Ampicillin (Page 3 of 4)

Septicemia

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.

Neonates (less than or equal to 28 days of postnatal age) – Dosage should be based on Gestational age and Postnatal age according to Table 3 (above).

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

Use only freshly prepared solutions. Intramuscular and intravenous injections should be administered within one hour after preparation since the potency may decrease significantly after this period.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

For Intramuscular Use – Dissolve contents of a vial with the amount of Sterile Water for Injection, USP, or Bacteriostatic Water for Injection, USP, listed in the table below:

NDC Label Claim Recommended Amount of Diluent Withdrawable Volume Concentration (in mg/mL)
25021-134-10 250 mg 1 mL 1 mL 250 mg
25021-135-10 500 mg 1.8 mL 2 mL 250 mg
25021-136-10 1 gram 3.5 mL 4 mL 250 mg
25021-137-20 2 grams 6.8 mL 8 mL 250 mg

While Ampicillin for Injection, USP, 1 g and 2 g, are primarily for intravenous use, they may be administered intramuscularly when the 250 mg or 500 mg vials are unavailable. In such instances, dissolve in 3.5 or 6.8 mL Sterile Water for Injection, USP, or Bacteriostatic Water for Injection, USP, respectively. The resulting solution will provide a concentration of 250 mg per mL.

Ampicillin for Injection, USP, 125 mg, is intended primarily for pediatric use. It also serves as a convenient dosage form when small parenteral doses of the antibiotic are required.

Bacteriostatic Water for Injection, USP is not to be used as a diluent when the product will be used in newborns.

For Direct Intravenous Use – Add 5 mL Sterile Water for Injection, USP, or Bacteriostatic Water for Injection, USP to the 250, and 500 mg vials and administer slowly over a 3- to 5- minute period.

Ampicillin for Injection, USP, 1 g or 2 g, may also be given by direct intravenous administration. Dissolve in 7.4 or 14.8 mL Sterile Water for Injection, USP, or Bacteriostatic Water for Injection, USP, respectively, and administer slowly over at least 10 to 15 minutes.

CAUTION: More rapid administration may result in convulsive seizures.

For Administration by Intravenous Drip – Reconstitute as directed above (For Direct Intravenous Use) prior to diluting with Intravenous Solution. Stability studies on ampicillin sodium at several concentrations in various intravenous solutions indicate the drug will lose less than 10% activity at the temperatures noted for the time periods stated.

Room Temperature (25°C)
Diluent Concentration s Stability Periods
Sterile Water for Injection up to 30 mg/mL 8 hours
0.9% Sodium Chloride Injection, USP up to 30 mg/mL 8 hours
5% Dextrose Injection, USP 10 to 20 mg/mL 1 hour
5% Dextrose Injection, USP up to 2 mg/mL 2 hours
5% Dextrose and 0.45% Sodium Chloride Injection, USP up to 2 mg/mL 2 hours
Lactated Ringer’s Injection, USP up to 30 mg/mL 8 hours
Refrigerated (4°C)
Diluent Concentrations Stability Periods
Sterile Water for Injection 30 mg/mL 48 hours
Sterile Water for Injection up to 20 mg/mL 72 hours
0.9% Sodium Chloride Injection, USP 30 mg/mL 24 hours
0.9% Sodium Chloride Injection, USP up to 20 mg/mL 48 hours
Lactated Ringer’s Injection, USP up to 30 mg/mL 24 hours
5% Dextrose Injection, USP up to 20 mg/mL 1 hour
5% Dextrose and 0.45% Sodium Chloride Injection, USP up to 10 mg/mL 1 hour

Only those solutions listed above should be used for the intravenous infusion of Ampicillin for Injection, USP. The concentrations should fall within the range specified. The drug concentration and the rate and volume of the infusion should be adjusted so that the total dose of ampicillin is administered before the drug loses its stability in the solution in use.

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