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
Timentin Indications, Dosage, Storage, Stability - Ticarcillin and Clavulanate
Timentin Indications, Dosage, Storage, Stability - Ticarcillin and Clavulanate
INDICATIONS
AND USES
Timentin is indicated in the treatment of infections caused by
susceptible strains of the designated microorganisms in the conditions
listed below:
Septicemia, including bacteremia, caused by (beta)-lactamase-producing
strains of Klebsiella spp.*, E. coli *, Staphylococcus
aureus *, or Pseudomonas aeruginosa * (or other Pseudomonas
species*)
Lower Respiratory Infections caused by (beta)-lactamase-producing strains
of Staphylococcus aureus, Hemophilus influenzae *, or Klebsiella
spp.*
Bone and Joint Infections caused by (beta)-lactamase-producing strains
of Staphylococcus aureus
Skin and Skin Structure Infections caused by (beta)-lactamase-producing
strains of Staphylococcus aureus, Klebsiella spp.*, or E. coli
*
Urinary Tract Infections (complicated and uncomplicated) caused by (beta)-lactamase-producing
strains of E. coli, Klebsiella spp., Pseudomonas aeruginosa*
(or other Pseudomonas spp.*), Citrobacter spp.*, Enterobacter
cloacae* , Serratia marcescens* , or Staphylococcus aureus*
Gynecologic Infections endometritis caused by (beta)-lactamase-producing
strains of B. melaninogenicus* , Enterobacter spp. (including
E. cloacae* ), Escherichia coli, Klebsiella pneumoniae*, Staphylococcus
aureus , or Staphylococcus epidermidis
Intra-abdominal Infections peritonitis caused by (beta)-lactamase-producing
strains of Escherichia coli, Klebsiella pneumoniae , or Bacteroides
fragilis* group
*Efficacy for this organism in this organ system was studied in fewer
than 10 infections.
NOTE: For information on use in pediatric patients ( ≥3 months
of age) see PRECAUTIONS-Pediatric
Use and CLINICAL STUDIES sections. There are insufficient
data to support the use of Timentin in pediatric
patients under 3 months of age or for the treatment of septicemia and/or
infections in the pediatric population where the suspected or proven pathogen
is Haemophilus influenzae type b.
While Timentin is indicated only for the conditions listed above,
infections caused by ticarcillin-susceptible organisms are also amenable
to Timentin treatment due to its ticarcillin content. Therefore,
mixed infections caused by ticarcillin-susceptible organisms and (beta)-lactamase-producing
organisms susceptible to ticarcillin/clavulanic acid should not require
the addition of another antibiotic.
Appropriate culture and susceptibility tests should be performed before
treatment in order to isolate and identify organisms causing infection
and to determine their susceptibility to ticarcillin/clavulanic acid.
Because of its broad spectrum of bactericidal activity against gram-positive
and gram-negative bacteria, Timentin is particularly useful for
the treatment of mixed infections and for presumptive therapy prior to
the identification of the causative organisms. Timentin has been
shown to be effective as single drug therapy in the treatment of some
serious infections where normally combination antibiotic therapy might
be employed. Therapy with Timentin may be initiated before results
of such tests are known when there is reason to believe the infection
may involve any of the (beta)-lactamase-producing organisms listed above;
however, once these results become available, appropriate therapy should
be continued.
Based on the in vitro synergism between ticarcillin/clavulanic
acid and aminoglycosides against certain strains of Pseudomonas aeruginosa
, combined therapy has been successful, especially in patients with
impaired host defenses. Both drugs should be used in full therapeutic
doses. As soon as results of culture and susceptibility tests become available,
antimicrobial therapy should be adjusted as indicated.
DOSAGE AND ADMINISTRATION
Timentin should be administered by intravenous infusion (30 min.).
Adults: The usual recommended dosage for systemic
and urinary tract infections for average (60 kg) adults is 3.1 grams Timentin
(3.1 gram vial containing 3 grams ticarcillin and 100 mg clavulanic
acid) given every 4 to 6 hours. For gynecologic infections, Timentin
should be administered as follows: Moderate infections 200 mg/kg/day
in divided doses every 6 hours and for severe infections 300 mg/kg/day
in divided doses every 4 hours. For patients weighing less than 60 kg,
the recommended dosage is 200 to 300 mg/kg/day, based on ticarcillin content,
given in divided doses every 4 to 6 hours.
