ZYDACLIN- clindamycin solution/ drops

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

CLINDAMYCIN HYDROCHLORIDE (UNII: T20OQ1YN1W) (CLINDAMYCIN - UNII:3U02EL437C)

Commercializzato da:

MWI

INN (Nome Internazionale):

CLINDAMYCIN HYDROCHLORIDE

Composizione:

CLINDAMYCIN 25 g in 1 mL

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION

Indicazioni terapeutiche:

INDICATIONS ZydaClin™ Oral Drops (for use in dogs and cats) 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 Bacteroides fragilis, Prevotella melaninogenicus, Fusobacterium necrophorum and Clostridium perfringens. Dental infections due to Staphylococcus aureus, Bacteroides fragilis, Prevotella melaninogenicus, Fusobacterium necrophorum and Clostridium perfringens. Osteomyelitis due to Staphylococcus aureus, Bacteroides fragilis, Prevotella melaninogenicus, Fusobacterium necrophorum and Clostridium perfringens. Cats: Skin infections (wounds and abscesses) due to Staphylococcus aureus, Staphylococcus intermedius, Streptococcus spp . Deep wounds and abscesses due to Clostridium perfringens and Bacteroides fragilis . Dental infections

Dettagli prodotto:

HOW SUPPLIED ZydaClin™ Oral Drops is available as 20mL filled in 30 mL bottles (25 mg/mL) supplied in packers containing 12 cartoned bottles with direction labels and calibrated dosing droppers. To report a suspected adverse reaction or to request a Safety Data Sheet (MSDS) call 1-800-524-6332.

Stato dell'autorizzazione:

Abbreviated New Animal Drug Application

Scheda tecnica

ZYDACLIN- CLINDAMYCIN SOLUTION/ DROPS
MWI
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ZYDACLIN™
_(clindamycin)_
ORAL DROPS
liquid
FOR USE IN DOGS & CATS
EQUIVALENT TO 25 MG PER ML CLINDAMYCIN
NOT FOR USE IN HUMANS
KEEP OUT OF REACH OF CHILDREN
CAUTION: Federal law restricts this drug to use by or on the order of
a licensed veterinarian.
ANADA 200-538, Approved by FDA
DESCRIPTION
ZydaClin™ Oral Drops contain clindamycin hydrochloride which is the
hydrate salt of clindamycin.
Clindamycin is a semisynthetic antibiotic produced by a
7(S)-chlorosubstitution of the 7(R)-hydroxly
group of a naturally produced antibiotic produced by _Streptomyces
lincolnensis var. lincolnensis._
ZydaClin™ Oral Drops ( For Use in Dogs and Cats) is a palatable
formulation intended for oral
administration. Each mL of ZydaClin™ Oral Drops liquid contains
clindamycin hydrochloride
equivalent to 25 mg clindamycin; and ethyl alcohol, 8.64%.
ACTION
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 the soluble RNA
fraction of certain ribosomes, thereby inhibiting the binding of amino
acids to those ribosomes.
Clindamycin differs from cell wall inhibitors in that it causes
irreversible modification of the protein-
synthesizing subcellular elements at the ribosomal level.
MICROBIOLOGY
Clindamycin is a lincosaminide antimicrobial agent with activity
against the wide variety of aerobic and
anaerobic bacterial pathogens. Clindamycin is a bacteriostatic
compound that inhibits bacterial protein
synthesis by binding to 50S ribosomal sub-unit. The minimum inhibitor
concentrations (MICs) of Gram-
positive and obligate anaerobic pathogens isolated from dogs and cats
in the United States are presented
in the Table 1 and Table 2. Bacteria were isolated in 1998-1999. All
MICs were performed in
accordance with the National committee for Clinical Standards (NCCLS).
PHARMACOLOGY
ABSORPTION: Clindamycin hydrochloride is rapidly absorbed from the
canine an