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
Unasyn Indications, Dosage, Storage, Stability - Ampicillin and Sulbactam
Unasyn Indications, Dosage, Storage, Stability - Ampicillin and Sulbactam
INDICATIONS AND USAGE
UNASYN is indicated for the treatment of infections due to susceptible
strains of the designated microorganisms in the conditions listed below.
Skin and Skin Structure Infections caused by beta-lactamase producing
strains of Staphylococcus aureus, Escherichia coli,* Klebsiella spp.*
(including K. pneumoniae*), Proteus mirabilis,* Bacteroides fragilis,*
Enterobacter spp.,* and Acinetobacter calcoaceticus.*
NOTE: For information on use in pediatric patients see PRECAUTIONS–Pediatric
Use and CLINICAL STUDIES sections. Intra-Abdominal Infections caused by
beta-lactamase producing strains of Escherichia coli, Klebsiella spp.
(including K. pneumoniae*), Bacteroides spp. (including B. fragilis),
and Enterobacter spp.*
Gynecological Infections caused by beta-lactamase producing strains of
Escherichia coli,* and Bacteroides spp.* (including B. fragilis*).* Efficacy
for this organism in this organ system was studied in fewer than 10 infections.
While UNASYN is indicated only for the conditions listed above, infections
caused by ampicillin-susceptible organisms are also amenable to treatment
with UNASYN due to its ampicillin content. Therefore, mixed infections
caused by ampicillin-susceptible organisms and beta-lactamase producing
organisms susceptible to UNASYN should not require the addition of another
antibiotic. Appropriate culture and susceptibility tests should be performed
before treatment in order to isolate and identify the organisms causing
infection and to determine their susceptibility to UNASYN. Therapy may
be instituted prior to obtaining the results from bacteriological and
susceptibility studies, when there is reason to believe the infection
may involve any of the beta-lactamase producing organisms listed above
in the indicated organ systems. Once the results are known, therapy should
be adjusted if appropriate.
DOSAGE AND ADMINISTRATION
UNASYN may be administered by either the IV or the IM routes. For IV
administration, the dose can be given by slow intravenous injection over
at least 10-15 minutes or can also be delivered, in greater dilutions
with 50-100 mL of a compatible diluent as an intravenous infusion over
15-30 minutes. UNASYN may be administered by deep intramuscular injection.
(See Preparation for Intramuscular Injection.)
The recommended adult dosage of UNASYN is 1.5 g (1 g ampicillin as the
sodium salt plus 0.5 g sulbactam as the sodium salt) to 3 g (2 g ampicillin
as the sodium salt plus 1 g sulbactam as the sodium salt) every six hours.
This 1.5 to 3 g range represents the total of ampicillin content plus
the sulbactam content of UNASYN, and corresponds to a range of 1 g ampicillin/0.5
g sulbactam to 2 g ampicillin/1 g sulbactam. The total dose of sulbactam
should not exceed 4 grams per day.
Pediatric Patients 1 Year of Age or Older: The recommended daily dose
of UNASYN in pediatric patients is 300 mg per kg of body weight administered
via intravenous infusion in equally divided doses every 6 hours. This
300 mg/kg/day dosage represents the total ampicillin content plus the
sulbactam content of UNASYN, and corresponds to 200 mg ampicillin/100
mg sulbactam per kg per day.
The safety and efficacy of UNASYN administered via intramuscular injection
in pediatric patients have not been established.
Pediatric patients weighing 40 kg or more should be dosed according to
adult recommendations, and the total dose of sulbactam should not exceed
4 grams per day. The course of intravenous therapy should not routinely
exceed 14 days. In clinical trials, most children received a course of
oral antimicrobials following initial treatment with intravenous UNASYN.
(See CLINICAL STUDIES section.)
Impaired Renal Function In patients with impairment of renal function
the elimination kinetics of ampicillin and sulbactam are similarly affected,
hence the ratio of one to the other will remain constant whatever the
renal function. The dose of UNASYN in such patients should be administered
less frequently in accordance with the usual practice for ampicillin and
according to the following recommendations: UNASYN Dosage Guide For Patients
With Renal Impairment Creatinine Clearance (mL/min/1.73m 2 ) Ampicillin/Sulbactam
Half-Life (Hours) Recommended UNASYN Dosage =30 1 1.5-3.0 g q 6h-q 8h
15-29 5 1.5-3.0 g q 12h 5-14 9 1.5-3.0 g q 24h When only serum creatinine
is available, the following formula (based on sex, weight, and age of
the patient) may be used to convert this value into creatinine clearance.
