Mirae Ceftriaxone Injection 1 Gram (Ceftriaxone Sodium Hydrate)

Adult administration

As ceftriaxone, administer 1-2g (potency) once daily via intravenous or intramuscular injection. For infections caused by pathogens indicated as moderate susceptibility or severe illness, the dose can be increased to 4g (potency) once daily. For intramuscular injections, dissolve 0.25g and 0.5g in 1% hydrochloride lidocaine solution of 1, 2 mL respectively, and 1g in 1% hydrochloride lidocaine solution of 3.5 mL, and inject deeply into the gluteal muscle. For intravenous injection, 0.25g.

Child administration

In neonates (within 14 days of birth), administer 20-50mg (potency) per Kg body weight once daily, not exceeding 50mg (potency). In infants and children (from 15 days to 12 years), administer 20 mg (potency) per Kg body weight.

This medication should not be mixed with solutions containing calcium or other drugs. In particular, in newborns, the combination of calcium and this drug can cause precipitation, posing a risk and must not be administered together. Patients with a history of allergy to this medication or those who have had hypersensitivity reactions to cephalosporins or penicillin antibiotics should not use this drug. Also, caution is needed when muscular injection in those allergic to the local anesthetic lidocaine, and this drug should not be used in preterm infants or certain newborns. Patients with a history of allergies or those prone to symptoms such as bronchial asthma, rashes, or hives should use this medication carefully. Patients with significantly impaired kidney function may require dosage adjustments due to the potential for increased drug concentration. During administration of this drug, regular blood tests, liver function tests, and kidney function tests should be conducted to detect any adverse reactions early. The most common side effects include changes in blood cell counts, diarrhea, rashes, and increased liver enzymes, while rare side effects may include severe allergic reactions, kidney damage, and central nervous system abnormalities. Nervous system symptoms such as dizziness or headaches may occur during administration, so caution is required while driving or operating machinery. Pregnant or lactating women should only use this drug under a doctor's guidance due to the possibility of it crossing the placenta or being transmitted through breast milk. It is safest not to use this drug in newborns or premature infants due to the risk of bilirubin encephalopathy. Elderly patients may experience increased side effects due to diminished bodily function; therefore, careful dosage and administration intervals should be observed. This medication may interact with other drugs, so it is important to consult with medical professionals, especially when using diuretics, aminoglycoside antibiotics, or vitamin K antagonists. To avoid the formation of precipitate, this drug should not be used with calcium-containing solutions, and it is recommended to use the injectable solution as soon as it is prepared. In the case of overdose, there is no specific antidote, and treatment should be based on symptoms; immediate notification to medical personnel is required if adverse symptoms appear.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in the oral/eye mucosa, difficulty or shortness of breath, asthma attacks, respiratory distress accompanied by cough and fever, jaundice (yellowing of the skin or eyes), extreme lethargy, sudden and severe headaches, thunderclap headaches, seizures, confusion, visual disturbances, paralysis, and altered urinary function.

Mild side effects

• Eosinophilia
• leukopenia
• thrombocytopenia
• diarrhea
• rashes
• increased liver enzymes
• headaches
• dizziness
• bronchospasm
• loose stools

This medication should be stored in a sealed container to prevent exposure to air or moisture and is best kept at room temperature, between 1 to 30 degrees Celsius. Storing it this way helps maintain the drug's effectiveness for a longer duration.

Appearance

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

Package unit

1 vial/box, 10 vials/box