Dilution Oxacillin

Oxacillin Sodium

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Usual Diluents

NS, D5W

Standard Dilutions [Amount of drug] [Infusion volume] [Infusion rate]

[250 mg] [50 ml] [30 min]
[500 mg] [50 ml] [30 min]
[1000 mg] [50 ml] [30 min]
[2000 mg] [50-100 ml] [30 min]*
*Infusion time may be increased to 60 minutes if the patient experiences pain or discomfort at the injection site assuming that the patient has a patent IV site.

Also available as a premixed IV:
Oxacillin 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

Stability / Miscellaneous

Dosing (Adults):
250 to 500 mg IM or IV every 4 to 6 hours (mild to moderate infections).
1 gram IM or IV every 4 to 6 hours (severe infections).

Dosing adjustment in renal impairment:
Clcr > 10 mL/minute: No changes.
Clcr<10 mL/minute: Use lower range of the usual dosage.
Hemodialysis: Not dialyzable (0% to 5%)

Pharmacokinetics
Oxacillin Sodium, with normal doses, has insignificant concentrations in the cerebrospinal and ascitic fluids. It is found in therapeutic concentrations in the pleural, bile, and amniotic fluids. Oxacillin Sodium is rapidly excreted as unchanged drug in the urine by glomerular filtration and active tubular secretion.

Oxacillin Sodium binds to serum protein, mainly albumin. The degree of protein binding reported varies with the method of study and the investigator, but generally has been found to be 94.2 ± 2.1%.

Intramuscular injections give peak serum levels 30 minutes after injection. A 250 mg dose gives a level of 5.3 µg/mL while a 500 mg dose peaks at 10.9 µg/mL. Intravenous injection gives a peak about 5 minutes after the injection is completed. Slow IV dosing with 500 mg gives a 5 minute peak of 43 µg/mL with a half-life of 20 to 30 minutes.

INDICATIONS AND USAGE
The penicillinase-resistant penicillins are indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drugs. Culture and susceptibility tests should be performed initially to determine the causative organism and their sensitivity to the drug.

The penicillinase-resistant penicillins may be used to initiate therapy in suspected cases of resistant staphylococcal infections prior to the availability of laboratory test results. The penicillinase-resistant penicillins 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 a penicillinase-resistant penicillin.

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.

For Intramuscular Use
Use Sterile Water for Injection, USP. Add 1.4 mL to the 250 mg vial, 2.7 mL to the 500 mg vial, 5.7 mL to the 1 gram vial, 11.5 mL to the 2 gram vial, and 23 mL to the 4 gram vial. Shake well until a clear solution is obtained. After reconstitution, vials will contain 250 mg of active drug per 1.5 mL of solution. The reconstituted solution is stable for 3 days at 70° F or for one week under refrigeration (40° F).

For Direct Intravenous Use
Use Sterile Water for Injection, USP or Sodium Chloride Injection, USP. Add 5 mL to the 250 mg and 500 mg vials, 10 mL to the 1 gram vial, 20 mL to the 2 gram vial, and 40 mL to the 4 gram vial. Withdraw the entire contents and administer slowly over a period of approximately 10 minutes.

For Administration by Intravenous Drip
Reconstitute as directed above prior to diluting with Intravenous Solution.

--- Storage/Stability ---

STABILITY PERIODS FOR OXACILLIN FOR INJECTION, USP

Concentration mg/mL	Sterile H2O for Injection	Isotonic Sodium Chloride	5% Dextrose in H2O	5% Dextrose in 0.45% NaCl	Lactated Ringers Solution
ROOM TEMPERATURE (25° C)
10-100	4 Days	4 Days
10-30				24 Hrs
0.5-2			6 Hrs		6 Hrs
REFRIGERATION (4° C)
10-100	7 Days	7 Days
10-30			4 Days	4 Days	4 Days
FROZEN (-15° C)
50-100	30 Days
250/1.5 mL	30 Days
100		30 Days
10-100			30 Days	30 Days	30 Days

Stability studies on Oxacillin Sodium at concentrations of 0.5 mg/mL and 2 mg/mL in various intravenous solutions listed below indicate the drug will lose less than 10% activity at room temperature (70° F) during a 6-hour period.

IV Solution
5% Dextrose in Normal Saline
10% D-Fructose in Water
10% D-Fructose in Normal Saline
Lactated Potassic Saline Injection
10% Invert Sugar in Normal Saline
10% Invert Sugar Plus 0.3% Potassium Chloride in Water
Travert 10% Electrolyte #1
Travert 10% Electrolyte #2
Travert 10% Electrolyte #3

Only those solutions listed above should be used for the intravenous infusion of Oxacillin Sodium. The concentration of the antibiotic should fall within the range specified. The drug concentration and the rate and volume of the infusion should be adjusted so that the total dose of oxacillin is administered before the drug loses its stability in the solution in use. If another agent is used in conjunction with oxacillin therapy, it should not be physically mixed with oxacillin but should be administered separately.

Pharmacy Bulk Package
This glass vial contains 10 grams Oxacillin Sodium and is designed for use in the pharmacy in preparing IV additives. Add 93 mL Sterile Water for Injection, USP or Sodium Chloride Injection, USP. The resulting solution will contain 100 mg oxacillin sodium per mL.
Following reconstitution in this manner, the resulting solutions are stable for 4 days at room temperature or 7 days under refrigeration. CAUTION: NOT TO BE DISPENSED AS A UNIT.

HOW SUPPLIED
Oxacillin for Injection, USP. Oxacillin sodium equivalent to 1, 2, or 10 grams oxacillin per vial.

Revised 01-2004Manufactured by
Sandoz GmbH, Kundl, Austria
for Sandoz Inc., Broomfield, CO 80020

Source: [package insert]