DRAXXIN KP- tulathromycin and ketoprofen injection injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TULATHROMYCIN (UNII: Q839I13422) (TULATHROMYCIN - UNII:Q839I13422), KETOPROFEN (UNII: 90Y4QC304K) (KETOPROFEN - UNII:90Y4QC304K)

Available from:

Zoetis Inc.

Administration route:

SUBCUTANEOUS

Prescription type:

PRESCRIPTION

Therapeutic indications:

Draxxin® KP is indicated for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica , Pasteurella multocida , Histophilus somni , and Mycoplasma bovis , and control of pyrexia associated with BRD in beef steers, beef heifers, beef calves 2 months of age and older, beef bulls, dairy bulls, and replacement dairy heifers. Not for use in reproducing animals over one year of age, dairy calves, or veal calves. The use of DRAXXIN KP Injection is contraindicated in animals previously found to be hypersensitive to tulathromycin and ketoprofen. NOT FOR HUMAN USE. KEEP OUT OF REACH OF CHILDREN. The Safety Data Sheet (SDS) provides more detailed occupational safety information. To obtain a Safety Data Sheet contact Zoetis Inc. at 1-888-963-8471.

Product summary:

DRAXXIN KP Injection is available in the following package sizes: 50 mL vial 100 mL vial 250 mL vial 500 mL vial

Authorization status:

New Animal Drug Application

Summary of Product characteristics

DRAXXIN KP- TULATHROMYCIN AND KETOPROFEN INJECTION INJECTION, SOLUTION
ZOETIS INC.
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DRAXXIN
KP
Draxxin® KP
(tulathromycin and ketoprofen injection)
INJECTABLE SOLUTION
Antibiotic and Anti-inflammatory
FOR SUBCUTANEOUS INJECTION
100 MG/ML TULATHROMYCIN + 120 MG/ML KETOPROFEN
FOR SUBCUTANEOUS INJECTION
ANTIBIOTIC:
100 mg of Tulathromycin/mL
NON-STEROIDAL ANTI-INFLAMMATORY DRUG:
120 mg Ketoprofen/mL
CAUTION
Federal law restricts this drug to use by or on the order of a
licensed veterinarian.
DESCRIPTION
DRAXXIN KP (tulathromycin and ketoprofen injection) Injectable
Solution is a ready to
use sterile parenteral preparation containing tulathromycin, a semi-
synthetic macrolide
antibiotic of the subclass triamilide and ketoprofen a non-steroidal
anti-inflammatory
drug. ACTIVE INGREDIENTS: Each mL of DRAXXIN KP contains 100 mg of
tulathromycin
as a free base and 120 mg ketoprofen as a free acid in a 50% propylene
glycol vehicle.
INACTIVE INGREDIENTS:
monothioglycerol (5 mg/mL), 2-pyrrolidone (70 mg/mL), citric acid (20
mg/mL) and
sodium hydroxide/hydrochloric acid added to adjust pH.
DRAXXIN KP contains an equilibrated mixture of two isomeric forms of
tulathromycin in
a 9:1 ratio and a racemic mixture of ketoprofen.
The structures of the tulathromycin isomers and ketoprofen are shown
below:
FIGURE 1. TULATHROMYCIN STRUCTURES
®
The chemical names of the tulathromycin isomers are (2R,3S,
4R,5R,8R,10R,11R,12S,
13S,14R)-13-[[2,6-dideoxy-3-C-methyl-3-Ο-methyl-4-C-[(propylamino)
methyl]-α-L-ribo-
hexopyranosyl]oxy]-2-ethyl-3,4,10-trihydroxy-3,5,8,10,12,
14-hexamethyl-11-[[3,4,6-
trideoxy-3-(dimethylamino)-β-D-xylohexopyranosyl]-oxy]-1-oxa-6-azacyclopentadecan-
15-one and (2R, 3R,6R,8R,9R,10S,11S,12R)-
11-[[2,6-dideoxy-3-C-methyl-3-Ο-methyl-4-
C-[(propylamino)methyl]-α-L-ribohexopyranosyl]oxy]-2-[(1S,2R)-1,2-dihydroxy-1-
methylbutyl]-8-hydroxy-3,6,8,10,12-pentamethyl-9-[[3,4,6-trideoxy
-3-(dimethylamino)-
β-D-xylo-hexopyranosyl]oxy]-1-oxa-4-azacyclotridecan-13-one,
respectively.
FIGURE 2. KETOPROFEN STRUCTURE