Cefazolin 3 g/150mL Injection, Solution
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Cephalosporin Antibacterial class.
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🏭 Manufacturer & labeler
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🩺 Clinical
- Cefazolin is an antibiotic used to fight a wide range of bacterial infections — things like pneumonia, urinary tract infections, skin infections, bone infections, and serious blood...
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- This is a really important question. Cefazolin and penicillin belong to related families of antibiotics, and there is a real — though not certain — chance of a cross-reaction. Up t...
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Supplement & herbal interactions
Cefazolin may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $0.5844 | $525.96 / 900 ml |
| Medicare drug plans payPart D · Q2 2026 | $1.50 | $1,348.20 / 900 ml |
| Medicare Part B allowsASP · J0689 | $1.290 / J0689 unit | — |
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🧾 Billing & reimbursement
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Cefazolin 3 g 00143-9140-25 | Hikma | 25 vials | — | — | FDA listed | — |
| Cefazolin Sodium 3 g/50mL 00264-3107-11 | B. | 50 ml | — | — | FDA listed | — |
| Cefazolin 3 g/150mLthis 00338-0096-06 | Baxter | 150 ml | — | — | FDA listed | — |
| Cefazolin 3 g 44567-0845-25 | WG | 25 vials | — | — | FDA listed | — |
| Cefazolin 3 g 60505-6266-05 | Apotex | 25 vials | — | AP | FDA listed | — |
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⏳ Availability & generic status
The FDA lists approved generic versions of this medicine, but that does not always mean a pharmacy can get one today. Patent rules, launch agreements, supply and pricing can affect when generics actually arrive.
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🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
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Age at onset
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00338-0096-06 You're viewing this | 6 BAG in 1 CARTON (0338-0096-06) / 150 mL in 1 BAG | 2024-05-31 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | ✓ Available |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Cefazolin in Dextrose Injection is a cephalosporin antibacterial indicated for: • Treatment of the following infections caused by susceptible isolates of the designated microorganisms in adult and pediatric patients for whom appropriate dosing with this formulation can be achieved : ( 1 ) ο Respiratory tract infections ( 1.1 ); ο Urinary tract infections ( 1.2 ); ο Skin and skin structure infections ( 1.3 ); ο Biliary tract infections ( 1.4 ); ο Bone and joint infections ( 1.5 ); ο Genital infections ( 1.6 ); ο Septicemia ( 1.7 ); ο Endocarditis ( 1.8 ) • Perioperative prophylaxis in adults and pediatric patients aged 10 to 17 years old for whom appropriate dosing with this formulation can be achieved ( 1.9 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefazolin in Dextrose Injection and other antibacterial drugs, Cefazolin in Dextrose Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.
( 1.10 ).
1.1Respiratory Tract Infections Cefazolin in Dextrose Injection is indicated for the treatment of respiratory tract infections due to Streptococcus pneumoniae, Staphylococcus aureus and Streptococcus pyogenes in adults and pediatric patients for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2.1 , 2.2 , 2.4 and 2.5 ) and Use in Specific Populations (8.4) ] . Limitations of Use Injectable benzathine penicillin is considered the drug of choice in treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever.
Cefazolin in Dextrose Injection is effective in the eradication of streptococci from the nasopharynx; however, data establishing the efficacy of cefazolin in the subsequent prevention of rheumatic fever are not available.
1.2Urinary Tract Infections Cefazolin in Dextrose Injection is indicated for the treatment of urinary tract infections due to Escherichia coli, and Proteus mirabilis in adults and pediatric patients for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2.1 , 2.2 , 2.4 and 2.5 ) and Use in Specific Populations (8.4) ] .
1.3Skin and Skin Structure Infections Cefazolin in Dextrose Injection is indicated for the treatment of skin and skin structure infections due to S. aureus , S. pyogenes , and Streptococcus agalactiae in adults and pediatric patients for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2.1 , 2.2 , 2.4 and 2.5 ) and Use in Specific Populations (8.4) ] .
