amoxi-drop® (amoxicillin)

Product Type: PRESCRIPTION ANIMAL DRUG LABEL
Autor Name: Pfizer Animal Health
Code Source: 61106-6036
Route of Administration: ORAL

Amoxi-Drop

Generic: amoxicillin

Ingredients:

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

Package Description:

• 15 mL in 1 BOTTLE, DROPPER
• 30 mL in 1 BOTTLE, DROPPER

For veterinary oral suspension
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-Drop (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.

ACTION

Amoxi-Drop 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 Dogs

Amoxi-Drop is 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-Drop is indicated in the treatment of susceptible strains of the organisms causing the following infections:
Upper respiratory tract infections due to Staphylococcus aureus , Staphylococcus spp., Streptococcus spp., Haemophilus spp., E. coli , Pasteurella spp., and Proteus mirabilis .
Genitourinary tract infections (cystitis) due to Staphylococcus aureus , Streptococcus spp., E. coli , Proteus mirabilis , and Corynebacterium spp.
Gastrointestinal tract infections due to E. coli , Proteus spp., Staphylococcus spp., and Streptococcus spp.
Skin and soft tissue infections (abscesses, lacerations, and wounds) due to Staphylococcus aureus , Staphylococcus spp., Streptococcus spp., E. coli , and Pasteurella multocida .

CONTRAINDICATIONS

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

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.

WARNINGS

For use in dogs and cats only. Not for use in animals which are raised for food production.

DOSAGE AND ADMINISTRATION Dogs

The recommended dosage is 5 mg/lb of body weight. Administer twice daily for 5-7 days. Continue for 48 hours after all symptoms have subsided.

Cats

The recommended dosage is 50 mg (5-10 mg/lb). Administer once daily for 5-7 days. Continue for 48 hours after all symptoms have subsided.

DIRECTIONS FOR MIXING ORAL SUSPENSION

Add required amount of water (see following table ) to the bottle and shake vigorously. Each mL of suspension will contain 50 mg of amoxicillin as the trihydrate.
Note: Any unused portion of the reconstituted suspension must be discarded after 14 days. After mixing, refrigeration preferable, but not required.
Do Not Store Dry Powder at Temperatures Above 25 °C (77°F)

HOW SUPPLIED

Amoxi-Drop is supplied in 15-mL bottles containing 0.75 g and 30-mL bottles containing 1.5 g of amoxicillin activity. When reconstituted with required amount of water, each mL contains 50 mg of amoxicillin as the trihydrate.

NADA #55-085, Approved by FDA
Manufactured by:
GlaxoSmithKline
Research Triangle Park, NC 27709
75-8000-06

Chemical Structure

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Label

amoxi-drop ^® (amoxicillin)
For veterinary oral suspension
For use in dogs and cats
Equivalent to 0.75 g amoxicillin
When reconstituted each mL
will contain 50 mg of amoxicillin
as the trihydrate.
15 mL Pfizer
NADA #55-085, Approved by FDA

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Label