Biomox® (amoxicillin) Antibiotic Tablets and Oral Suspension for Pets(Rx)

Trade Names:

A broad-spectrum antibiotic commonly used to treat many bacterial infections in dogs and cats (ex. bite wounds, dental infections, respiratory tract, gastrointestinal and urinary tract infections). Amoxicillin is available as tablets or as an oral suspension.

• A broad spectrum, synthetic member of the penicillin class; an antibiotic
• Given by mouth

• Because of its broad spectrum nature, it is useful against many bacteria infections and is frequently used when bacteria sensitivity is unknown
• Especially useful in anaerobic infections (those growing without oxygen)
• Often used in: bite wound infections, upper respiratory tract infections, dental infections, gastrointestinal tract infections, urinary tract infections

• Pets known to have had an allergic reaction to penicillin or another antibiotic before
• Use with caution in very small animals who may be dehydrated or have kidney or heart disorders

For liquids, shake well before accurately measuring the dose.

Give this medication with or without food.

Give medication as directed by your veterinarian. Read and follow the label carefully.

Give the exact amount prescribed and only as often as directed.

Give this medication for as long as your veterinarian directs. Finish the entire course of treatment.

Ideally, give the medication at the same time daily.

If a dose is missed, give it as soon as you can. If it is time already for the next dose, skip the missed dose and go back to the normal schedule. Do not give two doses at the same time.

Talk to your veterinarian about:

• When will your pet need to be rechecked
• What tests may need to be performed prior to and during treatment with this drug
• Risks and benefits of using this drug

Tell your veterinarian about:

• If your pet has experienced side-effects on other drugs/products
• If your pet has experienced digestive upset now or ever
• If your pet has experienced liver or kidney disease now or ever
• If your pet has experienced any other medical problems or allergies now or ever
• All medicines and supplements that you are giving your pet or plan to give your pet, including those you can get without a prescription. Your veterinarian may want to check that all of your pet's medicines can be given together.
• If your pet is pregnant or nursing or if you plan to breed your pet

Store suspension in the refrigerator. Discard reconstituted suspension in two weeks.

Store tablets at room temperature in a cool, dry place. Keep away from heat and direct sunlight.

Keep this and all medication out of reach of children and pets. Call your physician immediately if you accidentally take this product.

People with allergies to penicillins or beta-lactam antibiotics should not handle this drug since allergic reactions could occur from contact.

• Nausea may be experienced. Give the medication with food to reduce effect
• Decreased appetite, drooling, diarrhea, vomiting
• Allergic reactions are rare, but if your pet shows irregular breathing, rash, fever, hives, scratching, puffiness or facial swelling, or anything else unusual, stop therapy and contact your veterinarian immediately

Yes, but possible interactions may occur with aspirin, chloramphenicol, erythromycin, tetracyclines, aminoglycosides, cephalosporins and probenecid.

Contact your veterinarian immediately if pet eats more than the prescribed amount.

This is just a summary of information about amoxicillin. If you have any questions or concerns about amoxicillin or the condition it was prescribed for, contact your veterinarian.

As with all prescribed medicines, amoxicillin should only be given to the dog/cat for which it was prescribed. It should be given only for the condition for which it was prescribed.

BIOMOX^® ORAL SUSPENSION

Virbac

(amoxicillin)

Veterinary For Oral Suspension

For use in DOGS only.

NADA # 65-495, Approved by FDA

DESCRIPTION: BIOMOX^® (amoxicillin) is a broad-spectrum, semi-synthetic 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 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 andProteus 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 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 andStaphylococcus spp.

As is true with all antibiotic therapy, appropriate in vitro cultures and sensitivities should be conducted prior to treatment.

CONTRAINDICATIONS: The 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 a day for 5 to 7 days. Continue for 48 hours after all symptoms have subsided. If no improvement is noted within 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.

Note: 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.

SHAKE WELL BEFORE USING, KEEP TIGHTLY CLOSED

Store at controlled room temperature not to exceed 25°C (77° F).

Manufactured for: Virbac AH, Inc., P.O. Box 162059, Fort Worth, TX 76161

1-800-338-3659

92515, 92530 05/08 Rev.-02

Code No. GO/DRUGS/369/L

BIOMOX^® TABLETS

Virbac

brand of amoxicillin

Veterinary Tablets

For use in DOGS only.

NADA # 65-492, Approved by FDA

DESCRIPTION: BIOMOX^® (amoxicillin) is a broad-spectrum, semi-synthetic 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 andProteus 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 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 andStaphylococcus spp.

As is true with all antibiotic therapy, appropriate in vitro cultures and sensitivities should be conducted prior to treatment.

CONTRAINDICATIONS: The 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 and 1000 tablets.

Store at controlled room temperature between 15° and 30°C (59°F and 86°F).

Manufactured for: Virbac AH, Inc., P.O. Box 162059, Fort Worth, TX 76161

1-800-338-3659

Rev.-02 05/08

Code No. GO/DRUGS/369/L

Made in India