Label: AMPICILLIN SODIUM injection, powder, for solution
- NDC Code(s): 86108-335-01
- Packager: US Vet Inc
- Category: PRESCRIPTION ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Animal Drug Application
Drug Label Information
Updated November 2, 2020
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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.
- ADVERSE REACTIONS
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
INGREDIENTS AND APPEARANCE
ampicillin sodium injection, powder, for solution
Product Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:86108-335 Route of Administration INTRAVENOUS, INTRAMUSCULAR Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMPICILLIN SODIUM (UNII: JFN36L5S8K) (AMPICILLIN - UNII:7C782967RD) AMPICILLIN 1 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:86108-335-01 10 in 1 TRAY 1 1 in 1 VIAL, GLASS Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200335 11/02/2020 Labeler - US Vet Inc (117160633) Establishment Name Address ID/FEI Business Operations GC Hanford Manufacturing Company 002238863 MANUFACTURE, ANALYSIS