Cefazolin Sodium Powder for injection, each vial contains : Cefazolin sodium lyophilized equivalent with Cefazolin 1 g.
Cefazolin Sodium contains Cefazolin sodium (equivalent with Cefazolin) available in powder for injection.
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.
- Perioperative prophylaxis.
- Urinary tract infection.
- Biliary tract infections.
- Genital infection.
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|
- 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.
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.
Cefazolin Sodium Powder for injection Box, 10 vials @ 1 g
Reg. No. GKL2002362444A1
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 :
Sidoarjo – Indonesia