for only the necessary period as determined by sensitivity tests to prevent the emergence of resistant bacteria. Before administration, hypersensitivity should be thoroughly checked, and during administration, patients should be well observed for shock or severe allergic reactions. Regular monitoring of liver and kidney function, as well as blood tests, is recommended. This medication should not be administered through the same infusion site as calcium-containing solutions to avoid precipitation, so it is essential to separate the infusion sites or thoroughly manage the injection sequence. Aminoglycoside antibiotics should not be mixed in the same syringe, and careful monitoring of kidney function is required when used in combination. The safety of this medication during pregnancy has not been established, thus it should only be used when the benefits of treatment outweigh the risks, and caution should be exercised when administering it while breastfeeding. It is not safe to administer this medication to newborns and premature infants due to the risk of bilirubin encephalopathy. The elderly have decreased physiological functions, increasing the risk of side effects, so they should be administered with adjustments to dosage and intervals. This medication may affect the results of certain clinical tests such as blood glucose tests or urine sugar tests, so this should be noted at the time of testing. When administering intravenously, the injection rate should be slow, attention should be paid to any local adverse reactions, and prepared solutions should be used as quickly as possible. In cases of overdose, symptoms should be treated symptomatically as this medication cannot be removed by hemodialysis or peritoneal dialysis. Finally, symptoms such as dizziness may occur during the administration of this medication, so caution should be exercised when driving or operating machinery.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucous membranes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanying cough and fever, jaundice (yellowing of the skin or eyes), extreme lethargy, sudden and very severe headache, migraine headache, seizures, confusion of consciousness, visual disturbances, paralysis.

Mild side effects

  • Eosinophilia
  • leukopenia
  • thrombocytopenia
  • diarrhea
  • rash
  • increased liver enzymes
  • headache
  • dizziness
  • bronchial spasms
  • loose stools
Show 23 more
  • 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
  • ventricular premature contractions
  • sweating
  • flushing
  • palpitations
  • epistaxis
  • hypotension
  • Connes syndrome
  • pancreatitis
  • 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, and it is recommended to keep it at room temperature between 1 degree and 30 degrees. Proper storage maintains the effectiveness of the medication and ensures its safe use.

Appearance and packaging

Appearance

A colorless transparent vial filled with a white to pale yellow crystalline powder.

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.