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FDA approved Oxacillin Injection for Penicillinase-Producing Staphylococcal InfectionsFDA approved Bactocill for certain staph infections in hospitals

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Key Takeaway
Consider oxacillin for confirmed or suspected penicillinase-producing staphylococcal infections, but verify susceptibility and monitor for hypersensitivity.

The FDA has approved oxacillin injection (Bactocill in Plastic Container) for the treatment of infections caused by penicillinase-producing staphylococci that have demonstrated susceptibility to the drug. The approval, granted in 1989, provides a premixed frozen solution for intravenous administration, offering a convenient option for hospitalized patients with serious staphylococcal infections.

Oxacillin is a penicillinase-resistant penicillin that should be used only for infections proven or strongly suspected to be caused by susceptible bacteria. It is not indicated for infections caused by organisms susceptible to penicillin G. Clinicians should initiate therapy in suspected resistant staphylococcal infections before susceptibility results are available, but should adjust therapy once culture data are known.

The approval underscores the importance of appropriate antibiotic use to reduce the development of drug-resistant bacteria. Clinicians should be aware of the risk of serious hypersensitivity reactions and Clostridium difficile-associated diarrhea, as with other penicillins.

Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Mechanism of Action

Not reported in label.

Indication & Patient Population

Oxacillin is indicated for the treatment of infections caused by penicillinase-producing staphylococci that have demonstrated susceptibility to the drug. It may be used to initiate therapy in suspected cases of resistant staphylococcal infections prior to availability of susceptibility test results. It should not be used for infections caused by organisms susceptible to penicillin G. To reduce the development of drug-resistant bacteria, it should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.

Dosing & Administration

Oxacillin Injection, USP is supplied as a premixed frozen solution for continuous or intermittent intravenous infusion. The usual adult dosage is 250-500 mg IV every 4-6 hours for mild to moderate infections, and 1 gram IV every 4-6 hours for severe infections. This container system may be inappropriate for children, infants, and neonates; other dosage forms may be more appropriate. Duration of therapy depends on the severity and type of infection and the patient's clinical and bacteriological response. In severe staphylococcal infections, therapy should continue for at least 14 days and for at least 48 hours after the patient is afebrile, asymptomatic, and cultures are negative. Endocarditis and osteomyelitis may require longer therapy. Concurrent probenecid increases and prolongs serum penicillin levels. Do not add supplementary medication to the solution. Thaw frozen container at room temperature or under refrigeration; do not force thaw or refreeze. Thawed solution is stable for 21 days under refrigeration or 48 hours at room temperature.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Serious and occasionally fatal hypersensitivity reactions, including anaphylactic shock, have occurred in patients receiving penicillin. The incidence of anaphylactic shock is between 0.015% and 0.04%, with death in approximately 0.002% of treated patients. Therapy should be initiated only after a comprehensive drug and allergy history. If an allergic reaction occurs, discontinue the drug and provide supportive treatment. Individuals with a history of penicillin hypersensitivity may also experience allergic reactions to cephalosporins. Clostridium difficile-associated diarrhea (CDAD) has been reported with nearly all antibacterial agents, including oxacillin, and may range from mild diarrhea to fatal colitis. Use with caution in elderly patients due to risk of thrombophlebitis with IV administration.

Place in Therapy

Oxacillin is a penicillinase-resistant penicillin used for infections caused by susceptible penicillinase-producing staphylococci, such as methicillin-susceptible Staphylococcus aureus. It is an alternative to other antistaphylococcal penicillins and may be used empirically when resistant staphylococcal infection is suspected. It is not effective against methicillin-resistant staphylococci or organisms susceptible to penicillin G. As with all antibiotics, judicious use is recommended to minimize resistance.

The U.S. Food and Drug Administration has approved Bactocill (oxacillin) for the treatment of infections caused by staphylococci bacteria that produce an enzyme called penicillinase. These bacteria are resistant to some older penicillins, but Bactocill is designed to work against them. The approval was granted in 1989, and the drug is provided as a premixed frozen solution for intravenous use, making it convenient for hospitalized patients with serious staph infections.

Bactocill is a penicillin-type antibiotic. It should be used only for infections that are proven or strongly suspected to be caused by susceptible bacteria. It is not intended for infections caused by organisms that are sensitive to penicillin G. Doctors may start treatment with Bactocill before lab results confirm the exact bacteria, but they should adjust the treatment once culture results are available.

This approval highlights the importance of using antibiotics wisely to reduce the risk of drug-resistant bacteria. As with other penicillins, there is a risk of serious allergic reactions and Clostridium difficile-associated diarrhea. Patients should be aware of these risks and report any unusual symptoms to their healthcare provider.

For patients, this approval means there is another option for treating certain staph infections in the hospital. However, it is not a drug you can take at home. If you or a loved one is hospitalized with a staph infection, your doctor will decide if Bactocill is the right choice based on your specific situation. Always talk to your doctor about any questions or concerns you have about your treatment.

What this means for you:
Bactocill is a hospital-only antibiotic for certain staph infections; talk to your doctor about your treatment.

Study Details

Study typeFda approval
PublishedOct 1989
View Original Abstract ↓
INDICATIONS AND USAGE Oxacillin is indicated in the treatment of infections caused by penicillinase producing staphylococci which have demonstrated susceptibility to the drug. Cultures and susceptibility tests should be performed initially to determine the causative organism and its susceptibility to the drug. (See CLINICAL PHARMACOLOGY - Susceptibility Test Methods .) Oxacillin may be used to initiate therapy in suspected cases of resistant staphylococcal infections prior to the availability of susceptibility test results. Oxacillin should not be used in infections caused by organisms susceptible to penicillin G. If the susceptibility tests indicate that the infection is due to an organism other than a resistant Staphylococcus , therapy should not be continued with oxacillin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of Oxacillin Injection, USP and other antibacterial drugs, Oxacillin 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 the empiric selection of therapy.
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