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Ticar (Ticarcillin Disodium) - Indications and Dosage

 
 



INDICATIONS

Ticar is indicated for the treatment of the following infections:

Bacterial septicemia

Skin and soft-tissue infections

Acute and chronic respiratory tract infections‡§

Caused by susceptible strains of Pseudomonas aeruginosa, Proteus species (both indole-positive and indole-negative) and Escherichia coli.

§ Though clinical improvement has been shown, bacteriological cures cannot be expected in patients with chronic respiratory disease or cystic fibrosis.

Genitourinary tract infections (complicated and uncomplicated) due to susceptible strains of Pseudomonas aeruginosa, Proteus species (both indole-positive and indole-negative), Escherichia coli, Enterobacter and Streptococcus faecalis (enterococcus).

Ticarcillin is also indicated in the treatment of the following infections due to susceptible anaerobic bacteria:

  1. Bacterial septicemia.
  2. Lower respiratory tract infections such as empyema, anaerobic pneumonitis and lung abscess.
  3. Intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract).
  4. Infections of the female pelvis and genital tract, such as endometritis, pelvic inflammatory disease, pelvic abscess and salpingitis.
  5. Skin and soft-tissue infections.

Although ticarcillin is primarily indicated in gram-negative infections, its in vitro activity against gram-positive organisms should be considered in treating infections caused by both gram-negative and gram-positive organisms (see Microbiology).

Based on the in vitro synergism between ticarcillin and gentamicin sulfate, tobramycin sulfate or amikacin sulfate against certain strains of Pseudomonas aeruginosa, combined therapy has been successful, using full therapeutic dosages. (For additional prescribing information, see the gentamicin sulfate, tobramycin sulfate and amikacin sulfate package inserts.)

NOTE: Culturing and susceptibility testing should be performed initially and during treatment to monitor the effectiveness of therapy and the susceptibility of the bacteria.

DOSAGE AND ADMINISTRATION

Clinical experience indicates that in serious urinary tract and systemic infections, intravenous therapy in the higher doses should be used. Intramuscular injections should not exceed 2 grams per injection.

Adults

Bacterial septicemia

200 to 300 mg/kg/day by I.V. infusion in divided doses every 4 or 6 hours.

Respiratory tract infections

Skin and soft-tissue infections

Intra-abdominal infections

(The usual dose is 3 grams given every 4 hours [18 grams/day] or 4 grams given every 6 hours [16 grams/day] depending on weight and the severity of the infection.)

Infections of the female pelvis and genital tract

Urinary tract infections

Complicated:

150 to 200 mg/kg/day by I.V. infusion in divided doses every 4 or 6 hours. (Usual recommended dosage for average [70 kg] adults: 3 grams q.i.d.)

Uncomplicated:

1 gram I.M. or direct I.V. every 6 hours.

Infections complicated by renal insufficiency*:

Initial loading dose of 3 grams I.V. followed by I.V. doses, based on creatinine clearance and type of dialysis, as indicated below:

Creatinine clearance mL/min.:

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 (or 1 gram I.M. every 6 hours)

less than 10 with hepatic dysfunction

2 grams every 24 hours (or 1 gram I.M. every 12 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

*The half-life of ticarcillin in patients with renal failure is approximately 13 hours.

Children under 40 kg (88 lbs)

The daily dose for children should not exceed the adult dosage.

Bacterial septicemia

Respiratory tract infections

Skin and soft-tissue infections

Intra-abdominal infections

200 to 300 mg/kg/day by I.V. infusion in divided doses every 4 or 6 hours.

Infections of the female pelvis and genital tract

Urinary tract infections

Complicated:

150 to 200 mg/kg/day by I.V. infusion in divided doses every 4 or 6 hours.

Uncomplicated:

50 to 100 mg/kg/day I.M. or direct I.V. in divided doses every 6 or 8 hours.

Infections complicated by renal insufficiency:

Clinical data are insufficient to recommend an optimum dose.

Children weighing more than 40 kg (88 lbs) should receive adult dosages.