1.4Biliary Tract Infections Cefazolin in Dextrose Injection is indicated for the treatment of biliary infections due to E. coli , various isolates of streptococci, P. mirabilis, and S. aureus in adults and pediatric patients for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2.1 , 2.2 , 2.4 and 2.5 ) and Use in Specific Populations (8.4) ] .
1.5Bone and Joint Infections Cefazolin in Dextrose Injection is indicated for the treatment of bone and joint infections due to S. aureus in adults and pediatric patients for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2.1 , 2.2 , 2.4 and 2.5 ) and Use in Specific Populations (8.4) ] .
1.6Genital Infections Cefazolin in Dextrose Injection is indicated for the treatment of genital infections due to E. coli, and P. mirabilis in adults and pediatric patients for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2.1 , 2.2 , 2.4 and 2.5 ) and Use in Specific Populations (8.4) ].
1.7Septicemia Cefazolin in Dextrose Injection is indicated for the treatment of septicemia due to S. pneumoniae, S. aureus , P. mirabilis, and E. coli in adults and pediatric patients for whom appropriate dosing with this formulation can be achieved [see Dosage and Administration (2.1 , 2.2 ,…
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION If a dose of Cefazolin in Dextrose Injection is required that does not equal 1 gram, 2 grams or 3 grams, this product is not recommended for use and an alternative formulation of cefazolin should be considered. ( 2.1 ) For intravenous use only administered over approximately 30 minutes. ( 2.1 ) Recommended Dosing Schedule in Adult Patients with CLcr Greater Than or Equal To 55 m L/min.
( 2.1 ) Site and Type of Infection Dose Frequency Moderate to severe infections 500 mg to 1 gram every 6 to 8 hours Mild infections caused by susceptible gram-positive cocci 250 mg to 500 mg every 8 hours Acute, uncomplicated urinary tract infections 1 gram every 12 hours Pneumococcal pneumonia 500 mg every 12 hours Severe, life-threatening infections (e.g., endocarditis, septicemia) In rare instances, doses of up to 12 grams of cefazolin per day have been used 1 gram to 1.5 grams every 6 hours Perioperative prophylaxis less than 120 kg: 1 gram to 2 grams ½ to 1 hour prior to start of surgery greater than or equal to 120 kg: 3 grams 500 mg to 1 gram additional dose during surgery for lengthy procedures 500 mg to 1 gram every 6 to 8 hours for 24 hours postoperatively Recommended Dosing Schedule in Pediatric Patients with CLcr Greater than or Equal to 70 mL/min.
( 2.1 , 2.2 , and 2.3 ) Site and Type of Infection Dose Frequency Moderate to severe infections For the treatment indications ( 1.1 to 1.8 ) 25 to 50 mg per kg divided into 3 or 4 equal doses Severe infections May increase to 100 mg per kg divided into 3 or 4 equal doses Perioperative prophylaxis (10 to 17 years old) less than 50 kg: 1 gram ½ to 1 hour prior to start of surgery greater than or equal to 50 kg: 2 grams 500 mg to 1 g additional dose during surgery for lengthy procedures 500 mg to 1 g every 6 to 8 hours for 24 hours postoperatively • Dosage adjustment is required for adult patients with CLcr that is less than 55 mL/min and pediatric patients with CLcr that is less than 70 mL/min.
( 2.4 and 8.6 ) • See full prescribing information for preparation and administration instructions. ( 2.5 )
2.1Important Administration Instructions If a dose of Cefazolin in Dextrose Injection is required that does not equal 1 gram, 2 grams or 3 grams, this product is not recommended for use and an alternative formulation of cefazolin should be considered. Administer Cefazolin in Dextrose Injection intravenously over approximately 30 minutes.
2.2Dosage for the Treatment of Infections Dosage for the Treatment of Infections in Adults with Creatinine Clearance (CLcr) Equal to 55 mL/min or Greater The recommended adult dosages for the treatment of infections [see Indications and Usage (1.1 to 1.8) ] are outlined in Table 1 below. Administer Cefazolin in Dextrose Injection intravenously over approximately 30 minutes. Table 1: Recommended Dosing Schedule in Adult Patients with CLcr Greater Than or Equal To 55 mL/min.
