SPC Ceftriaxone Sodium Injection 1g

Adult administration

For adults and children over 12 years old, administer 1–2g (potency) of ceftriaxone as an intravenous or intramuscular injection once daily. For infections caused by severe pathogens or moderately sensitive organisms, the dose can be increased up to 4g (potency) once daily. Elderly individuals should follow the adult dosage without changes. For gonorrhea treatment, a single intramuscular injection of 250mg (potency) is recommended. For pre- and post-operative infections,

Child administration

For neonates (under 14 days old), administer 20–50mg (potency) per kg of body weight once daily, not to exceed 50mg (potency). For infants, young children, and children (15 days to 12 years old), administer 20–

This medication should not be mixed or administered simultaneously with solutions containing calcium or other drugs. Especially, it should not be used for newborns under 28 days old as it may lead to dangerous precipitates when administered with calcium-containing solutions. Serious side effects have been reported in newborns or premature infants regarding precipitates in the lungs and kidneys, requiring caution. Patients with allergic reactions or hypersensitivity to cephalosporins or penicillin antibiotics should not use this medication. Furthermore, it is contraindicated for premature infants, newborns with issues related to bilirubin binding, and newborns receiving calcium-containing solutions. Patients with a history of hypersensitivity or allergies, severe renal impairment should use this medication cautiously, and dose or interval adjustments may be necessary. It is important to regularly monitor liver function, kidney function, and blood tests during administration. This medication can cause various side effects, including diarrhea, rash, decreased blood cell counts, elevated liver enzymes, and, rarely, serious allergic reactions or neurological abnormalities. Always assess the patient's condition thoroughly before administration, and if any abnormal symptoms occur, discontinue the medication immediately and seek appropriate treatment. Caution should be exercised when driving or operating machinery as dizziness may occur. The safety of this medication during pregnancy has not been sufficiently confirmed, hence it should be used cautiously for pregnant women or women who may become pregnant, and nursing mothers should also exercise caution. It is generally best to avoid administration to newborns and premature infants due to the risk of bilirubin encephalopathy. Elderly patients may experience side effects more easily due to decreased physiological function, and careful dose and interval adjustments are advised. Interactions with other medications should also be taken into account, especially since co-administration with calcium, diuretics, or aminoglycoside antibiotics can increase the risk of kidney damage. Additionally, this medication can affect blood coagulation, thus patients on anticoagulants should be monitored for bleeding risks. Prepared solutions should be used as soon as possible and should be stored at appropriate temperatures. It is crucial to administer this medication for the minimum necessary duration to prevent the emergence of resistant bacteria.

Serious side effects

Urticaria, severe swelling (edema), cold sweat, chest tightness, difficulty breathing, severe rashes with high fever, blisters, skin peeling, pain in mouth/eye mucosa, difficulty breathing or shortness of breath, asthma attack, respiratory abnormalities with coughing and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headaches, lightning headaches, seizures, confusion, visual disturbances, paralysis, significantly decreased urine output

Mild side effects

Eosinophilia, leukopenia, thrombocytopenia, diarrhea, rash, elevated liver enzymes, headache, dizziness, bronchospasm, nausea, vomiting, pruritus, hematuria, diabetes, phlebitis, injection site pain, fever, swelling, chills, increased serum creatinine, stomatitis, candidiasis, hypotension, Conn's syndrome, pancreatitis, stomatitis, agranulocytosis, acute generalized exanthematous pustulosis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, seizures,

This medication should be stored in a sealed container to prevent air or moisture ingress, and the storage temperature should be maintained between 1 to 30 degrees Celsius at room temperature. Proper storage can help maintain the medication's effectiveness over time.

Appearance

A colorless, transparent vial containing a white to light yellow crystalline powder.

Package unit

10 vials