UMBRELLIN- amoxicillin and clavulanate potassium suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Aspen Veterinary Resources Ltd

Administration route:

ORAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

Umbrellin™ 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. Umbrellin™ 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 Umbre

Product summary:

Umbrellin™ 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: Aspen Veterinary Resources® , LTD. Liberty, MO 64068 pivetalvet.com Rev. 01/22 Made in India

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

UMBRELLIN- AMOXICILLIN AND CLAVULANATE POTASSIUM SUSPENSION
ASPEN VETERINARY RESOURCES LTD
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UMBRELLIN
(AMOXICILLIN AND CLAVULANATE POTASSIUM FOR ORAL SUSPENSION)
ORAL DROPS
_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
Umbrellin™ 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
Umbrellin™ 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.
Umbrellin™ Drops combines the d