In urinary tract infections, a dosage of 3.2 grams Timentin (3.2
gram vial containing 3 grams ticarcillin and 200 mg clavulanic acid) given
every 8 hours is adequate.
Pediatric Patients ( ≥3 months):
For patients <60 kg:
In patients <60 kg, Timentin is dosed at 50 mg/kg/dose based
on the ticarcillin component. Timentin should be administered as
follows: Mild to moderate infections 200 mg/kg/day in divided doses every
6 hours; for severe infections, 300 mg/kg/day in divided doses every 4
hours.
For patients ≥60 kg:
For mild to moderate infections, 3.1 grams Timentin (3 grams of
ticarcillin and 100 mg of clavulanic acid) administered every 6 hours;
for severe infections, 3.1 grams every 4 hours.
Renal impairment:
For infections complicated by renal insufficiency ** , an initial loading
dose of 3.1 grams should be followed by doses based on creatinine clearance
and type of dialysis as indicated below:
|
Creatinine clearance mL/min.
over 60
30 to 60
10 to 30
less than 10
less than 10 with
hepatic dysfunction
|
Dosage
3.1 grams every 4 hrs.
2 grams every 4 hrs.
2 grams every 8 hrs.
2 grams every 12 hrs.
2 grams every 24 hrs.
|
To calculate creatinine clearance ***
from a serum creatinine value
use the following formula.
C cr = (140-Age) (wt. in kg)
72 × S cr (mg/100
mL)
This is the calculated creatinine clearance for adult males;
for females it is 15% less. |
|
|
patients on peritoneal dialysis
patients on hemodialysis
|
3.1 grams every 12 hrs.
2 grams every 12 hrs.
supplemented with 3.1
grams after each dialysis
|
*** Cockcroft, D.W., et al: Prediction of Creatinine
Clearance from Serum Creatinine. Nephron
16:31-41, 1976.
|
|
** The half-life of ticarcillin in patients with
renal failure is approximately 13 hours.
|
Dosage for any individual patient must take into consideration the site
and severity of infection, the susceptibility of the organisms causing
infection, and the status of the patient's host defense mechanisms.
The duration of therapy depends upon the severity of infection. Generally,
Timentin should be continued for at least 2 days after the signs
and symptoms of infection have disappeared. The usual duration is 10 to
14 days; however, in difficult and complicated infections, more prolonged
therapy may be required.
Frequent bacteriologic and clinical appraisals are necessary during therapy
of chronic urinary tract infection and may be required for several months
after therapy has been completed; persistent infections may require treatment
for several weeks, and doses smaller than those indicated above should
not be used.
In certain infections, involving abscess formation, appropriate surgical
drainage should be performed in conjunction with antimicrobial therapy.
INTRAVENOUS ADMINISTRATION
DIRECTIONS FOR USE
3.1 gram and 3.2 gram Vials and Piggyback Bottles
The 3.1 gram or 3.2 gram vial should be reconstituted by adding approximately
13 mL of Sterile Water for Injection, USP, or Sodium Chloride Injection,
USP, and shaking well. When dissolved, the concentration of ticarcillin
will be approximately 200 mg/mL with corresponding concentrations of 6.7
mg/mL and 13.4 mg/mL clavulanic acid for the 3.1 gram and 3.2 gram respective
doses. Conversely, each 5.0 mL of the 3.1 gram dose reconstituted with
approximately 13 mL of diluent will contain approximately 1 gram of ticarcillin
and 33 mg of clavulanic acid. For the 3.2 gram dose reconstituted with
13 mL of diluent, each 5.0 mL will contain 1 gram of ticarcillin and 66
mg of clavulanic acid.
