Label: AMOXICILLIN AND CLAVULANATE POTASSIUM DROPS- amoxicillin and clavulanate potassium suspension
- NDC Code(s): 69043-024-11
- Packager: Cronus Pharma LLC
- Category: PRESCRIPTION ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Animal Drug Application
Updated October 7, 2021
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- SPL UNCLASSIFIED SECTION
Amoxicillin trihydrate/clavulanate potassium 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.
Amoxicillin and Clavulanate Potassium for Oral Suspension 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.
Amoxicillin and Clavulanate Potassium for Oral Suspension combines the distinctive properties of a broad-spectrum antibiotic and a β-lactamase inhibitor to effectively extend the antibacterial spectrum of amoxicillin to include β-lactamase-producing as well as non-β-lactamase-producing aerobic and anaerobic organisms.
Amoxicillin is bactericidal in action and acts through the inhibition of biosynthesis of cell wall mucopeptide of susceptible organisms. The action of clavulanic acid extends the antimicrobial spectrum of amoxicillin to include organisms resistant to amoxicillin and other β-lactam antibiotics.
Amoxicillin/clavulanate has been shown to have a wide range of activity which includes β-lactamase-producing strains of both gram-positive and gram-negative aerobes, facultative anaerobes, and obligate anaerobes. Many strains of the following organisms, including β-lactamase-producing strains, isolated from veterinary sources, were found to be susceptible to amoxicillin/clavulanate in vitro but the clinical significance of this activity has not been demonstrated for some of these organisms in animals. Aerobic bacteria, including Staphylococcus aureus1, β-lactamase-producing Staphylococcus aureus1 (penicillin resistant), Staphylococcus species1, Staphylococcus epidermidis, Staphylococcus intermedius, Streptococcus faecalis, Streptococcus species1, Corynebacterium pyogenes, Corynebacterium species, Erysipelothrix rhusiopathiae, Bordetella bronchiseptica, Escherichia coli1,Proteus mirabilis, Proteus species, Enterobacter species, Klebsiella pneumoniae, Salmonella dublin, Salmonella typhimurium, Pasteurella multocida1, Pasteurella haemolytica, Pasteurella species1.
1The susceptibility of these organisms has also been demonstrated in in vivo studies.
Studies have demonstrated that both aerobic and anaerobic flora are isolated from gingival cultures of dogs with clinical evidence of periodontal disease. Both gram-positive and gram-negative aerobic and anaerobic subgingival isolates indicate sensitivity to amoxicillin/clavulanic acid during antimicrobial susceptibility testing.
The recommended quantitative disc susceptibility method (FEDERAL REGISTER 37:20527–29; Bauer AW, Kirby WMM, Sherris JC, et al: Antibiotic susceptibility testing by standardized single disc method. Am J Clin Path 45:493, 1966) utilized 30 mcg Augmentin® (AMC) discs for estimating the susceptibility of bacteria to amoxicillin and clavulanate potassium tablets and amoxicillin and clavulanate potassium for oral suspension.
INDICATIONS AND USAGE
Amoxicillin and Clavulanate Potassium for Oral Suspension 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. Amoxicillin and clavulanate potassium for oral suspension 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 Amoxicillin and Clavulanate Potassium for Oral Suspension prior to obtaining results from bacteriological and susceptibility studies.
A culture should be obtained prior to treatment to determine susceptibility of the organisms to Amoxicillin and Clavulanate Potassium for Oral Suspension. Following determination of susceptibility results and clinical response to medication, therapy may be reevaluated.
Amoxicillin and Clavulanate Potassium for Oral Suspension contains a semisynthetic penicillin (amoxicillin) and has the potential for producing allergic reactions.
If an allergic reaction occurs, administer epinephrine and/or steroids.
To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet, contact Cronus Pharma LLC at 1-844-227-6687. For additional information about adverse experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.
DOSAGE AND ADMINISTRATION
Dogs: The recommended dosage is 6.25 mg/lb (1 mL/10 lb) of body weight twice a day. Skin and soft tissue infections such as abscesses, cellulitis, wounds, superficial/juvenile pyoderma, and periodontal infections should be treated for 5–7 days or for 48 hours after all symptoms have subsided. If no response is seen after 5 days of treatment, therapy should be discontinued and the case reevaluated. Deep pyoderma may require treatment for 21 days; the maximum duration of treatment should not exceed 30 days.
Cats: The recommended dosage is 62.5 mg (1 mL) twice a day. Skin and soft tissue infections such as abscesses and cellulitis/dermatitis should be treated for 5–7 days or 48 hours after all symptoms have subsided, not to exceed 30 days. If no response is seen after 3 days of treatment, therapy should be discontinued and the case reevaluated.
Urinary tract infections may require treatment for 10–14 days or longer. The maximum duration of treatment should not exceed 30 days.
Reconstitution instructions - Oral Suspension
Add 14 mL of water to the 15-mL bottle and shake vigorously. Each mL of suspension will contain 50 mg of amoxicillin activity as the trihydrate and 12.5 mg of clavulanic acid activity as the potassium salt.
Any unused portion of the reconstituted suspension must be discarded after 10 days.
Refrigeration of the reconstituted suspension is required.
- STORAGE CONDITIONS
Amoxicillin and Clavulanate Potassium for Oral Suspension 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
Cronus Pharma LLC,
East Brunswick, NJ 08816.
Contact No: 1-844-227-6687
Made in India
Revised: April 2021
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Amoxicillin and Clavulanate Potassium for Oral Suspension
For veterinary oral suspension
For use in dogs and cats
When reconstituted each mL contains 50 mg of amoxicillin as the trihydrate and 12.5 of clavulanic acid as the potassium salt.
Do Not Use if Product is Discolored
Caution: Federal law resrticts this drug to use by or on the order of a licensed veterinarian.
Approved by FDA under ANADA # 200-709
INGREDIENTS AND APPEARANCE
AMOXICILLIN AND CLAVULANATE POTASSIUM DROPS
amoxicillin and clavulanate potassium suspension
Product Information Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:69043-024 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AMOXICILLIN ANHYDROUS (UNII: 9EM05410Q9) (AMOXICILLIN ANHYDROUS - UNII:9EM05410Q9) AMOXICILLIN ANHYDROUS 50 mg in 1 mL CLAVULANATE POTASSIUM (UNII: Q42OMW3AT8) (CLAVULANIC ACID - UNII:23521W1S24) CLAVULANIC ACID 12.5 mg in 1 mL Product Characteristics Color white Score Shape Size Flavor BUBBLE GUM Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69043-024-11 1 in 1 CARTON 1 15 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200709 09/25/2021 Labeler - Cronus Pharma LLC (079421067)