Ampicillin (Page 4 of 5)

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 0781

Label

Claim

Recommended

Amount of

Diluent

Withdrawable

Volume

Concentration

(in mg/mL)

3400-95

125 mg

1.2 mL

1 mL

125 mg

3402-95

250 mg

1 mL

1 mL

250 mg

3407-95

500 mg

1.8 mL

2 mL

250 mg

3404-95

1 gram

3.5 mL

4 mL

250 mg

3408-95

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 125 mg, 250 mg, 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

Concentrations

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.

HOW SUPPLIED

Product: 50090-4552

NDC: 50090-4552-0 1 INJECTION, POWDER, FOR SOLUTION in a VIAL, GLASS

REFERENCES

1.
Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing; Twenty-fifth Informational Supplement. CLSI document M100-S25. Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2015.
2.
Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk Diffusion Susceptibility Tests; Approved Standard-Twelfth Edition. CLSI document M02-A12. Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2015.
3.
Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard-Tenth Edition. CLSI document M07-A10, Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2015.

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46219548

Manufactured in Austria by Sandoz GmbH for

Sandoz Inc., Princeton, NJ 08540

Rev. October 2017

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