ClinCaps

This treatment applies to the following species:

Dogs

Company: Henry Schein^® Animal Health

Antibiotic

(CLINDAMYCIN HYDROCHLORIDE CAPSULES)

For Animal Use Only

ANADA 200-298, Approved by FDA

Description

CLINCAPS (Clindamycin Hydrochloride Capsules) contain clindamycin hydrochloride which is the hydrated salt of clindamycin. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chlorosubstitution of the 7(R)-hydroxyl group of a naturally produced antibiotic produced by Streptomyces lincolnensis var. lincolnensis.

CLINCAPS:

25 mg Capsule, each yellow and colorless capsule contains clindamycin hydrochloride equivalent to 25 mg of clindamycin.

75 mg Capsule, each green and colorless capsule contains clindamycin hydrochloride equivalent to 75 mg of clindamycin.

150 mg Capsule, each blue and colorless capsule contains clindamycin hydrochloride equivalent to 150 mg of clindamycin.

300 mg Capsule, each turquoise and colorless capsule contains clindamycin hydrochloride equivalent to 300 mg of clindamycin.

ACTIONS: 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 a wide variety of aerobic and anaerobic bacterial pathogens. Clindamycin is a bacteriostatic compound that inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit. The minimum inhibitory concentrations (MICs) of Gram-positive and obligate anaerobic pathogens isolated from dogs in the United States are presented in Table 1. Bacteria were isolated in 1998-1999. All MICs were performed in accordance with the National Committee for Clinical Laboratory Standards (NCCLS).

Table 1. Clindamycin MIC Values (µg/mL) from Diagnostic Laboratory Survey Data Evaluating Canine Pathogens in the U.S. during 1998-99¹

Organism	Number of Isolates	MIC₅₀	MIC₈₅	MIC₉₀	Range
Soft Tissue/Wound²
Staphylococcus aureus	17	0.5	0.5	≥4.0	0.25-≥4.0
Staphylococcus intermedius	28	0.25	0.5	≥4.0	0.125-≥4.0
Staphylococcus spp.	18	0.5	0.5	≥4.0	0.25-≥4.0
Beta-hemolytic streptococci	46	0.5	0.5	≥4.0	0.25-≥4.0
Streptococcus spp.	11	0.5	≥4.0	≥4.0	0.25-≥4.0
Osteomyelitis/Bone³
Staphylococcus aureus	20	0.5	0.5	0.5	0.5⁴
Staphylococcus intermedius	15	0.5	≥4.0	≥4.0	0.25-≥4.0
Staphylococcus spp.	18	0.5	≥4.0	≥4.0	0.25-≥4.0
Beta-hemolytic streptococci	21	0.5	2.0	2.0	0.25-≥4.0
Streptococcus spp.	21	≥4.0	≥4.0	≥4.0	0.25-≥4.0
Dermal/Skin⁵
Staphylococcus aureus	25	0.5	≥4.0	≥4.0	0.25-≥4.0
Staphylococcus intermedius	48	0.5	≥4.0	≥4.0	0.125-≥4.0
Staphylococcus spp.	32	0.5	≥4.0	≥4.0	0.25-≥4.0
Beta-hemolytic streptococci	17	0.5	0.5	0.5	0.25-0.5

^1.The correlation between the in vitro susceptibility data and clinical response has not been determined.

² Soft Tissue/Wound: includes samples labeled wound, abscess, aspirate, exudates, draining tract, lesion, and mass

³ Osteomyelitis/Bone: includes samples labeled bone, fracture, joint, tendon

⁴ No range, all isolates yielded the same value

⁵ Dermal/Skin: includes samples labeled skin, skin swab, biopsy, incision, lip

Pharmacology

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

Dog Serum Levels: Serum levels at or above 0.5 ìg/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.

Clindamycin Serum Concentrations 2.5 mg/lb (5.5 mg/kg) After B.I.D. Oral Dose of Clindamycin Hydrochloride Capsules to 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 product administration is due to the parent molecule (clindamycin). Urine bioactivity, however, reflects a mixture of clindamycin and active metabolites, especially N-dimethyl 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.

ClinCaps Indications

CLINCAPS (Clindamycin Hydrochloride Capsules) is 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.

Contraindications

CLINCAPS (Clindamycin Hydrochloride Capsules) are contraindicated in animals with a history of hypersensitivity to preparations containing clindamycin or lincomycin.

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

Warnings

Keep out of reach of children. Not for human use.

Precautions

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

The use of clindamycin hydrochloride occasionally results in overgrowth of non-susceptible organisms such as clostridia and yeasts. Therefore, the administration of CLINCAPS 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, CLINCAPS should be used with caution in animals receiving such agents.

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

Adverse Reactions

Side effects occasionally observed in either clinical trials or during clinical use were vomiting and diarrhea.

ClinCaps Dosage And Administration

Dogs: Infected Wounds, Abscesses and Dental Infections.

Oral: 2.5-15.0 mg/lb body weight every 12 hours. Duration: Treatment with CLINCAPS products 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.

Dosage Schedule

Capsules:

CLINCAPS 25 mg, administer 1-6 capsules every 12 hours for each 10 pounds of body weight.

CLINCAPS 75 mg, administer 1-6 capsules every 12 hours for each 30 pounds of body weight.

CLINCAPS 150 mg, administer 1-6 capsules every 12 hours for each 60 pounds of body weight.

CLINCAPS 300 mg, administer 1-6 capsules every 12 hours for each 120 pounds of body weight.

Dogs: Osteomyelitis

Oral: 5.0-15.0 mg/lb body weight every 12 hours. Duration: Treatment with CLINCAPS 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.

Dosage Schedule

Capsules:

CLINCAPS 25 mg, administer 2-6 capsules every 12 hours for each 10 pounds of body weight.

CLINCAPS 75 mg, administer 2-6 capsules every 12 hours for each 30 pounds of body weight.

CLINCAPS 150 mg, administer 2-6 capsules every 12 hours for each 60 pounds of body weight.

CLINCAPS 300 mg, administer 2-6 capsules every 12 hours for each 120 pounds of body weight.

How Supplied

CLINCAPS is available as:

25 mg capsules supplied in bottles of 600

75 mg capsules supplied in bottles of 200

150 mg capsules supplied in bottles of 100

300 mg capsules supplied in bottles of 100

Keep container tightly closed.

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

ClinCaps Caution

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Manufactured by IVX Animal Health, Inc., St. Joseph, MO 64503

Manufactured for: HENRY SCHEIN ANIMAL HEALTH, LLC. DUBLIN, OHIO 43017

	NET CONTENTS:
25 mg	600 capsules	801022 Iss. 10-02
75 mg	200 capsules	801023 Rev. 2-04
150 mg	100 capsules	801024 Iss. 10-02
300 mg	100 capsules	801037 Iss. 5-04

CPN: 10822056

HENRY SCHEINÂ® ANIMAL HEALTH
400 METRO PLACE NORTH, DUBLIN, OH, 43017-7545

Telephone:		614-761-9095
Toll-Free:		1-855-724-3461

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