Antirobe Capsules (150 mg) (Canada)

Feline Tissue Levels: Tissue concentrations measured at 10 days (µg/g; means) of clindamycin hydrochloride liquid in cats 2 hours after oral administration at 22 mg/kg body weight once every 24 hours for 10 days.

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 ANTIROBE capsules 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.

Toxicology And Safety

Animal toxicity studies with clindamycin hydrochloride showed the following:

LD₅₀ I.P. Administration - Mouse, 419 mg/kg

LD₅₀ I.V. Administration - Mouse, 143 mg/kg

LD₅₀ Oral Administration - Rat, 2618 mg/kg

One year oral toxicity studies in rats and dogs at doses of 30, 100 and 300 mg/kg/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 for six months tolerated the drug well; however, dogs orally dosed at 600 mg/kg/day vomited, had anorexia, and subsequently lost weight. Safety studies in gestating bitches or breeding males have not been run, however, teratology and reproductive studies in male and female rats at 50 mg/kg and higher showed no drug related effects.

Clindamycin hydrochloride (ANTIROBE AQUADROPS solution) was well tolerated with little evidence of toxicity in domestic shorthair cats when administered orally at 10x the minimum recommended therapeutic daily dose of 11 mg/kg for 15 days, 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). Lymphocytic inflammation of the gallbladder was noted in a greater number of treated cats at the 110 mg/kg/day dose level than for control cats. No other effects were noted. Safety in gestating queens or breeding male cats has not been established.

Antirobe Capsules (150 mg) Indications

Dogs: For treatment of infected wounds, abscesses and dental infections caused by or associated with Staphylococcus spp., Streptococcus spp., Bacteroides spp., Fusobacterium necrophorum and Clostridium perfringens and osteomyelitis caused by Staphylococcus aureus.

Antirobe Capsules (150 mg) Dosage And Administration

Dogs:

Infected Wounds, Abscesses and Dental Infections: 5.5 mg/kg body weight every 12 hours.

Treatment with ANTIROBE capsules or ANTIROBE AQUADROPS solution may be continued up to a maximum of 28 days if clinical judgment indicates. Treatment of acute infections should not be continued for more than three or four days if no response to therapy is seen.

Canine osteomyelitis: 11 mg/kg body weight every 12 hours.

Treatment with ANTIROBE capsules or ANTIROBE AQUADROPS solution is recommended for a minimum of 28 days. Treatment should not be continued for longer than 28 days if no response to therapy is seen.

Antirobe Capsules (150 mg) Indications

Cats: For treatment of infected wounds, abscesses and dental infections caused by or associated with Staphylococcus aureus, Staphylococcus intermedius, Streptococcus spp., Clostridium perfringens and Bacteroides fragilis.

Antirobe Capsules (150 mg) Dosage And Administration

Cats:

11 - 22 mg/kg body weight of ANTIROBE AQUADROPS solution once every 24 hours, depending on the severity of the condition. To provide 11 mg/kg, administer orally 0.5 mL/kg body weight once every 24 hours; to provide 22 mg/kg, administer orally 1 mL/kg body weight once every 24 hours.

Treatment with ANTIROBE AQUADROPS solution may be continued up to a maximum of 14 days if clinical judgment indicates. Treatment of acute infections should not be continued for more than three to four days if no clinical response to therapy is seen.

IN VITRO SUSCEPTIBILITY TESTING:

Susceptibility tests should be done on samples collected prior to initiation of therapy with ANTIROBE capsules or ANTIROBE AQUADROPS solution. Clindamycin susceptibility testing is performed by using CLEOCIN™ Susceptibility Disks (clindamycin 2 µg) and CLEOCIN Susceptibility Powder (20 mg). A standardized disk testing procedure¹ is recommended for determining susceptibility of aerobic bacteria to clindamycin. A description is contained in the CLEOCIN Susceptibility Disk insert. Using this method, the laboratory can designate isolates as resistant, intermediate, or susceptible. Tube or agar dilution methods may be used for aerobic and anaerobic bacteria. When the directions in the CLEOCIN Susceptibility Powder insert are followed, a MIC (minimal inhibitory concentration) of 1.6 µg/mL may be considered susceptible; MICs of 1.6 to 4.8 µg/mL may be considered intermediate and MICs greater than 4.8 µg/mL may be considered resistant.

¹Bauer, A.W., W.M. Kirby, J.C. Sherris and M. Turck. Antibiotic susceptibility testing by a standardized single disk method, Am. J. Clin. Path. 45:493-496, 1966. Standardized Disk Susceptibility Test, Federal Register 37:20527-29, 1972.

Warnings

Keep out of reach of children.

CAUTIONS

1. ANTIROBE capsules and ANTIROBE AQUADROPS solution are contraindicated in animals with a history of hypersensitivity to preparations containing clindamycin or lincomycin. In the event of a hypersensitivity reaction following the administration of this drug, immediate appropriate therapy should be instituted.

2. The use of ANTIROBE capsules or ANTIROBE AQUADROPS solution occasionally results in overgrowth of non-susceptible organisms such as clostridia and yeasts. Should superinfections occur, appropriate measures should be taken as indicated by the clinical situation.

3. Because of potential adverse gastrointestinal effects, do not administer to rabbits, hamsters, guinea pigs, horses, chinchillas or ruminating animals.

4. While high dose studies in rats suggest that clindamycin is not a teratogen and did not significantly affect the reproductive performance of males or females, safety in gestating bitches and queens or breeding male dogs and cats has not been established.

5. Clindamycin hydrochloride has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, ANTIROBE capsules and ANTIROBE AQUADROPS solution should be used with caution in animals receiving such agents. Partial cross resistance has been demonstrated between clindamycin, erythromycin and macrolide antibiotics.

6. During prolonged therapy of one month or greater, periodic liver and kidney function tests and blood counts should be performed. Patients with severe renal and/or very severe hepatic disturbances accompanied by severe metabolic aberrations should be dosed with caution and should be monitored by serum examination during high-dose clindamycin therapy.

Storage

PRESENTATION:

ANTIROBE capsules:

25 mg, yellow and white capsule containing 25 mg of clindamycin. Available in bottles of 200 capsules.

75 mg, dark green and white capsule containing 75 mg of clindamycin. Available in bottles of 200 capsules.

150 mg, white and white capsule containing 150 mg of clindamycin. Available in bottles of 100 capsules.

ANTIROBE AQUADROPS solution: Palatable formulation, each mL containing 25 mg clindamycin and ethyl alcohol, 8.64%. Available in 20 mL bottles.

Zoetis is a trademark, Antirobe and Aquadrops are registered trademarks of Zoetis or its licensors, used under license by Zoetis Canada Inc.

Zoetis Canada Inc., Kirkland QC H9H 4M7

1614-11-2

11719801

CPN: 1198264.4