If a dose of Cefazolin in Dextrose Injection is required that does not equal 1 gram, 2 grams, or 3 grams, this product is not recommended for use and an alternative formulation of cefazolin should be considered. Site and Type of Infection Dose Frequency Moderate to severe infections 500 mg to 1 gram every 6 to 8 hours Mild infections caused by susceptible gram-positive cocci 250 mg to 500 mg every 8 hours Acute, uncomplicated urinary tract infections 1 gram every 12 hours Pneumococcal pneumonia 500 mg every 12 hours Severe, life-threatening infections (e.g., endocarditis, septicemia) In rare instances, doses of up to 12 grams of cefazolin per day have been used.
1 gram to 1.5 grams every 6 hours Dosage for the Treatment of Infections in Pediatric Patients with CLcr Equal to 70 mL/min or Greater The recommended pediatric dosages for the treatment of infections [see Indications and Usage (1.1 to 1.8) ] are outlined in Table 2 below. Administer Cefazolin in Dextrose Injection intravenously over approximately 30 minutes. If a dose of Cefazolin in Dextrose Injection is…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Injection: 1 gram cefazolin per 50 mL, 2 gram cefazolin per 100 mL or 3 gram cefazolin per 150 mL in a single-dose Galaxy container supplied as a frozen, premixed, iso-osmotic, sterile, nonpyrogenic solution. Injection : 1 gram in 50 mL, 2 grams in 100 mL and 3 grams in 150 mL ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Hypersensitivity to cefazolin or other cephalosporin class antibacterial drugs, penicillins, or other beta-lactams ( 4.1 )
4.1Hypersensitivity to Cefazolin or the Cephalosporin Class of Antibacterial Drugs, Penicillins, or Other Beta-lactams Cefazolin in Dextrose Injection is contraindicated in patients who have a history of immediate hypersensitivity reactions (e.g., anaphylaxis, serious skin reactions) to cefazolin or the cephalosporin class of antibacterial drugs, penicillins, or other beta-lactams [ see Warnings and Precautions (5.1) ].
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Hypersensitivity Reactions : Cross-hypersensitivity may occur in up to 10% of patients with a history of penicillin allergy. If an allergic reaction occurs, discontinue the drug. ( 5.1 ) • Clostridioides difficile -associated Diarrhea (CDAD) : May range from mild diarrhea to fatal colitis.
Evaluate if diarrhea occurs. ( 5.3 ) • Prothrombin Activity : May be associated with a fall in prothrombin activity. Prothrombin time should be monitored in patients at risk and exogenous vitamin K administered as indicated ( 5.5 )
5.1Hypersensitivity Reactions to Cefazolin, Cephalosporins, Penicillins, or Other Beta-lactams Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving beta-lactam antibacterial drugs. Hypersensitivity reactions can progress to Kounis syndrome, a serious allergic reaction that can result in myocardial infarction. Before therapy with Cefazolin in Dextrose Injection is instituted, careful inquiry should be made to determine whether the patient has had previous immediate hypersensitivity reactions to cefazolin, cephalosporins, penicillins, or carbapenems.
Exercise caution if this product is to be given to penicillin-sensitive patients because cross-hypersensitivity among beta-lactam antibacterial drugs has been clearly documented and may occur in up to 10% of patients with a history of penicillin allergy. If an allergic reaction to Cefazolin in Dextrose Injection occurs, discontinue the drug.
5.2Seizures in Patients with Renal Impairment Seizures may occur with the administration of Cefazolin in Dextrose Injection, particularly in patients with renal impairment when the dosage is not reduced appropriately. Discontinue Cefazolin in Dextrose Injection if seizures occur or make appropriate dosage adjustments in patients with renal impairment [see Dosage and Administration (2.4) ] . Anticonvulsant therapy should be continued in patients with known seizure disorders.
5.3Clostridioides difficile- associated Diarrhea Clostridioide s difficile -associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including cefazolin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile . C. difficile produces toxins A and B, which contribute to the development of CDAD.
