Macrosyn: Product Information

MACROSYN- tulathromycin injection, solution
Bimeda, Inc.

MACROSYNTM

(tulathromycin injection)

Injectable Solution

Antibiotic

100 mg of tulathromycin/mL

For use in beef cattle (including suckling calves), non-lactating dairy cattle (including dairy calves), veal calves, and swine.

Not for use in female dairy cattle 20 months of age or older.

CAUTION

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

DESCRIPTION

Macrosyn Injectable Solution is a ready-to-use sterile parenteral preparation containing tulathromycin, a semi-synthetic macrolide antibiotic of the subclass triamilide. Each mL of Macrosyn contains 100 mg of tulathromycin, 500 mg propylene glycol, 19.2 mg citric acid and 5 mg monothioglycerol. Sodium hydroxide or hydrochloric acid may be added to adjust pH.

Macrosyn consists of an equilibrated mixture of two isomeric forms of tulathromycin in a 9:1 ratio.

Structures of the isomers are shown below.

Chemical Structure
(click image for full-size original)

Figure 1

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-Ο-methyl-4-C-[(propylamino) methyl]-α-L-ribo-hexopyrano-syl]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-ribo-hexopyrano-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)-β-D-xylohexo-pyranosyl]oxy]-1-oxa-4-azacyclotridecan-13-one, respectively.

INDICATIONS

Beef and Non-Lactating Dairy Cattle

BRD – Macrosyn Injectable Solution is indicated for the treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica , Pasteurella multocida , Histophilus somni , and Mycoplasma bovis ; and for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica , Pasteurella multocida , Histophilus somni , and Mycoplasma bovis.

IBK – Macrosyn Injectable Solution is indicated for the treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis.

Foot Rot – Macrosyn Injectable Solution is indicated for the treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii.

Suckling Calves, Dairy Calves, and Veal Calves

BRD – Macrosyn Injectable Solution is indicated for the treatment of BRD associated with M. haemolytica , P. multocida , H. somni , and M. bovis.

Swine

Macrosyn 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.

DOSAGE AND ADMINISTRATION

Cattle

Inject subcutaneously as a single dose in the neck at a dosage of 2.5 mg/kg (1.1 mL/100 lb) body weight (BW). Do not inject more than 10 mL per injection site.

Table 1. Macrosyn Cattle Dosing Guide

Animal Weight (Pounds)

Dose Volume (mL)

100

1.1

200

2.3

300

3.4

400

4.5

500

5.7

600

6.8

700

8.0

800

9.1

900

10.2

1000

11.4

Swine

Inject intramuscularly as a single dose in the neck at a dosage of 2.5 mg/kg (0.25 mL/22 lb) BW. Do not inject more than 2.5 mL per injection site.

Table 2. Macrosyn Swine Dosing Guide

Animal Weight (Pounds)

Dose Volume (mL)

15

0.2

30

0.3

50

0.6

70

0.8

90

1.0

110

1.3

130

1.5

150

1.7

170

1.9

190

2.2

210

2.4

230

2.6

250

2.8

270

3.1

290

3.3

CONTRAINDICATIONS

The use of Macrosyn 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

Cattle

Cattle intended for human consumption must not be slaughtered within 18 days from the last treatment. This drug is not approved for use in female dairy cattle 20 months of age or older, including dry dairy cows. Use in these cattle may cause drug residues in milk and/or in calves born to these cows.

Swine

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

PRECAUTIONS

Cattle

The effects of Macrosyn 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.

Swine

The effects of Macrosyn 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.

Page 1 of 4 1 2 3 4

VetLabel.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by VetLabel.com. Every individual animal healthcare product label entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

Our database mirrors the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. VetLabel.com provides the full animal health subset of the FDA's repository. Veterinary information provided here is not intended as a substitute for direct consultation with a qualified veterinary professional.

Terms of Use | Copyright © 2021. All Rights Reserved.