Ceftriaxone
Visa No.: 893110832024
Product: Ceftriaxone EG 1g/10ml
API: Ceftriaxone
Product Category: Antibiotics
Version approved leaflet: 41/QĐ-QLD_06/02/2017_157
INDICATIONS
Ceftriaxone is indicated for the treatment of severe infections caused by susceptible organisms, including:
- Respiratory tract infections: pneumonia, acute bronchitis.
- Renal and genitourinary tract infections (including gonorrhea).
- Septicemia, endocarditis, and bacterial meningitis.
- Bone, joint, skin, soft tissue infections, and wound infections.
- Surgical prophylaxis.
DOSAGE AND ADMINISTRATION
Dosage
Adults and children > 12 years of age:
- Usual dose: 1–2 g/day, administered as a single dose or pided into two equal doses. In severe infections, doses up to 4 g/day may be used.
- Surgical prophylaxis: A single dose of 1 g intravenously, administered 30 minutes to 2 hours before surgery.
- Uncomplicated gonorrhea: A single 250 mg intramuscular injection.
Children < 12 years of age:
- Usual dose: 50–75 mg/kg/day, administered as a single dose or pided into two equal doses. Maximum 2 g/day.
- Treatment of meningitis: Initial dose 100 mg/kg/day (not exceeding 4 g/day), followed by dose adjustment as appropriate. Duration of treatment is 7–14 days.
Combined renal and hepatic impairment: Dose adjustment should be based on laboratory parameters. When creatinine clearance is below 10 mL/min, the dose of ceftriaxone should not exceed 2 g per 24 hours.
Patients undergoing hemodialysis: A dose of 2 g administered at the end of a dialysis session is sufficient to maintain effective drug concentrations until the next dialysis session, usually within 72 hours..
Method of administration
Intravenous administration
Preparation for intravenous injection: Dissolve 1 g of ceftriaxone in 10 mL of water for injection. Inject slowly over 2–4 minutes, either directly into a vein or via an intravenous line.
Preparation for intravenous infusion: Dissolve 2 g of ceftriaxone in 40 mL of a calcium-free infusion solution such as 0.9% sodium chloride, 5% or 10% glucose. Do not use Ringer’s lactate solution for infusion. The infusion should be administered over at least 30 minutes.
Stability of reconstituted solutions
Ceftriaxone solutions reconstituted with water for injection are stable for 10 days when stored under refrigeration (5 ± 3°C), and 2 days at room temperature (25 ± 2°C)
CONTRAINDICATIONS
Hypersensitivity to the active substance, cephalosporin antibiotics, or other beta-lactam antibiotics.
Concomitant use of ceftriaxone with intravenous calcium-containing products in neonates (≤ 28 days of age), in accordance with FDA recommendations.
WARNINGS AND PRECAUTIONS
Prescription only medicine. Read the instructions before use. Consult a physician or pharmacist if needed. Keep out of reach of children