INTRAVENOUS INFUSION: The dissolved drug should be
further diluted to desired volume using the recommended solution listed
in the COMPATIBILITY AND STABILITY Section (STABILITY PERIOD) to a concentration
between 10 mg/mL to 100 mg/mL. The solution of reconstituted drug may
then be administered over a period of 30 minutes by direct infusion or
through a Y-type intravenous infusion set. If this method or the "piggyback"
method of administration is used, it is advisable to discontinue temporarily
the administration of any other solutions during the infusion of Timentin
.
Stability For I.V. solutions, see STABILITY PERIOD below.
When Timentin is given in combination with another antimicrobial,
such as an aminoglycoside, each drug should be given separately in accordance
with the recommended dosage and routes of administration for each drug.
After reconstitution and prior to administration, Timentin , as
with other parenteral drugs, should be inspected visually for particulate
matter. If this condition is evident, the solution should be discarded.
The color of reconstituted solutions of Timentin normally ranges
from light to dark yellow depending on concentration, duration and temperature
of storage while maintaining label claim characteristics.
COMPATIBILITY AND STABILITY
3.1 gram and 3.2 gram Vials and Piggyback Bottles
(Dilutions derived from a stock solution of 200 mg/mL)
The concentrated stock solution at 200 mg/mL is stable for up to 6 hours
at room temperature 21° to 24°C (70° to 75°F) or up to 72 hours under
refrigeration 4°C (40°F).
If the concentrated stock solution (200 mg/mL) is held for up to 6 hours
at room temperature 21° to 24°C (70° to 75°F) or up to 72 hours under
refrigeration 4°C (40°F) and further diluted to a concentration between
10 mg/mL and 100 mg/mL with any of the diluents listed below, then the
following stability periods apply.
STABILITY PERIOD
(3.1 gram and 3.2 gram Vials and Piggyback Bottles)
|
Intravenous Solution
(ticarcillin concentrations of
10 mg/mL to 100 mg/mL)
|
Room Temperature
21° to 24°C (70° to 75°F) |
Refrigerated
4°C (40°F) |
|
Dextrose Injection 5%, USP
|
24 hours |
3 days |
|
Sodium Chloride Injection, USP
|
24 hours |
7 days |
|
Lactated Ringer's Injection, USP
|
24 hours |
7 days |
If the concentrated stock solution (200 mg/mL) is stored for up to 6
hours at room temperature and then further diluted to a concentration
between 10 mg/mL and 100 mg/mL, solutions of Sodium Chloride Injection,
USP, and Lactated Ringer's Injection, USP, may be stored frozen -18°C
(0°F) for up to 30 days. Solutions prepared with Dextrose Injection 5%,
USP, may be stored frozen -18°C (0°F) for up to 7 days. All thawed solutions
should be used within 8 hours or discarded. Once thawed, solutions should
not be refrozen.
NOTE: Timentin is incompatible with Sodium Bicarbonate.
Unused solutions must be discarded after the time periods listed above.
HOW SUPPLIED
Timentin (sterile ticarcillin disodium and clavulanate potassium).
Each 3.1 gram vial contains sterile ticarcillin disodium equivalent to
3 grams ticarcillin and sterile clavulanate potassium equivalent to 0.1
gram clavulanic acid.
NDC 0029-6571-26
3.1 gram Vial
NDC 0029-6571-21
3.1 gram Piggyback Bottle
Timentin is also supplied as:
NDC 0029-6571-40 3.1
gram ADD-Vantage®§ Antibiotic Vial
Each 31 gram Pharmacy Bulk Package contains sterile ticarcillin disodium
equivalent to 30 grams ticarcillin and sterile clavulanate potassium equivalent
to 1 gram clavulanic acid.
NDC 0029-6579-21 31
gram Pharmacy Bulk Package
Timentin vials should be stored at or below 24°C (75°F).
NDC 0029-6571-31
Timentin as an iso-osmotic, sterile, nonpyrogenic, frozen solution
in Galaxy® II (PL 2040) Plastic Containers supplied in 100
mL single-dose containers equivalent to 3 grams ticarcillin and clavulanate
potassium equivalent to 0.1 gram clavulanic acid.
§ADD-Vantage® is a trademark of Abbott Laboratories.
II Galaxy® is a trademark of Baxter International Inc.
Rx only
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