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Oxacillin (Oxacillin Sodium) - Indications and Dosage

 
 



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 Plate Testing).

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 for Injection, USP and other antibacterial drugs, Oxacillin 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 the empiric selection of therapy.

DOSAGE AND ADMINISTRATION

The intent of the pharmacy bulk package for this product is for preparation of solutions for IV infusion only.

The penicillinase-resistant penicillins are available for oral administration and for intramuscular and intravenous injection. The sodium salts of methicillin, oxacillin, and nafcillin may be administered parenterally and the sodium salts of cloxacillin, dicloxacillin, oxacillin, and nafcillin are available for oral use.

Bacteriologic studies to determine the causative organisms and their susceptibility to oxacillin 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 oxacillin 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 term of therapy.

Concurrent administration of oxacillin 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.

Oral preparations of the penicillinase-resistant penicillins should not be used as initial therapy in serious, life-threatening infections (See PRECAUTIONS: General). Oral therapy with the penicillinase-resistant penicillins may be used to follow-up the previous use of a parenteral agent as soon as the clinical condition warrants. With intravenous administration, particularly in elderly patients, care should be taken because of the possibility of thrombophlebitis.

RECOMMENDED DOSAGES FOR OXACILLIN FOR INJECTION, USP
Drug Adults Infants and Children
<40 kg (88 lbs)
Other Recommendations
Oxacillin 250 to 500 mg IV every 4 to 6 hours (mild to moderate infections) 50 mg/kg/day IV in equally divided doses every 6 hours (mild to moderate infections)
1 gram IV every 4 to 6 hours (severe infections) 100 mg/kg/day IV in equally divided doses every 4 to 6 hours (severe infections) Premature and Neonates 25 mg/kg/day IV

Directions for use

For Administration by Intravenous Drip

Reconstitute as directed below ( Pharmacy Bulk Package) prior to further dilution.

STABILITY PERIODS FOR OXACILLIN FOR INJECTION, USP 1

Concentration

mg/mL

Sterile

Water for

Injection,

USP

0.9%

Sodium

Chloride

Injection,

USP

Sodium

Lactate

Injection,

USP

(M/6

Sodium

Lactate)

5%

Dextrose

Injection,

USP

5%

Dextrose

and

0.45%

Sodium

Chloride

Injection,

USP

10%

Invert

Sugar

Injection,

USP

Lactated

Ringers

Injection,

USP

ROOM TEMPERATURE (25°C)
10-100 4 Days 4 Days
10-30 24 Hrs 24 Hrs
0.5-2 6 Hrs 6 Hrs 6 Hrs
REFRIGERATION (4°C)
10-100 7 Days 7 Days
10-30 4 Days 4 Days 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 30 Days 30 Days

1 IMPORTANT: This chemical stability information in no way indicates that it would be acceptable practice to use this product well after the preparation time. Good professional practice suggests that a product should be used as soon after preparation as feasible.

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 Pharmacy Bulk Package bottle contains 10 grams Oxacillin Sodium and is designed for use in the pharmacy in preparing IV admixtures. Add 93 mL Sterile Water for Injection, USP or Sodium Chloride Injection, USP 0.9%. The resulting solution will contain 100 mg oxacillin per mL and will require further dilution.

CAUTION: NOT TO BE DISPENSED AS A UNIT.

Directions For Proper Use of Pharmacy Bulk Package

  1. The container closure may be penetrated only one time after reconstitution, utilizing a suitable sterile dispensing set which allows measured distribution of the contents.
  2. Use of this product is restricted to a suitable work area, such as a laminar flow hood.
  3. Once this container closure has been punctured, withdrawal of the contents should be completed without delay. If prompt fluid transfer cannot be accomplished, discard the contents no later than 4 hours after initial closure puncture. This time limit should begin with the introduction of solvent or diluent into the Pharmacy Bulk Package bottle.
  4. A plastic ball attached to the pharmacy bulk package provides a suitable hanging device while dispensing contents.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

HOW SUPPLIED

Oxacillin for Injection, USP, is available in a Pharmacy Bulk Package bottle which contains oxacillin sodium monohydrate equivalent to 10 grams oxacillin.

NDC 0781-3103-95 10 grams Pharmacy Bulk Package bottle, Packaged in carton of ten Pharmacy Bulk Package bottles.


Storage

Store the dry powder at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].

07-2011M

46067043

Manufactured in Austria by Sandoz GmbH

for Sandoz Inc., Princeton, NJ 08540

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