Cefavex

Cefavex

cefazolin

Manufacturer:

North China Pharma

Distributor:

Sannovex
Full Prescribing Info
Contents
Cefazolin sodium.
Description
Each vial contains Cefazolin (as sodium) 1 gram.
Cefazolin sodium is a broad-spectrum bactericidal, semi-synthetic cephalosporin for parenteral administration. Chemically cefazolin is the sodium salt of 7-[ 1-(1H)-tetrazolylacetamide] - 3 - [2-(5-methyl1-1,3,4-thiadiazolyl)-thiomethyl]-delta3-cephem-4-carboxylic acid.
Indications/Uses
Cefazolin is indicated in the treatment of the following infections when due to susceptible micro-organisms: Respiratory tract infections due to S. pneumoniae, Klebsiella sp., S. influenzae, S. aureus (including penicillinase-producing strains), and group A B-hemolytic streptococci.
Genitourinary tract infections due to E. coli, P. mirabilis, Klebsiella sp., and some strains of Enterobacter and enterococci.
Skin and skin structure infections due to S. aureus (including penicillinase-producing strains) and group A B-hemolytic streptococci and other strains of streptococci.
Biliary tract infections due to Escherichia coli, various strains of streptococci, Proteus mirabilis, Klebsiella species and Staphylococcus aureus.
Bone and joint infections due to S. aureus, Septicemia due to S. pneumoniae, S. aureus (penicillin susceptible and penicillin-resistant).
Endocarditis due to S. aureus (penicillin-susceptible and penicillin-resistant) and group A B-hemolytic streptococci.
Perioperative prophylaxis.
Dosage/Direction for Use
See Table 1.

Click on icon to see table/diagram/image

Dosage adjustment for patients with reduced renal function. Cefazolin may be used in patients with reduced renal function with the following dosage adjustments: Patients with creatinine clearance of 55 mL or more per minute, usual doses; creatinine clearance 35 to 54 mL/min., usual doses but at intervals of at least 8 hours; creatinine clearance 11 to 34 mL/min., ½ the usual dose every 12 hours; creatinine clearance 10 mL or less per minute, half the usual dose every 18 hours to 24 hours.
Pediatric Dosage. In children, a total daily dosage of 25 to 50 mg/kg of body weight, divided into three or four equal doses, is effective for most mild to moderately severe infections. Total daily dosage may be increased to 100 mg/kg of body weight for severe infections. Since safety for use in premature infants and in infants less than one month has not been established, the use of Cefazolin in these patients is not recommended.
In children with mild to moderate renal impairment (creatinine clearance of 70 to 40 mL/min.), 60% of the normal daily dose in equally divided dose every 12 hours should be sufficient. In patients with moderate impairment (creatinine clearance of 40 to 20 mL/min.), 25% of the normal daily dose given in equally divided doses every 12 hours should be adequate. Children with severe renal impairment (creatinine clearance of 20 to 5 mL/min.) may be given 10% of the normal daily dose every 24 hours. All dosage recommendation apply after an initial loading dose.
Direction for Reconstitution: For intramuscular injections, IV-direct (bolus) injections, or intravenous infusion, reconstitute with Sterile Water for Injection according to the following table: See table 2. For intramuscular injections, IV-direct (bolus) injections, or intravenous infusion, reconstitute with Sterile Water for Injection according to the following table: See Table 2.

Click on icon to see table/diagram/image

Intramuscular administration: Reconstitute with 0.9% Sodium Chloride Solution or Sterile Water for Injection. Shake well until dissolved. It should be injected into a large muscle mass. Pain of injection is infrequent with Cefazolin.
Intravenous administration: Cefazolin may be administered by intravenous injection or by continuous or intermittent infusion.
Intermittent Intravenous infusion: Cefazolin can be administered along with primary intravenous fluid management program in a volume control set or in a separate, secondary bottle. Reconstituted 500 mg or 1 g of Cefazolin may be diluted in 50 to 100 mL, and 2 g in 100mL of Sterile Water for injection or one of the following intravenous solutions: 0.9% Sodium Chloride Solution, (also may be used with Sterile dextrose and 0.45% or 0.2% Sodium Chloride Solution). Lactated Ringer's Injection, 5 or 10% invert sugar in Sterile Water for Injection, Ringer's Injection.
Intravenous Injection: Dilute the reconstituted 500 mg or 1 g of Cefazolin in a minimum of 10 mL, and 2 g in a minimum of 20 mL sterile Water for Injection. Inject the solution slowly over 3 to 5 minutes. It can be administered directly into vein or through tubing.
SHAKE WELL BEFORE USING.
Contraindications
Cefazolin is contraindicated in patients with known allergy to the Cephalosporin group or antibiotics.
Special Precautions
Because of the partial cross-allergenicity of the penicillin and the cephalosporin's, Cefazolin should be given cautiously in penicillin-sensitive patients. When Cefazolin is administered to patients with impaired renal function, lower daily dosage is required. Safety for use in pregnancy, lactation, premature, and infants under one month of age has not been established.
Adverse Reactions
Allergic reactions, including skin rashes, urticaria and anaphylaxis may occur in patients hypersensitive to penicillin's or cephalosporin. Neutropenia and leucopenia have occurred infrequently. Transient rise in SGOT, SGPT and alkaline phosphates, as well as in BUN levels, have been observed rarely.
Caution For Usage
Incompatibilities: A false positive reaction for glucose in the urine may occur with Benedict's solution, Fehling's solution or Clinitest tablets. Positive Coomb's tests have occurred. Generally, Cephalosporins are incompatible with high weight molecules; therefore, they should be administered separately. Mixtures of Cefazolin with other antibiotics are not recommended. Cefazolin contains a methylthiadiazolethione, side chain and similarly to cephalosphorins containing the related N-methylthiotetrazol side-chain, may cause a disulfiram-like reaction with alcohol, and possibly enhance the effects of warfarin. The renal excretion of cefazolin and many other cephalosphorins is delayed by probenecid.
Storage
Store at temperatures not exceeding 30°C.
MIMS Class
Cephalosporins
ATC Classification
J01DB04 - cefazolin ; Belongs to the class of first-generation cephalosporins. Used in the systemic treatment of infections.
Presentation/Packing
Form
Cefavex powd for inj 1 g
Packing/Price
1's (P250/vial)
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