Dosage Form: FOR ANIMAL USE ONLY
Biomox®
(amoxicillin)
Veterinary Tablets
For use in DOGS only.
Biomox Tablets 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:
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 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) tablets are 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 it 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) 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.
Biomox Tablets 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 and 1000 tablets.
Manufactured for:
Virbac AH, Inc.
P.O. Box 162059
Fort Worth, TX 76161
1-800-338-3659
Printed in USA
Rev. -02
05/08
READ ACCOMPANYING LITERATURE BEFORE USE.
For use in DOGS only.
Recommended Dosage:
5 mg per pound of body weight twice a day.
Dosage should be continued for 5 - 7 days or 48 hours after all symptoms have subsided.
AM10A
AM11A
AM12A
PRINCIPAL DISPLAY PANEL - 50 mg Tablet Bottle Label
NDC-051311-201-50
Virbac
ANIMAL HEALTH
BIOMOX®
(amoxicillin)
50 mg
Each tablet contains amoxicillin trihydrate
equivalent to 50 mg of amoxicillin.
CAUTION: Federal law restricts this
drug to use by or on the order of
a licensed veterinarian.
NADA # 65-492, Approved by FDA
500 Tablets
PRINCIPAL DISPLAY PANEL - 100 mg Tablet Bottle Label
NDC-051311-203-50
Virbac
ANIMAL HEALTH
BIOMOX®
(amoxicillin)
100 mg
Each tablet contains amoxicillin trihydrate
equivalent to 100 mg of amoxicillin.
CAUTION: Federal law restricts this
drug to use by or on the order of
a licensed veterinarian.
NADA # 65-492, Approved by FDA
500 Tablets
PRINCIPAL DISPLAY PANEL - 200 mg Tablet Bottle Label
NDC-051311-205-50
Virbac
ANIMAL HEALTH
BIOMOX®
(amoxicillin)
200 mg
Each tablet contains amoxicillin trihydrate
equivalent to 200 mg of amoxicillin.
CAUTION: Federal law restricts this
drug to use by or on the order of
a licensed veterinarian.
NADA # 65-492, Approved by FDA
500 Tablets
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NADA | NADA065492 | 05/24/2010 | |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NADA | NADA065492 | 05/24/2010 | |
| BIOMOX amoxicillin tablet | ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NADA | NADA065492 | 05/24/2010 | |
| Labeler - Virbac AH, Inc. (131568396) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Okasa PVT Ltd | 915793457 | MANUFACTURE | |
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