COMPOSITION :
Cefazolin Sodium Powder for injection, each vial contains : Cefazolin sodium lyophilized equivalent with Cefazolin 1 g.
DESCRIPTIONS :
Cefazolin Sodium contains Cefazolin sodium (equivalent with Cefazolin) available in powder for injection.
INDICATIONS :
Cefazolin is indicated for the treatment of serious infections caused by sensitive organisms, i.e., :
- Upper respiratory tract infection.
- Skin infections and skin structure.
- Bone and joint infections.
- Septicemia.
- Perioperative prophylaxis.
- Urinary tract infection.
- Biliary tract infections.
- Genital infection.
- Endocarditis.
DOSAGE AND ADMINISTRATIONS :
Usual dosage for adults
| Type of infection | Dosage | Frequency |
| Moderate to severe infection | 500 mg – 1 g | Every 6 – 8 hours |
| Mild infections caused by sensitive gram positive cocci | 250 – 500 mg | Every 8 hours |
| Uncomplicated and acute urinary tract infections | 1 g | Every 12 hours |
| Pneumococcal pneumonia | 500 mg | Every 12 hours |
| Severe life threatening infections (e.g., endocarditis, septicemia)* | 1 – 1.5 g | Every 6 hours |
*In this condition, the dose of Cefazolin can be increased to 12 g/day.
Usage on perioperative prophylaxis :
- 1 g IV or IM 1/2 – 1 hour before surgery.
- For long surgery (2 hours or more), 500 mg – 1 g IV or IM during surgery.
- 500 mg – 1 g IV or IM every 6 – 8 hours, used 24 hours after surgery.
Use in patients with reduced kidney function, the dosage must be adjusted :
| Creatinine clearance | Serum creatinine | Dosage |
| ≥ 55 ml/minutes | ≤ 1.5 mg % | Usual dose |
| 35 – 54 ml/minutes | 1,6 – 3 mg % | The usual dose is an 8 hours drinking interval |
| 11 – 34 ml/minutes | 3,1 – 4.5 mg % | 1/2 usual dose/12 hours |
| ≤ 10 ml/minutes | ≥ 4.6 mg % | 1/2 usual dose/18 – 24 hours |
Use in children :
- Mild to moderate infections : 25 mg/kgBW/day in 3 – 4 divided doses.
- Severe infection : 100 mg/kgBW/day.
Usage table based on weight :
| Weight | 25 mg/kg/day in 3 divided doses | 25 mg/kg/day in 4 divided doses | |||
| 1 bs | Kg | Dosage | Amount of solvent | Dosage | Amount of solvent |
| 10 | 4.5 | 40 mg | 0.35 ml | 30 mg | 0.25 ml |
| 20 | 9.0 | 75 mg | 0.60 ml | 55 mg | 0.45 ml |
| 30 | 13.6 | 115 mg | 0.90 ml | 85 mg | 0.70 ml |
| 40 | 18.1 | 150 mg | 1.20 ml | 115 mg | 0.90 ml |
| 50 | 22.7 | 190 mg | 1.50 ml | 140 mg | 1.10 ml |
Use in children with impaired kidney function :
| Creatinine clearance (ml/minutes)/ml/seconds | Dosage |
| 40 – 70/0.67 – 1.17 | 7.5 – 30 mg/kgBW every 12 hours |
| 20 – 40/0.33 – 0.67 | 3.1 – 12.5 mg/kgBW every 12 hours |
| 5 – 20/0.08 – 0.33 | 2.5 – 10 mg/kgBW every 24 hours |
Reconstitution
- For IM injection, direct IV or IV infusion, reconstitute with sterile aqua pro injection as indicated on the label :
| Vial | Amount of solvent | Concentration | Volume of injection solution |
| 1 g | 2.5 ml | 330 mg/ml | 3.0 ml |
- Then the solution is shaken well and observed visually the presence of foreign particles in the solution, before use. If there are foreign particles, the solution must not be used.
- Reconstitution solutions can be pale yellow to yellow without any potential changes.
- The reconstitution solution is stable for 24 hours at temperature below 30ºC and stable for 96 hours when stored at refrigerator temperature (2 – 8)ºC.
CONTRAINDICATIONS :
Patients who are allergic to cephalosporins.
WARNINGS AND PRECAUTIONS :
- Use of Cefazolin during pregnancy and lactation, only when really needed.
- Use in premature infants and infants under 1 month, safety and effectiveness is unknown.
DRUG INTERACTIONS :
- The use of aminoglycoside class antibiotics will increase the occurrence of nephrotoxicity.
- Probenecid can reduce tubular renal secretion, so that Cefazolin levels in the blood will increase.
ADVERSE REACTIONS :
- Gastrointestinal disorders, allergies (e.g., itching, skin rash), liver and kidney disorders, local reactions (pain after intramuscular use is very rare).
- Hematologic disorders, such as : Leukopenia, neutropenia, thrombocytopenia, thrombocytemia.
- Other side effects that may arise are itching in the anus and genitalia, genital candidiasis and vaginitis.
PRESENTATION :
Cefazolin Sodium Powder for injection Box, 10 vials @ 1 g
Reg. No. GKL2002362444A1
STORAGE :
STORE BELOW 30ºC, PROTECT FROM LIGHT
The reconstitution solution is stable for 24 hours at temperature below 30ºC and stable for 96 hours when stored at refrigerator temperature (2 – 8)ºC.
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
