DOSAGE AND ADMINISTRATION
The Single Use ADD-Vantage® vials are for intravenous use only.
Infections of the respiratory tract and soft tissues.
Patients weighing 40 kg (88 lbs) or more: 250 to 500 mg every 6 hours.
Patients weighing less than 40 kg (88 lbs): 25 to 50 mg/kg/day in equally divided doses at 6- to 8- hour intervals.
Infections of the gastrointestinal and genitourinary tracts (including those caused by Neisseria gonorrhoeae in females).
Patients weighing 40 kg (88 lbs) or more: 500 mg every 6 hours.
Patients weighing less than 40 kg (88 lbs): 50 mg/kg/day in equally divided doses at 6- to 8- hour intervals.
In the treatment of chronic urinary tract and intestinal infections, frequent bacteriological and clinical appraisal is necessary. Smaller doses than those recommended above should not be used. Higher doses should be used for stubborn or severe infections. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy. Urethritis in males due to N. gonorrhoeae.
Adults – Two doses of 500 mg each at an interval of 8 to 12 hours.
Treatment may be repeated if necessary or extended if required.
In the treatment of complications of gonorrheal urethritis, such as prostatitis and epididymitis, prolonged and intensive therapy is recommended. Cases of gonorrhea with a suspected primary lesion of syphilis should have darkfield examinations before receiving treatment. In all other cases where concomitant syphilis is suspected, monthly serological tests should be made for a minimum of four months.
The doses for the preceding infections may be given by intravenous route. A change to oral ampicillin may be made when appropriate.
Adults and children – 150 to 200 mg/kg/day in equally divided doses every 3 to 4 hours. (Treatment may be initiated with intravenous drip therapy and continued with intramuscular injections.) The doses for other infections may be given by either the intravenous or intramuscular route.
Adults and children – 150 to 200 mg/kg/day. Start with intravenous administration for at least three days and continue with the intramuscular route every 3 to 4 hours.
Treatment of all infections should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. A minimum of 10-days treatment is recommended for any infection caused by Group A beta-hemolytic streptococci to help prevent the occurrence of acute rheumatic fever or acute glomerulonephritis.
DIRECTIONS FOR USE
ADD-Vantage® Vial – ampicillin for injection 1 and 2 grams.
The ADD-Vantage® vials for intravenous use only are to be used with ADD-Vantage® diluent containers: 0.9% Sodium Chloride Injection, USP, 50 mL and 100 mL, or 5% Dextrose Injection, USP, 50 mL and 100 mL.
Reconstitute ADD-Vantage® vial as directed in INSTRUCTIONS FOR USE. Use only freshly prepared solutions. Intravenous injections should be administered immediately after reconstitution since the potency may decrease.
Summary of Utility Times for Constituted Ampicillin for Injection in the Hospira ADD-Vantage® System
|Vial Size||IV Solution||Final Concentration||Utility Times|
|1 g Vial||5% Dextrose Injection, USP||10 mg/mL||2 Hours at 25° C|
|1 g Vial||0.9% Sodium Chloride Injection, USP||10 mg/mL||8 Hours at 25° C|
|2 g Vial||5% Dextrose Injection, USP||20 mg/mL||1 Hour at 25° C|
|2 g Vial||0.9% Sodium Chloride Injection, USP||40 mg/mL||6 Hours at 25° C|
INSTRUCTIONS FOR USE
To Open Diluent Container:
Peel overwrap from the corner and remove 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)
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 1⁄2 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 seated, do not attempt to remove. (SEE FIGURE 4.)
Recheck the vial to assure that it is tight by trying to turn it further in the direction of assembly.
- Remove the protective covers from the top of the vial and the vial port on the diluent container as follows:
- 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.
- To remove the vial port cover, grasp the tab on the pull ring, pull up to break the three tie strings, then pull back to remove the cover. (SEE FIGURE 3.)
To Prepare Admixture:
- Squeeze the bottom of the diluent container gently to inflate the portion of the container surrounding the end of the drug vial.
- 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.)
- 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.
- Mix container contents thoroughly and use within the specified time.
Preparation for Administration
(Use Aseptic Technique)
- Confirm the activation and admixture of vial contents.
- Check for leaks by squeezing container firmly. If leaks are found, discard unit as sterility may be impaired.
- Close flow control clamp of administration set.
- Remove cover from outlet port at bottom of container.
- 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.
- Lift the free end of the hanger loop on the bottom of the vial, breaking the two tie strings. Bend the loop outward to lock it in the upright position, then suspend container from hanger.
- Squeeze and release drip chamber to establish proper fluid level in chamber.
- Open flow control clamp and clear air from set. Close clamp.
- Attach set to venipuncture device. If device is not indwelling, prime and make venipuncture.
- Regulate rate of administration with flow control clamp.
WARNING: Do not use flexible container in series connections.