Hypertoxin-producing isolates of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial drug use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial drug treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated.
5.4Hypersensitivity to Dextrose-containing Products Hypersensitivity reactions, including anaphylaxis, have been reported with administration of dextrose- containing products. These reactions have been reported in patients receiving high concentrations of dextrose (i.e. 50% dextrose) 1 . The reactions have also been reported when corn-derived dextrose solutions were administered to patients with or without a history of hypersensitivity to corn products. 2
5.5Prothrombin Activity Cefazolin in Dextrose Injection may be associated with a fall in prothrombin activity. Those at risk include patients with renal or hepatic impairment or poor nutritional state, as well as patients receiving a protracted course of antimicrobial therapy, and patients previously stabilized on anticoagulant therapy. Prothrombin time should…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following serious adverse reactions to Cefazolin in Dextrose Injection are described below and elsewhere in the labeling: • Hypersensitivity Reactions to Cefazolin, Cephalosporins, Penicillins, or Other Beta-lactams [see Warnings and Precautions (5.1) ] • Seizures in Patients with Renal Impairment [see Warnings and Precautions (5.2) ] • Clostridioides difficile -associated Diarrhea [see Warnings and Precautions (5.3) ] • Adult and Pediatric Patients : Most common adverse reactions: gastrointestinal (nausea, vomiting, diarrhea), and allergic reactions (anaphylaxis, urticaria, skin rash).
( 6 ) • Pediatric Patients with Perioperative Prophylaxis : The most frequently reported adverse reactions (incidence ≥ 5%) were nausea, infusion site pain, and headache. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare at 1-866-888-2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following adverse reactions were reported from clinical trials: Gastrointestinal: Diarrhea, oral candidiasis (oral thrush), mouth ulcers, vomiting, nausea, stomach cramps, epigastric pain, heartburn, flatus, anorexia and pseudomembranous colitis.
Onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment [see Warnings and Precautions (5.3) ] . Allergic: Anaphylaxis, eosinophilia, urticaria, itching, drug fever, skin rash, Stevens-Johnson syndrome. Hematologic: Neutropenia, leukopenia, thrombocytopenia, thrombocythemia.
Hepatic: Transient rise in SGOT, SGPT, and alkaline phosphatase levels has been observed. Reports of hepatitis have been received. Renal: Reports of increased BUN and creatinine levels, as well as renal failure, have been received.
Local Reactions: Instances of phlebitis have been reported at site of injection. Some induration has occurred. Other Reactions: Pruritus (including genital, vulvar and anal pruritus, genital moniliasis, and vaginitis).
Dizziness, fainting, lightheadedness, confusion, weakness, tiredness, hypotension, somnolence and headache. Adverse Reactions in Pediatric Patients for Perioperative Prophylaxis Two studies (Study 1: NCT 3231228 and Study 2: NCT 01904357) were conducted to assess the safety and pharmacokinetics of a single 30-minute infusion of either 1 gram or 2 grams (based on weight) of cefazolin for injection and dextrose injection for perioperative prophylaxis in pediatric patients. Study 1 was a multicenter, open-label, non-comparative, parallel group study to evaluate the safety and pharmacokinetics of a single 30-minute infusion of either 1 gram or 2 grams (based on weight) of cefazolin for injection and dextrose injection for perioperative prophylaxis in 61 pediatric patients 10 to 17 years of age.
Thirty-three subjects with a weight of at least 25 kg but less than 60 kg received a single dose of 1 gram of cefazolin for injection and dextrose injection and 28 subjects with a weight of at least 60 kg received a single dose of 2 grams of cefazolin for injection and dextrose injection. The mean age of the safety population was 14 years and ranged from 10 to 17 years. There were no adverse reactions leading to study discontinuation or deaths reported during the study.
