Animal NDC 51311-300-15 Biomox

Amoxicillin

Animal NDC Product Code 51311-300-15

Field Name Field Value
Animal NDC Code 51311-300-15
Proprietary Name Biomox 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 Virbac Ah, 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 NADA065495 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.

Biomox 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

Other

Veterinary For Oral Suspension
For use in DOGS only.

Manufactured for:Virbac AH, Inc.P.O. Box 162059Fort Worth, TX 761611-800-338-36599251505/08Rev.-02

Description

BIOMOX® (amoxicillin) is a broad-spectrum, semisynthetic antibiotic which provides bactericidal activity against a wide range of common gram-positive and gram-negative pathogens. Amoxicillin chemically is D-(-)a-amino-p-hydroxybenzyl penicillin trihydrate.

Inactive Ingredients

Cherry Flavor, Silicon Dioxide NF, FD&C Red #40, Polyoxyethylene-Polyoxypropylene Glycol, Sodium Benzoate, Sodium Citrate, Sodium Saccharin, and Sucrose.

Action

Amoxicillin has bactericidal activity against susceptible organisms similar to that of ampicillin. It acts by inhibiting the biosynthesis of bacterial wall mucopeptides. Most strains of the following gram-positive and gram-negative bacteria have demonstrated susceptibility to amoxicillin, both in vitro and in vivo: nonpenicillinase-producing staphylococci, alpha- and beta-hemolytic streptococci, Streptococcus faecalis, Escherichia coli and Proteus mirabilis. Amoxicillin does not resist destruction by penicillinase; therefore, it is not effective against penicillinase-producing bacteria, particularly resistant staphylococci. Most strains of Enterobacter and Klebsiella and all strains of Pseudomonas are resistant.Amoxicillin may be given without regard to meals because it is stable in gastric acid. It is rapidly absorbed following oral administration and diffuses readily into most body fluids and tissues. It diffuses poorly into the brain and spinal fluid except when the meninges are inflamed. Most of the amoxicillin is excreted in the urine unchanged.

Indications

BIOMOX® (amoxicillin) for oral suspension is indicated in the treatment of the following infections in dogs when caused by susceptible strains of organisms:BACTERIAL DERMATITIS due to Staphylococcus aureus, Streptococcus spp., Staphylococcus spp., and E. coli.SOFT TISSUE INFECTIONS (abscesses, wounds, lacerations) due to Staphylococcus aureus, Streptococcus spp., E. coli, Proteus mirabilis and Staphylococcus spp.As is true with all antibiotic therapy, appropriate in vitro cultures and sensitivities should be conducted prior to treatment.

Contraindications

Use of amoxicillin is contraindicated in animals with a history of an allergic reaction to penicillin.

Adverse Reactions

Amoxicillin is a semisynthetic penicillin and, therefore, has the potential for producing allergic reactions. Epinephrine and/or steroids should be administered if an allergic reaction occurs.

Warnings

For use in dogs only.

Precautions

Until adequate reproductive studies are accomplished, Biomox (amoxicillin) for oral suspension should not be used in pregnant or breeding animals.

Caution

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

Dosage And Administration

The recommended dosage is 5 mg per pound of body weight administered twice daily for 5 to 7 days. Continue for 48 hours after all symptoms have subsided. If no improvement is noted in 5 days, the diagnosis should be reconsidered and therapy changed.

Directions For Mixing Oral Suspension

Add sufficient water to the bottle as indicated in the table below and shake vigorously. Each mL of suspension will contain 50 mg of amoxicillin as the trihydrate.Bottle SizeAmount of Water toAdd for Reconstitution15 mL11 mL30 mL21 mLNote: When stored at room temperature or in refrigerator, discard unused portion of reconstituted suspension after 14 days.

Supply

Biomox® (amoxicillin) for oral suspension is supplied in bottles containing 0.75 g of amoxicillin activity in bottles of 15 mL or 1.5 g of amoxicillin activity in bottles of 30 mL. After reconstitution with the required amount of water, each mL will contain 50 mg of amoxicillin as the trihydrate.

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

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