DECTOGARD POUR-ON- doramectin solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DORAMECTIN (UNII: KGD7A54H5P) (DORAMECTIN - UNII:KGD7A54H5P)

Available from:

Aurora Pharmaceutical, Inc.

Administration route:

TOPICAL

Prescription type:

OTC

Therapeutic indications:

DectoGard Pour-On solution is indicated for the treatment and control of the following species of gastrointestinal roundworms, lungworms, eyeworms, grubs (see PRECAUTIONS), biting and sucking lice, horn flies, and mange mites in cattle. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. Gastrointestinal roundworms Ostertagia ostertagi (adults and L4 , including inhibited larvae) O. lyrata (adults) Haemonchus placei (adults and L4 ) Trichostrongylus axei (adults and L4 ) T. colubriformis (adults and L4 ) Cooperia oncophora (adults1 and L4 ) C. pectinata (adults) C. punctata (adults and L4 ) C. surnabada (adults) Bunostomum phlebotomum (adults) Oesophagostomum radiatum (adults and L4 ) Trichuris spp. (adults) Lungworms (adults and fourth stage larvae) Dictyocaulus viviparus Doramectin topical solution has been proved to effectively control infections and to protect cattle from reinfection with Cooperia oncophora, Dictyocaulus vivi

Product summary:

DectoGard Pour-On solution is available in 1-L, 2.5-L, and 5-L multi-dose containers.

Authorization status:

Abbreviated New Animal Drug Application

Summary of Product characteristics

DECTOGARD POUR-ON- DORAMECTIN SOLUTION
AURORA PHARMACEUTICAL, INC.
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DECTOGARD
_(DORAMECTIN TOPICAL SOLUTION) _POUR-ON
ANTIPARASITIC
0.5% POUR-ON SOLUTION FOR CATTLE
5 MG/ML
PRODUCT DESCRIPTION:
DectoGard Pour-On solution is a ready-to-use, systemically active,
clear, light blue
solution containing 0.5% w/v doramectin (5 mg/mL). It is formulated to
deliver the
recommended dosage of 500 mcg/kg (227 mcg/lb) of body weight when
given by topical
administration at the rate of 1 mL/22 lb (10 kg) of body weight.
PRODUCT CHARACTERISTICS:
DectoGard Pour-On solution is a highly active, broad-spectrum
parasiticide for topical
administration to cattle. It contains doramectin, a novel
fermentation-derived
macrocyclic lactone discovered by Pfizer Inc. Doramectin is isolated
from fermentations
of selected strains derived from the soil organism _Streptomyces
avermitilis_.
A primary mode of action of macrocyclic lactones is to modulate
chloride ion channel
activity in the nervous system of nematodes and arthropods.
Macrocyclic lactones bind
to receptors that increase membrane permeability to chloride ions.
This inhibits the
electrical activity of nerve cells in nematodes and muscle cells in
arthropods and causes
paralysis and death of the parasites. In mammals, the neuronal
receptors to which
macrocyclic lactones bind are localized within the central nervous
system (CNS), a site
reached by only negligible concentrations of doramectin.
One dose of DectoGard Pour-On solution effectively treats and controls
a wide range of
roundworm and arthropod parasites that impair the health and
productivity of cattle.
Studies have demonstrated the safety margin of doramectin. In USA
trials, no toxic
signs were seen in cattle given up to 25 times the recommended dose of
doramectin
injectable solution. A study using doramectin injectable solution also
demonstrated
safety in neonatal calves treated with up to 3 times the recommended
dose. In breeding
animals (bulls, and cows during folliculogenesis, organogenesis,
implantation, and
throug