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 May 16, 2016

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  • SPL UNCLASSIFIED SECTION

    Amoxi-Drop 

    (amoxicillin)

    For veterinary oral suspension

    For use in dogs and cats

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  • CAUTION

    Federal law restricts this drug to use by or on the order of a licensed veterinarian.

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  • 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.

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  • 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.

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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 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.

    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.

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  • CONTRAINDICATIONS

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

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  • WARNINGS

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

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  • 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.

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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.

    Do Not Store Dry Powder at Temperatures Above 25°C (77°F)

    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.

    Do Not Store Dry Powder at Temperatures Above 25°C (77°F)

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  • 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.

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  • SPL UNCLASSIFIED SECTION

    NADA #55-085, Approved by FDA

    PRODUCT OF SINGAPORE

    Manufactured by:

    Norbrook Laboratories Ltd.

    Newry, N. Ireland, UK

    Distributed by:

    Zoetis Inc.

    Kalamazoo, MI 49007

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  • PRINCIPAL DISPLAY PANEL - 15 mL Carton 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.

    Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

    15 mL

    NADA #55-085, Approved by FDA

    Amoxi-Drop 15 mL Carton

    Amoxi-Drop 15 mL Carton

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  • PRINCIPAL DISPLAY PANEL - 30 mL Carton

     Amoxi-Drop

    (amoxicillin)

    For veterinary oral suspension For use in dogs and cats

    Equivalent to 1.5 g amoxicillin

    When reconstituted each mL will contain 50 mg of amoxicillin as the trihydrate.

    Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian.

    30 mL

    NADA #55-085, Approved by FDA

    Carton label 30mL

    Carton label 30mL

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  • INGREDIENTS AND APPEARANCE
    AMOXI-DROP 
    amoxicillin suspension
    Product 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:54771-6036-1 30 mL in 1 BOTTLE, DROPPER
    2 NDC:54771-6036-6 15 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)
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