Finished product reference

Cefazolin

Injection, Powder, for Solution · Parenteral · 500 mg

List code
224

What it is and how it works

Mechanism of Action Cefazolin is an antibacterial drug .

Indications

Cefazolin for 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 1 month of age and older for whom appropriate dosing with this formulation can be achieved: Respiratory tract infections Urinary tract infections Skin and skin structure infections Biliary tract infections Bone and joint infections Genital infections Septicemia Endocarditis Perioperative prophylaxis in adult patients To reduce the development of drug-resistant bacteria and maintain the effectiveness of Cefazolin for Injection and other antibacterial drugs, Cefazolin for Injection should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria Respiratory Tract Infections Cefazolin for Injection is indicated for the treatment of respiratory tract infections due to Streptococcus pneumoniae, Klebsiella species, Hemophilus influenzae, Staphylococcus aureus (methicillin-susceptible), and Group A beta-hemolytic streptococciin adults and p…

Dosage and administration (summary)

Cefazolin for Injection, 2 grams/vial: For intravenous infusion For intravenous bolus injection Not for intramuscular administration Recommended Dosage in Adult Patients with CLcr that is greater than or equal to 55 mL/min 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)* 1 gram to 1.5 grams every 6 hours Perioperative prophylaxis 1 gram to 2 grams 1/2 to 1 hour prior to start…

Contraindications

Cefazolin for 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 . Hypersensitivity to cefazolin or other cephalosporin class antibacterial drugs, penicillins, or other beta-lactams

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 Clostridioides difficile -Associated Diarrhea (CDAD): May range in severity from mild to fatal colitis. Evaluate if diarrhea occurs. Prothrombin Activity: May be associated with a fall in prothrombin activity.

Pregnancy

Pregnancy Risk Summary Available data from published prospective cohort studies, case series and case reports over several decades with cefazolin use in pregnant women have not established a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

Storage and supply

Cefazolin for Injection is available as 2 grams of cefazolin as a white to off-white crystalline powder in single-dose vial for reconstitution. Cefazolin for Injection, USP Packaged NDC No. 2 grams/vial Carton of 25 vials 72572-054-25 Before reconstitution protect from light and store at 20°C to 25°C (68°F to 77°F) .

Source: Cefazolin (Cefazolin) — US FDA prescribing information, 2025-11-01, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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