Tulissin 25: Product Information

TULISSIN 25- tulathromycin injection, solution
Virbac AH, Inc.

Antibiotic

25 mg of tulathromycin/mL
For use in suckling calves, dairy calves, veal calves, and swine. Not for use in ruminating cattle.

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

DESCRIPTION

TULISSIN 25 Injectable Solution is a ready-to-use sterile parenteral preparation containing tulathromycin, a semi-synthetic macrolide antibiotic of the subclass triamilide. Each mL of TULISSIN 25 contains 25 mg of tulathromycin as the free base in a 50% propylene glycol vehicle, monothioglycerol (5 mg/mL), citric acid (4.8 mg/mL) with hydrochloric acid and sodium hydroxide added to adjust pH. TULISSIN 25 consists of an equilibrated mixture of two isomeric forms of tulathromycin in a 9:1 ratio.

The chemical names of the isomers are (2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[[2,6-dideoxy-3-C-methyl-3-O-methyl-4-C-[(propylamino) methyl]-α-L-ribohexopyrano-syl]oxy]-2-ethyl-3,4,10-trihydroxy-3,5,8,10,12,14-hexamethyl-11-[[3,4,6-trideoxy-3-(dimethylamino)-ß-D-xylo-hexopyranosyl]-oxy]-1-oxa-6-azacyclopentadecan-15-one and (2R,3R,6R,8R,9R,10S,11S,12R)-11-[[2,6-dideoxy-3-C-methyl-3-O-methyl-4-C-[(propylamino)methyl]-α-L-ribohexopyrano-syl]oxy]-2-[(1R,2R)-1,2-dihydroxy-1-methylbutyl]-8-hydroxy-3,6,8,10,12-pentamethyl-9-[[3,4,6-trideoxy-3-(dimethylamino)-ß-D-xylohexopyranosyl]oxy]-1-oxa-4-azacyclotridecan-13-one, respectively.

INDICATIONS

Swine

TULISSIN 25 Injectable Solution is indicated for the treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae ; and for the control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.

Suckling Calves, Dairy Calves, and Veal Calves

BRD — TULISSIN 25 Injectable Solution is indicated for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis.

DOSAGE AND ADMINISTRATION

Swine
Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (1 mL/22 lb) Body Weight (BW). Do not inject more than 4 mL per injection site.

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Calves Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1 mL/22 lb) body weight (BW). Do not inject more than 11.5 mL per injection site.

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CONTRAINDICATIONS

The use of TULISSIN 25 Injectable Solution is contraindicated in animals previously found to be hypersensitive to the drug.

WARNINGS FOR USE IN ANIMALS ONLY. NOT FOR HUMAN USE. KEEP OUT OF REACH OF CHILDREN. NOT FOR USE IN CHICKENS OR TURKEYS.

RESIDUE WARNINGS

Swine
Swine intended for human consumption must not be slaughtered within 5 days from the last treatment.

Calves
Calves intended for human consumption must not be slaughtered within 22 days from the last treatment with TULISSIN 25 Injectable Solution. This drug is not for use in ruminating cattle.

PRECAUTIONS

Swine
The effects of Tulissin 25 Injectable Solution on porcine reproductive performance, pregnancy, and lactation have not been determined. Intramuscular injection can cause a transient local tissue reaction that may result in trim loss of edible tissue at slaughter.
Cattle
The effects of Tulissin 25 Injectable Solution on bovine reproductive performance, pregnancy, and lactation have not been determined. Subcutaneous injection can cause a transient local tissue reaction that may result in trim loss of edible tissue at slaughter

ADVERSE REACTIONS

Swine
In one field study, one out of 40 pigs treated with tulathromycin injection (100 mg/mL) at 2.5 mg/kg BW exhibited
mild salivation that resolved in less than four hours.

Calves
In one BRD field study, two calves treated with tulathromycin injection (100 mg/mL) at 2.5 mg/kg BW exhibited
transient hypersalivation. One of these calves also exhibited transient dyspnea, which may have been related to
pneumonia.

Post Approval Experience
The following adverse events are based on post approval adverse drug experience reporting for tulathromycin injection (100 mg/mL). Not all adverse events are reported to the FDA CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using these data. The following adverse events are listed in decreasing order of reporting frequency in cattle: Injection site reactions and anaphylaxis/anaphylactoid reactions. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae.

