Animal NDC 54771-7521-1 Quest Plus

Moxidectin And Praziquantel

Animal Product Information

Field Name Field Value
Animal NDC Code 54771-7521-1
Proprietary Name Quest Plus 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 Moxidectin And Praziquantel 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
    QUEST PLUS Gel (moxidectin/praziquantel) when administered at the recommended dose level of 0.4 mg moxidectin/kg and 2.5 mg praziquantel/kg (2.2 lb) body weight is effective in the treatment and control of the following stages of gastrointestinal parasites in horses and ponies:Large Strongyles:     Strongylus vulgaris – (adults and L4/L5 arterial stages)     Strongylus edentatus – (adults and tissue stages)     Triodontophorus brevicauda – (adults)     Triodontophorus serratus – (adults)Small Strongyles(adults):     Cyathostomumspp., including          Cyathostomum catinatum          Cyathostomum pateratum     Cylicostephanus spp., including          Cylicostephanuscalicatus           Cylicostephanus goldi           Cylicostephanus longibursatus           Cylicostephanus minutus     Cylicocyclus spp., including          Cylicocyclus insigne          Cylicocyclus leptostomum          Cylicocyclus nassatus          Cylicocyclus radiatus     Coronocyclusspp., including          Coronocyclus coronatus          Coronocyclus labiatus          Coronocyclus labratus     Gyalocephalus capitatus      Petrovinema poculatusSmall Strongyles:     Undifferentiated lumenal larvaeEncysted cyathostomes:     Late L3 and L4 mucosal cyathostome larvaeAscarids:     Parascarisequorum – (adults and L4 larval stages)Pinworms:     Oxyuris equi – (adults and L4 larval stages)Hairworms:     Trichostrongylus axei– (adults)Large-mouth stomach worms:     Habronema muscae– (adults)Horse stomach bots:     Gasterophilus intestinalis– (2nd and 3rd instars)     Gasterophilus nasalis– (3rd instars)Tapeworms:     Anoplocephala perfoliata – (adults)One administration of the recommended dose rate of QUEST PLUS Gel also suppresses strongyle egg production through 84 days.
Active Ingredient(s)
  • Praziquantel
  • Moxidectin
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 NADA141216 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.

Quest Plus 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



Indications



QUEST PLUS Gel (moxidectin/praziquantel) when administered at the recommended dose level of 0.4 mg moxidectin/kg and 2.5 mg praziquantel/kg (2.2 lb) body weight is effective in the treatment and control of the following stages of gastrointestinal parasites in horses and ponies:

Large Strongyles:

    Strongylus vulgaris – (adults and L4/L5 arterial stages)

    Strongylus edentatus – (adults and tissue stages)

    Triodontophorus brevicauda – (adults)

    Triodontophorus serratus – (adults)

Small Strongyles(adults):

    Cyathostomumspp., including

         Cyathostomum catinatum

         Cyathostomum pateratum

    Cylicostephanus spp., including

         Cylicostephanuscalicatus

          Cylicostephanus goldi

          Cylicostephanus longibursatus

          Cylicostephanus minutus

    Cylicocyclus spp., including

         Cylicocyclus insigne

         Cylicocyclus leptostomum

         Cylicocyclus nassatus

         Cylicocyclus radiatus

    Coronocyclusspp., including

         Coronocyclus coronatus

         Coronocyclus labiatus

         Coronocyclus labratus

    Gyalocephalus capitatus

     Petrovinema poculatus

Small Strongyles:

    Undifferentiated lumenal larvae

Encysted cyathostomes:

    Late L3 and L4 mucosal cyathostome larvae

Ascarids:

    Parascarisequorum – (adults and L4 larval stages)

Pinworms:

    Oxyuris equi – (adults and L4 larval stages)

Hairworms:

    Trichostrongylus axei– (adults)

Large-mouth stomach worms:

    Habronema muscae– (adults)

Horse stomach bots:

    Gasterophilus intestinalis– (2nd and 3rd instars)

    Gasterophilus nasalis– (3rd instars)

Tapeworms:

    Anoplocephala perfoliata – (adults)

One administration of the recommended dose rate of QUEST PLUS Gel also suppresses strongyle egg production through 84 days.


Strategic Protection Programs



Consult your veterinarian for assistance in the diagnosis, treatment, and control of parasitism. For best control of parasites, all horses and ponies should be included in a strategic treatment program, with particular attention given to high performance animals. In foals, initial treatment is recommended at 6 months of age, after which they should be included in a recurrent treatment program. Because QUEST PLUS Gel provides eff ective control of the mucosal stages of small strongyles (encysted cyathostomes) and tapeworms, it is useful in reducing the frequency of treatment required for successful strategic equine parasite control. A veterinarian can assist in preparing the best program for your needs.

QUEST PLUS Gel when used at the recommended dose rate suppresses strongyle egg production through 84 days following a single oral administration. This residual strongyle control reduces pasture contamination and provides a period of protection from reinfection for horses and ponies maintained on the same pasture.


Mode Of Action



QUEST PLUS Gel contains two active pharmaceutical ingredients, moxidectin and praziquantel. Moxidectin acts by interfering with chloride channel-mediated neurotransmission in the parasite. This results in paralysis and elimination of the parasite. Moxidectin is safe for use in horses and ponies because it does not have the same injurious eff ect on the mammalian nervous system. Praziquantel increases the tapeworm’s membrane permeability to calcium and other cations causing severe contraction and paralysis of the tapeworm’s muscles.

