Animal NDC 86108-335-01 Ampicillin Sodium
Animal Product Information
Ampicillin Sodium Animal Product Labeling Information
The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Table of Contents
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.
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.
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.
The use of this drug is contraindicated in animals with a history of an allergic reaction to penicillin.
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.
Restricted Drug (California) - Use only as Directed.
Do not use in horses intended for human consumption.
Not for human use.
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
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.
Amount of Diluent to be Added
Stability studies with the concentrated product (300 mg/mL) demonstrated that ampicillin is stable for 1 hour at room temperature (70° - 75° F).
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 86108-335-01 1 gm vial
NDC 86108-335-03 3 gm vial
Approved by FDA under ANADA # 200-335
US VET Inc.
Hamilton, NY 13346
INS15793 04 Rev. 05/2020
Package/Label Principal Display Panel
For Intravenous or Intramuscular Use in Horses Only
Each vial contains: Ampicillin sodium equivalent to 1 gram ampicillin.
CAUTION: Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Mfd. For: US VET Inc.
Hamilton, NY 13346
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