The serum creatinine should represent a steady state of renal function.
Males weight (kg) × (140 – age) 72 × serum creatinine
Females 0.85 × above value
COMPATIBILITY, RECONSTITUTION AND STABILITY
UNASYN sterile powder is to be stored at or below 30°C (86°F) prior to
reconstitution. When concomitant therapy with aminoglycosides is indicated,
UNASYN and aminoglycosides should be reconstituted and administered separately,
due to the in vitro inactivation of aminoglycosides by any of the aminopenicillins.
DIRECTIONS FOR USE
General Dissolution Procedures: UNASYN sterile powder for intravenous
and intramuscular use may be reconstituted with any of the compatible
diluents described in this insert. Solutions should be allowed to stand
after dissolution to allow any foaming to dissipate in order to permit
visual inspection for complete solubilization. Preparation for Intravenous
Use 1.5 g and 3.0 g Bottles: UNASYN sterile powder in piggyback units
may be reconstituted directly to the desired concentrations using any
of the following parenteral diluents. Reconstitution of UNASYN, at the
specified concentrations, with these diluents provide stable solutions
for the time periods indicated in the following table: (After the indicated
time periods, any unused portions of solutions should be discarded.) Diluent
Maximum Concentration (mg/mL) UNASYN (Ampicillin/Sulbactam)
|
|
Maximum Concentration
|
|
|
|
(mg/ mL)
|
|
|
Diluent
|
UNASYN (Ampicillin/ Sulbactam)
|
Use Periods
|
|
Sterile Water for Injection
|
45 (30/ 15)
|
8 hrs @ 25° C
|
|
|
45 (30/ 15)
|
48 hrs @ 4° C
|
|
|
30 (20/ 10)
|
72 hrs @ 4° C
|
|
0.9% Sodium Chloride Injection
|
45 (30/ 15)
|
8 hrs @ 25° C
|
|
|
45 (30/ 15)
|
48 hrs @ 4° C
|
|
|
30 (20/ 10)
|
72 hrs @ 4° C
|
|
5% Dextrose Injection
|
30 (20/ 10)
|
2 hrs @ 25° C
|
|
|
30 (20/ 10)
|
4 hrs @ 4° C
|
|
|
3 (2/ 1)
|
4 hrs @ 25° C
|
|
Lactated Ringer’s Injection
|
45 (30/ 15)
|
8 hrs @ 25° C
|
|
|
45 (30/ 15)
|
24 hrs @ 4° C
|
|
M/ 6 Sodium Lactate Injection
|
45 (30/ 15)
|
8 hrs @ 25° C
|
|
|
45 (30/ 15)
|
8 hrs @ 4° C
|
|
5% Dextrose in 0.45% Saline
|
3 (2/ 1)
|
4 hrs @ 25° C
|
|
|
15 (10/ 5)
|
4 hrs @ 4° C
|
|
10% Invert Sugar
|
3 (2/ 1)
|
4 hrs @ 25° C
|
|
|
30 (20/ 10)
|
3 hrs @ 4° C
|
|
If piggyback bottles are unavailable, standard vials of UNASYN sterile
powder may be used. Initially, the vials may be reconstituted with Sterile
Water for Injection to yield solutions containing 375 mg UNASYN per mL
(250 mg ampicillin/125 mg sulbactam per mL). An appropriate volume should
then be immediately diluted with a suitable parenteral diluent to yield
solutions containing 3 to 45 mg UNASYN per mL (2 to 30 mg ampicillin/1
to 15 mg sulbactam/per mL).
1.5 gADD-Vantage® Vials: UNASYN in the ADD-Vantage® system is intended
as a single dose for intravenous administration after dilution with the
ADD-Vantage® Flexible Diluent Container containing 50 mL, 100 mL or 250
mL of 0.9% Sodium Chloride Injection, USP.
3 g ADD-Vantage® Vials: UNASYN in the ADD-Vantage® system is intended
as a single dose for intravenous administration after dilution with the
ADD-Vantage® Flexible Diluent Container containing 100 mL or 250 mL of
0.9% Sodium Chloride Injection, USP. UNASYN in the ADD-Vantage® system
is to be reconstituted with 0.9% Sodium Chloride Injection, USP only.
See INSTRUCTIONS FOR USE OF THE ADD-Vantage® VIAL. Reconstitution of UNASYN,
at the specified concentration, with 0.9% Sodium Chloride Injection, USP
provides stable solutions for the time period indicated below:
|
|
Maximum Concentration (mg/ mL)
|
|
|
Diluent
|
UNASYN (Ampicillin/ Sulbactam)
|
Use Period
|
|
0.9% Sodium Chloride
|
30 (20/ 10)
|
8 hrs @ 25° C
|
|
Injection
|
|
|
|
In 0.9% Sodium Chloride Injection, USP
|
|
|
|
|
The final diluted solution of UNASYN should be completely administered
within 8 hours in
|
|
|
order to assure proper potency.
|
|
|
|
Preparation for Intramuscular Injection
|
|
|
|
|
1.5 g and 3.0 g Standard Vials: Vials for intramuscular
use may be reconstituted with Sterile
|
|
|
|
Water for Injection USP, 0.5% Lidocaine Hydrochloride Injection
USP or 2% Lidocaine
|
|
|
|
Hydrochloride Injection USP. Consult the following table for
recommended volumes to be added
|
|
|
|
to obtain solutions containing 375 mg UNASYN per mL (250 mg
ampicillin/ 125 mg sulbactam
|
|
|
|
per mL). Note: Use only freshly prepared solutions and administer
within one hour after
|
|
|
preparation.
|
|
|
|
UNASYN
|
Volume of Diluent
|
Withdrawal
|
|
Vial Size
|
to be Added
|
Volume*
|
|
1.5 g
|
3.2 mL
|
4.0 mL
|
|
3.0 g
|
6.4 mL
|
8.0 mL
|
*There is sufficient excess present to allow withdrawal and administration
of the stated volumes.
Animal Pharmacology: While reversible glycogenosis was observed in laboratory
animals, this phenomenon was dose- and time-dependent and is not expected
to develop at the therapeutic doses and corresponding plasma levels attained
during the relatively short periods of combined ampicillin/sulbactam therapy
in man.
HOW SUPPLIED UNASYN® (ampicillin sodium/sulbactam sodium) is supplied
as a sterile off-white dry powder in glass vials and piggyback bottles.
The following packages are available:
Vials containing 1.5 g (NDC 0049-0013-83) equivalent of UNASYN® (1 g
ampicillin as the sodium salt plus 0.5 g sulbactam as the sodium salt)
Vials containing 3 g (NDC 0049-0014-83) equivalent of UNASYN® (2 g ampicillin
as the sodium salt plus 1 g sulbactam as the sodium salt)
Bottles containing 1.5 g (NDC 0049-0022-83) equivalent of UNASYN® (1
g ampicillin as the sodium salt plus 0.5 g sulbactam as the sodium salt)
Bottles containing 3 g (NDC 0049-0023-83) equivalent of UNASYN® (2 g ampicillin
as the sodium salt plus 1 g sulbactam as the sodium salt)
Pharmacy Bulk Package containing 15 g (NDC 0049-0024-28) equivalent of
UNASYN® (10 g ampicillin as the sodium salt plus 5 g sulbactam as the
sodium salt)
ADD-Vantage® vials containing 1.5 g (NDC 0049-0031-83) equivalent of
UNASYN® (1 g ampicillin as the sodium salt plus 0.5 g sulbactam as the
sodium salt) are distributed by Pfizer Inc.
ADD-Vantage® vials containing 3 g (NDC 0049-0032-83) equivalent of UNASYN®
(2 g ampicillin as the sodium salt plus 1 g sulbactam as the sodium salt)
are distributed by Pfizer Inc.
The 1.5 g UNASYN® ADD-Vantage® vials are only to be used with Abbott
Laboratories’ ADD-Vantage® Flexible Diluent Container containing 0.9%
Sodium Chloride Injection, USP, 50 mL, 100 mL, or 250 mL sizes.
The 3 g UNASYN® ADD-Vantage® vials are only to be used with Abbott Laboratories’
ADD-Vantage® Flexible Diluent Container containing 0.9% Sodium Chloride
Injection, USP, 100 mL or 250 mL sizes.
REFERENCES
1. National Committee for Clinical Laboratory Standards, Performance
Standards for Antimicrobial Disk Susceptibility Tests–Fourth Edition.
Approved Standard NCCLS Document M2-A4, Vol. 10, No. 7 NCCLS, Villanova,
PA, April 1990.
2. National Committee for Clinical Laboratory Standards, Methods for
Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically,
Second Edition. Approved Standard NCCLS Document M7-A2, Vol. 10, No. 8
NCCLS, Villanova, PA, April 1990.
1997 PFIZER INC
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