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Oxacillin (oxacillin (oxacillin for injection) for injection) 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 Tests).
Oxacillin (oxacillin (oxacillin for injection) for injection) may be used to initiate therapy in suspected cases of resistant staphylococcal infections prior to the availability of susceptibility test results. Oxacillin (oxacillin (oxacillin for injection) for injection) 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 (oxacillin (oxacillin for injection) for injection) .
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Oxacillin Injection, USP and other antibacterial drugs, Oxacillin (oxacillin (oxacillin for injection) for injection) 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.
DOSAGE AND ADMINISTRATION
Oxacillin (oxacillin (oxacillin for injection) for injection) Injection, USP supplied as a premixed frozen solution is to be administered as a continuous or intermittent intravenous infusion. The usual dose recommendation is as follows:
|250-500 mg||I.V. every 4-6 hours (mild to moderate infections)|
|1 gram||I.V. every 4-6 hours (severe infections)|
This container system may be inappropriate for the dosage requirements for children, infants and neonates. Other dosage forms may be more appropriate.
Bacteriologic studies to determine the causative organisms and their susceptibility to oxacillin (oxacillin (oxacillin for injection) for injection) should always be performed. Duration of therapy varies with the type of 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 oxacillin (oxacillin (oxacillin for injection) for injection) should be continued for at least 14 days. Therapy should be continued for at least 48 hours after the patient has become afebrile, asymptomatic, and cultures are negative. Treatment of endocarditis and osteomyelitis may require a longer duration of therapy.
Concurrent administration of oxacillin (oxacillin (oxacillin for injection) for injection) and probenecid increases and prolongs serum penicillin levels. Probenecid decreases the apparent volume of distribution and slows the rate of excretion by competitively inhibiting renal tubular secretion of penicillin. Penicillin-probenecid therapy is generally limited to those infections where very high serum levels of penicillin are necessary.
With intravenous administration, particularly in elderly patients, care should be taken because of the possibility of thrombophlebitis.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Do not add supplementary medication to Oxacillin (oxacillin (oxacillin for injection) for injection) Injection, USP.
Store in a freezer capable of maintaining a temperature of -20°C/-4°F or less.
Directions for Use of GALAXY Plastic Container
Thaw at room temperature (25°C/77°F) or under refrigeration (5°C/41°F). [DO NOT FORCE THAW BY IMMERSION IN WATER BATHS OR BY MICROWAVE IRRADIATION]. Components of the solution may precipitate in the frozen state and will dissolve upon reaching room temperature with little or no agitation. Potency is not affected. Mix after solution has reached room temperature. Check for minute leaks by squeezing bag firmly. If leaks are found, discard solution as sterility may be impaired. Do not use if the solution is cloudy or precipitated or if seals are not intact. The thawed solution is stable for 21 days under refrigeration or 48 hours at room temperature. Do not refreeze.
Use sterile equipment.
Caution: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.
Preparation for intravenous administration
- Suspend container from eyelet support.
- Remove protector from outlet port at bottom of container.
- Attach administration set. Refer to complete directions accompanying set.
Oxacillin (oxacillin (oxacillin for injection) for injection) Injection, USP is supplied as a premixed frozen iso-osmotic solution in 50 mL single dose GALAXY plastic containers as follows:
|2G3538||NDC 0338-1013-41||1 gram oxacillin|
|2G3539||NDC 0338-1015-41||2 grams oxacillin|
Store at or below -20°C/-4°F. [See Directions for use of GALAXY Container (PL 2040).]
3. National Committee for Clinical Laboratory Standards. Disk Diffusion Supplemental Tables. NCCLS Document M100-S13 (M2); NCCLS, Wayne, PA, January, 2003.
4. National Committee for Clinical Laboratory Standards. MIC Testing Supplemental Tables. NCCLS Document M100-S13 (M7); NCCLS, Wayne, PA, January, 2003.
Baxter Healthcare Corporation Deerfield, IL 60015, USA. Rev. February 2007. FDA Rev date: 04/17/08
Last reviewed on RxList: 8/26/2008
This monograph has been modified to include the generic and brand name in many instances.
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