DECTOMAX- doramectin injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Zoetis Inc.

INN (International Name):

DORAMECTIN

Composition:

DORAMECTIN 10 mg in 1 mL

Administration route:

INTRAMUSCULAR

Prescription type:

OTC

Therapeutic indications:

Dectomax injectable solution is indicated for the treatment and control of the following harmful species of gastrointestinal roundworms, lungworms, eyeworms, grubs (see PRECAUTIONS), sucking lice (see PRECAUTIONS), and mange mites. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.  Lungworms (adults and fourth stage larvae)   Dictyocaulus viviparus Eyeworms (adults)   Thelazia spp. Grubs (parasitic stages)   Hypoderma bovis   H. lineatum Sucking Lice   Haematopinus eurysternus   Linognathus vituli   Solenopotes capillatus Mange Mites   Psoroptes bovis   Sarcoptes scabiei 1 Adults Dectomax injectable solution has been proved to effectively control infections and to protect cattle from reinfection with Cooperia oncophora and Haemonchus placei for 14 days, Ostertagia ostertagi for 21 days, and C. punctata , Oesophagostomum radiatum , and Dictyocaulus viviparus for 28 days after treatment. Dectomax injectable solution is indicated for the treatment and control of the following species of gastrointestinal roundworms, lungworms, kidney worms, sucking lice (see PRECAUTIONS), and mange mites. Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

Product summary:

Dectomax is available in 100-mL, 200-mL, and 500-mL multi-dose, rubber-capped glass vials.

Authorization status:

New Animal Drug Application

Summary of Product characteristics

DECTOMAX- DORAMECTIN INJECTION, SOLUTION
ZOETIS INC.
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DECTOMAX
(DORAMECTIN INJECTION)
ANTIPARASITIC
_1% INJECTABLE SOLUTION FOR CATTLE AND SWINE_
_10 MG/ML_
Approved by FDA under NADA # 141-061
PRODUCT DESCRIPTION
Dectomax injectable solution is a ready-to-use, colorless to pale
yellow, sterile solution
containing 1% w/v doramectin (10 mg/mL). In cattle, Dectomax is
formulated to deliver
the recommended dosage (200 mcg/kg of body weight) when given by
subcutaneous
(SC) or intramuscular (IM) injection at the rate of 1 mL/110 lb of
body weight. In swine,
Dectomax is formulated to deliver the recommended dosage (300 mcg/kg
of body
weight) when given by IM injection at the rate of 1 mL/75 lb of body
weight.
PRODUCT CHARACTERISTICS
Dectomax injectable solution is a highly active, broad-spectrum
parasiticide for
parenteral administration to cattle and swine. It contains doramectin,
a novel
fermentation-derived macrocyclic lactone. 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 Dectomax injectable solution effectively treats and
controls a wide range of
roundworm and arthropod parasites that impair the health and
productivity of cattle and
swine.
Studies have demonstrated the safety margin of Dectomax injection in
cattle and swine.
In USA trials, no toxic signs were seen in cattle given up to 25 times
the recommended
dose, or in swine given up to 10 times the reco