FELIX PHARMACEUTICALS PRIVATE LIMITED FELIX PHARMACEUTICALS PRIVATE LIMITED

Clindamycin Hydrochloride Clindamycin Hydrochloride CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN White to off white colored F;18;25 Clindamycin Hydrochloride Clindamycin Hydrochloride CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN White to off white colored F;18;75 Clindamycin Hydrochloride Clindamycin Hydrochloride CLINDAMYCIN HYDROCHLORIDE CLINDAMYCIN White to off white colored F;18;150

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

Clindamycin Hydrochloride 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.
Clindamycin Hydrochloride Tablets (For Use in Dogs Only):
25 mg Tablet, each white to off white colored round shaped tablet contains clindamycin hydrochloride equivalent to 25 mg of clindamycin.

75 mg Tablet, each white to off white colored round shaped tablet contains clindamycin hydrochloride equivalent to 75 mg of clindamycin.

150 mg Tablet, each white to off white colored round shaped tablet, contains clindamycin hydrochloride equivalent to 150 mg of clindamycin.

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.
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-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 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 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).
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

¹The correlation between the in vitro susceptibility data and clinical response has not been determined. ²Soft Tissue/Wound: includes samples labeled wound, abscess, aspirate, exudates, draining tract, lesion, and mass ³Osteomyelitis/Bone: includes samples labeled bone, fracture, joint, tendon ⁴No range, all isolates yielded the same value ⁵Dermal/Skin: includes samples labeled skin, skin swab, biopsy, incision, lip graph

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 Bacteroides 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.

Clindamycin Hydrochloride 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.

Keep out of reach of children. Not for human use.
Keep Clindamycin Hydrochloride Tablets in a secure location out of reach of dogs, cats, and other animals to prevent accidental ingestion or overdose.

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 Clindamycin Hydrochloride 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, Clindamycin Hydrochloride Tablets 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 suspected adverse drug experiences, for technical assistance or to obtain a copy of the Safety Data Sheet, contact Felix Pharmaceuticals Private Limited at 1-833-571-1525. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae 

Dogs: Infected Wounds, Abscesses, and Dental Infections
Oral: 2.5-15.0 mg/lb body weight every 12 hours
Duration: Treatment with Clindamycin Hydrochloride Tablets 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
Clindamycin Hydrochloride Tablets 25 mg, administer 1-6 tablets every 12 hours for each 10 pounds of body weight. Clindamycin Hydrochloride Tablets 75 mg, administer 1-6 tablets every 12 hours for each 30 pounds of body weight. Clindamycin Hydrochloride Tablets 150 mg, administer 1-6 tablets every 12 hours for each 60 pounds of body weight.
Dogs: Osteomyelitis
Oral: 5.0-15.0 mg/lb body weight every 12 hours
Duration: Treatment with Clindamycin Hydrochloride Tablets 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
Clindamycin Hydrochloride Tablets 25 mg, administer 2-6 tablets every 12 hours for each 10 pounds of body weight.
Clindamycin Hydrochloride Tablets 75 mg, administer 2-6 tablets every 12 hours for each 30 pounds of body weight.
Clindamycin Hydrochloride Tablets 150 mg, administer 2-6 tablets 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 20° to 25°C (68° to 77°F), excursions permitted between 15° and 30°C (between 59° and 86°F) [see USP Controlled Room Temperature].

Clindamycin Hydrochloride Tablets are available as: 25 mg - bottles of 400 75 mg - bottles of 200 150 mg - bottles of 100

NDC Number	Tablet Size	Tablets/Bottle
86101-052-18	25 mg	400
86101-053-15	75 mg	200
86101-054-11	150 mg	100

Approved by FDA under ANADA # 200-813
Distributed By:
Felixvet Inc.,
1300 NW Briarcliff Parkway,
Suite 100, Kansas City, Missouri 64150
Manufactured in India
Neutral Code No. MP/DRUGS/28/53/2020
Rev. June 2025

NDC: 86101-052-18                    400 Tablets Clindamycin Hydrochloride Tablets 25 mg Equiv. to 25 mg clindamycin For Use in Dogs Only Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Approved by FDA under ANADA # 200-813
25mg

NDC: 86101-053-15                    200 Tablets Clindamycin Hydrochloride Tablets 75 mg Equiv. to 75 mg clindamycin For Use in Dogs Only Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Approved by FDA under ANADA # 200-813 75mg

NDC: 86101-054-11                    100 Tablets Clindamycin Hydrochloride Tablets 150 mg Equiv. to 150 mg clindamycin For Use in Dogs Only Caution: Federal law restricts this drug to use by or on the order of a licensed veterinarian. Approved by FDA under ANADA # 200-813
150mg