AMPICILLIN- ampicillin injection, powder, for suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AMPICILLIN TRIHYDRATE (UNII: HXQ6A1N7R6) (AMPICILLIN - UNII:7C782967RD)

Available from:

GC Hanford Manufacturing Company

INN (International Name):

AMPICILLIN TRIHYDRATE

Composition:

AMPICILLIN 25 g

Administration route:

INTRAMUSCULAR

Prescription type:

PRESCRIPTION

Therapeutic indications:

Ampicillin for injectable suspension has proved effective in the treatment of many infections previously beyond the spectrum of penicillin therapy. This drug is particularly indicated in the treatment of the following infections caused by susceptible strains of organisms: Dogs and Cats - Respiratory Tract Infections: Upper respiratory infections, tonsillitis and bronchopneumonia due to hemolytic streptococci, Staphylococcus aureus, Escherichia coli, Proteus mirabilis and Pasteurella spp. Urinary Tract Infections due to Proteus mirabilis, Escherichia coli, Staphylococcus spp., hemolytic streptococci and Enterococcus spp. Gastrointestinal Infections due to Enterococcus spp., Staphylococcus spp. and Escherichia coli . Skin, Soft Tissue and Post-Surgical Infections: Abscesses, pustular dermatitis, cellulitis and infections of the anal gland, due to Escherichia coli, Proteus mirabilis , hemolytic streptococci, Staphylococcus spp. and Pasteurella spp. Cattle and Calves Including Non-Ruminating (Veal Cal

Product summary:

Ampicillin for injectable suspension, veterinary is supplied in vials containing 25 grams ampicillin activity as ampicillin trihydrate.

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

AMPICILLIN- AMPICILLIN INJECTION, POWDER, FOR SUSPENSION
GC HANFORD MANUFACTURING COMPANY
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STERILE AMPICILLIN FOR INJECTABLE SUSPENSION, VETERINARY
DESCRIPTION:
Ampicillin for injectable suspension, veterinary is a broad-spectrum
penicillin which has bactericidal
activity against a wide range of common gram-positive and
gram-negative bacteria.
Each 25 g vial contains: 25 g ampicillin activity as ampicillin
trihydrate, 90 mg methylparaben (as
preservative), 10 mg propylparaben (as preservative), 200 mg lecithin,
500 mg povidone, 200 mg
sodium chloride, 600 mg sodium citrate anhydrous.
CLINICAL PHARMACOLOGY:
The antimicrobial action of ampicillin is bactericidal, and only a
small percentage of the antibiotic is
serum-bound. Peak serum levels in dogs and cats are reached
approximately one-half hour following
subcutaneous or intramuscular injection, and in cattle 1 hour to 2
hours following intramuscular
injection.
_In vitro_ studies have demonstrated sensitivity of the following
organisms to ampicillin: gram-positive
bacteria - alpha- and beta-hemolytic streptococci, staphylococci
(non-penicillinase-producing), _Bacillus_
_anthracis_ and most strains of enterococci and clostridia;
gram-negative bacteria - _Proteus mirabilis, E._
_coli_ and many strains of Salmonella and _Pasteurella multocida_.
The drug does not resist destruction by penicillinase and, hence, is
not effective against strains of
staphylococci resistant to penicillin G. Susceptibility tests should
be conducted to estimate the _in vitro_
susceptibility of bacterial isolates to ampicillin.
INDICATIONS:
Ampicillin for injectable suspension has proved effective in the
treatment of many infections previously
beyond the spectrum of penicillin therapy. This drug is particularly
indicated in the treatment of the
following infections caused by susceptible strains of organisms:
DOGS AND CATS - RESPIRATORY TRACT INFECTIONS: Upper respiratory
infections, tonsillitis and
bronchopneumonia due to hemolytic streptococci, _Staphylococcus
aureus, Escherichia