BETACILLIN- amoxicillin and clavulanate potassium tablet, coated

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Beli Sekarang

Unduh Karakteristik produk (SPC)
13-08-2021

Bahan aktif:

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

Tersedia dari:

MWI Animal Health

Rute administrasi :

ORAL

Jenis Resep:

PRESCRIPTION

Indikasi Terapi:

INDICATIONS:  Betacillin 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. Betacillin 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 Betaci

Ringkasan produk:

HOW SUPPLIED:  Betacillin 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.

Status otorisasi:

Abbreviated New Animal Drug Application

Karakteristik produk

                                BETACILLIN- AMOXICILLIN AND CLAVULANATE POTASSIUM TABLET, COATED
MWI ANIMAL HEALTH
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BETACILLIN™ TABLETS
(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: Betacillin 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: Betacillin 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.
Betacillin Tablets combine the distinctive properties of a
broad-spectrum antibiotic and a
β-l
                                
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