Label: EQUIMAX- ivermectin and praziquantel paste
- NDC Code(s): 61133-7000-1
- Packager: Bimeda, Inc.
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Animal Drug Application
Updated August 21, 2020
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- GENERAL PRECAUTIONS
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:
Large Strongyles (adults)
Strongylus vulgaris (also early forms in blood vessels)
S. edentatus (also tissue stages)
Small Strongyles (adults, including those resistant to some benzimidazole class compounds)
Small Strongyles (fourth-stage larvae)
Pinworms (adults and fourth-stage larvae)
Ascarids (adults and third- and fourth-stage larvae)
Large-mouth Stomach Worms (adults)
Bots (oral and gastric stages)
Lungworms (adults and fourth-stage larvae)
Intestinal Threadworms (adults)
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.
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.
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.
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
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.
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.
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
- EQUIMAX carton
- EQUIMAX syringe
INGREDIENTS AND APPEARANCE
ivermectin and praziquantel paste
Product Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:61133-7000 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ivermectin (UNII: 8883YP2R6D) (ivermectin - UNII:8883YP2R6D) ivermectin 200 ug praziquantel (UNII: 6490C9U457) (praziquantel - UNII:6490C9U457) praziquantel 1.5 mg Product Characteristics Color WHITE Score Shape Size Flavor APPLE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61133-7000-1 1 in 1 CARTON Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA141215 01/14/2010 Labeler - Bimeda, Inc. (060492923)