AMOXICILLIN AND CLAVULANATE POTASSIUM tablet, coated

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

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下载 产品特点 (SPC)
11-08-2021

有效成分:

AMOXICILLIN (UNII: 804826J2HU) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9), CLAVULANATE POTASSIUM (UNII: Q42OMW3AT8) (CLAVULANIC ACID - UNII:23521W1S24)

可用日期:

Covetrus

给药途径:

ORAL

处方类型:

PRESCRIPTION

疗效迹象:

INDICATIONS:  Amoxicillin 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 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) due to susceptible st

產品總結:

HOW SUPPLIED: Amoxicillin 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.

授权状态:

Abbreviated New Animal Drug Application

产品特点

                                AMOXICILLIN AND CLAVULANATE POTASSIUM- AMOXICILLIN AND CLAVULANATE
POTASSIUM TABLET, COATED
COVETRUS
----------
AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS
FOR USE IN DOGS AND CATS
CAUTION: Federal law restricts this drug to use by or on the order of
a licensed
veterinarian.
DESCRIPTION: Amoxicillin and clavulanate potassium tablets 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 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%
of the administered dose of clavulanic acid is excreted in the urine
within the first 6
hours.
Amoxicillin and clavulanate potassium tablets 
                                
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