Antirobe

Oral:

Serious side effects have been reported with oral clindamycin including the following:

• Abdominal pain
• Gastrointestinal upset
• Pain or difficulty when swallowing
• White patches in the mouth
• Blisters
• Rash
• Hives
• Yellowing of the skin or eyes
• Decreased urination

Topical:

Serious side effects have been reported with topical clindamycin including the following:

• Dry, itching, burning, or peeling skin
• Headache
• Diarrhea
• Abdominal pain or gastrointestinal upset
• Thick, white discharge or burning, itching, or swelling of the vagina with use of vaginal clindamycin products

Injectable:

Serious side effects have been reported with injectable clindamycin including the following:

• Abdominal pain
• Gastrointestinal upset
• Pain or difficulty when swallowing
• White patches in the mouth
• Blisters
• Rash
• Hives
• Yellowing of the skin or eyes
• Decreased urination

Do not take clindamycin if you:

• are allergic to clindamycin or to any of its ingredients
• are allergic to lincomycin (Lincocin)

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age

Oral:

The recommended dose of oral clindamycin for the treatment of bacterial infections is 150 to 450 mg every 6 hours.

Topical:

The recommended dose of topical clindamycin for the treatment of acne is application to the affected skin 1 to 2 times daily. The recommended dose of clindamycin vaginal preparations is application once daily at bedtime.

Injectable:

The recommended dose of clindamycin injection for the treatment of bacterial infections is 600 to 2700 mg per day in 2, 3, or 4 doses.

Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

Because clindamycin therapy has been associated with severe colitis which may end fatally, it should be reserved for serious infections where less toxic antimicrobial agents are inappropriate. It should not be used in patients with nonbacterial infections such as most upper respiratory tract infections. C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficilemay need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

Caution: Federal (USA) law restricts this drug to use by or on the order of a licensed veterinarian.

Absorption

Clindamycin hydrochloride is rapidly absorbed from the canine and feline 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.

Cat Serum Levels

Serum levels at or above 0.5 μg/mL can be maintained by oral dosing at a rate of 5 mg/lb of clindamycin hydrochloride liquid 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 Antirobe 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.

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 5OS 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 a wide variety of aerobic and anaerobic bacterial pathogens. Clindamycin is a bacteriostatic compound that inhibits bacterial protein synthesis by binding to the 5OS ribosomal sub-unit. The minimum inhibitory concentrations (MICs) of Gram-positive and obligate anaerobic pathogens isolated from dogs and cats in the United States are presented in Table 1 and Table 2. Bacteria were isolated in 1998-1999. All MICs were performed in accordance with the Clinical and Laboratory Standards Institute (CLSI).

During prolonged therapy of one month or greater, periodic liver and kidney function tests and blood counts should be performed.

The use of Antirobe occasionally results in overgrowth of non-susceptible organisms such as clostridia and yeasts. Therefore, the administration of Antirobe should be avoided in those species sensitive to the gastrointestinal effects of clindamycin (see CONTRAINDICATIONS). Should superinfections occur, appropriate measures should be taken as indicated by the clinical situation.

Patients with very severe renal disease and/or very severe hepatic disease accompanied by severe metabolic aberrations should be dosed with caution, and serum clindamycin levels monitored during high-dose therapy.

Clindamycin hydrochloride has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore, Antirobe should be used with caution in animals receiving such agents.

Safety in gestating bitches and queens or breeding male dogs and cats has not been established.

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 capsules 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.

Cat Data

The recommended daily therapeutic dose range for clindamycin hydrochloride (Antirobe AQUADROPS Liquid) is 11 to 33 mg/kg/day (5 to 15 mg/lb/day) depending on the severity of the condition. Clindamycin hydrochloride (Antirobe AQUADROPS Liquid) 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.

Store at controlled room temperature 20° to 25°C (68° to 77°F).

100 Capsules

Antirobe®
clindamycin hydrochloride
capsules, USP

150 mg

Equiv. to 150 mg clindamycin

For Use in Dogs Only

Caution: Federal (USA) law
restricts this drug to use by or on the order of a licensed veterinarian.

NADA #120-161, Approved by FDA

Pfizer