Label: AMOXI-DROP- amoxicillin suspension
- NDC Code(s): 54771-6036-1, 54771-6036-6
- Packager: Zoetis Inc.
- Category: PRESCRIPTION ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Animal Drug Application
Drug Label Information
Updated November 14, 2024
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- SPL UNCLASSIFIED SECTION
- CAUTION
- DESCRIPTION
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CLINICAL PHARMACOLOGY
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.
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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
- WARNINGS
- ADVERSE REACTIONS
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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 Reconstitution 15 mL 12 mL 30 mL 23 mL Note: Any unused portion of the reconstituted suspension must be discarded after 14 days. After mixing, refrigeration preferable, but not required.
- HOW SUPPLIED
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 15 mL Label
- PRINCIPAL DISPLAY PANEL - 30 mL Label
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INGREDIENTS AND APPEARANCE
AMOXI-DROP
amoxicillin suspensionProduct Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:54771-6036 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMOXICILLIN (UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9) AMOXICILLIN ANHYDROUS 50 mg in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54771-6036-6 15 mL in 1 BOTTLE, DROPPER 2 NDC:54771-6036-1 30 mL in 1 BOTTLE, DROPPER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA055085 01/28/1977 Labeler - Zoetis Inc. (828851555)
