EPRINEX POUR-ON FOR BEEF AND DAIRY CATTLE- eprinomectin solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

eprinomectin (UNII: 75KP30FD8O) (eprinomectin - UNII:75KP30FD8O)

Available from:

Boehringer Ingelheim Animal Health USA Inc.

Administration route:

TOPICAL

Prescription type:

OTC

Therapeutic indications:

EPRINEX (eprinomectin) Pour-On is indicated for the treatment and control of gastrointestinal roundworms (including inhibited Ostertagia ostertagi ), lungworms, grubs, sucking and biting lice, chorioptic and sarcoptic mange mites, and horn flies in beef and dairy cattle of all ages, including lactating dairy cattle. Applied at the recommended dose volume of 1 mL/10 kg (22 lb) body weight, to achieve a dose level of 500 mcg eprinomectin/kg body weight, EPRINEX Pour-On is indicated for the effective treatment and control of the following parasites. Gastrointestinal Roundworms   Haemonchus placei (adults and L4)   Ostertagia ostertagi (including inhibited L4) (adults and L4)   Trichostrongylus axei (adults and L4)   Trichostrongylus colubriformis (adults and L4)   Trichostrongylus longispicularis (adults only)   Cooperia oncophora (adults and L4)   Cooperia punctata (adults and L4)   Cooperia surnabada (adults and L4)   Nematodirus helvetianus (adults and L4)   Oesophagostomum radiatum (adults and L4)   Bunostomum phlebotomum (adults and L4)   Strongyloides papillosus (adults only)   Trichuris spp. (adults only) Lungworms   Dictyocaulus viviparus (adults and L4) Cattle Grubs (all parasitic stages)   Hypoderma lineatum, Hypoderma bovis Lice   Damalinia bovis, Linognathus vituli, Haematopinus   eurysternus, Solenopotes capillatus Mange Mites   Chorioptes bovis, Sarcoptes scabiei Horn Flies   Haematobia irritans EPRINEX (eprinomectin) Pour-On for Beef and Dairy Cattle has been proved to effectively control infections and to protect cattle from re-infection with Dictyocaulus viviparus for 21 days after treatment and Haematobia irritans for 7 days after treatment. Varying weather conditions, including rainfall, do not affect the efficacy of EPRINEX Pour-On. For best results EPRINEX Pour-On should be applied to all cattle in the herd. Cattle introduced to the herd later should be treated prior to introduction. Consult your veterinarian or an entomologist for the most effective timing of applications for the control of external parasites. Chorioptic Mange: In clinical studies evaluating the efficacy of EPRINEX Pour-On against chorioptic mange mites, mites were not recovered from skin scrapings taken 8 weeks after treatment; however, chronic skin lesions were still present on some animals. Horn flies: For optimal control of horn flies, as EPRINEX Pour-On provides 7 days of persistent activity against horn flies, the product should be used as part of an integrated control program utilizing other control methods to provide extended control.

Product summary:

EPRINEX (eprinomectin) Pour-On for Beef and Dairy Cattle is available in a 250 mL/8.5 fl oz (126623) or 1 L/33.8 fl oz (126865) bottle with a measure-squeeze-pour system, or in a 2.5 L/84.5 fl oz (126624), 5 L/169 fl oz (126622), or 10 L/338 fl oz (154210) collapsible pack or 20 L/676 fl oz (126619) container intended for use with appropriate automatic dosing equipment.

Authorization status:

New Animal Drug Application

Summary of Product characteristics

EPRINEX POUR-ON FOR BEEF AND DAIRY CATTLE- EPRINOMECTIN SOLUTION
BOEHRINGER INGELHEIM ANIMAL HEALTH USA INC.
----------
EPRINEX
POUR-ON FOR BEEF
AND DAIRY CATTLE
(EPRINOMECTIN)
Approved by FDA under NADA # 141-079
PARASITICIDE
Contains 5 mg eprinomectin/mL
NOT FOR USE IN CALVES TO BE PROCESSED FOR VEAL.
INTRODUCTION
EPRINEX Pour-On delivers effective internal and external parasite
control in one
application. Discovered and developed by scientists from Merck
Research Laboratories,
EPRINEX Pour-On contains eprinomectin, a unique avermectin. Its
broad-spectrum
efficacy in a weatherproof formulation, margin of safety, zero
slaughter withdrawal and
zero milk discard, make it a convenient product for parasite control
in beef and dairy
cattle, including lactating dairy cattle.
MODE OF ACTION
Eprinomectin is a member of the macrocyclic lactone class of
endectocides which have a
unique mode of action. Compounds of the class bind selectively and
with high affinity to
glutamate-gated chloride ion channels which occur in invertebrate
nerve and muscle
cells.
This leads to an increase in the permeability of the cell membrane to
chloride ions with
hyperpolarization of the nerve or muscle cell, resulting in paralysis
and death of the
parasite. Compounds of this class may also interact with other
ligand-gated chloride
channels, such as those gated by the neurotransmitter
gamma-aminobutyric acid
(GABA).
The margin of safety for compounds of this class is attributable to
the fact that
mammals do not have glutamate-gated chloride channels, the macrocyclic
lactones have
a low affinity for other mammalian ligand-gated chloride channels and
they do not readily
cross the blood-brain barrier.
INDICATIONS
EPRINEX (eprinomectin) Pour-On is indicated for the treatment and
control of
gastrointestinal roundworms (including inhibited _Ostertagia
ostertagi_), lungworms,
grubs, sucking and biting lice, chorioptic and sarcoptic mange mites,
and horn flies in
beef and dairy cattle of all ages, including lactating dairy cattle.
Applied at the recom