This spastic paralysis results in the inability of tapeworms to attach to the host’s intestinal wall.
Detached tapeworms are either destroyed by the host’s immune defense system or passed in the feces.


Administration And Dosage



QUEST PLUS Gel is specially formulated as a palatable gel which is easily administered to horses and ponies. QUEST PLUS Gel is packaged in ready-to-use SURE-DIAL® syringes. The syringe is calibrated in 50-pound increments, up to 1500 pounds. This enables the administration of the recommended dose level by choosing a setting consistent with the animal’s weight.

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


How To Set The Dose



Since the dose is based on the weight of the animal, you need to use a scale or weight tape to find each animal’s weight before treating with QUEST PLUS Gel. Once the weight is known, set the dose for each horse or pony as follows.
    1. Hold the syringe with the capped end pointing to the left and so that you can see the
         weight measurements and tick marks (small black lines). Each tick mark relates to 50 lb
         of body weight.
    2. Turn the white dial ring until the left side of the ring lines up with the weight of the animal.


How To Give Quest Plus Gel To A Horse Or Pony



1. Make sure there is no feed in the animal’s mouth.
2. Remove the cap from the end of the syringe. Save the cap for reuse.
3. Place the tip of the syringe inside the animal’s mouth at the space between the teeth.
4. Gently push the plunger until it stops, depositing the gel on the back of the tongue.
5. Remove the syringe from the animal’s mouth and raise the animal’s head slightly to make
      sure it swallows the gel.
6. Replace the syringe cap.


Treating A Second Horse Or Pony With The Same Syringe



If the first animal you treat weighs less than 1500 lb, there will be gel left in the syringe. You can use this gel to treat other horses or ponies. To set the next dose, add the weight of the animal you want to treat to the dose setting already on the syringe. For example, if the syringe was first used to treat a 250 lb animal, the white dial ring is set on 250 lb. To treat a 500 lb animal next, move the white dial ring to the 750 lb marking (250+500=750). You need more than one syringe to treat horses weighing more than 1500 lb.


Animal Safety



QUEST PLUS Gel can be safely administered at the recommended dose to horses and ponies of all breeds at least 6 months of age and older. Transient ataxia, incoordination, lethargy, depression and droopy lips and eyelids may be seen when very young or debilitated animals are treated. In these instances, supportive care may be advisable. QUEST PLUS Gel is safe for use in breeding, pregnant, and lactating mares. In a reproductive safety study, 10 mares received QUEST PLUS Gel at three times the recommended dosage, and 10 mares received tap water (control). Mares were dosed at least once a month from breeding through 30 days post-foaling, with increased frequency (every 2 weeks) around breeding. Nine out of 10 QUEST PLUS Gel treated mares became pregnant, and gave birth to live foals. Ten control mares became pregnant, and 8 out of the 10 mares gave birth to live foals.

One QUEST PLUS Gel treated mare had episodes of depression, decreased appetite, and diarrhea shortly after receiving 5 of the 17 (29%) doses. The same mare had one episode of colic shortly after one administration of QUEST PLUS Gel. This mare’s colic, depression, decreased appetite, and diarrhea all resolved without treatment. Another QUEST PLUS Gel treated mare had an abnormal reproductive cycle (prolonged time to ovulation) following foal heat (at least 39 days). This mare became pregnant on the fi rst breeding and gave birth to a female foal that was normal at birth; however, the foal developed an enlarged clitoris by Day 30 post-foaling. To report adverse drug reactions or to obtain a copy of the Safety Data Sheet (SDS) call 1-888-963-8471.


Environmental Safety



Care should be taken to avoid the release of significant volumes of this product into either ground or free-running water since moxidectin may be injurious to aquatic life. SURE-DIAL® syringes and their contents should be disposed of in an approved landfill or by incineration.


Precautions



QUEST PLUS Gel has been formulated specifically for use in horses and ponies only.

Reproductive safety studies on breeding stallions have not been conducted.

This product should not be used in other animal species as severe adverse reactions, including fatalities in dogs, may result.


Warnings



Extreme caution should be used when administering the product to foals, young and miniature horses, as overdosage may result in serious adverse reactions. Do not use in sick, debilitated, or underweight animals. Do not use in horses intended for human consumption.


Human Warnings



Not for use in humans. Keep this and all drugs out of the reach of children. Do not ingest. If swallowed, induce vomiting. Wash hands and contaminated skin with soap and water. If accidental contact with eyes occurs, flush repeatedly with water. If irritation or any other symptom attributable to exposure to this product persists, consult your physician.


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.


How Supplied



QUEST PLUS Gel is available in one syringe applicator size.
Each SURE-DIAL® syringe contains 0.5 oz (14.0 g) of QUEST PLUS Gel which is suffi cient to treat a single horse weighing up to 1500 lb, or two or more lighter animals with a combined body weight of up to 1500 lb.

0.5 oz (14.0 g) syringe - 20 mg moxidectin and 125 mg praziquantel per mL

Store at or below 77°F (25°C). Avoid freezing. If frozen, thaw completely before use. Store partially used syringes with the cap tightly secured.


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