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
Unipen Indications, Dosage, Storage, Stability - Nafcillin Sodium
Unipen Indications, Dosage, Storage, Stability - Nafcillin 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. Cultures and
susceptibility tests should be performed initially to determine
the causative organism
and their sensitivity to the drug
(See CLINICAL PHARMACOLOGY:
Susceptibility 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 endocardits
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 penicillinase-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 thrombophlebits.
RECOMMENDED DOSAGES FOR NAFCILLIN SODIUM FOR
INJECTION, USP
|
Drug
|
Adults
|
Infants and Children
< 40 kg
(88 lbs)
|
Other
Recommendations
|
|
Nafcillin
|
500 mg
IM every 4 to 6 hrs. IV
every 4 hrs.
|
25 mg/ kg
IM twice daily
|
Neonates 10 mg/ kg
IM twice daily
|
|
1 gram
IM or IV every
4 hrs,
(severe infections)
|
|
|
DIRECTIONS FOR USE
For Intramuscular Use: Reconstitute with Sterile Water for
Injection, USP, 0.9% Sodium Chloride Injection, USP or Bacteriostatic
Water for Injection, USP (with benzyl
alcohol or parabens);
add 1.8 mL to the 500 mg
vial for 2 mL resulting
solution; 3.4 mL to the 1 g vial
for 4 mL resulting solution; 6.6 mL to the 2 g vial
for 8 mL resulting solution. All reconstituted vials have a concentration
of 250 mg per
mL.
The clear solution
should be administered by deep
intragluteal injection immediately after reconstitution.
Reconstituted Stability: Reconstitute with the required
amount of Sterile Water for Injection, US P, 0.9% Sodium Chloride
Injection, USP or Bacteriostatic Water for Injection, USP (with
benzyl alcohol
or parabens) The resulting solutions are stable
for 3 days at room temperature
or 7 day under refrigeration
and 90 days frozen.
For Direct Intravenous Use: The required amount of drug
should be diluted in 15 to 30 mL of Sterile Water for Injection,
USP or Sodium Chloride Injection, USP and injected
over a 5- to 10- minute period. This may be accomplished through
the tubing of an intravenous
infusion if desirable.
For Administration by Intravenous Drip: Reconstitute as
directed above (For Intramuscular Use) prior to diluting with Intravenous
Solution.
STABILITY PERIODS FOR NAFCILLIN SODIUM FOR INJECTION,
USP
|
Concentration mg/ mL
|
Sterile
H2O for
injection
|
Isotonic
Sodium
Chloride
|
M/6 Molar
Sodium
Lactate
Solution
|
5%
Dextrose in H2O
|
5%
Dextrose in 0.45% NaCl
|
10%
Invert
Sugar
|
Lactated
Ringers
Solution
|
|
ROOM TEMPERATURE (25° C)
|
|
10-200
|
24 Hrs
|
24 Hrs
|
|
|
|
|
|
|
30
|
|
|
24 Hrs
|
|
|
|
|
|
2-30
|
|
|
|
24 Hrs
|
24 Hrs
|
|
|
|
10-30
|
|
|
|
|
|
24 Hrs
|
24 Hrs
|
|
REFRIGERATION (4° C)
|
|
10-200
|
7 Days
|
7 Days
|
|
|
|
|
|
|
10-30
|
|
|
7 Days
|
7 Days
|
7 Days
|
7 Days
|
7 Days
|
|
FROZEN (- 15° C)
|
|
250
|
90 Days
|
90 Days
|
|
|
|
|
|
|
10-250
|
|
|
90 Days
|
90 Days
|
90 Days
|
90 Days
|
90 Days
|
Only those solutions listed above should be used for the intravenous
infusion of Nafcillin Sodium, USP. 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 nafcillin is administered
before the drug loses its
stability in the solution in use.
There is no clinical
experience available
on the use of this agent
in neonates or infants for this route of administration. This route
of administration should be used for relatively short-term therapy
(24 to 48 hours) because of the occasional occurrence of thrombophlebitis
particularly in elderly patients.
If another agent is used
in conjunction with nafcillin therapy, it should not be physically
mixed with nafcillin but
should be administered separately.
Pharmacy Bulk Package: This glass
vial contains 10 grams
Nafcillin Sodium For Injection, USP and is designed for use in the
pharmacy in preparing I.V. additives. Add 93 mL Sterile Water for
Injection, USP or 0. 9% Sodium Chloride Injection, USP. The resulting
solution will
contain 100 mg nafcillin
activity per mL. Solutions
in a concentration
of 10 mg to 200 mg
per mL are stable
for 24 hours at room temperature
or 7 days under refrigeration. Solutions in a concentration
of 250 mg per
mL are stable for 3 days
at room temperature
or 7 days under refrigeration
and 90 days frozen.
CAUTION: NOT TO BE
DISPENSED AS A UNIT.
FOR INFORMATION ONLY
''Piggyback'' I. V. Package: This glass
vial contains the labeled
quantity of Nafcillin and is intended for intravenous
administration. The diluent and volume
are specified on the label
of each package. When the ''piggyback'' vial
is reconstituted with either Sterile Water for Injection, USP or
0. 9% Sodium Chloride Injection, USP and the resulting solutions
are in a concentration
of 10 to 200 mg/mL, the solutions are stable
for 24 hours at room temperature
or 7 days under refrigeration
and 90 days frozen.
HOW SUPPLIED
Nafcillin Sodium For Injection, USP Nafcillin sodium
equivalent to 500
mg, 1 gram, 2 grams, or 10 grams nafcillin per
vial.
NDC 0015-7224-20 - 500 mg
vial packaged in 10s
NDC 0015-7225-20 - 1 gram
vial packaged in 10s
NDC 0015-7226-20 - 2 gram
vial packaged in 10s
NDC 0015-7101-28 - 10 gram
Pharmacy Bulk Package packaged in 10s
Also Available:
NDC 0015-7195-28 – 1 gram
'' Piggyback'' packaged in 10s
NDC 0015-7196-28 – 2 gram
'' Piggyback'' packaged in 10s
For information on package sizes available, refer to current
price schedule.
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