The most frequently reported adverse reactions were nausea (14.8%), infusion site pain (6.6%), and headache (4.9%). Study 2 was a multicenter, non-comparative study that evaluated the safety and pharmacokinetics of a single 30-minute infusion of either 1 gram or 2 grams (based on weight) of cefazolin for injection and dextrose injection for perioperative prophylaxis in 12 pediatric patients 10 to 12 years of age. Subjects weighing at least 25 kg to less than 50 kg received a single…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS The renal excretion of cefazolin is inhibited by probenecid. Co-administration of probenecid with Cefazolin in Dextrose Injection is not recommended. Probenecid : The renal excretion of cefazolin is inhibited by probenecid. Co-administration of probenecid with Cefazolin in Dextrose Injection is not recommended. ( 7 )
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary Available data from published prospective cohort studies, case series and case reports over several decades with cephalosporin use, including cefazolin, in pregnant women have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Cefazolin crosses the placenta. Animal reproduction studies with rats, mice and rabbits administered cefazolin during organogenesis at doses 1 to 3 times the maximum recommended human dose (MRHD) did not demonstrate adverse developmental outcomes.
In rats subcutaneously administered cefazolin prior to delivery and throughout lactation, there were no adverse effects on offspring at a dose approximately 2 times the MRHD (see Data ) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data While available studies cannot definitively establish the absence of risk, published data from case-control studies and case reports over several decades have not identified an association with cephalosporin use during pregnancy and major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Available studies have methodologic limitations, including small sample size, retrospective data collection, and inconsistent comparator groups.
Animal Data Reproduction studies have been performed in rats, mice and rabbits administered cefazolin during organogenesis at doses of 2000, 4000 and 240 mg/kg/day (approximately 1 to 3 times the maximum recommended human dose on a body surface area comparison). There was no evidence of any adverse effects on embryofetal development due to cefazolin. In a peri‑postnatal study in rats, cefazolin administered subcutaneously up to 1200 mg/kg/day (approximately 2 times the MRHD based on body surface area comparison) to pregnant dams prior to delivery and through lactation caused no adverse effects on offspring.
8.2Lactation Risk Summary Data from published literature report that cefazolin is present in human milk, but is not expected to accumulate in a breastfed infant. There are no data on the effects of cefazolin on the breastfed child or on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Cefazolin in Dextrose Injection and any potential adverse effects on the breastfed child from Cefazolin in Dextrose Injection or from the mother’s underlying condition.
8.4Pediatric Use Cefazolin in Dextrose Injection is indicated for the treatment of respiratory tract infections, urinary tract infections, skin and skin structure infections, biliary tract infections, bone and joint infections, genital infections, septicemia, and endocarditis in pediatric patients for whom appropriate dosing with this formulation can be achieved and for perioperative prophylaxis in pediatric patients aged 10 to 17 years old [see Indications and Usage (1.1 to 1.8 )] . Safety and effectiveness of Cefazolin in Dextrose Injection in premature infants and neonates have not been established and is not recommended for use in this age group of pediatric patients.
Dosing for cefazolin in pediatric patients younger than one month old has not been established. Because of the limitations of the available strengths and administration requirements (i.e., administration of fractional doses is not recommended) of Cefazolin in Dextrose Injection, and to avoid unintentional overdose, this product is not recommended for use if a dose of Cefazolin in Dextrose Injection that does not equal 1 gram or 2 grams is required and an alternative formulation of cefazolin should be considered [see Dos…
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Available data from published prospective cohort studies, case series and case reports over several decades with cephalosporin use, including cefazolin, in pregnant women have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Cefazolin crosses the placenta. Animal reproduction studies with rats, mice and rabbits administered cefazolin during organogenesis at doses 1 to 3 times the maximum recommended human dose (MRHD) did not demonstrate adverse developmental outcomes.
In rats subcutaneously administered cefazolin prior to delivery and throughout lactation, there were no adverse effects on offspring at a dose approximately 2 times the MRHD (see Data ) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data While available studies cannot definitively establish the absence of risk, published data from case-control studies and case reports over several decades have not identified an association with cephalosporin use during pregnancy and major birth defects, miscarriage, or other adverse maternal or fetal outcomes. Available studies have methodologic limitations, including small sample size, retrospective data collection, and inconsistent comparator groups.
