País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
AMOXICILLIN ANHYDROUS (UNII: 9EM05410Q9) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9), CLAVULANATE POTASSIUM (UNII: Q42OMW3AT8) (CLAVULANIC ACID - UNII:23521W1S24)
MWI Animal Health
ORAL
PRESCRIPTION
Betacillin Drops 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 Drops has 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, Pasteurella multocida, and Pasteurella spp. Urinary tract infections (cystitis) due to susceptible strains of E. coli . Therapy may be initiated with Betac
Betacillin Drops are supplied in 15-mL bottles containing 50 mg of amoxicillin/12.5 mg of clavulanic acid per mL. Approved by FDA under ANADA # 200-709 Augmentin® is a trademark owned by GlaxoSmithKline. Manufactured for: Cronus Pharma LLC, East Brunswick, NJ 08816. Contact No: 1-844-227-6687 (1-844-2-CRONUS) Made in India Iss.09/21 Distributed by: MWI Boise, ID 83705 www.VetOne.net
Abbreviated New Animal Drug Application
BETACILLIN DROPS- AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION MWI ANIMAL HEALTH ---------- BETACILLIN™ DROPS (Amoxicillin and Clavulanate Potassium for Oral Suspension) _FOR VETERINARY ORAL SUSPENSION_ _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 Drops is 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. CLINICAL PHARMACOLOGY Betacillin Drops is stable in the presence of gastric acid and is 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 Drops combines the distinctive pro Leia o documento completo