ClindaCure

WARNINGS AND PRECAUTIONS SECTION

WARNINGS AND PRECAUTIONS SECTION

Approved for use in dogs and cats. Equivalent to 25 mg/mL clindamycin NET CONTENTS: 20 mL (0.68 fl oz) Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Not For Use in Humans Keep Out of Reach of Children

DESCRIPTION

DESCRIPTION SECTION

Clindamycin Hydrochloride Oral Drops (clindamycin hydrochloride liquid) contains 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 . Clindamycin Hydrochloride Oral Drops (For Use in Dogs and Cats) is a palatable formulation intended for oral administration. Each mL of Clindamycin Hydrochloride Oral Drops contains clindamycin hydrochloride equivalent to 25 mg clindamycin; and ethyl alcohol, 8.64%.

INDICATIONS

INDICATIONS & USAGE SECTION

Clindamycin Hydrochloride Oral Drops (for use in dogs and cats) is indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below:

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Dogs: Infected Wounds, Abscesses and Dental Infections Oral: 2.5 - 15.0 mg/lb body weight every 12 hours. Duration: Treatment with Clindamycin Hydrochloride Oral Drops 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: Oral Solution Clindamycin Hydrochloride Oral Drops , administer 1-6 mL/10 lbs body weight every 12 hours. Dogs: Osteomyelitis Oral: 5.0-15.0 mg/lb body weight every 12 hours. Duration: Treatment with Clindamycin Hydrochloride Oral Drops 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: Oral Solution Clindamycin Hydrochloride Oral Drops , administer 2-6 mL/10 lbs body weight every 12 hours. Cats: Infected Wounds, Abscesses and Dental Infections 5.0 - 15.0 mg/lb body weight once every 24 hours depending on the severity of the condition. Duration: Treatment with Clindamycin Hydrochloride Oral Drops 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. Dosage Schedule: Clindamycin Hydrochloride Oral Drops , to provide 5.0 mg/lb, administer 1 mL/5 lbs body weight once every 24 hours; to provide 15.0 mg/lb, administer 3 mL/5 lbs body weight once every 24 hours.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Clindamycin Hydrochloride Oral Drops is 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

WARNINGS SECTION

Not for use in humans. Keep out of reach of children. To obtain a Safety Data Sheet(s), contact Vedco, Inc. at (888) 708-3326 or www.vedco.com. Keep ClindaCure ® in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.

PRECAUTIONS

PRECAUTIONS SECTION

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 Oral Drops occasionally results in overgrowth of non-susceptible organisms such as clostridia and yeasts. Therefore, the administration of Clindamycin Hydrochloride Oral Drops 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, Clindamycin Hydrochloride Oral Drops 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.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

Side effects occasionally observed in either clinical trials or during clinical use were vomiting and diarrhea. To report a suspected adverse reaction or to request a material safety data sheet (MSDS), call (888) 708-3326.

ACTIONS

MECHANISM OF ACTION SECTION

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.

PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

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

ANIMAL SAFETY SUMMARY

ANIMAL PHARMACOLOGY & OR TOXICOLOGY SECTION

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.

HOW SUPPLIED

HOW SUPPLIED SECTION

ClindaCure ® 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

STORAGE AND HANDLING SECTION

Store at controlled room temperature between 20° to 25° C (68° to 77° F) [see USP]. Keep container tightly closed when not in use. Rev. 10-22 Distributed By: VEDCO, INC. St. Joseph, MO 64507

20 mL label rev. 09-24

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL