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Ampicillin (Ampicillin Sodium) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Ampicillin for Injection, USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the following conditions:

Respiratory tract Infections caused by S. pneumoniae (formerly D. pneumoniae). Staphylococcus aureus (penicillinase and nonpenicillinase-producing), H. influenzae , and Group A beta-hemolytic Streptococci.

Bacterial Meningitis caused by E. coli, Group B Streptococci, and other Gram-negative bacteria (Listeria monocytogenes , N. meningitidis). The addition of an aminoglycoside with ampicillin may increase its effectiveness against Gram-negative bacteria.

Septicemia and Endocarditis caused by susceptible Gram-positive organisms including Streptococcus sp., penicillin G-susceptible staphylococci, and enterococci. Gram-negative sepsis caused by E. coli, Proteus mirabilis and Salmonella sp. respond to ampicillin. Endocarditis due to enterococcal strains usually respond to intravenous therapy. The addition of an aminoglycoside may enhance the effectiveness of ampicillin when treating streptococcal endocarditis.

Urinary Tract Infections caused by sensitive strains of E. coli and Proteus mirabilis.

Gastrointestinal Infections caused by Salmonella typhosa (typhoid fever), other Salmonella sp., and Shigella sp. (dysentery) usually respond to oral or intravenous therapy.

Bacteriology studies to determine the causative organisms and their susceptibility to ampicillin should be performed. Therapy may be instituted prior to obtaining results of susceptibility testing.

It is advisable to reserve the parenteral form of this drug for moderately severe and severe infections and for patients who are unable to take the oral forms. A change to oral ampicillin may be made as soon as appropriate.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Ampicillin for Injection, USP and other antibacterial drugs, Ampicillin for Injection, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Indicated surgical procedures should be performed.

DOSAGE AND ADMINISTRATION

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 either the intramuscular or intravenous route. A change to oral ampicillin may be made when appropriate.

Bacterial Meningitis

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.

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.

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.

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 intramusculary 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.

For Direct Intravenous Use – Add 5 mL Sterile Water for Injection, USP, or Bacteriostatic Water for Injection, USP to the 125, 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

Concentrations

Stability Periods

Sterile Water for Injection USP

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% NaCl 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 USP

30 mg/mL

48 hours

Sterile Water for Injection USP

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% NaCl 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

Ampicillin for Injection, USP for IM or IV Injection. Ampicillin sodium equivalent to 125 mg, 250 mg, 500 mg, 1 gram or 2 grams ampicillin per vial.

NDC 0781-3400-95

125 mg vial packaged in 10s

NDC 0781-3402-95

250 mg vial packaged in 10s

NDC 0781-3407-95

500 mg vial packaged in 10s

NDC 0781-3404-95

1 gram vial packaged in 10s

NDC 0781-3408-95

2 gram vial packaged in 10s

Also available as:

NDC 0781-3409-95

10 gram Pharmacy Bulk Package packaged in 10s

09-2013M

46119403

Manufactured in Austria by Sandoz GmbH

for Sandoz Inc., Princeton, NJ 08540

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