Animal Data Reproduction studies have been performed in rats, mice and rabbits administered cefazolin during organogenesis at doses of 2000, 4000 and 240 mg/kg/day (approximately 1 to 3 times the maximum recommended human dose on a body surface area comparison). There was no evidence of any adverse effects on embryofetal development due to cefazolin. In a peri‑postnatal study in rats, cefazolin administered subcutaneously up to 1200 mg/kg/day (approximately 2 times the MRHD based on body surface area comparison) to pregnant dams prior to delivery and through lactation caused no adverse effects on offspring.
🧒 Pediatric Use ▾
8.4Pediatric Use Cefazolin in Dextrose Injection is indicated for the treatment of respiratory tract infections, urinary tract infections, skin and skin structure infections, biliary tract infections, bone and joint infections, genital infections, septicemia, and endocarditis in pediatric patients for whom appropriate dosing with this formulation can be achieved and for perioperative prophylaxis in pediatric patients aged 10 to 17 years old [see Indications and Usage (1.1 to 1.8 )] . Safety and effectiveness of Cefazolin in Dextrose Injection in premature infants and neonates have not been established and is not recommended for use in this age group of pediatric patients.
Dosing for cefazolin in pediatric patients younger than one month old has not been established. Because of the limitations of the available strengths and administration requirements (i.e., administration of fractional doses is not recommended) of Cefazolin in Dextrose Injection, and to avoid unintentional overdose, this product is not recommended for use if a dose of Cefazolin in Dextrose Injection that does not equal 1 gram or 2 grams is required and an alternative formulation of cefazolin should be considered [see Dosage and Administration (2.2 , 2 , 3 , 2.4 and 2.5) ] .
The safety and effectiveness of cefazolin for injection and dextrose injection for perioperative prophylaxis have been established in pediatric patients aged 10 to 17 years old. Use of cefazolin for injection and dextrose injection in these age groups is supported by evidence from adults with additional safety and pharmacokinetic data in pediatric patients aged 10 to 17 years old. Safety and pharmacokinetics were evaluated in two multicenter, non-comparative studies (Study 1 and Study 2).
These studies were conducted to assess the safety and pharmacokinetics of a single 30-minute infusion of either 1 gram or 2 grams (based on weight) of cefazolin for injection and dextrose injection for perioperative prophylaxis in pediatric patients. Study 1 evaluated the safety and pharmacokinetics of 1 g of cefazolin for injection and dextrose injection in pediatric patients aged 10 to 17 years old scheduled for surgery with a weight of at least 25 kg but less than 60 kg and 2 g in pediatric patients with a weight of at least 60 kg.
Study 2 evaluated 1 g of another cefazolin injection product in pediatric patients aged 10 to 12 years old scheduled for surgery with a weight of at least 25 kg but less than 50 kg and 2 g in pediatric patients with a weight of at least 50 kg to less than 85 kg [see Dosage and Administration (2.3) , Adverse Reactions (6.1) and Clinical Pharmacology (12.3) ] . The safety and effectiveness of Cefazolin in Dextrose Injection for perioperative prophylaxis have not been established in pediatric patients younger than 10 years old .
🧓 Geriatric Use ▾
8.5Geriatric Use Of the 920 subjects who received cefazolin in clinical studies, 313 (34%) were 65 years and over, while 138 (15%) were 75 years and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see Dosage and Administration (2.3) and Warnings and Precautions (5.2) ] .
🆘 Overdosage ▾
10 OVERDOSAGE Accidental overdosage resulting in seizures may occur in patients with renal impairment who receive doses greater than the recommended dosage of Cefazolin in Dextrose Injection [see Warnings and Precautions (5.2) ]. If seizures associated with accidental overdosage occur, discontinue Cefazolin in Dextrose Injection and give supportive treatment.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Cefazolin is an antibacterial drug [ see Microbiology (12.4) ].
12.2Pharmacodynamics The pharmacokinetic/pharmacodynamic relationship for cefazolin has not been evaluated in patients.
