UMBRELLIN- amoxicillin and clavulanate potassium tablet, coated

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Aspen Veterinary Resources Ltd

给药途径:

ORAL

处方类型:

PRESCRIPTION

疗效迹象:

INDICATIONS:  Umbrellin™ 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. Umbrellin™ 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 strains of E. coli. Therapy may be initiated with Umbrellin™ Tablet

產品總結:

HOW SUPPLIED:  Umbrellin™ 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

UMBRELLIN- AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, COATED
ASPEN VETERINARY RESOURCES LTD
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UMBRELLIN™
(AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS)
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: Umbrellin™ 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: Umbrellin™ 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.
Umbrellin™ Tablets combine the distinctive properties of a
broad-spectrum anti