Antirobe® (clindamycin hydrochloride capsules)

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

ANTIROBE 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.

ANTIROBE Capsules (For Use in Dogs Only):

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

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

150 mg Capsule, each white capsule contains clindamycin hydrochloride equivalent to 150 mg of clindamycin.

ANTIROBE (clindamycin hydrochloride capsules) is (for use in dogs only) indicated for the treatment of infections caused by susceptible strains of the designated microorganisms in the specific conditions listed below:

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.

ANTIROBE (clindamycin hydrochloride capsules) 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.

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

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 or breeding male dogs has not been established.

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

To report a suspected adverse reaction call 1-888-963-8471.

Infected Wounds, Abscesses, and Dental Infections

Oral: 2.5-15.0 mg/lb body weight every 12 hours

Duration: Treatment with ANTIROBE 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

ANTIROBE 25 mg, administer 1-6 capsules every 12 hours for each 10 pounds of body weight.
ANTIROBE 75 mg, administer 1-6 capsules every 12 hours for each 30 pounds of body weight.
ANTIROBE 150 mg, administer 1-6 capsules every 12 hours for each 60 pounds of body weight.

Osteomyelitis

Oral: 5.0-15.0 mg/lb body weight every 12 hours

Duration: Treatment with ANTIROBE 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:
ANTIROBE 25 mg, administer 2-6 capsules every 12 hours for each 10 pounds of body weight.
ANTIROBE 75 mg, administer 2-6 capsules every 12 hours for each 30 pounds of body weight.
ANTIROBE 150 mg, administer 2-6 capsules every 12 hours for each 60 pounds of body weight.

 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.

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

ANTIROBE Capsules are available as:
25 mg - bottles of 600
75 mg - bottles of 200
150 mg - bottles of 100.

To report suspected adverse events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS), contact Zoetis Inc. at 1-888-963-8471 or www.zoetis.com.

For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or online at www.fda.gov/reportanimalae.

Approved by FDA under NADA # 120-161

zoetis

Manufactured by:
Fareva Amboise, France

Distributed by:
Zoetis Inc., Kalamazoo, MI 49007

Product of China

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