ZYDACLIN- clindamycin hydrochloride tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

clindamycin hydrochloride (UNII: T20OQ1YN1W) (clindamycin - UNII:3U02EL437C)

Available from:

VetOne

Administration route:

ORAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

ZydaClin™ Tablets (clindamycin hydrochloride tablets) (for use in dogs only) are indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below: Dogs: Skin infections (wounds and abscesses) due to: coagulase positive staphylococci (Staphylococcus aureus or Staphylococcus intermedius ). Deep wounds and abscesses due to Bateroides fragilis , Prevotella melaninogenicus , Fusobacterium necrophorum and Clostridium perfringens . Dental infections due to Staphyloccus aureus, Bacteroides fragilis, Prevotella melaninogenicus, Fusobacterium necrophorum and Clostridium perfringens . Osteomyelitis due to Staphylococcus aureus, Bacteroides fragilis, Prevotella melaninogenicus, Fusobacterium necrophorum and Clostridium perfringens . ZydaClin Tablets are contraindicated in animals with a history of hypersensitivity to preparations containing clindamycin or lincomycin. Because of potential adverse gastrointestinal effects, do not administer to rabbits, hamsters, guinea pigs, horses, chinchillas or ruminating animals.

Product summary:

ZydaClin Tablets are available as: 25 mg - bottles of 400

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

ZYDACLIN- CLINDAMYCIN HYDROCHLORIDE TABLET
VETONE
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ZYDACLIN™ TABLETS (CLINDAMYCIN HYDROCHLORIDE TABLETS)
CAUTION:
Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
DESCRIPTION
ZydaClin™ Tablets contain clindamycin hydrochloride which is the
hydrated salt of
clindamycin. Clindamycin is a semisynthetic antibiotic produced by a
7(S)-
chlorosubstitution of the 7(R)-hydroxyl group of a naturally produced
antibiotic
produced by _Streptomyces lincolnensis var. lincolnensis_.
ZydaClin Tablets (For Use in Dogs Only): 25 MG TABLET, each white
bisected tablet is
marked “C” above the bisect and “25” below the bisect and
contains clindamycin
hydrochloride equivalent to 25 mg of clindamycin.
CLINICAL PHARMACOLOGY
ABSORPTION: Clindamycin hydrochloride is rapidly absorbed from the
canine
gastrointestinal tract.
DOG SERUM LEVELS: Serum levels at or above 0.5 μg/mL can be
maintained by oral
dosing at a rate of 2.5 mg/lb of clindamycin hydrochloride every 12
hours. This
same study revealed that average peak serum concentrations of
clindamycin occur 1
hour and 15 minutes after oral dosing. The elimination half-life for
clindamycin in dog
serum was approximately 5 hours. There was no bioactivity accumulation
after a
regimen of multiple oral doses in healthy dogs.
METABOLISM AND EXCRETION: Extensive studies of the metabolism and
excretion of
clindamycin hydrochloride administered orally in animals and humans
have shown that
unchanged drug and bioactive and bioinactive metabolites are excreted
in urine and
feces. Almost all of the bioactivity detected in serum after
clindamycin hydrochloride
administration is due to the parent molecule (clindamycin). Urine
bioactivity, however,
reflects a mixture of clindamycin and active metabolites, especially
N-demethyl
clindamycin and clindamycin sulfoxide.
SITE AND MODE OF ACTION: Clindamycin is an inhibitor of protein
synthesis in the
bacterial cell. The site of binding appears to be in the 50S sub-unit
of the ribosome.
Binding occurs to