NAFCILLIN SODIUM 1 g/1
NAFCILLIN SODIUM · INJECTION, POWDER, FOR SOLUTION · ONESOURCE SPECIALTY PHARMA LIMITED
NAFCILLIN SODIUM is a injection, powder, for solution containing nafcillin sodium at 1 g/1, taken intramuscular. Manufactured by ONESOURCE SPECIALTY PHARMA LIMITED.
Key Facts
- Brand Name
- NAFCILLIN SODIUM
- Generic Name
- NAFCILLIN SODIUM
- NDC Code (Product)
83270-309- Manufacturer
- ONESOURCE SPECIALTY PHARMA LIMITED
- Strength
- 1 g/1
- Dosage Form
- INJECTION, POWDER, FOR SOLUTION
- Route
- INTRAMUSCULAR, INTRAVENOUS
- Marketing Status
- Application #
- ANDA200002
- Marketing Start
- 02/20/2026
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Nafcillin is indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drug. Culture and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug (see CLINICAL PHARMACOLOGY — Susceptibility Test Methods . Nafcillin should not be used in infections caused by organisms susceptible to penicillin G. If the susceptibility tests indicate that the infection is due to methicillin-resistant Staphylococcus sp., therapy with Nafcillin for Injection, USP should be discontinued and alternative therapy provided. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Nafcillin for Injection, USP and other antibacterial drugs, Nafcillin for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to t…
Dosage & Administration
DOSAGE AND ADMINISTRATION Nafcillin for Injection is available for intramuscular and intravenous use. The usual I.V dosage for adults is 500 mg every 4 hours. For severe infections, 1 gram every 4 hours is recommended. Administer slowly over at least 30 to 60 minutes to minimize the risk of vein irritation and extravasation. RECOMMENDED DOSAGE FOR NAFCILLIN FOR INJECTION, USP Drug Adults Infants and Children <40 kg (88 lbs) Other Recommendations Nafcillin 500 mg IM every 4 to 6 hours. IV every 4 hours 25 mg/kg IM twice daily Neonates 10 mg/kg IM twice daily Nafcillin 1 gram IM or IV every 4 hours (severe infections) Bacteriologic studies to determine the causative organisms and their susceptibility to nafcillin should always be performed. Duration of therapy varies with the type and severity of infection as well as the overall condition of the patient; therefore, it should be determined by the clinical and bacteriological response of the patient. In severe staphylococcal infections, therapy with nafcillin should be continued for at least 14 days. The treatment of endocarditis and osteomyelitis may require a longer duration of therapy. No dosage alterations are necessary for patient…
Warnings
WARNINGS Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients on penicillin therapy. These reactions are more likely to occur in individuals with a history of penicillin hypersensitivity and/or a history of sensitivity to multiple allergens. Before initiating therapy with Nafcillin, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, or other allergens. If an allergic reaction occurs, Nafcillin should be discontinued and appropriate therapy instituted. Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Nafcillin for Injection, USP, 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 strains 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 pres…
Contraindications
CONTRAINDICATIONS A history of a hypersensitivity (anaphylactic) reaction to any penicillin is a contraindication.
Adverse Reactions
ADVERSE REACTIONS Body as a Whole The reported incidence of allergic reactions to penicillin ranges from 0.7 to 10 percent (see WARNINGS ). Sensitization is usually the result of treatment, but some individuals have had immediate reactions to penicillin when first treated. In such cases, it is thought that the patients may have had prior exposure to the drug via trace amounts present in milk or vaccines. Two types of allergic reactions to penicillins are noted clinically, immediate and delayed. Immediate reactions usually occur within 20 minutes of administration and range in severity from urticaria and pruritus to angioedema, laryngospasm, bronchospasm, hypotension, vascular collapse, and death. Such immediate anaphylactic reactions are very rare (see WARNINGS ) and usually occur after parenteral therapy but have occurred in patients receiving oral therapy. Another type of immediate reaction, an accelerated reaction, may occur between 20 minutes and 48 hours after administration and may include urticaria, pruritus, and fever. Although laryngeal edema, laryngospasm, and hypotension occasionally occur, fatality is uncommon. Delayed allergic reactions to penicillin therapy usually oc…
Frequently Asked Questions
What is NAFCILLIN SODIUM used for?
NAFCILLIN SODIUM contains NAFCILLIN SODIUM. It is a injection, powder, for solution taken intramuscular. Consult your doctor for specific uses.
Is NAFCILLIN SODIUM a controlled substance?
NAFCILLIN SODIUM is not classified as a controlled substance by the DEA.
What is the generic name for NAFCILLIN SODIUM?
The generic name for NAFCILLIN SODIUM is NAFCILLIN SODIUM. There are 8 other brand versions of NAFCILLIN SODIUM.
What is the NDC code for NAFCILLIN SODIUM 1 g/1?
The NDC (National Drug Code) for NAFCILLIN SODIUM 1 g/1 is 83270-309, listed by ONESOURCE SPECIALTY PHARMA LIMITED.