Animal NDC 54771-6045-2 Anthelcide Eq

Oxibendazole

Animal Product Information

Field Name Field Value
Animal NDC Code 54771-6045-2
Proprietary Name Anthelcide Eq What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Oxibendazole What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Zoetis Inc.
Product Type Otc Animal Drug
Usage Information
    Anthelcide EQ Paste is indicated for removal and control of: large strongyles (Strongylus edentatus, S. equinus, S. vulgaris); small strongyles (species of the genera Cylicostephanus, Cylicocyclus, Cyathostomum, Triodontophorus, Cylicodontophorus, and Gyalocephalus); large roundworms (Parascaris equorum); pinworms (Oxyuris equi) including various larval stages; and threadworms (Strongyloides westeri).
Active Ingredient(s)
  • Oxibendazole
Marketing Category NADA - NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number NADA121042 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Anthelcide Eq Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Description



Anthelcide EQ Paste is a paste formulation of oxibendazole, a broad-spectrum benzimidazole anthelmintic. This formulation has been developed for ease of administration. Each syringe contains 0.85 oz (24 g) of paste.

 Anthelcide EQ Paste contains:
 Oxibendazole 22.7%

Indications



Anthelcide EQ Paste is indicated for removal and control of: large strongyles (Strongylus edentatus, S. equinus, S. vulgaris); small strongyles (species of the genera Cylicostephanus, Cylicocyclus, Cyathostomum, Triodontophorus, Cylicodontophorus, and Gyalocephalus); large roundworms (Parascaris equorum); pinworms (Oxyuris equi) including various larval stages; and threadworms (Strongyloides westeri).


Contraindications



Anthelcide EQ is contraindicated in severely debilitated horses or horses suffering from infectious disease, toxemia, or colic.


Warning



  Do not use in horses intended for human consumption.


Precautions



Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism.

Keep Out of Reach of Children.


Other Warnings



Parasite resistance may develop to any dewormer, and has been reported for most classes of dewormers. Treatment with a dewormer used in conjunction with parasite management practices appropriate to the geographic area and the animal(s) to be treated may slow the development of parasite resistance. Fecal examinations or other diagnostic tests and parasite management history should be used to determine if the product is appropriate for the herd prior to the use of any dewormer. Following the use of any dewormer, effectiveness of treatment should be monitored (for example, with the use of a fecal egg count reduction test or another appropriate method). A decrease in a drug’s effectiveness over time as calculated by fecal egg count reduction tests may indicate the development of resistance to the dewormer administered. Your parasite management plan should be adjusted accordingly based on regular monitoring.


Dosage And Administration



The dosage of oxibendazole is 10 mg/kg (2.2 lb) of body weight (15 mg/kg for strongyloides). Each mark on the syringe delivers Anthelcide EQ to treat 100 lb (67 lb for strongyloides). Horses maintained on premises where reinfection is likely to occur should be retreated in 6–8 weeks.

Do not underdose. Ensure each animal receives a complete dose based on a current body weight. Underdosing may result in ineffective treatment, and encourage the development of parasite resistance.

Dosage Table
10 mg/kg 15 mg/kg
Syringe Mark Horse Weight (lb) Syringe Mark Horse Weight (lb)
 100 100 300 200
 200 200 600 400
 400 400 900 600
 600 600 1200 800
 800 800  
 1000 1000  
 1200 1200  

Anthelcide EQ is compatible with carbon disulfide, which can be used concurrently for bot control (Gasterophilus spp.) when administered by a veterinarian. Routine carbon disulfide cautions must be observed.


Use Of Syringe



Determine the weight of the horse and dial the correct setting on the plunger, having the side of the wheel nearest the barrel on the desired mark. Remove the cap from the syringe. Insert the tip of the syringe into the side of the animal's mouth between the incisor and molar teeth and press the plunger down as far as it will go, depositing the paste on the back of the tongue.


How Supplied



Anthelcide EQ paste is supplied in 0.85-oz (24-g) syringes.


Storage



Store at controlled room temperature 15°–30°C (59°–86°F).


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.