Ceftriaxone Sodium Hydrate Injection 500 mg

Adult administration

Adults and children over 12 years: administer 1–2 g of ceftriaxone intravenously or intramuscularly once daily. In cases of severe disease or infections caused by moderately susceptible pathogens, the dosage may be increased to 4 g once daily.

Child administration

For neonates (up to 14 days of age): administer 20–50 mg per kg of body weight once daily, not exceeding 50 mg per kg. For infants and children (15 days to 12 years): administer 20 mg per kg of body weight once daily.

This drug should not be mixed with solutions containing calcium or administered simultaneously with other medications. In particular, it must not be administered to neonates under 28 days of age, as there is a risk of precipitation when calcium combines with this drug. Care should be taken with neonates or infants who are administered this drug along with calcium-containing solutions, as precipitation in the lungs and kidneys may lead to fatal outcomes. Patients allergic to this drug or with hypersensitivity to cephalosporins or penicillins should not use it. Patients allergic to local anesthetics such as lidocaine should not receive this drug by injection, and this drug should not be administered intravenously if it contains lidocaine. Use of this drug is prohibited in neonates, especially those with a combined age of less than 41 weeks post-conception and gestation. Neonates with jaundice, hypoalbuminemia, or acidosis, who have issues with bilirubin binding, should also not be administered this drug due to the risk of bilirubin encephalopathy. Caution is required for patients with a history of allergies or those predisposed to bronchial asthma or urticaria. Patients with severely impaired kidney function may need dosage adjustments due to increased drug concentrations. In patients who have difficulty taking medication orally, the elderly, or patients in poor overall condition, symptoms of vitamin K deficiency may appear, requiring frequent monitoring of blood coagulation status and supplementation with vitamin K as needed. Common side effects may include eosinophilia, leukopenia, thrombocytopenia, diarrhea, rash, and increased liver enzymes. Rarely, severe allergic reactions, interstitial pneumonia, severe skin reactions, and acute renal failure have been reported, so any unusual symptoms should be reported to healthcare professionals immediately. Regular testing of liver and kidney function, as well as blood tests, during treatment is crucial to monitor for abnormalities. In case of overdose, there is no specific antidote, and supportive treatment should be provided based on symptoms; since this drug can cause dizziness, caution is advised when driving or operating machinery. If pregnant or breastfeeding, the use of this drug should only occur after consulting a doctor due to potential effects on the fetus or newborn. This drug is not recommended for neonates and premature infants due to the risk of bilirubin encephalopathy. Elderly patients may experience side effects more readily due to decreased physical function, so caution is needed regarding dosage and intervals. This drug may affect results of certain clinical tests such as urine glucose tests or blood glucose tests, so this should be taken into account during testing. This drug may cause pain at the injection site or phlebitis when administered intravenously; therefore, it should be infused slowly and the injection site should be well monitored. This drug and calcium-containing solutions should not be administered via the same route; even in non-neonates, the injection ports must be thoroughly cleaned before and after administration. Caution is required since this drug may affect kidney function when combined with other antibiotics or diuretics, and particularly it should not be mixed with aminoglycoside antibiotics in the same syringe.

Serious side effects

Urticaria, severe swelling (edema), allergic dermatitis, erythema multiforme, anaphylaxis or anaphylactoid reactions, shock, pseudomembranous colitis, severe colitis, interstitial pneumonia, eosinophilic pulmonary infiltrate, encephalopathy, ataxia, sensory abnormalities, multiforme erythema, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute kidney failure, thrombotic phlebitis, precipitation of ceftriaxone-calcium salt in the gallbladder, elevated bilirubin, kernicterus, oliguria, anaphylaxis.

Mild side effects

• Eosinophilia
• leukopenia
• thrombocytopenia
• diarrhea
• rash
• increased liver enzymes
• anemia
• headache
• dizziness
• bronchospasm

This drug should be stored in a sealed container to prevent air or moisture ingress, at room temperature between 1 degree and 30 degrees Celsius. Proper storage will maintain its efficacy and prevent degradation.

Appearance

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

Package unit

10 vials/box [1 vial x 10]