CLINTABS- 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:

Virbac AH, Inc.

INN (International Name):

clindamycin hydrochloride

Composition:

clindamycin 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION

Therapeutic indications:

CLINTABS® (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 Bacteroides 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 . CLINTABS tablets are contraindicated in animals with a history of hypersensitivity to preparations containing clindamycin or lincomycin. Because of potential adverse gastrointestinal effects, do not adminis

Product summary:

CLINTABS tablets are available as: 25 mg - bottles of 400 75 mg - bottles of 200 150 mg - bottles of 100 Approved by FDA under ANADA # 200-316 To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Virbac AH, Inc. at 1-800-338-3659 or us.virbac.com. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

CLINTABS- CLINDAMYCIN HYDROCHLORIDE TABLET
VIRBAC AH, INC.
----------
CLINTABS
(CLINDAMYCIN HYDROCHLORIDE TABLETS)
CAUTION:
Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
DESCRIPTION
Clintabs tablets contain clindamycin hydrochloride which is the
hydrated salt of
clindamycin. Clindamycin is a semisyntheic antibiotic produced by a
7(S)-
chlorosubstitution of the 7(R)-hydroxyl group of a naturally produced
antibiotic
produced by _Streptomyces lincolnensis var. lincolnensis._
CLINTABS 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.
75 MG TABLET, each white bisected tablet is marked "C" above the
bisect and "75" below
the bisect and contains clindamycin hydrochloride equivalent to 75 mg
of clindamycin.
150 MG TABLET, each white tablet is marked "C 150" on one side and
contains
clindamycin hydrochloride equivalent to 150 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,
refl