"The U.S. Food and Drug Administration announced today that injectable drugs used in total parenteral nutrition (TPN) in critical shortage will be imported into the United States and available to patients this week.
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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 may be used to initiate therapy in suspected cases of resistant staphylococcal infections prior to the availability of susceptibility test results. 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 an organism other than a resistant Staphylococcus, therapy should not be continued with Nafcillin Injection, USP.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of Nafcillin Injection, USP and other antibacterial drugs, Nafcillin 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
Nafcillin Injection, USP supplied as a premixed frozen solution is to be administered as an intravenous infusion. The usual I.V. dosage for adults is 500 mg every 4 hours. For severe infections, 1 g every 4 hours is recommended. Administer slowly over at least 30 to 60 minutes to minimize the risk of vein irritation and extravasation. 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. Therapy should be continued for at least 48 hours after the patient has become afebrile, asymptomatic, and cultures are negative. The treatment of endocarditis and osteomyelitis may require a longer duration of therapy.
Nafcillin-probenecid therapy is generally limited to those infections where very high serum levels of nafcillin are necessary.
No dosage alterations are necessary for patients with renal dysfunction, including those on hemodialysis. Hemodialysis does not accelerate nafcillin clearance from the blood.
For patients with hepatic insufficiency and renal failure, measurement of nafcillin serum levels should be performed and dosage adjusted accordingly.
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 Nafcillin Injection, USP.
Store in a freezer capable of maintaining a temperature of -20°C (-4°F) or less.
Directions For Use Of Galaxy Container (Pl 2040 Plastic)
Nafcillin Injection, USP in GALAXY container (PL 2040 Plastic) is for intravenous administration using sterile equipment.
Store in a freezer capable of maintaining a temperature of -20°C/-4°F.
Thawing of Plastic Containers
Thaw frozen container 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.] Check for minute leaks by squeezing bag firmly. If leaks are detected, discard solution as sterility may be impaired.
Do not add supplementary medication.
The container should be visually inspected. 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. Agitate after solution has reached room temperature. If after visual inspection the solution remains cloudy or if an insoluble precipitate is noted or if any seals or outlet ports are not intact, the container should be discarded.
The thawed 1 g and 2 g solutions are stable for 21 days under refrigeration (5°C/41°F) or 72 hours at room temperature (25°C/77°F). Do not refreeze.
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.
Storage And Handling
Nafcillin Injection, USP is supplied as a premixed frozen iso-osmotic solution in 50 mL and 100 mL single dose GALAXY containers (PL 2040 Plastic) as follows:
2G3540 NDC 0338-1017-41 1 gram nafcillin in 50 mL
2G3556 NDC 0338-1019-48 2 grams nafcillin in 100 mL
Store at or below -20°C/-4°F. See Directions for Use of GALAXY Container (PL 2040 Plastic).
Handle frozen product containers with care. Product containers may be fragile in the frozen state.
Baxter Healthcare Corporation. Deerfield, IL 60015 USA. Rev. October 2011
Last reviewed on RxList: 11/18/2011
This monograph has been modified to include the generic and brand name in many instances.
Additional Nafcillin Injection Information
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