ClindaCure: Product Information (Page 2 of 2)

PHARMACOLOGY

Absorption: Clindamycin hydrochloride is rapidly absorbed from the canine and feline gastrointestinal tract.

Dog Serum Levels:

image of dog serum level

Serum levels at or above 0.5 μg/mL can be maintained by oral dosing at a rate of 5.0 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.

Cat Serum Levels:

image of cat serum level
(click image for full-size original)

Serum levels at or above 0.5 μg/mL can be maintained by oral dosing at a rate of 5.0 mg/lb of clindamycin hydrochloride every 24 hours. The average peak serum concentration of clindamycin occurs approximately 1 hour after oral dosing. The elimination half-life of clindamycin in feline serum is approximately 7.5 hours. In healthy cats, minimal accumulation occurs after multiple oral doses of clindamycin hydrochloride, and steady-state should be achieved by the third dose.

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 Oral Drops product 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.

ANIMAL SAFETY SUMMARY

Rat and Dog Data: One year oral toxicity studies in rats and dogs at doses of 30, 100 and 300 mg/kg/day (13.6, 45.5 and 136.4 mg/lb/day) have shown clindamycin hydrochloride to be well tolerated. Differences did not occur in the parameters evaluated to assess toxicity when comparing groups of treated animals with contemporary controls. Rats administered clindamycin hydrochloride at 600 mg/kg/day (272.7 mg/lb/day) for six months tolerated the drug well; however, dogs orally dosed at 600 mg/kg/day (272.7 mg/lb/day) vomited, had anorexia, and subsequently lost weight. At necropsy these dogs had erosive gastritis and focal areas of necrosis of the mucosa of the gallbladder.

Safety in gestating bitches or breeding males has not been established.

ANIMAL SAFETY SUMMARY

Cat Data: The recommended daily therapeutic dose range for clindamycin hydrochloride (Clindamycin Hydrochloride Oral Drops) is 11 to 33 mg/kg/day (5 to 15 mg/lb/day) depending on the severity of the condition. Clindamycin hydrochloride (Clindamycin Hydrochloride Oral Drops) was tolerated with little evidence of toxicity in domestic shorthair cats when administered orally at 10x the minimum recommended therapeutic daily dose (11 mg/kg; 5 mg/lb) for 15 days, and at doses up to 5x the minimum recommended therapeutic dose for 42 days.

Gastrointestinal tract upset (soft feces to diarrhea) occurred in control and treated cats with emesis occurring at doses 3x or greater than the minimum recommended therapeutic dose (11 mg/kg/day; 5 mg/lb/day). Lymphocytic inflammation of the gallbladder was noted in a greater number of treated cats at the 110 mg/kg/day (50 mg/lb/day) dose level than for control cats. No other effects were noted. Safety in gestating queens or breeding male cats has not been established.

HOW SUPPLIED

Clindamycin Hydrochloride Oral Drops is available as 20 mL filled in 30 mL bottles (25 mg/mL) supplied in packers containing 12 cartoned bottles with direction labels and calibrated dosing droppers.

STORAGE

Store at controlled room temperature between 20° to 25° C (68° to 77° F) [see USP].

ANADA 200-398, Approved by FDA

Distributed By:

VEDCO, INC.

St. Joseph, MO 64507

Manufactured by:

First Priority, Inc., Elgin, IL 60123-1146

www.prioritycare.com

Rev. 08-11

20 mL bottle/case label
(click image for full-size original)

Image of bottle/case label (rev. 08-11)

Image of carton label
(click image for full-size original)

Image of Carton label (Iss. 05-07)

CLINDACURE
clinamycin hydrochloride liquid
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:50989-181
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLINDAMYCIN HYDROCHLORIDE (CLINDAMYCIN) CLINDAMYCIN 25 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50989-181-09 12 CARTON in 1 CASE contains a CARTON
1 1 BOTTLE, GLASS in 1 CARTON This package is contained within the CASE (50989-181-09) and contains a BOTTLE, GLASS
1 20 mL in 1 BOTTLE, GLASS This package is contained within a CARTON and a CASE (50989-181-09)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANADA ANADA200398 08/15/2011
Labeler — VEDCO (021634266)
Establishment
Name Address ID/FEI Operations
FIRST PRIORITY INCORPORATED 179925722 manufacture

Revised: 09/2021 VEDCO

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