Amoxi-Tabs

Pfizer Animal Health
Pfizer Inc

amoxi❖tabs (amoxicillin)

FULL PRESCRIBING INFORMATION: CONTENTS*

• CAUTION
• AMOXI-TABS DESCRIPTION
• CLINICAL PHARMACOLOGY
• AMOXI-TABS INDICATIONS AND USAGE
  • Dogs
  • Cats
• AMOXI-TABS CONTRAINDICATIONS
• WARNING
• AMOXI-TABS ADVERSE REACTIONS
• AMOXI-TABS DOSAGE AND ADMINISTRATION
  • Dogs
  • Cats
• HOW SUPPLIED
• PRINCIPAL DISPLAY PANEL - 150 mg Tablet Bottle Label
• PRINCIPAL DISPLAY PANEL - 200 mg Tablet Bottle Label
• PRINCIPAL DISPLAY PANEL - 400 mg Tablet Bottle Label

FULL PRESCRIBING INFORMATION

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.

AMOXI-TABS 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.

AMOXI-TABS 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.

AMOXI-TABS 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.

AMOXI-TABS 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.

AMOXI-TABS 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

amoxi❖tabs ^®
(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 - 200 mg Tablet Bottle Label

amoxi❖tabs ^®
(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 - 400 mg Tablet Bottle Label

amoxi❖tabs ^®
(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