Ampicillin Sodium

GC Hanford Manufacturing Company

FULL PRESCRIBING INFORMATION: CONTENTS*

• AMPICILLIN SODIUM DESCRIPTION
• ACTION
• INDICATIONS
• AMPICILLIN SODIUM CONTRAINDICATIONS
• AMPICILLIN SODIUM ADVERSE REACTIONS
• WARNINGS
• CAUTION
• AMPICILLIN SODIUM DOSAGE AND ADMINISTRATION
• DIRECTIONS FOR USE
• HOW SUPPLIED
• PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

FULL PRESCRIBING INFORMATION

AMPICILLIN SODIUM DESCRIPTION

Ampicillin sodium is a semisynthetic penicillin with a broad spectrum of activity. Ampicillin is derived from the penicillin nucleus, 6-aminopenicillanic acid (6 APA). Chemically it is D(-)α-aminobenzyl penicillin sodium salt.

ACTION

Ampicillin sodium provides bactericidal activity against a wide range of common Gram-positive and Gram-negative pathogens. Ampicillin’s activity occurs during the stage of active multiplication of the pathogen and acts through inhibition of biosynthesis of cell wall mucopeptide. In vivo studies have demonstrated the susceptibility of many strains of the following Gram-positive bacteria: Staphylococcus spp. and Streptococcus spp. (including S. equi). In vivo studies have also demonstrated the susceptibility of many strains of the following Gram-negative bacteria: E. coli and Proteus mirabilis. Because it does not resist destruction by penicillinase, it is not effective against penicillinase-producing bacteria, particularly resistant staphylococci. Most strains of Pseudomonas, Klebsiella and Aerobacter are resistant.

Ampicillin sodium diffuses readily into all body tissues and fluids, with the exception of brain and spinal fluid except when the meninges are inflamed. It produces high and persistent blood levels. Most of the ampicillin is excreted unchanged in the urine.

INDICATIONS

Ampicillin sodium is indicated in the treatment of susceptible strains of the organisms causing the following infections in the horse: Respiratory tract infections (pneumonia and strangles) due to Staphylococcus spp., Streptococcus spp. (including S. equi), E. coli, and Proteus mirabilis.

Skin and soft tissue infections (abscesses and wounds) due to Staphylococcus spp., Streptococcus spp., E. coli, and Proteus mirabilis.

As with all antibiotics, appropriate in vitroculturing and susceptibility testing of samples taken before treatment should be conducted.

AMPICILLIN SODIUM CONTRAINDICATIONS

The use of this drug is contraindicated in animals with a history of an allergic reaction to penicillin.

AMPICILLIN SODIUM ADVERSE REACTIONS

Ampicillin is a semisynthetic penicillin and has the potential for producing allergic reactions. If an allergic reaction occurs, administer epinephrine and/or steroids. Possible minor irritation at the injection site may occur.

WARNINGS

Restricted Drug (California) - Use only as Directed.

Do not use in horses intended for human consumption.

Not for human use.

CAUTION

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

AMPICILLIN SODIUM DOSAGE AND ADMINISTRATION

HORSES - The recommended dose is 3 mg per pound of body weight administered twice a day. Ampicillin sodium may be administered by either the intravenous or intramuscular route. Treatment should be continued 48 hours after all symptoms have subsided. If no response is seen in 4-5 days, diagnosis should be re-evaluated.

DIRECTIONS FOR USE

The dry filled vials should be reconstituted immediately before use by the addition of the appropriate amount of Sterile Water for Injection, USP indicated below. This results in a final concentration of approximately 300 mg per mL.

Stability studies with the concentrated product (300 mg/mL) demonstrated that ampicillin is stable for 1 hour at room temperature (70° - 75° F).

HOW SUPPLIED

Ampicillin Sodium is supplied in vials containing 1 gram and 3 grams of ampicillin activity.

Store dry powder at room temperature, 15° to 30°C (59° to 86°F).

NDC 10515-335-01                   1 gm vial
NDC 10515-335-03                   3 gm vial

ANADA 200-335       Approved by FDA

Manufactured by:
G.C. Hanford Mfg. Co.

Syracuse, NY 13201                   INS15793 03           7/2011

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL