Label: EQUIMAX- ivermectin and praziquantel paste

  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated August 21, 2020

If you are a consumer or patient please visit this version.

  • GENERAL PRECAUTIONS

    FOR ORAL USE IN HORSES ONLY

    For the treatment and control of worms and bots in horses with a single dose.

    Safe for horses 4 weeks of age and older. Contents will treat up to 1320 lb body weight.

    Net Weight: 0.225 oz (6.42 g)

  • INDICATIONS

    Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism.
    EQUIMAX (ivermectin/praziquantel) Oral Paste is indicated for the treatment and control of the following parasites:
    Tapeworms
    Anoplocephala perfoliata
    Large Strongyles (adults)
    Strongylus vulgaris (also early forms in blood vessels)
    S. edentatus (also tissue stages)
    S. equinus
    Triodontophorus spp.
    Small Strongyles (adults, including those resistant to some benzimidazole class compounds)
    Cyathostomum spp.
    Cylicocyclus spp.
    Cylicostephanus spp.
    Cylicodontophorus spp.
    Small Strongyles (fourth-stage larvae)
    Pinworms (adults and fourth-stage larvae)
    Oxyuris equi
    Ascarids (adults and third- and fourth-stage larvae)
    Parascaris equorum
    Hairworms (adults)
    Trichostrongylus axei
    Large-mouth Stomach Worms (adults)
    Habronema muscae
    Bots (oral and gastric stages)
    Gasterophilus spp.
    Lungworms (adults and fourth-stage larvae)
    Dictyocaulus arnfieldi
    Intestinal Threadworms (adults)
    Strongyloides westeri
    Summer Sores caused by Habronema and Draschia spp. cutaneous third-stage larvae
    Dermatitis caused by Neck Threadworm microfilariae, Onchocerca sp.

  • DOSAGE AND ADMINISTRATION

    This syringe contains sufficient paste to treat one 1320-lb horse at the recommended dose rate of 91 mcg ivermectin per lb (200 mcg/kg) and 0.68 mg praziquantel per lb (1.5 mg/kg) of body weight. Each weight marking on the syringe plunger delivers enough paste to treat 220 lb (100 kg) of body weight.


    1. While holding plunger, turn the knurled ring on the plunger 1/4 turn to the left and slide it so the side nearest the barrel is at the prescribed      weight marking.
    2. Lock the ring in place by making a 1/4 turn to the right.
    3. Make sure that the horse’s mouth contains no feed.
    4. Remove the cover from the tip of the syringe.
    5. Insert the syringe tip into the horse’s mouth at the space between the teeth.
    6. Depress the plunger as far as it will go, depositing paste on the back of the tongue.
    7. Immediately raise the horse’s head for a few seconds after dosing.
        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.

    Parasite Control Program: All horses should be included in a regular parasite control program with particular attention being paid to
    mares, foals, and yearlings. Foals should be treated initially at 4 weeks of age, and routine treatment repeated as appropriate. Consult
    your veterinarian for a control program to meet your specific needs. EQUIMAX Oral Paste effectively controls gastrointestinal
    nematodes, cestodes and bots of horses. Regular treatment will reduce the chances of colic caused by Anoplocephala perfoliata and
    verminous arteritis caused by Strongylus vulgaris.

    Product Advantages: Broad-spectrum Control: EQUIMAX Oral Paste kills important internal parasites, including tapeworms, bots and
    the arterial stages of S. vulgaris, with a single dose. EQUIMAX Oral Paste contains two potent antiparasitic agents that are neither
    benzimidazoles nor organophosphates.

  • SAFETY

    EQUIMAX Oral Paste may be used in horses 4 weeks of age and older. Stallions and breeding, pregnant or lactating mares
    may be treated without adverse effects on fertility.

    In a tolerance study in which 3- to 4-week-old foals were treated at 10X once, loose watery stools were observed on
    post-treatment days 1, 2, and 5-9 in one foal. These signs resolved without treatment by day 10, and no other foals were affected.