CLINICAL PHARMACOLOGY

At physiological pH, tulathromycin (a weak base) is approximately 50 times more soluble in hydrophilic than
lipophilic media. This solubility profile is consistent with the extracellular pathogen activity typically associated
with the macrolides.1 Markedly higher tulathromycin concentrations are observed in the lung parenchyma as
compared to the plasma, and these elevated concentrations can remain in lung tissue for several days beyond
that which can be measured in the plasma. However the clinical relevance of these elevated lung concentrations is
undetermined.

As a class, macrolides tend to be primarily bacteriostatic, but may be bactericidal against some pathogens.2
When acting as a cidal compound, they tend to exhibit concentration independent killing; the rate of bacterial
eradication does not change once serum drug concentrations reach 2 to 3 times the minimum inhibitory
concentration (MIC) of the targeted pathogen. Under these conditions, the time that serum concentrations remain
above the MIC becomes the major determinant of antimicrobial activity. Macrolides also exhibit a post-antibiotic
effect (PAE), the duration of which tends to be both drug and pathogen dependent. In general, by increasing the
macrolide concentration and the exposure time, the PAE will increase to some maximal duration. 3 Tulathromycin
is eliminated from the body primarily unchanged via biliary excretion.

1 Carbon, C. 1998. Pharmacodynamics of Macrolides, Azalides, and Streptogramins: Effect on Extracellular
Pathogens. Clin. Infect. Dis., 27:28-32.

2 Nightingale, C.J. 1997. Pharmacokinetics and Pharmacodynamics of Newer Macrolides. Pediatr. Infect. Dis. J.,
16:438-443.

3 Andes D, Anon J, Jacobs MR, Craig WA. (2004). Application of pharmacokinetics and pharmacodynamics to
antimicrobial therapy of respiratory tract infections. Clin Lab Med., 24:477-502.

Swine
Following intramuscular (IM) administration to feeder pigs at a dosage of 2.5 mg/kg BW, tulathromycin is nearly
completely absorbed, with peak plasma concentrations achieved within ~0.25 hr. The volume of distribution
exceeds 15 L/kg, which is consistent with extensive tissue binding. This large distribution volume results in a long
terminal elimination half-life (60 to 90 hours) despite a rapid systemic free drug clearance (187 mL/kg/hr). There are
no gender differences in swine tulathromycin pharmacokinetics.

Comparative Bioavailability Summary
Despite slightly lower peak concentrations with tulathromycin injection 25 mg/mL, a single IM dose of 2.5 mg
tulathromycin/kg BW of either tulathromycin injection (100 mg/mL) or tulathromycin injection (25 mg/mL)
resulted in comparable tulathromycin total systemic exposure. Therefore, tulathromycin injection 25 mg/mL is
considered to be therapeutically equivalent to tulathromycin injection 100 mg/mL when administered to swine by
IM injection at a dose of 2.5 mg tulathromycin/kg BW.

Calves
Following subcutaneous (SC) administration into the neck of feeder calves at a dosage of 2.5 mg/kg BW,
tulathromycin is nearly completely absorbed, with peak plasma concentrations achieved within ~0.25 hr. The
volume of distribution exceeds 11 L/kg4, which is consistent with extensive tissue binding. This large distribution
volume results in a long terminal elimination half-life of more than 100 hours, despite a rapid systemic free drug
clearance (170 mL/kg/hr). No pharmacokinetic differences are observed in castrated male versus female calves.

Comparative Bioavailability Summary
Despite lower peak concentrations with tulathromycin injection 25 mg/mL, a single SC dose of 2.5 mg
tulathromycin/kg BW of either tulathromycin injection (100 mg/mL) or tulathromycin injection (25 mg/mL)
resulted in comparable total systemic tulathromycin exposure. Therefore, tulathromycin injection 25 mg/mL is
considered to be therapeutically equivalent to tulathromycin injection 100 mg/mL when administered to calves by
SC injection at a dose of 2.5 mg tulathromycin/kg BW.
4 Clearance and volume estimates are based on intersubject comparisons of 2.5 mg/kg BW administered by either
subcutaneous or intravenous injection

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