Animal NDC 54771-6036-6 Amoxi-drop

Amoxicillin

Animal NDC Product Code 54771-6036-6

Field Name Field Value
Animal NDC Code 54771-6036-6
Proprietary Name Amoxi-drop What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Amoxicillin What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Zoetis Inc.
Product Type Prescription Animal Drug
Active Ingredient(s)
  • Amoxicillin
Marketing Category NADA - NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number NADA055085 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Amoxi-drop Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

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 tissuinfections (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.

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.

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

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.

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.

Contraindications

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

Warnings

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

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. 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.Bottle Size                               Amount of Water                                             Required for Reconstitution15 mL                                                  12 mL30 mL                                                  23 mLNote: 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)

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. Bottle Size Amount of Water Required for Reconstitution 15 mL 12 mL 30 mL 23 mLNote: Any unused portion of the reconstituted suspension must be discarded after 14 days. After mixing, refrigeration preferable, but not required.

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.

* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.