CEFAZOLIN SODIUM FOR

2 Recommended Dose and Dosage Adjustment After reconstitution CEFAZOLIN SODIUM FOR INJECTION BP may be administered either intramuscularly or intravenously. In both cases total daily dosages are the same.

ADULTS:

Adult Dosage Guide Type of Infection Dose Frequency Mild infections caused by susceptible Gram-positive cocci 250 mg to 500 mg Every 8 hours Acute, uncomplicated urinary tract infections* 1 g Every 12 hours Moderate to severe infections 500 mg to 1 g Every 6 to 8 hours * This dosage recommendation applies to intramuscular use.

The efficacy of cefazolin sodium when administered intravenously at 12-hour intervals has not been established. Cefazolin sodium has been administered in dosages of 6 g per day in serious infections such as endocarditis. Treatment should be continued for at least 10 days in beta-haemolytic streptococcal infections to minimize possible complications associated with the disease.

17 ≥407 125 mg to 500mg every 18 hours Perioperative Prophylactic Use: The recommended dosage regimen to prevent postoperative infection in contaminated or potentially contaminated surgery is: a. One gram intravenously or intramuscularly administered ½ hour to 1 hour prior to the start of surgery so that at the time of the initial surgical incision adequate antibiotic levels are present in the serum and tissues.

b. 5 g -1 g administered intravenously or intramuscularly during surgery. ) c. 5 gram -1 gram intravenously or intramuscularly every 6 to 8 hours for 24 hours postoperatively. , open-heart surgery and prosthetic arthroplasty).

Pediatric Use:

A total daily dosage of 25 mg to 50 mg per kg (approximately 10 mg to 20 mg per pound) of body weight, divided into three or four equal doses, is effective for most mild to moderately severe infections in children. For severe infections total daily dosage maybe increased to 100 mg per kg (45 mg per pound) of body weight.

The use of cefazolin in prematures and in infants under one month is not recommended since the safety for use in these patients has not been established. 8 mL of diluent. 25 mL * 225 mg/mL concentration may be obtained by reconstituted the 500 mg vial with 2 mL of diluent.

17 mL/s). 33 mL/s) should receive 10 percent of the normal daily dose every 24 hours. All dosage recommendations apply after an initial loading dose. 3 Reconstitution Reconstituted Solutions Parenteral drug products should be SHAKEN TO DISSOLVE ALL POWDER when reconstituted, and inspected visually for particulate matter prior to administration.

The following reactions have been reported:

Gastrointestinal: Diarrhea, oral candidiasis (oral thrush), vomiting, nausea, stomach cramps, anorexia. During antibiotic treatment symptoms of pseudo membranous colitis can appear. There have been rare reports of nausea and vomiting.

There have been reports of pseudo membranous colitis with the use of cephalosporins. It is therefore important to consider its diagnosis in patients who develop diarrhea in association with antibiotic use.

Allergic:

Allergic reactions occur infrequently and include: anaphylaxis, eosinophilia, itching, drug fever, skin rash.

Haematologic:

Neutropenia, anemia, leukopenia, thrombocythemia, positive direct and indirect antiglobulin (Coombs’) tests.

Hepatic and Renal:

Without clinical evidence of renal or hepatic impairment transient increases in AST (SGOT), ALT (SGPT), BUN and alkaline phosphatase levels have been observed. Transient hepatitis and cholestatic jaundice have been reported rarely, as with some penicillins and some other cephalosporins.

Pr CEFAZOLIN SODIUM FOR INJECTION BP Page 12 of 21 Local Reactions:

Phlebitis at the site of injection has occurred rarely. Infrequently there is pain at the site of injection following intramuscular injection. Some induration has been reported.

Other Reactions:

Vulvar pruritus, genital moniliasis, vaginitis and anal pruritus.

, Skin 01/2021 7 WARNINGS AND PRECAUTIONS, Renal 09/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES .....................................................................................................

2 TABLE OF CONTENTS ..................................................................................................................... 2 PART I: HEALTH PROFESSIONAL INFORMATION ................................................................................

4 1 INDICATIONS ......................................................................................................................... 1 Pediatrics ......................................................................................................................

2 Geriatrics....................................................................................................................... 5 2 CONTRAINDICATIONS .............................................................................................................

5 4 DOSAGE AND ADMINISTRATION .............................................................................................. 2 Recommended Dose and Dosage Adjustment................................................................. 3 Reconstitution ...............................................................................................................

4 Administration............................................................................................................... 8 5 OVERDOSAGE ........................................................................................................................

9 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING .................................................. 9 7 WARNINGS AND PRECAUTIONS ............................................................................................... 1 Special Population .......................................................................................................

CEFAZOLIN SODIUM FOR INJECTION BP is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.