AMOXICILLIN TRIHYDRATE AND CLAVULANATE POTASSIUM- amoxicillin trihydrate, clavulanate potassium tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

AMOXICILLIN ANHYDROUS (UNII: 9EM05410Q9) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9), CLAVULANATE POTASSIUM (UNII: Q42OMW3AT8) (CLAVULANIC ACID - UNII:23521W1S24)

Available from:

Putney, Inc.

INN (International Name):

AMOXICILLIN ANHYDROUS

Composition:

AMOXICILLIN ANHYDROUS 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

INDICATIONS: Amoxicillin Trihydrate and Clavulanate Potassium Tablets are indicated in the treatment of: Dogs: Skin and soft tissue infections such as wounds, abscesses, cellulitis, superficial/juvenile and deep pyoderma due to susceptible strains of the following organisms: β-lactamase-producing Staphylococcus aureus , non-β-lactamase-producing Staphylococcus aureus , Staphylococcus spp., Streptococcus spp., and E. coli . Periodontal infections due to susceptible strains of both aerobic and anaerobic bacteria. Amoxicillin Trihydrate and Clavulanate Potassium Tablets have been shown to be clinically effective for treating cases of canine periodontal disease. Cats: Skin and soft tissue infections such as wounds, abscesses, and cellulitis/dermatitis due to susceptible strains of the following organisms: β-lactamase-producing Staphylococcus aureus , non-β-lactamase-producing Staphylococcus aureus , Staphylococcus spp., Streptococcus spp., E. coli , and Pasteurella spp. Urinary tract infections (cystitis)

Product summary:

HOW SUPPLIED: Amoxicillin Trihydrate and Clavulanate Potassium Tablets in the following strengths are supplied in strip packs. Each carton holds 15 strips with 14 tablets per strip (210 tablets per carton). Each 62.5-mg tablet contains amoxicillin trihydrate equivalent to 50 mg of amoxicillin activity and 12.5 mg of clavulanic acid as the potassium salt. For use in dogs and cats. Each 125-mg tablet contains amoxicillin trihydrate equivalent to 100 mg of amoxicillin activity and 25 mg of clavulanic acid as the potassium salt. For use in dogs only. Each 250-mg tablet contains amoxicillin trihydrate equivalent to 200 mg of amoxicillin activity and 50 mg of clavulanic acid as the potassium salt. For use in dogs only. Each 375-mg tablet contains amoxicillin trihydrate equivalent to 300 mg of amoxicillin activity and 75 mg of clavulanic acid as the potassium salt. For use in dogs only. Dispense according to recommendations outlined in Dosage and Administration section. Augmentin is a trademark owned by GlaxoSmithKline, LLC.

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

AMOXICILLIN TRIHYDRATE AND CLAVULANATE POTASSIUM- AMOXICILLIN
TRIHYDRATE,
CLAVULANATE POTASSIUM TABLET
PUTNEY, INC.
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AMOXICILLIN TRIHYDRATE AND CLAVULANATE POTASSIUM TABLETS
VETERINARY TABLETS
FOR USE IN DOGS AND CATS
ANADA #200-592, Approved by FDA
CAUTION: Federal law restricts this drug to use by or on the order of
a licensed veterinarian.
DESCRIPTION: Amoxicillin Trihydrate and Clavulanate Potassium Tablets
(amoxicillin
trihydrate/clavulanate potassium) are an orally administered
formulation comprised of the broad-
spectrum antibiotic amoxicillin trihydrate and the β-lactamase
inhibitor, clavulanate potassium (the
potassium salt of clavulanic acid).
Amoxicillin trihydrate is a semisynthetic antibiotic with a broad
spectrum of bactericidal activity against
many gram-positive and gram-negative, aerobic and anaerobic
microorganisms. It does not resist
destruction by β-lactamases; therefore, it is not effective against
β-lactamase-producing bacteria.
Chemically, it is D(-)-α-amino-p-hydroxybenzyl penicillin trihydrate.
Clavulanic acid, an inhibitor of β-lactamase enzymes, is produced by
the fermentation of _Streptomyces_
_clavuligerus. _Clavulanic acid by itself has only weak antibacterial
activity. Chemically, clavulanate
potassium is potassium z-(3R,5R)-2-β-hydroxyethylidene
clavam-3-carboxylate.
ACTIONS: Amoxicillin Trihydrate and Clavulanate Potassium Tablets are
stable in the presence of
gastric acid and are not significantly influenced by gastric or
intestinal contents. The 2 components are
rapidly absorbed resulting in amoxicillin and clavulanic acid
concentrations in serum, urine, and tissues
similar to those produced when each is administered alone.
Amoxicillin and clavulanic acid diffuse readily into most body tissues
and fluids with the exception of
brain and spinal fluid, which amoxicillin penetrates adequately when
meninges are inflamed. Most of the
amoxicillin is excreted unchanged in the urine. Clavulanic acid's
penetration into spinal fluid is unknown
at this time. Approximately 15