Your browser does not support JavaScript! AMOXI-TABS (AMOXICILLIN) TABLET, FILM COATED [PFIZER ANIMAL HEALTH]

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AMOXI-TABS (amoxicillin) tablet, film coated
[Pfizer Animal Health]


Category DEA Schedule Marketing Status
PRESCRIPTION ANIMAL DRUG LABEL New Animal Drug Application
Drug Label Sections

Veterinary Tablets

For use in dogs and cats

CAUTION

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

DESCRIPTION

Amoxi-Tabs (amoxicillin) is a semisynthetic antibiotic with a broad spectrum of activity. It provides bactericidal activity against a wide range of common gram-positive and gram-negative pathogens. Chemically, it is D(-)-α-amino-p-hydroxybenzyl penicillin trihydrate.

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: α- and β-haemolytic streptococci, nonpenicillinase-producing 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.

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.

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.

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

The use of this drug is contraindicated in animals with a history of an allergic reaction to penicillin.

WARNING

For use in dogs and cats only.

ADVERSE REACTIONS

Amoxicillin is a semisynthetic penicillin and has the potential for producing allergic reactions. If an allergic reaction occurs, administer epinephrine and/or steroids.

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.

Do Not Store at Temperatures Above 25°C (77°F)

HOW SUPPLIED

Amoxi-Tabs are supplied in 5 strengths: 50 mg, 100 mg, 150 mg, and 200 mg in bottles of 500 tablets; 400 mg in bottles of 250 tablets.

NADA #55-078 & #55-081, Approved by FDA

MADE IN INDIA

Distributed by:
Pfizer Animal Health
Div. of Pfizer Inc
NY, NY 10017

P1501359
75-8004-06IN.00
Jan 2008

PRINCIPAL DISPLAY PANEL - 150 mg Tablet Bottle Label

amoxitabs®
(amoxicillin)
Veterinary Tablets

For use in dogs only

Each film-coated tablet contains
amoxicillin trihydrate equivalent
to 150 mg of amoxicillin.

Caution: Federal law restricts this
drug to use by or on the order
of a licensed veterinarian.

150 mg

500 tablets

NADA #55-078, Approved by FDA

Pfizer

PRINCIPAL DISPLAY PANEL - 150 mg Tablet Bottle Label

PRINCIPAL DISPLAY PANEL - 200 mg Tablet Bottle Label

amoxitabs®
(amoxicillin)
Veterinary Tablets

For use in dogs only

Each film-coated tablet contains
amoxicillin trihydrate equivalent
to 200 mg of amoxicillin.

Caution: Federal law restricts this
drug to use by or on the order
of a licensed veterinarian.

200 mg

500 tablets

NADA #55-078, Approved by FDA

Pfizer

PRINCIPAL DISPLAY PANEL - 200 mg Tablet Bottle Label

PRINCIPAL DISPLAY PANEL - 400 mg Tablet Bottle Label

amoxitabs®
(amoxicillin)
Veterinary Tablets

For use in dogs only

Each film-coated tablet contains
amoxicillin trihydrate equivalent
to 400 mg of amoxicillin.

Caution: Federal law restricts this
drug to use by or on the order
of a licensed veterinarian.

400 mg

250 tablets

NADA #55-078, Approved by FDA

Pfizer

PRINCIPAL DISPLAY PANEL - 400 mg Tablet Bottle Label
AMOXI-TABS 
amoxicillin tablet, film coated
Product Information
Product TypePRESCRIPTION ANIMAL DRUG LABELItem Code (Source)NDC:61106-8007
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
amoxicillin (amoxicillin anhydrous) amoxicillin anhydrous150 mg
Product Characteristics
ColorPURPLEScoreno score
ShapeROUNDSize10mm
FlavorImprint Code BMP208
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61106-8007-7500 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NADANADA05507802/04/1976
AMOXI-TABS 
amoxicillin tablet, film coated
Product Information
Product TypePRESCRIPTION ANIMAL DRUG LABELItem Code (Source)NDC:61106-6044
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
amoxicillin (amoxicillin anhydrous) amoxicillin anhydrous200 mg
Product Characteristics
ColorORANGE (Coral) Scoreno score
ShapeROUNDSize11mm
FlavorImprint Code BMP203
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61106-6044-4500 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NADANADA05507802/04/1976
AMOXI-TABS 
amoxicillin tablet, film coated
Product Information
Product TypePRESCRIPTION ANIMAL DRUG LABELItem Code (Source)NDC:61106-6046
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
amoxicillin (amoxicillin anhydrous) amoxicillin anhydrous400 mg
Product Characteristics
ColorGREENScoreno score
ShapeROUNDSize14mm
FlavorImprint Code BMP196
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61106-6046-6250 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NADANADA05507802/04/1976
Labeler - Pfizer Animal Health (039055157)
Registrant - Pfizer Inc (943955690)
Establishment
NameAddressID/FEIBusiness Operations
Aurobindo Pharma Ltd.918917683MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
Beecham Pharmaceuticals595132580API MANUFACTURE

Revised: 11/2012
 
Pfizer Animal Health

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