12.3Pharmacokinetics Studies have shown that following intravenous administration of cefazolin to normal subjects, mean serum concentrations peaked at approximately 185 mcg/mL and were approximately 4 mcg/mL at 8 hours for a 1 gram dose. The serum half-life for cefazolin is approximately 1.8 hours following IV administration. In a study of constant intravenous infusion with dosages of 3.5 mg/kg for 1 hour (approximately 250 mg) and 1.5 mg/kg the next 2 hours (approximately 100 mg), cefazolin serum concentrations at the third hour of approximately 28 mcg/mL.
Plasma pharmacokinetic parameters of cefazolin in healthy adult subjects (N=12) following a single 15- minute IV infusion of 2 grams of cefazolin for injection and dextrose injection are summarized in Table 7 . Table 7: Mean (Standard Deviation) Plasma Pharmacokinetic Parameters of Cefazolin in Healthy Adult Subjects N C max (mcg/mL) T max T max reported as median (range) (h) AUC 0-inf (mcg*h/mL) T 1/2 (h) CL (L/h) V z (L) Single 2 grams Dose as a 15- Minute IV Infusion 12 280.9 (45.9) 0.25 (0.25-0.33) 509.9 (89.3) 2.01 (0.28) 4.03 (0.68) 11.50 (1.53) N= number of subjects observed; C max = maximum plasma concentration; T max = time to maximum plasma concentration; AUC 0-inf = area under the plasma concentration-time curve extrapolated to infinity; t 1/2 = apparent plasma terminal elimination half-life; CL = total clearance; V z = volume of distribution Plasma pharmacokinetic parameters of cefazolin in healthy adult subjects with a weight of greater than or equal to 120 kg (N=12) following a single 30-minute IV infusion of 3 grams of Cefazolin in Dextrose Injection are summarized in Table 8.
Table 8: Mean (Standard Deviation) Plasma Pharmacokinetic Parameters of Cefazolin in Healthy Adult Subjects ≥ 120 kg N C max (mcg/mL) T max T max reported as median (range) (h) AUC 0-inf (mcg*h/mL) T 1/2 (h) CL (L/h) V z (L) Single 3 grams Dose as a 30-Minute IV Infusion 12 223 (26.0) 0.55 (0.54-1.26) 585 (76.5) 2.29 (0.28) 5.20 (0.67) 17.0 (1.54) N= number of subjects observed; C max = maximum plasma concentration; T max = time to maximum plasma concentration; AUC 0-inf = area under the plasma concentration-time curve extrapolated to infinity; t 1/2 = apparent plasma terminal elimination half-life; CL = total clearance; V z = volume of distribution Studies in patients hospitalized with infections indicate that cefazolin produces mean peak serum concentrations approximately equivalent to those seen in healthy subjects.
Bile concentrations in patients without obstructive biliary disease can reach or exceed serum concentrations by up to five times; however, in patients with obstructive biliary disease, bile concentrations of cefazolin are considerably lower than serum concentrations (less than 1.0 mcg/mL). In synovial fluid, the cefazolin concentration becomes comparable to that reached in serum at about 4 hours after drug administration. Studies of cord blood show prompt transfer of cefazolin across the placenta.
Cefazolin is present in very low concentrations in the milk of nursing mothers. Cefazolin is excreted unchanged in the urine. In the first 6 hours approximately 60% of the drug is excreted in the urine and this increases to 70% to 80% within 24 hours.
Specific Populations Pediatric Patients for Perioperative Prophylaxis A simulation based on pharmacokinetic data from healthy adults (n=24), pediatric patients aged 10 to 17 years (n=26: Study 1 [see Adverse Reactions (6.1) ] ), and pediatric patients aged 10 to 12 years (n=12: Study 2 [see Adverse Reactions (6.1) ] indicate that the administration of a 1 gram dose of cefazolin for injection and dextrose injection for pediatric patients weighing less than 50 kg and a 2 grams dose of cefazolin for inj…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Cefazolin is an antibacterial drug [ see Microbiology (12.4) ].
