Amoxi-tabs® (amoxicillin)

Product Type: PRESCRIPTION ANIMAL DRUG LABEL
Autor Name: Pfizer Animal Health
Code Source: 61106-6043
Route of Administration: ORAL

Amoxi-Tabs

Generic: amoxicillin

Ingredients:

• amoxicillin amoxicillin anhydrous : Active ingredient - moiety is basis of strength - 50 mg in 1 1

Package Description:

• 500 1 in 1 BOTTLE

Amoxi-Tabs

Generic: amoxicillin

Ingredients:

• amoxicillin amoxicillin anhydrous : Active ingredient - moiety is basis of strength - 100 mg in 1 1

Package Description:

• 500 1 in 1 BOTTLE

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 - 50 mg Tablet Bottle Label

amoxi ??– tabs ^®
(amoxicillin)
Veterinary Tablets
For use in dogs and cats
Each film-coated tablet contains
amoxicillin trihydrate equivalent
to 50 mg of amoxicillin.
Caution: Federal law restricts this
drug to use by or on the order
of a licensed veterinarian.
50 mg
500 tablets
NADA #55-081, Approved by FDA
Pfizer

PRINCIPAL DISPLAY PANEL - 50 mg Tablet Bottle Label

PRINCIPAL DISPLAY PANEL - 100 mg Tablet Bottle Label

amoxi ??– tabs ^®
(amoxicillin)
Veterinary Tablets
For use in dogs and cats
Each film-coated tablet contains
amoxicillin trihydrate equivalent
to 100 mg of amoxicillin.
Caution: Federal law restricts this
drug to use by or on the order
of a licensed veterinarian.
100 mg
500 tablets
NADA #55-081, Approved by FDA
Pfizer

PRINCIPAL DISPLAY PANEL - 100 mg Tablet Bottle Label