Vault #: ART-24750 Version: 4.0 Status: Approved Approved Date (UTC): 07 Feb 2020 Name: P1523357 Title: INS COMMON AMOXI FCT EN USA_APL

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 Staphylo- 23357 coccus aureus, Streptococcus spp., and E. coli. P1523357 Genitourinary tract infections (cystitis) due to Staph- ylococcus aureus, Streptococcus spp., E. coli, and ® Proteus mirabilis. Gastrointestinal tract infections due to E. coli. (amoxicillin tablets), USP Skin and soft tissue infections (abscesses, lacera- tions, and wounds) due to Staphylococcus aureus, Veterinary Tablets Streptococcus spp., E. coli, and Pasteurella multo- cida. As with all antibiotics, appropriate in vitro culturing

23357 and susceptibility testing of samples taken before treatment should be conducted. CONTRAINDICATIONS: The use of this drug is con- traindicated in animals with a history of an allergic reaction to penicillin. WARNING: For use in dogs and cats only. ADVERSE REACTIONS: Amoxicillin is a semisyn- thetic penicillin and has the potential for For use in dogs and cats producing allergic reactions. If an allergic reaction occurs, administer epinephrine CAUTION: Federal (USA) law restricts this drug to 23357 and/or steroids. use by or on the order of a licensed veterinarian. DOSAGE AND ADMINISTRATION: DESCRIPTION: Amoxi-Tabs (amoxicillin tablets) is a Dogs: The recommended dosage is semi- synthetic antibiotic with a broad spectrum of 5 mg/lb of body weight twice a day. activity. It provides bactericidal activity against a Cats: The recommended dosage is wide range of common gram-positive and gram-neg- 50 mg (5–10 mg/lb) once a day. ative pathogens. Chemically, it is D(-)-α-amino-p-hy- droxy- benzyl penicillin trihydrate. Dosage should be continued for 5–7 days or 48 hours after all symptoms have subsided. If no CLINICAL PHARMACOLOGY: Amoxi-Tabs is stable improvement is seen in 5 days, review diagnosis and in the presence of gastric acid and may be given change therapy. without regard to meals. It is rapidly absorbed after oral administration. It diffuses readily into most body Do Not Store at Temperatures Above 25°C (77°F) tissues and fluids with the exception of brain and Keep Bottle Tightly Closed. spinal fluid, except when meninges are inflamed. HOW SUPPLIED: Amoxi-Tabs are supplied in 5 Most of the amoxicillin is excreted unchanged in strengths: 50 mg, 100 mg, 150 mg, and 200 mg in bot- the urine. tles of 500 tablets; 400 mg in bottles of 250 tablets. Amoxicillin is similar to ampicillin in its bactericidal Approved by FDA under NADA # 055-078 action against susceptible organisms. It acts Approved by FDA under NADA # 055-081 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 bac- teria: α- and β-haemolytic streptococci, nonpeni- cillinase-producing staphylococci, Streptococcus Distributed by: faecalis, Escherichia coli, and Proteus mirabilis. Zoetis Inc. Because it does not resist destruction by penicilli- Kalamazoo, MI 49007 nase, it is not effective against penicillinase-produc- ing bacteria, particularly resistant staphylococci. All strains of Pseudomonas and most strains of Kleb- siella and Enterobacter are resistant. INDICATIONS AND USAGE: Dogs: Amoxi-Tabs are indicated in the treatment of susceptible strains of the organisms causing the fol- lowing infections: Respiratory tract infections (tonsillitis, tracheobron- chitis) due to Staphylococcus aureus, Streptococ- cus spp., E. coli, and Proteus mirabilis. Genitourinary tract infections (cystitis) due to Staph- P1523357 ylococcus aureus, Streptococcus spp., E. coli, and Revised: January 2020 Proteus mirabilis. Gastrointestinal tract infections (bacterial gastroen- teritis) due to Staphylococcus aureus, Streptococ- cus spp., E. coli, and Proteus mirabilis. Bacterial dermatitis due to Staphylococcus aureus, Streptococcus spp., and Proteus mirabilis.

P1523357

GLOBAL EXTERNAL SUPPLY Date: 03 Feb 2020 11:37Time: Proof Nº 02 TEXT SIZE The BODY text Description INS COMMON AMOXI FCT EN USA_APL on this A/W is at: Artwork Code P1523357 Component Leaflet 8.5 pt Supplier Aurobindo India Pharma Code 23357 Market USA GTIN N/A Dimensions 2 3/4” x 10 1/2” Perigord Nº 529907 CR Number 200008359 Drawing Number Colours BLACK N/A

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Tel: +353 (0)1 440 3222 SKU No Web: www.perigord-as.com N/A E-mail: [email protected] Zoetis | This copy of the document was retrieved from the system by Michaella Braskie on 13 Feb 2020.