Label: AMOXI-TABS- amoxicillin tablet, film coated
- NDC Code(s): 54771-6044-4, 54771-6046-6, 54771-8007-7
- Packager: Zoetis Inc.
- Category: PRESCRIPTION ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Animal Drug Application
Drug Label Information
Updated November 14, 2024
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- Official Label (Printer Friendly)
- CAUTION
- DESCRIPTION
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CLINICAL PHARMACOLOGY
Amoxi-Tabs is stable in the presence of gastric acid and may be given without regard to meals. It is rapidly absorbed after oral administration. It diffuses readily into most body tissues and fluids with the exception of brain and spinal fluid, except when meninges are inflamed. Most of the amoxicillin is excreted unchanged in the urine.
Amoxicillin is similar to ampicillin in its bactericidal action against susceptible organisms. It acts through the inhibition of biosynthesis of cell wall mucopeptide. In vitro and/or in vivo studies have demonstrated the susceptibility of most strains of the following gram-positive and gram-negative bacteria: a- and b-haemolytic streptococci, nonpenicillinaseproducing staphylococci, Streptococcus faecalis, Escherichia coli, and Proteus mirabilis. Because it does not resist destruction by penicillinase, it is not effective against penicillinase-producing bacteria, particularly resistant staphylococci. All strains of Pseudomonas and most strains of Klebsiella and Enterobacter are resistant.
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INDICATIONS AND USAGE
Dogs: Amoxi-Tabs are indicated in the treatment of susceptible strains of the organisms causing the following infections:
Respiratory tract infections (tonsillitis, tracheobronchitis) due to Staphylococcus aureus, Streptococcus spp., E. coli, and Proteus mirabilis. Genitourinary tract infections (cystitis) due to Staphylococcus aureus, Streptococcus spp., E. coli, and Proteus mirabilis.
Genitourinary tract infections(cystitis) due to Staphylococcus aureus, Streptococcus spp., E. coli, and Proteus mirabilis.
Gastrointestinal tract infections (bacterial gastroenteritis) due to Staphylococcus aureus, Streptococcus spp., E. coli, and Proteus mirabilis. Bacterial dermatitis due to Staphylococcus aureus, Streptococcus spp., and Proteus mirabilis.
Bacterial dermatitis due to Staphylococcus aureus, Streptococcus spp., and Proteus mirabilis.
Soft tissue infections (abscesses, lacerations, and wounds) due to Staphylococcus aureus, Streptococcus spp., E. coli, and Proteus mirabilis.
Cats:Amoxi-Tabs are indicated in the treatment of susceptible strains of the organisms causing the following infections:
Upper respiratory tract infections due to Staphylococcus aureus, Streptococcus spp., and E. coli.
Genitourinary tract infections (cystitis) due to Staphylococcus aureus, Streptococcus spp., E. coli, and Proteus mirabilis.
Gastrointestinal tract infections due to E. coli. Skin and soft tissue infections (abscesses, lacerations, and wounds) due to Staphylococcus aureus, Streptococcus spp., E. coli, and Pasteurella multocida.
As with all antibiotics, appropriate in vitro culturing and susceptibility testing of samples taken before treatment should be conducted.
- CONTRAINDICATIONS
- WARNING
- ADVERSE REACTIONS
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DOSAGE AND ADMINISTRATION
DOSAGE AND ADMINISTRATION:
Dogs: The recommended dosage is 5 mg/lb of body weight twice a day.
Cats: The recommended dosage is 50 mg (5–10 mg/lb) once a day.
Dosage should be continued for 5–7 days or 48 hours after all symptoms have subsided. If no improvement is seen in 5 days, review diagnosis and change therapy.
- STORAGE AND HANDLING
- HOW SUPPLIED
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 150 mg Tablet Bottle Label
- PRINCIPAL DISPLAY PANEL - 200 mg Tablet Bottle Label
- PRINCIPAL DISPLAY PANEL - 400 mg Tablet Bottle Label
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INGREDIENTS AND APPEARANCE
AMOXI-TABS
amoxicillin tablet, film coatedProduct Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:54771-8007 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMOXICILLIN (UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9) AMOXICILLIN ANHYDROUS 150 mg Product Characteristics Color purple Score no score Shape ROUND Size 10mm Flavor Imprint Code BMP208 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54771-8007-7 500 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA055078 02/04/1976 AMOXI-TABS
amoxicillin tablet, film coatedProduct Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:54771-6044 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMOXICILLIN (UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9) AMOXICILLIN ANHYDROUS 200 mg Product Characteristics Color orange (Coral) Score no score Shape ROUND Size 11mm Flavor Imprint Code BMP203 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54771-6044-4 500 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA055078 02/04/1976 AMOXI-TABS
amoxicillin tablet, film coatedProduct Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:54771-6046 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMOXICILLIN (UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9) AMOXICILLIN ANHYDROUS 400 mg Product Characteristics Color green Score no score Shape ROUND Size 14mm Flavor Imprint Code BMP196 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54771-6046-6 250 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA055078 02/04/1976 Labeler - Zoetis Inc. (828851555)