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Timentin Injection

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Timentin Injection

Indications
Dosage
How Supplied

INDICATIONS

TIMENTIN® is indicated in the treatment of infections caused by susceptible isolates of the designated bacteria in the conditions listed below:

Septicemia

Septicemia (including bacteremia) caused by β-lactamase-producing isolates of Klebsiella spp*., Escherichia coli* , Staphylococcus aureus*, or Pseudomonas aeruginosa* (or other Pseudomonas species)

Lower Respiratory Infections

Lower respiratory infections caused by β-lactamase-producing isolates of S. aureus, Haemophilus influenza*, or Klebsiella spp*.

Bone And Joint Infections

Bone and joint infections caused by β -lactamase-producing isolates of S. aureus

Skin And Skin Structure Infections

Skin and skin structure infections caused by β -lactamase-producing isolates of S. aureus, Klebsiella spp*, or E. coli*

Urinary Tract Infections

Urinary tract infections (complicated and uncomplicated) caused by β-lactamase-producing isolates of E. coli, Klebsiella spp., P. aeruginosa* (or other Pseudomonas spp.* ), Citrobacter spp.*, Enterobacter cloacae*, Serratia marcescens*, or S. aureus

Gynecologic Infections

Endometritis caused by β-lactamase-producing isolates of Prevotella melaninogenicus*, Enterobacter spp. (including E. cloacae*), E. coli, Klebsiella pneumonia*, S. aureus, or Staphylococcus epidermidis

Intra-abdominal Infections

Peritonitis caused by β-lactamase-producing isolates of E. coli, K. pneumoniae, or Bacteroidesfragilis* group

Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of TIMENTIN and other antibacterial drugs, TIMENTIN should be used only to treat 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

Adults

The usual recommended dosage for systemic and urinary tract infections for adults is 3.1 grams of TIMENTIN (3 grams ticarcillin and 100 mg clavulanic acid) given every 4 to 6 hours.

For gynecologic infections, TIMENTIN should be administered as follows (based on ticarcillin content): Moderate infections, 200 mg/kg/day in divided doses every 6 hours; 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 given in divided doses every 4 to 6 hours.

The duration of therapy depends upon the severity of infection. The usual duration is 10 to 14 days; however, in difficult and complicated infections, more prolonged therapy may be required.

Pediatric Patients ( ≥ 3 Months of Age)

Patients < 60 kg: Mild to moderate infections, 200 mg/kg/day based on ticarcillin content in divided doses every 6 hours; severe infections, 300 mg/kg/day in divided doses every 4 hours.

Patients ≥ 60 kg: Mild to moderate infections, 3.1 grams every 6 hours; severe infections, 3.1 grams every 4 hours.

Renal Impairment

For patients with 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 in Table 1.

Table 1: Dosage Adjustments for Renal Impairment

Creatinine Clearance (mL/minute)a Dosageb
Over 60 3 grams every 4 hours
30 to 60 2 grams every 4 hours
10 to 30 2 grams every 8 hours
Less than 10 2 grams every 12 hours
Less than 10 with hepatic dysfunction 2grams every 24 hours
Patients on peritoneal dialysis 3 grams every 12 hours
Patients on hemodialysis 2 grams every 12 hours supplemented with 3    grams after each dialysis
a To calculate creatinine clearance1 from a serum creatinine value use the following formula:
Ccr = (140-Age) (weight in kg)/72 x Scr (mg/100 mL)
This is the calculated creatinine clearance for adult males; for females it is 15% less.
b Based on ticarcillin content.

Administration And Directions For Use

TIMENTIN should be administered by intravenous infusion over a 30-minute period.

Directions for Reconstitution and Further Dilution

3.1-gram Glass Vials: The 3.1-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 a corresponding concentration of 6.7 mg/mL for clavulanic acid. The color of reconstituted solutions of TIMENTIN normally ranges from light to dark yellow, depending on concentration, duration, and temperature of storage.

The dissolved drug should be further diluted to desired volume using the recommended solution listed under Stability [see section on Stability] to a concentration between 10 mg/mL to 100 mg/mL.

Pharmacy Bulk Package: The container closure may be penetrated only one time utilizing a suitable sterile transfer device or dispensing set that allows measured distribution of the contents. A sterile substance that must be reconstituted prior to use may require a separate closure entry.

Restrict use of Pharmacy Bulk Packages to an aseptic area such as a laminar flow hood.

Reconstituted contents of the vial should be withdrawn immediately. However, if this is not possible, aliquoting operations must be completed within 4 hours of reconstitution. Discard the reconstituted stock solution 4 hours after initial entry.

Add 76 mL of Sterile Water for Injection, USP, or Sodium Chloride Injection, USP, to the 31-gram Pharmacy Bulk Package and shake well. For ease of reconstitution, the diluent may be added in 2 portions. Each 1 mL of the resulting concentrated stock solution contains approximately 300 mg of ticarcillin and 10 mg of clavulanic acid.

The desired dosage should be withdrawn from the stock solution and further diluted to desired volume using the recommended solution listed under Stability [see section on Stability] to a concentration between 10 mg/mL to 100 mg/mL.

