A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Bactocill Indications, Dosage, Storage, Stability - Oxacillin Sodium
Bactocill Indications, Dosage, Storage, Stability - Oxacillin Sodium
INDICATIONS
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
(See CLINICAL PHARMACOLOGY-
Susceptibilily Plate Testing).
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.
DOSAGE AND ADMINISTRATION
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 sensitivity to the penicillinase-resistant penicillins 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 penicillinase-resistant penicillins 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 the penicillinase-resistant penicillins 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 peniciIlinase-resistant penicillins
may be used to follow-up the previous use of a parenteral
agent as soon as the clinical
condition warrants. For intramuscular
gluteal injections,
care should be taken to avoid sciatic
nerve injury. With intravenous
administration, particularly in elderly patients, care should be
taken because of the possibility of thrombophlebitis.
RECOMMENDED DOSAGES FOR OXACILLIN SODIUM FOR INJECTION, USP
|
Drug
|
Adults
|
Infants and Children < 40 kg
(88 lbs)
|
Other Recommendations
|
| Oxacillin
|
250 to 500 mg
IM or IV every
4 to 6 hours (mild to moderate infections)
|
50 mg/ kg/ day IM or IV
in equally divided doses every 6 hours (mild to moderate
infections)
|
|
|
1 gram
IM or IV every
4 to 6 hours (severe infections)
|
100 mg/ kg/ day IM or IV
in equally divided doses every 4 to 6 hours (severe infections)
|
Premature and Neonates 25 mg/ kg/ day
IM or IV
|
DIRECTIONS FOR USE
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 (For Direct Intravenous Use) prior to diluting with
Intravenous Solution.
STABILITY PERIODS FOR OXACILLIN SODIUM FOR INJECTI ON, USP
|
Concentration mg/ mL
|
Sterile H2O for lnjection
|
Isotonic Sodium Chloride
|
M/6 Molar Lactate Solution
|
5% Dexthose in H2O
|
5% Dextrosein 0.45% NaCl
|
10% Invert Sugar
|
Lactated Ringers Solution
|
|
ROOM TEMPERATURE (25o C)
|
| 10-100 |
4 Days
|
4 Days
|
|
|
|
|
|
| 10-30 |
|
|
24 Hrs
|
|
24 Hrs
|
|
|
| 0.5-2 |
|
|
|
6 Hrs
|
|
6 Hrs
|
6 Hrs
|
|
REFRIGERATION (4o C)
|
| 10-100 |
7 Days
|
7 Days
|
|
|
|
|
|
| 10-30 |
|
|
4 Days
|
4 Days
|
4 Days
|
4 Days
|
4 Days
|
|
FROZEN (- 15o 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
|
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.
''Piggyback'' IV Package:
This glass vial
contains the labeled quantity of Oxacillin Sodium and is intended
for intravenous
administration. The diluent
and volume are specified
on the label of each package.
Discard solution after 24 hours at room
temperature.
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 Sodium For Injection, USP. Oxacillin sodium
equivalent to 250,
500 mg, 1, 2, 4 or 10 grams oxacillin
per vial.
- NDC 0015-7978-20–250 mg
vial packaged in 10s
- NDC 0015-7979-20–500 mg
vial packaged in 10s
- NDC 0015-7981-20–1 gram
vial packaged in 10s
- NDC 0015-7970-20–2 gram
vial packaged in 10s
- NDC 0015-7300-29–4 gram
vial packaged in 10s
- NDC 0015-7981-28–1 gram
''Piggyback'' vial packaged
in 10s
- NDC 0015-7970-28–2 gram
''Piggyback'' vial packaged
in 10s
- NDC 0015-7103-28–10 gram
Pharmacy Bulk Package packaged in 10s
Also available: PROSTAPHLIN (oxacillin sodium
Capsules, USP). Oxacillin sodium
equivalent to 250
or 500 mg oxacillin
per capsule.
- NDC 0015-7977–250 mg
- NDC 0015-7982–500 mg
PROSTAPHLIN (oxacillin sodium
for Oral Solution, USP). Each 5 mL of reconstituted solution
contains oxacillin
sodium equivalent
to 250 mg oxacillin.
For information on package sizes available, refer to the current
price schedule.
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