    In a reproductive safety study, eleven mares were treated with a 3X dose of EQUIMAX Oral Paste every two weeks throughout
    breeding, pregnancy and lactation, up until the foal was three months of age. Ten mares served as controls and were treated with the
    vehicle paste in a similar manner. An increased incidence of colic was observed in treated mares as compared to control mares. In
    addition, elevations of GGT and AST were more frequent in the 3X treated mares, and in two mares these enzymes were elevated at the
    time of colic episodes.

    One treated mare was dropped from the study because she did not conceive after three breeding attempts.

    Two treated mares had abnormally short diestrous periods of two days and eight days on the first estrous cycle following the birth of
    the study foal. In addition, one of these two mares failed to ovulate in the second and third estrous cycles.

    In the first few weeks of life, foals born to the 3X treated mares had a higher incidence of transient ocular discharge and gastrointestinal
    disturbances (loose stools, diarrhea) and depression requiring medical intervention as compared to foals born to control mares.

  • PRECAUTIONS

    EQUIMAX Oral Paste has been formulated specifically for use in horses and ponies only. This product should not be used in other animal species as severe adverse reactions, including fatalities in dogs, may result.

  • WARNING

    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. Refrain from eating or smoking when handling. Wash hands after use. Avoid contact with eyes. The Safety Data Sheet (SDS) contains more detailed occupational safety information. To report adverse reactions in users, to obtain more information, or to obtain a SDS, contact Bimeda Inc. at 1-888-524-6332.

  • ENVIRONMENTAL WARNINGS

    Ivermectin and excreted ivermectin residues may adversely affect aquatic organisms. Do not contaminate ground or surface water. Dispose of the syringe in an approved landfill or by incineration.

    POST APPROVAL EXPERIENCE

    (Rev. 2010): The following adverse events are based on post-approval adverse drug experience reporting with Equimax. Not all adverse reactions are reported to FDA CVM. It is not always possible to reliably estimate the adverse event frequency or establish a causal relationship to product exposure using these data. 

    The following adverse events are listed in decreasing order of reporting frequency: Abdominal pain, diarrhea, depression/lethargy
    and anorexia.

    To report side effects, call Bimeda Inc. at 1-888-524-6332. For additional information about reporting side effects for animal drugs,
    contact FDA at 1-888-FDA-VETS or www.fda.gov/reportanimalae.

    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 geographical 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.

    STORAGE

    Store at room temperature (25°C/77°F), with excursions permitted between 15°–30°C (59°–86°F).

  • NOTE TO USER

    Swelling and itching reactions after treatment with ivermectin paste have occurred in horses carrying heavy infections of neck threadworm (Onchocerca sp. microfilariae). These reactions were most likely the result of microfilariae dying in large numbers. Symptomatic treatment may be advisable. Consult your veterinarian should any such reactions occur. Healing of summer sores involving extensive tissue changes may require other appropriate therapy in conjunction with treatment with EQUIMAX Oral Paste. Reinfection, and measures for its prevention, should also be considered. Consult your veterinarian if the condition does not improve.

    To report adverse reactions, call Bimeda Inc. at 1-888-524-6332.

  • SPL UNCLASSIFIED SECTION

    Approved by FDA under NADA # 141-215

    Manufactured by:
    Virbac AH Inc.
    P.O. Box 162059
    Fort Worth, TX 76161

    Made in USA

    Equimax is a Registered Trademark of Virbac SA.
    301985-03
    Rev 02/20

    Distributed by:
    Bimeda, Inc.
    Le Sueur, MN 56058

  • EQUIMAX carton

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  • EQUIMAX syringe

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  • INGREDIENTS AND APPEARANCE
    EQUIMAX 
    ivermectin and praziquantel paste
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:61133-7000
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ivermectin (UNII: 8883YP2R6D) (ivermectin - UNII:8883YP2R6D) ivermectin200 ug
    praziquantel (UNII: 6490C9U457) (praziquantel - UNII:6490C9U457) praziquantel1.5 mg
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorAPPLEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61133-7000-11 in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA14121501/14/2010
    Labeler - Bimeda, Inc. (060492923)