DOSAGE AND ADMINISTRATION

Infections of the respiratory tract and soft tissues.

Patients weighing 40 kg (88 lbs) or more: 250 mg 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.

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.

Table 3: Dosage in Neonates (less than or equal to 28 days of postnatal age) for Bacterial Meningitis and Septicemia:

Gestational Age (weeks)	Postnatal Age (days)	Dosage
less than or equal to 34	less than or equal to 7	100 mg/kg/day in equally divided doses every 12 hours
less than or equal to 34	greater than or equal to 8 and less than 28	150 mg/kg/day in equally divided doses every 12 hours
greater than 34	less than or equal to 28	150 mg/kg/day in equally divided doses every 8 hours

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)
67850-023-10	250 mg	1 mL	1 mL	250 mg
67850-024-10	500 mg	1.8 mL	2 mL	250 mg
67850-021-10	1 g	3.5 mL	4 mL	250 mg
67850-022-10	2 g	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	** 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% Soduim Chloride Injection, USP	30 mg/mL	24 hours
0.9% Soduim 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

Ampicillin for Injection, USP, is supplied as follows:

** NDC**	** Ampicillin for Injection, USP**	** Package Factor**
67850-023-10	250 mg per vial	10 vials per carton
67850-024-10	500 mg per vial	10 vials per carton
67850-021-10	1 gram per vial	10 vials per carton
67850-022-10	2 grams per vial	10 vials per carton

Each vial contains ampicillin sodium equivalent to 250 mg, 500 mg, 1 gram or 2 grams ampicillin per vial.

Storage Conditions

Store dry powder at 20˚ to 25˚C (68˚ to 77˚F). [See USP Controlled Room Temperature.]

Sterile, Nonpyrogenic, Preservative-free.
The container closure is not made with natural rubber latex.

Clinitest is a registered trademark of Miles, Inc.
Clinistix is a registered trademark of Bayer Corporation.
Tes-Tape is a registered trademark of Eli Lilly Company.

Manufactured for:

Methapharm, Inc.
Coral Springs, FL,
33065 USA

Made in Romania

Revised: February 2018

P014PUS4/00B