Directions for Intravenous Infusion

After reconstitution and further dilution and prior to administration, TIMENTIN should be inspected visually for particulate matter. If particulate matter is present, the solution should be discarded.

The solution of reconstituted drug may be administered over a 30-minute period by direct infusion or through a Y-type intravenous infusion set. If this method of administration is used, it is advisable to temporarily discontinue the administration of any other solutions during the infusion of TIMENTIN.

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 [see DRUG INTERACTIONS].

GALAXY® Container (PL 2040 Plastic): Prior to administration, TIMENTIN should be inspected visually for particulate matter. If particulate matter is present, the solution should be discarded.

Caution

Do not use plastic containers in series connections. Such use could result in an embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed.

Preparation for Administration

See HOW SUPPLIED/Storage and Handling for thawing and handling instructions:

  • Suspend the container from eyelet support.
  • Remove protector from outlet port at bottom of container.
  • Attach administration set. Refer to complete directions accompanying set.

Stability

NOTE: TIMENTIN is incompatible with Sodium Bicarbonate.

3.1-gram Glass Vials

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 Vials)

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 24hours 3days
Sodium Chloride Injection, USP 24hours 7days
Lactated Ringer’s Injection, USP 24hours 7days

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.

Unused solutions must be discarded after the time periods listed above.

Pharmacy Bulk Package

Aliquots of the reconstituted stock solution at 300 mg/mL are stable for up to 6 hours between 21° and 24°C (70° and 75°F) or up to 72 hours under refrigeration 4°C (40°F). The reconstituted stock solution should be held under refrigeration 4°C (40°F).

If the aliquots of the reconstituted stock solution (300 mg/mL) are held up to 6 hours between 21° and 24°C (70° and 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 (31-gram Pharmacy Bulk Package)

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 24hours 3days
Sodium Chloride Injection 0.9%, USP 24hours 4days
Lactated Ringer’s Injection, USP 24hours 4days
Sterile Water for Injection, USP 24hours 4days

If an aliquot of concentrated stock solution (300 mg/mL) is stored for up to 6 hours between 21° and 24°C (70° and 75°F) and then further diluted to a concentration between 10 mg/mL and 100 mg/mL, solutions of Sodium Chloride Injection, USP, Lactated Ringer's Injection, USP, and Sterile Water for 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.

Unused solutions must be discarded after the time periods listed above.

GALAXY Container (PL 2040 Plastic)

Do not add supplementary medication to the container. The thawed solution is stable for 24 hours at room temperature 22°C (72°F) or for 7 days under refrigeration at 4°C (39°F).

HOW SUPPLIED

Dosage Forms And Strengths

The 3.1-gram glass vial of TIMENTIN for Injection is a white to pale yellow sterile powder for reconstitution containing ticarcillin disodium equivalent to 3 grams ticarcillin and clavulanate potassium equivalent to 0.1 gram clavulanic acid.

The 31-gram Pharmacy Bulk Package of TIMENTIN for Injection is a white to pale yellow sterile powder for reconstitution containing ticarcillin disodium equivalent to 30 grams ticarcillin and clavulanate potassium equivalent to 1 gram clavulanic acid.

The 100-mL single-dose GALAXY Container (PL 2040 Plastic) of TIMENTIN is a frozen solution containing ticarcillin disodium equivalent to 3.0 grams ticarcillin and clavulanate potassium equivalent to 0.1 gram clavulanic acid.

Storage And Handling

Each 3.1-gram vial of TIMENTIN for Injection 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

Each 31-gram Pharmacy Bulk Package of TIMENTIN for Injection 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

Each 100-mL single-dose GALAXY Container (PL 2040 Plastic) of TIMENTIN Injection contains ticarcillin disodium equivalent to 3.0 grams ticarcillin and clavulanate potassium equivalent to 0.1 gram clavulanic acid.

NDC 0029-6575-31 100 mL GALAXY Container (PL 2040 Plastic)

3.1-gram Vials and 31-gram Pharmacy Bulk Packages of TIMENTIN for Injection should be stored at or below 25°C (77°F).

GALAXY Containers (PL 2040 Plastic) of TIMENTIN Injection should be stored at or below -20°C (-4°F). Avoid unnecessary handling of containers.

Thawing of Plastic Containers: Thaw frozen container at room temperature 22°C (72°F) or in a refrigerator 4°C (39°F). [Do not force thaw by immersion in water baths or by microwave irradiation.] Check for minute leaks by squeezing container firmly. If leaks are detected discard solution as sterility may be impaired. Do not add supplementary medication.

The container should be visually inspected. Thawed solutions should not be used unless clear; solutions will be light to dark yellow in color. Components of the solution may precipitate in the frozen state and will dissolve upon reaching room temperature with little or no agitation. If, after visual inspection, the solution remains cloudy or if an insoluble precipitate is noted or if any seals or outlet ports are not intact, the container should be discarded.

The thawed solution is stable for 24 hours at room temperature 22°C (72°F) or for 7 days under refrigeration 4°C (39°F).

Do not refreeze.

* Efficacy for this organism in this organ system was studied in fewer than 10 infections.

GlaxoSmithKline, Research Triangle Park, NC 27709. Revised: June 2014

Last reviewed on RxList: 6/27/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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