Clintabs® Tablets brand of clindamycin hydrochloride tablets, USP

Product Type: PRESCRIPTION ANIMAL DRUG LABEL
Autor Name: Virbac AH, Inc.
Code Source: 51311-404
Route of Administration: ORAL

Clintabs

Generic: clindamycin hydrochloride

Ingredients:

• clindamycin hydrochloride clindamycin : Active ingredient - basis of strength - 25 mg in 1 1

Package Description:

• 400 1 in 1 BOTTLE

Clintabs

Generic: clindamycin hydrochloride

Ingredients:

• clindamycin hydrochloride clindamycin : Active ingredient - basis of strength - 75 mg in 1 1

Package Description:

• 200 1 in 1 BOTTLE

Clintabs

Generic: clindamycin hydrochloride

Ingredients:

• clindamycin hydrochloride clindamycin : Active ingredient - basis of strength - 150 mg in 1 1

Package Description:

• 100 1 in 1 BOTTLE

DESCRIPTION

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

Clintabs 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.
75 mg Tablet, each white bisected tablet is marked "C" above the bisect and "75" below the bisect and contains clindamycin hydrochloride equivalent to 75 mg of clindamycin.
150 mg Tablet, each white tablet is marked "C 150" on one side and contains clindamycin hydrochloride equivalent to 150 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).

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 approxi mately 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-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 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.

INDICATIONS

Clintabs (brand of 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

Clintabs 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.

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 Clintabs 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, Clintabs 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

Dogs

HOW SUPPLIED

Clintabs Tablets are available as:
25 mg - bottles of 400 75 mg - bottles of 200 150 mg - bottles of 100 ANADA #200-316, Approved by FDA
To report a suspected adverse reaction or to request a material safety data sheet (MSDS), call 1-800-338-3659.
Store at controlled room temperature 20 ° to 25° C (68° to 77° F) [see USP].

Caution

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

Mfd. for
Virbac AH, Inc.
Fort Worth, TX 76137-4611, USA
Revised December 08
301617-04
Clintabs is a registered trademark of Virbac AH, Inc.

PRINCIPAL DISPLAY PANEL - 25 mg/400 Tablet Bottle Label

NDC-051311-400-40
Virbac ANIMAL HEALTH
Clintabs ^® Tablets
clindamycin hydrochloride
25 mg tablets, USP
Equiv. to 25 mg clindamycin
For Use in Dogs Only
Caution: Federal (USA) law restricts this
drug to use by or on the order of
a licensed veterinarian.
ANADA # 200-316, Approved by FDA
400 Tablets

PRINCIPAL DISPLAY PANEL - 25 mg/400 Tablet Bottle Label

PRINCIPAL DISPLAY PANEL - 75 mg/200 Tablet Bottle Label

NDC-051311-402-75
Virbac ANIMAL HEALTH
Clintabs ^® Tablets
clindamycin hydrochloride
75 mg tablets, USP
Equiv. to 75 mg clindamycin
For Use in Dogs Only
Caution: Federal (USA) law restricts this
drug to use by or on the order of
a licensed veterinarian.
ANADA # 200-316, Approved by FDA
200 Tablets

PRINCIPAL DISPLAY PANEL - 75 mg/200 Tablet Bottle Label

PRINCIPAL DISPLAY PANEL - 150 mg/100 Tablet Bottle Label

NDC-051311-404-15
Virbac ANIMAL HEALTH
Clintabs ^® Tablets
clindamycin hydrochloride
150 mg tablets, USP
Equiv. to 150 mg clindamycin
For Use in Dogs Only
Caution: Federal (USA) law restricts this
drug to use by or on the order of
a licensed veterinarian.
ANADA # 200-316, Approved by FDA
100 Tablets

PRINCIPAL DISPLAY PANEL - 150 mg/100 Tablet Bottle Label