Neonates: In the neonate, for severe infections (sepsis) due to susceptible strains of Pseudomonas, Proteus and E. coli, the following ticarcillin dosages may be given I.M. or by 10 to 20 minute I.V. infusion:

Infants under 2000 grams body weight:

Infants over 2000 grams body weight:

Aged 0 to 7 days

75 mg/kg/12 hours

(150 mg/kg/day)

Aged 0 to 7 days

75 mg/kg/8 hours

(225 mg/kg/day)

Aged over 7 days

75 mg/kg/8 hours

(225 mg/kg/day)

Aged over 7 days

100 mg/kg/8 hours

(300 mg/kg/day)

This dosage schedule is intended to produce peak serum concentrations of 125 to 150 mcg/mL 1 hour after a dose of ticarcillin and trough concentrations of 25 to 50 mcg/mL immediately before the next dose.

NOTE: Gentamicin, tobramycin or amikacin may be used concurrently with ticarcillin for initial therapy until results of culture and susceptibility studies are known.

Seriously ill patients should receive the higher doses. Ticar has proved to be useful in infections in which protective mechanisms are impaired, such as in acute leukemia and during therapy with immunosuppressive or oncolytic drugs.

DIRECTIONS FOR USE

3 gram Standard Vials

Intramuscular Use

(concentration of approximately 385 mg/mL): For initial reconstitution use Sterile Water for Injection, USP, Sodium Chloride Injection, USP, or 1% Lidocaine Hydrochloride solution (without epinephrine).

Each gram of ticarcillin should be reconstituted with 2 mL of Sterile Water for Injection, USP, Sodium Chloride Injection, USP, or 1% Lidocaine Hydrochloride solution (without epinephrine) and used promptly. Each 2.6 mL of the resulting solution will then contain 1 gram of ticarcillin.

For full product information, refer to manufacturer’s package insert for Lidocaine Hydrochloride.

Do not use more than 1 gram of reconstituted Ticar in a single intramuscular injection. As with all intramuscular preparations, Ticar (ticarcillin disodium) should be injected well within the body of a relatively large muscle using usual techniques and precautions.

Intravenous Administration

(concentration of approximately 200 mg/mL): For initial reconstitution use Sodium Chloride Injection, USP, Dextrose Injection 5% or Lactated Ringer’s Injection.

Reconstitute each gram of ticarcillin with 4 mL of the appropriate diluent. After the addition of 4 mL of diluent per gram of ticarcillin, each 1.0 mL of the resulting solution will have an approximate concentration of 200 mg. Once dissolved, further dilute if desired.

Direct Intravenous Injection

In order to avoid vein irritation, administer solution as slowly as possible.

Intravenous Infusion

Administer by continuous or intermittent intravenous drip. Intermittent infusion should be administered over a 30 minute to 2-hour period in equally divided doses.

In order to avoid vein irritation, the solution should be administered as slowly as possible. A dilution of approximately 50 mg/mL or more will further reduce the incidence of vein irritation.

Stability studies in the intravenous solutions listed below indicate that ticarcillin disodium will provide sufficient activity between 21° and 24°C (70° and 75°F) within the stated time periods at concentrations between 10 mg/mL and 50 mg/mL — see Stability Period section below.

After reconstitution and prior to administration Ticar as with other parenteral drugs should be inspected visually for particulate matter and discoloration.

STABILITY PERIOD

Intravenous Solution

Room Temperature

Refrigeration

(concentration of 10 mg/mL to 100 mg/mL)

21° to 24°C (70° to 75°F)

4°C (40°F)

Sodium Chloride Injection, USP

72 hours

14 days

Dextrose Injection 5%

72 hours

14 days

Lactated Ringer’s Injection

48 hours

14 days

Refrigerated solutions stored longer than 72 hours should not be used for multidose purposes.

After reconstitution and dilution to a concentration of 10 mg/mL to 100 mg/mL, this solution can be frozen -18°C (0°F) and stored for up to 30 days. The thawed solution must be used within 24 hours.

Unused solutions should be discarded after the time periods mentioned above.

It is recommended that Ticar and gentamicin sulfate, tobramycin sulfate or amikacin sulfate not be mixed together in the same I.V. solution due to the gradual inactivation of gentamicin sulfate, tobramycin sulfate or amikacin sulfate under these circumstances. The therapeutic effect of Ticar and these aminoglycoside drugs remains unimpaired when administered separately.

HOW SUPPLIED

Ticar (sterile ticarcillin disodium). Each vial contains ticarcillin disodium equivalent to 3 grams of ticarcillin.

NDC 0029-6552-26……………………………………………..3 gram Vial

Store dry powder at room temperature or below.

DATE OF ISSUANCE SEPT. 2002

©2002, GlaxoSmithKline

All rights reserved.

GlaxoSmithKline

Research Triangle Park, NC 27709

TR:L7

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