Animal NDC 13985-957-25 Zydaclin
Clindamycin Hydrochloride
Animal Product Information
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Zydaclin Animal Product Labeling Information
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Table of Contents
Caution:
Federal law restricts this drug to use by or on the order of a licensed veterinarian.
Description
ZydaClin™ Tablets 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.
ZydaClin 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.
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, 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 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 proteinsynthesizing 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 sub-unit. 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 Clinical and Laboratory Standards Institute (CLSI).
Indications
ZydaClin™ Tablets (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 Bateroides 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.
Contraindications
ZydaClin Tablets 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.
Keep ZydaClin Tablets in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.
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 ZydaClin Tablets 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, ZydaClin Tablets 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.
To report adverse reactions or a suspected adverse reaction, call 1-800-338-3659.
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 clindamycin hydrochloride 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:
Tablets
ZydaClin Tablets 25 mg, administer 1-6 tablets every 12 hours for each 10 pounds of body weight.
Dogs:
Osteomyelitis
Oral: 5.0-15.0 mg/lb body weight every 12 hours.
Duration: Treatment with clindamycin hydrochloride 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:
Tablets
ZydaClin Tablets 25 mg, administer 2-6 tablets every 12 hours for each 10 pounds of body weight.
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 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 gall bladder.
Safety in gestating bitches or breeding males has not been established.
Storage
Store at controlled room temperature 20˚ to 25˚ C (68˚ to 77˚ F) [see USP].
How Supplied
ZydaClin Tablets are available as:
25 mg - bottles of 400
Other
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.
Distributed by: MWI
Boise, ID 83705
www.VetOne.net Rev.: 10/23 302276-02
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