BIOMOX- amoxicillin tablet 
Virbac AH, Inc.

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Approved by FDA under NADA # 065-492
BIOMOX®
(amoxicillin tablets)

For use in DOGS only.

DESCRIPTION

BIOMOX® (amoxicillin tablets) are 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-(-)α-amino-p-hydroxybenzyl penicillin trihydrate.

Inactive Ingredients

Dibasic Calcium Phosphate Dihydrate, Magnesium Stearate, Microcrystalline Cellulose and Sodium Starch Glycolate.

ACTION

Amoxicillin has bactericidal activity against susceptible organisms similar to that of ampicillin. It acts by inhibiting the biosynthesis of bacterial cell wall mucopeptides. Most strains of the following grampositive and gram-negative bacteria have demonstrated susceptibility to amoxicillin, both in vitro and in vivo: nonpenicillinase-producing staphylococci, alpha- and beta- hemolytic streptococci, Enterococcus 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 tablets) are indicated for treatment of the following infections in dogs when caused by susceptible strains of organisms:

BACTERIAL DERMATITIS due to Staphylococcus aureus, Strepto-coccus spp., Staphylococcus spp., and Escherichia coli.

SOFT TISSUE INFECTIONS
(abscesses, wounds, lacerations) due to Staphylococcus aureus,Enterococcus faecalis, Escherichia coli, Proteus mirabilis, and Staphylococcus spp.

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 tablets) 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 or 48 hours after all symptoms have subsided. If no improvement is noted in 5 days, the diagnosis should be reconsidered and therapy changed.

SUPPLY

Biomox® (amoxicillin tablets) are supplied in 50 mg, 100 mg and 200 mg concentrations in bottles of 500 tablets.

Manufactured for:
Virbac AH, Inc.
P.O. Box 162059
Fort Worth, TX 76161
1-800-338-3659

Printed in USA Rev. -06 05/19

©2019 Virbac Corporation. All Rights Reserved.BIOMOX is a registered trademark of Virbac AH, Inc.

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BIOMOX 
amoxicillin tablet
Product Information
Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:51311-201
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
amoxicillin (UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9) AMOXICILLIN ANHYDROUS50 mg
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize6mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51311-201-50500 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NADANADA06549205/24/2010
BIOMOX 
amoxicillin tablet
Product Information
Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:51311-203
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
amoxicillin (UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9) AMOXICILLIN ANHYDROUS100 mg
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize10mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51311-203-50500 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NADANADA06549205/24/2010
BIOMOX 
amoxicillin tablet
Product Information
Product TypePRESCRIPTION ANIMAL DRUGItem Code (Source)NDC:51311-205
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
amoxicillin (UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9) AMOXICILLIN ANHYDROUS200 mg
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize11mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51311-205-50500 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NADANADA06549205/24/2010
Labeler - Virbac AH, Inc. (131568396)
Establishment
NameAddressID/FEIBusiness Operations
Medispray Laboratories Private Ltd915793457manufacture
Establishment
NameAddressID/FEIBusiness Operations
Centrient Pharmaceuticals Netherlands860184986api manufacture
Establishment
NameAddressID/FEIBusiness Operations
Alcami Missouri Corporation117877975analysis
Establishment
NameAddressID/FEIBusiness Operations
Alcami Carolinas Corporation831351445analysis

Revised: 1/2022
Document Id: 3d906a26-01ab-4c10-950f-76800b847232
Set id: 2f628ed5-75cb-47a1-a5e7-2902c6f3d336
Version: 8
Effective Time: 20220105
 
Virbac AH, Inc.