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Timentin Add-Vantage Dosage

Generic name: TICARCILLIN DISODIUM 30mg in 1mL, CLAVULANATE POTASSIUM 1mg in 1mL
Dosage form: injection, powder, for solution

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

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 of 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.

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 of 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.

Dosage

over 60

3.1 grams every 4 hrs.

 

30 to 60

2 grams every 4 hrs.

 

10 to 30

2 grams every 8 hrs.

 

less than 10

2 grams every 12 hrs.

 

less than 10 with hepatic dysfunction

2 grams every 24 hrs.

 

patients on peritoneal dialysis

3.1 grams every 12 hrs.

patients on hemodialysis

2 grams every 12 hrs.

 

supplemented with 3.1

 

grams after each dialysis

 

NOTE: TIMENTIN in the ADD-VANTAGE® system should only be administered for 3.1-gram dosing.

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

formula for calculating creatinine clearance
Source of creatinine clearance formula: Cockroft, D.W., et al: Prediction of Creatine Clearance from Serum Creatinine. Nephron 16:31-41,1976

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.

INSTRUCTIONS FOR USE

To Open Diluent Container:

Peel overwrap at corner and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed.

This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.

To Assemble Vial and Flexible Diluent Container:

(Use Aseptic Technique)

1.
Remove the protective covers from the top of the vial and the vial port on the diluent container as follows:

a. To remove the breakaway vial cap, swing the pull ring over the top of the vial and pull down far enough to start the opening (see Figure 1), then pull straight up to remove the cap (see Figure 2).

NOTE: Do not access vial with syringe.

Figure 1

Figure 1

Figure 2

Figure 2

b. To remove the vial port cover, grasp the tab on the pull ring, pull up to break the 3 tie strings, then pull back to remove the cover (see Figure 3).

Figure 3

Figure 3

2. Screw the vial into the vial port until it will go no further. THE VIAL MUST BE SCREWED IN TIGHTLY TO ASSURE A SEAL. This occurs approximately ½ turn (180°) after the first audible click (see Figure 4). The clicking sound does not assure a seal; the vial must be turned as far as it will go.

NOTE:Once vial is sealed, do not attempt to remove (see Figure 4).

Figure 4

Figure 4

3. Recheck the vial to assure that it is tight by trying to turn it further in the direction of assembly.

4. Label appropriately.

To Reconstitute the Drug:

1. Squeeze the bottom of the diluent container gently to inflate the portion of the container surrounding the end of the drug vial.

2. With the other hand, push the drug vial down into the container telescoping the walls of the container. Grasp the inner cap of the vial through the walls of the container (see Figure 5).

Figure 5

Figure 5

3. Pull the inner cap from the drug vial (see Figure 6). Verify that the rubber stopper has been pulled out, allowing the drug and diluent to mix.

Figure 6

Figure 6

4. Mix container contents thoroughly and use within the specified time.

Preparation for Administration

(Use Aseptic Technique):

1.
Confirm the activation and admixture of vial contents.
2.
Check for leaks by squeezing container firmly. If leaks are found discard unit as sterility may be impaired.
3.
Close flow control clamp of administration set.
4.
Remove cover from outlet port at bottom of container.
5.
Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated. NOTE: See full directions on administration set carton.
6.
Lift the free end of the hanger loop on the bottom of the vial, breaking the 2 tie strings. Bend the loop outward to lock it in the upright position, then suspend container from hanger.
7.
Squeeze and release drip chamber to establish proper fluid level in chamber.
8.
Open flow control clamp and clear air from set. Close clamp.
9.
Attach set to venipuncture device. If device is not indwelling, prime and make venipuncture.
10.
Regulate rate of administration with flow control clamp.

WARNING: Do not use flexible container in series connections.

RECONSTITUTION DIRECTIONS

Intravenous Infusion

Use a 50-mL or 100-mL ADD-VANTAGE® DILUENT CONTAINER containing either Sodium Chloride Injection, USP, or 5% Dextrose in Water (refer to INSTRUCTIONS FOR USE section). The resulting concentration of the 3.1-gram dose reconstituted in 50 mL of diluent is approximately 60 mg/mL of ticarcillin and approximately 2 mg/mL of clavulanic acid. The resulting concentration of the 3.1-gram dose reconstituted in 100 mL of diluent is approximately 30 mg/mL of ticarcillin and approximately 1 mg/mL of clavulanic acid.

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, which may already be in place. If this method of administration is used, it is advisable to discontinue temporarily 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. 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.

STABILITY PERIOD

INTRAVENOUS SOLUTION

ROOM TEMPERATURE

(ticarcillin concentration of ~ 30 mg/mL or ~ 60 mg/mL)

21° to 24°C (70° to 75°F)

Sodium Chloride Injection, USP

24 hours

5% Dextrose in Water

12 hours

NOTE: TIMENTIN is incompatible with Sodium Bicarbonate.

Unused portions of solutions should be discarded after the time periods listed above.

Avoid excessive heat.

Protect from freezing.

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