Baycox (toltrazuril) 5% Oral Suspension (Canada)

This page contains information on Baycox (toltrazuril) 5% Oral Suspension for veterinary use.
The information provided typically includes the following:
  • Baycox (toltrazuril) 5% Oral Suspension Indications
  • Warnings and cautions for Baycox (toltrazuril) 5% Oral Suspension
  • Direction and dosage information for Baycox (toltrazuril) 5% Oral Suspension

Baycox (toltrazuril) 5% Oral Suspension

This treatment applies to the following species:
Manufacturer: Bayer

5% Toltrazuril Oral Suspension Prof.Std.

Veterinary Use Only

DIN 02355353

Active Ingredient

toltrazuril

Medicinal ingredient per mL: 50 mg toltrazuril

Indication: Baycox® is indicated for the treatment of preclinical coccidiosis due to Isospora suis in neonatal piglets, and for the prevention of clinical signs of coccidiosis and reduction of coccidian shedding in lambs on farms with a confirmed history of coccidiosis caused by Eimeria crandallis and Eimeria ovinoidalis.

Dosage and Administration: Piglets: Shake well before use. Weigh three representative litters at 3 days of age to determine an average piglet weight. The recommended dosage of toltrazuril is 20 mg per kg body weight. This corresponds to a dose of 1 ml Baycox® per 2.5 kg body weight.

Administer a single oral dose at 3 to 4 days of age.

Lambs: Shake well before use. Each animal should be treated with a single dose of 20 mg toltrazuril/kg body weight corresponding to 1 mL Baycox® per 2.5 kg body weight. To obtain maximum benefit, sheep should be treated in the prepatent period before the expected onset of clinical signs. The prepatent period of Eimeria ovinoidalis is 12-15 days and the prepatent period of Eimeria crandalis is 15-20 days. If animals are to be treated collectively rather than individually, they should be grouped according to their body weight and dosed accordingly, in order to avoid under- or overdosing. In order to maximize effectiveness of Baycox® in lambs it is important to time therapy according to individual farm management and lifecycle of the organism involved.

Cautions:

As with any antiparasiticide, frequent and repeated use of antiprotozoals from the same class may lead to the development of resistance.

Warnings: Piglets: Treated swine must not be slaughtered for use in food for at least 70 days after the latest treatment with this drug. Do not use in piglets intended to be used as suckling or barbecue pigs since they may be marketed before 70 days after administration of this drug. Lambs: Treated sheep must not be slaughtered for use in food for at least 48 days after the latest treatment with this drug. Do not use in lactating sheep producing milk for human consumption. Avoid direct contact with skin by wearing rubber gloves while handling this drug. Dispose the unused drug in accordance with the Provincial/Municipal guidelines.

Keep out of reach of children.

Pharmacology

Chemical Name: 1-[3-methyl-4- (4’-trifluoromethylthiophenoxy)-phenyl]-3 methyl-1,3,5-triazine-2,4,6(1H,3H,5H)-trione

Molecular formula: C18H14F3N304S

Structural formula:

Molecular weight: 425.38

Mode of Action: Light and electron microscope studies show that toltrazuril is active against all intracellular stages of coccidia, including schizonts, micro and macrogamonts. It interferes with the division of the protozoal nucleus, the activity of the mitochondria and damages the wall forming bodies in the microgametes. Toltrazuril produces severe vacuolisation of the protozoal endoplasmic reticulum in all intracellular development stages.

Pharmacodynamics, Pharmacokinetics: After oral administration, toltrazuril is absorbed slowly from the gut, indicated by a radio-active study using [triazine-2-14C]-marked toltrazuril. This is followed by a long-lasting distribution among the different compartments of the body. The plasma half-life is 51 hours in piglets and about 170 hours in lambs. Excretion is characterized by a high fecal fraction with a relatively high excretion rate. There is no significant enterohepatic circulation.

Two metabolites of toltrazuril, both oxidation products, toltrazuril-sulfoxide and toltrazuril-sulfone, are found in the tissues and organs of piglets and lambs.

Efficacy: Piglets: The efficacy of a single oral treatment with toltrazuril against preclinical neonatal coccidiosis in pigs has been widely demonstrated by several investigators in countries as diverse as Australia, Canada, Denmark, Italy, Malaysia and Venezuela, under various conditions of management and hygiene. Treated piglets showed improvement regarding their clinical picture (diarrhea was the most frequently noted criterion), oocyst shedding, and had better weight gains than the untreated animals.

Lambs: Naturally infected lambs were treated with toltrazuril 20 mg/kg body weight 10 days after turn out onto pasture. The oocyst excretion was observed up until 9 weeks of age vs an untreated control group for 5 weeks.

The metaphylactic efficacy of toltrazuril was studied in Norway. Seven to 9 days after turnout on pasture, lambs were treated with toltrazuril at 20 mg/kg to prevent coccidiosis. Treatment with Baycox® reduced the oocytes output significantly and prevented the development of diarrhea and improved weight gain during the first 4-5 weeks after treatment.

Safety: Piglets: The tolerance of neonatal pigs to Baycox® was tested extensively under controlled conditions and assessed on the basis of clinical, haematological and clinicochemical parameters, which were determined before and after treatment and by comparison with untreated controls. Animals were also examined for gross pathological and histological changes.

Studies performed with single treatments of 20 mg/kg (recommended rate), 60 mg/kg (3 x recommended), 100 mg/kg (5 x recommended) and at 30 mg/kg once a day for 2 days showed that the formulation is well tolerated at the therapeutic dosage:

- there was no influence on body weight development in any of the groups,

- the haematological and clinical-chemical investigations revealed no changes related to treatment,

- the gross pathology studies showed no indication of change to the animals or their organs.

Lambs: A tolerability study was performed in 1-3 week old lambs. Four groups of lambs were treated with 0 - 20 - 60 - 2x40 mg/kg body weight. The last group was treated twice on 2 consecutive days. Clinical examinations as well as hematology, clinical chemistry, body weight development, feed intake and gross and histopathology were performed. No compound related effects were seen in any of the groups dosed with toltrazuril.

Storage

Store below 30°C. Protect from freezing.

Baycox® (toltrazuril) 5% Oral Suspension is available in 250 mL bottles.

® Baycox, Bayer and Bayer Cross are trademarks of Bayer AG used under license by Bayer Inc.

Bayer Inc., 77 Belfield Road, Toronto, ON M9W 1G6

Revision 4 - Bayer Version December 5, 2013 (Nonannotated)

NAC No.: 1223049.2

BAYER HEALTHCARE
Animal Health Division, Bayer Inc.

77 BELFIELD ROAD, TORONTO, ON, M9W 1G6
Telephone:   416-248-0771 or 800-268-1331
Toll-Free:   800-62-BAYER
Order Desk:   800-387-9179
Order Desk Fax:   800-361-3306
Fax:   416-240-4918
Website:   www.animalhealth.bayer.ca
Every effort has been made to ensure the accuracy of the Baycox (toltrazuril) 5% Oral Suspension information published above. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the Canadian product label or package insert.

Copyright © 2014 North American Compendiums. Updated: 2014-05-28

(web2)