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Cefazolin in Dextrose Injection is supplied as a premixed, frozen, iso-osmotic, sterile, nonpyrogenic solution in single-dose Galaxy plastic containers as follows: Product Description Number of Containers/Carton NDC Number 1 gram cefazolin in 50 mL (20 mg/mL) 24 count NDC 0338-3503-41 2 grams cefazolin in 100 mL (20 mg/mL) 12 count NDC 0338-3508-41 3 grams cefazolin in 150 mL (20 mg/mL) 6 count NDC 0338-0096-06 Store in a freezer capable of maintaining a temperature of -20°C (-4°F) or below.
Handle frozen product containers with care. Product containers may be fragile in the frozen state. Thaw frozen container at room temperature 20°C to 25°C (68°F to 77°F) or under refrigeration 2°C to 8°C (36°F to 46°F).
Do not force thaw by immersion in water baths or by microwave irradiation. The thawed solution is stable for 30 days under refrigeration (5°C/41°F) or 48 hours at 25°C/77°F. Do not refreeze [see Dosage and Administration (2.5) ] .
📋 Description ▾
11 DESCRIPTION Cefazolin in Dextrose Injection is a frozen, premixed, iso-osmotic, sterile, nonpyrogenic, single-dose solution containing either 1 g Cefazolin, USP, equivalent to 1.05 g Cefazolin Sodium, USP per 50 mL, 2 g Cefazolin, USP, equivalent to 2.1 g Cefazolin Sodium, USP per 100 mL or 3 g Cefazolin, USP, equivalent to 3.15 g Cefazolin Sodium, USP per 150 mL Galaxy container (PL 2040 Plastic). Dextrose, USP has been added to adjust osmolality (4 % as dextrose hydrous). The approximate osmolality for Cefazolin in Dextrose Injection is 290 mOsmol/kg.
Cefazolin Sodium is a semi-synthetic cephalosporin antibacterial for parenteral administration and has the following IUPAC nomenclature: Sodium (6R,7R)-3-[[(5-methyl-1,3,4- thiadiazol-2-yl)thio]methyl]-8-oxo-7-[2-(1 H -tetrazol-1-yl)acetamido]-5-thia-1-azabicyclo[4.2.0]oct-2- ene-2-carboxylate. Its molecular formula is C 14 H 13 N 8 O 4 S 3 ·Na and its molecular weight is 454.51 (free acid). Cefazolin Sodium USP has the following structural formula: The sodium content is 48 mg/g of cefazolin sodium.
The pH of Cefazolin in Dextrose Injection may have been adjusted with sodium bicarbonate, or sodium hydroxide/hydrochloric acid during manufacture. Water for injection, USP is added as drug vehicle. Contains no preservative.
The solution is intended for intravenous use after thawing to room temperature. This Galaxy container (PL 2040 Plastic) is fabricated from a specially designed multilayer plastic (PL 2040). Solutions are in contact with the polyethylene layer of this container and can leach out certain chemical components of the plastic in very small amounts within the expiration period.
However, the suitability of the plastic has been confirmed in tests in animals according to the USP biological tests for plastic containers, as well as by tissue culture toxicity studies. Cefazolin Sodium, USP Structural Formula.jpg
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Serious Allergic Reactions Advise patients that allergic reactions, including serious allergic reactions could occur and that serious reactions require immediate treatment and discontinuation of Cefazolin in Dextrose Injection. Patients should report to their health care provider any previous allergic reactions to cefazolin, cephalosporins, penicillins, or other similar antibacterials. Seizures Advise patients that seizures could occur with Cefazolin in Dextrose Injection.
Instruct patients to inform a healthcare provider at once of any signs and symptoms of seizures, for immediate treatment, dosage adjustment, or discontinuation of Cefazolin in Dextrose Injection. Diarrhea Advise patients that diarrhea is a common problem caused by antibacterials, which usually ends when the antibacterial is discontinued. Sometimes after starting treatment with antibacterials, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibacterials.
If this occurs, patients should contact a physician as soon as possible. Antibacterial Resistance Patients should be counseled that antibacterial drugs, including Cefazolin in Dextrose Injection should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold).
When Cefazolin in Dextrose Injection is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by Cefazolin in Dextrose Injection or other antibacterial drugs in the future.